# Presentation: 514537

##  III. STAGE OF DISEASE

** ****III. STAGE OF DISEASE**
**TNM and Collaborative Staging**

**Notes:**
This section of advanced abstracting for gynecologic cancers discusses the TNM and FIGO staging of gynecologic cancers, as well as Collaborative Staging for the various GYN sites.

## AJCC TNM Stage

**T, N and M based on extent of cancer**
**Stage groupings based on prognosis**
**Evidence based**
**Correlated with ****FIGO**** **

**Notes:**
Most of you are familiar with what T (tumor), N (regional nodes) and M (distant spread of metastases) stand for.  You probably also understand that stage of disease correlates with extent of involvement. The TNM components are grouped into stages based on prognosis. Defining staging elements and how they are grouped is evidence-based.  That doesn’t mean the definitions and stage groupings are non-controversial or that they won’t be “improved” with every new AJCC edition.  Our understanding of cancer progression—and consequently our staging manuals—is always changing.

AJCC TNM staging is based on the older FIGO staging, which is well-known to gynecologists.  FIGO stages are listed adjacent to T, N, and M staging components and stage groupings in the AJCC manual.

## AJCC Staging: Benefit

**Strict criteria allow comparisons of cases**
**With similar characteristics**
**Among facilities**
**Over time**
**Preferred staging for clinical research**

**Notes:**
Strict AJCC staging criteria allow tumors to be compared fairly accurately among facilities, research organizations, and even countries.  Research facilities are more likely to insist that AJCC pathological and clinical staging be assigned using the strict AJCC TNM rules.  This allows them to compare stages over time.  AJCC staging is the preferred staging system for describing cancer cases in clinical research studies.

## AJCC Staging: Disadvantages

**Restrictions of staging criteria frequently prevent assigning stages to some tumors**
**Changes in new editions of staging criteria limit comparisons over time**

**Notes:**
AJCC TNM staging has limitations, some of them caused by its strict criteria for staging. For example, status of regional lymph nodes is difficult to determine clinically for GYN cancers.  Since many sites are treated with radiation and or chemotherapy, regional nodes are not always examined pathologically. An unknown lymph node status can result in both clinical and pathological unknown AJCC stages, even when the physician is fairly certain of the overall stage. 

## AJCC Staging: Documentation

**AJCC staging by managing physicians required by CoC for approved programs**
**Registrars should also determine AJCC stage independently**
**Helpful in resolving discrepancies between assigned and derived AJCC stages**
**Facilitates QA **
**May be saved on separate field in abstract **

**Notes:**
AJCC TNM stage is derived in the Collaborative Staging (CS) process when individual data items describing a specific tumor are entered. Physicians at CoC-approved programs are required to also document AJCC TNM stage in the patient chart.  Registries at CoC approved cancer programs collect physician-assigned TNM staging in addition to Collaborative Stage data items. The managing physician’s assigned staging is recorded exactly the way the physician documented it. Previously, registrars or the registry software could add stage group in the registry database if the physician had provided T, N and M components. Per CoC I & R item 20937 (1/18/07), this is no longer allowed. The reason is that CS derived staging now provides a complete stage for the abstract.

Physicians are currently required to document one complete stage, either pathologic or clinical.  If the physician assigns only one AJCC stage, the registrar may assign the other in the cancer registry database. Registrars may also assign and enter both AJCC stages in a text or user-defined field as a reference for facilitating QA and resolving discrepancies.  Make sure the “staged by” field accurately reflects who assigned each stage.

Even if you don’t actually assign AJCC stage yourself, understanding the various staging schemes will help you assess stage of disease, both assigned and derived AJCC.  If there is an inconsistency, staging the case yourself will help you understand which is probably correct. To resolve a discrepancy, first review the data elements you collected.  The CS algorithm is only as accurate as the data you give it. If you and the derived stage agree, following up with the physician is the next step.

Understanding TNM is especially important if you are one of those registrars physicians call on for advice on TNM staging. Cancer registrars are often thought of as the staging gurus at healthcare facilities.  That’s a nice reputation to have—and keep.

## Sixth Edition Changes in TNM

**Major change: addition of scoring risk factors for GTT**
**Text descriptions clarified**

**Notes:**
The AJCC Cancer Staging Manual, 6th edition, has been out for a few years, but the changes in gestational trophoblastic tumor staging may not have been noticed because the tumors are so rare. The changes were significant. They introduced the concept of scoring risk factors to modify stage of disease and support more accurate determinations of prognosis (shown on next slide).  Other than GTT and some clarifications of some text descriptions, the 6th edition is not much different from 5th edition for GYN cases.

## Staging GTT

**Clinical and pathologic not discussed**
**Prognosis dependant on risk factors**
**T category **
**T1 = Confined to uterus**
**T2 = Other GYN by mets or direct extension**
**No regional nodes (N)**
**M category**
**M1a = lung mets**
**M1b = all other distant mets**

**Notes:**
Per AJCC, the usual anatomic staging system doesn’t reflect prognosis for GTT.  Clinical and pathological staging designations aren’t discussed in the chapter, but the GTT staging form does have columns for recording both clinical and pathological stage. The AJCC staging manual, p. 294, mentions many of the standard methods of clinically evaluating stage, including histological diagnosis, CXR, CT and MRI for brain mets. General criteria for clinical and pathological staging are on page 5 of the manual. Use the information prior to definitive treatment to assign a clinical stage. If the primary has been completely resected with negative margins or sufficient tissue has been examined to establish the highest T category (T2), then pathological stage can be assigned. A positive biopsy of the vagina would prove pT2 disease.  A D&C is not a complete resection and is not definitive treatment for choriocarcinoma.  Information from a D&C would contribute to clinical staging. If the D&C found choriocarcinoma and a hysterectomy followed that had clear margins, a pathological stage could be assigned. In the absence of an N category, you need only a pathological T and clinical evaluation of distant sites for pathological staging. A positive biopsy of any lymph node or distant site is sufficient for a pathological stage 4.
GTT is highly treatable with chemotherapy. Cure rates approach 100%. The brain and liver are not as susceptible to chemotherapy. Disease in those sites has a poorer prognosis. Although the GTT chapter in the AJCC manual discusses non-malignant and malignant GTT, you are only required to collect GTT with a behavior code of “3” in ICDO-3. 
Prognosis for GTT is based mainly on a set of risk factors.  The T and M categories are very simple. There is no N category. All nodes are distant (M1b). M1 (without an “a” or “b”) exists in the table of distant mets but is not in any of the stage groups. When a combination is not in the table of stage groups, stage is unknown (99). 
T1 tumors are confined to the uterus. T2 tumors involve other GYN structures either by discontinuous mets or direct extension. Any further extension is distant disease. M1 is used when it’s not known which distant organs are involved. M1a means only the lungs have distant disease. M1b means other distant sites are involved. 

(A table of the risk factors is on the next slide. A slide on how levels of risk affect treatment of GTT is located in the treatment section of this presentation.)

## GTT Risk Scoring Table

| Prognostic Factor | 0 | 1 | 2 | 4 |
| --- | --- | --- | --- | --- |
| Age | < 40 | > 40 |  |  |
| Prior pregnancy | Mole | Abort | Term |  |
| Mo. from pregnancy | < 4 | 4- <7 | 7- 12 | > 12 |
| Pre-tx hCG level | < 103 | 103 - < 104 | 104 - < 105 |  >105 |
| Largest tumor (cm) | < 3 | 3 - < 5 | > 5 |  |
| Site of metastasis | Lung | Spleen, Kidney | GI Tract | Brain, Liver |
| Number of mets |  | 1-4 | 5-8 | > 8 |

**Seven  risk factors are included on the table below. **
**Previous failed chemotherapy was omitted for lack of space**

***Note: Score of 7 or less is low risk; score of 8 or more is high risk***

**Notes:**
This table was adapted from Table 32.1 Prognostic Scoring Index, AJCC Cancer Staging Manual, 6th ed., p. 295.

The table shows how prognostic risk factors are calculated to determine if a patient is low risk, with a score of 7 or less, or high risk, with a score of 8 or more.  Low-risk patients are usually treated with single-agent chemo. High-risk patients are usually treated with combination drugs. 

The eighth factor, previous failed chemotherapy, was omitted for lack of space.  The table is sufficient to show how the scoring works. Each major stage grouping (stages I, II, III, and IV) uses a staging suffix “A” for low-risk patients, a staging suffix “B” for high-risk patients and no suffix when risk score is unknown.

The key for the sites of metastases row:
0 – lung
1 – spleen & kidney
2 – GI tract
4 – brain  & liver
(There is no risk score 3 in the AJCC table.)

## SEER Summary Stage

**Required  by central registries**
**Used for historical comparisons**
**Simpler concepts than TNM**
**Applicable to more tumors than TNM**
**May not correlate with TNM **
**Derived by CS algorithm **

**Notes:**
SEER Summary Stage, required by NPCR central registries, has practical uses. It can be used for historical comparisons of data, since it does not change frequently like other staging systems. Physicians and other healthcare professionals often use the terms local, regional and distant to describe a cancer. Since summary stages are simpler in concept than AJCC, they are useful in providing a quick, simple statement of how far the cancer has spread.  Sometimes a GYN cancer is an unknown stage in AJCC but the extent of disease can be described in more general terms using Summary Stage. And not every tumor has an AJCC staging schema. An example is a uterine sarcoma, which cannot be staged in AJCC but can be staged using the summary stage schema. 

The SEER SS schemas may help you interpret the other systems.  For example, if you are not sure if a lymph node is regional or distant because you couldn’t find it named in one staging manual, another staging manual may list it.  Caution must be used, however, because the various staging systems are not completely equivalent.  If a cancer seems to be an early stage in one system and an advanced stage in another system, review the case to confirm extent of disease wasn’t misinterpreted in one of the systems. 

Knowing the different staging systems can help you select the most accurate codes for Collaborative Staging data fields.  The derived AJCC and SEER Summary Stages help you assess the accuracy of assigned stages.  However, when there is an apparent conflict or ambiguity between assigned and derived stages in an abstract, use the Collaborative Staging Manual guidelines for entering Collaborative Staging data items. Don’t second guess the data to try to get a preconceived answer.

## SEER Summary Stages

**0**** Non-invasive**
**1**** Local**
**   ****Regional**
**2**** By direct extension**
**3**** By regional LN involvement**
**4**** By direct extension and LN involvement**
**5**** Regional, NOS**
**7**** Distant**
**9**** Unknown stage**

**Notes:**
This is just a quick reminder of all the stages in the SEER Summary Staging System. When they are derived from Collaborative Staging data items, you should know what they mean and whether they fit the GYN cancer you are evaluating.  If the summary stage doesn’t seem to fit, then it’s best to review the codes in the Collaborative Staging fields again.

## Collaborative Staging (CS)

**Collects **
**Basic elements used for staging**
**How coding elements assessed: clinically or pathologically**
**Derives **
**Mixed or “best” stage **
**TNM and Summary stages**
**Algorithm can be changed as needed**

**Notes:**
Collaborative Staging (CS) resolves several major problems inherent with other staging systems.  By collecting the basic tumor facts used to stage a case, CS is flexible for the future.  If other staging systems add staging categories, CS can also easily add them without changing what is already there. When other staging systems changed their definitions for a certain stage, it was almost impossible before CS to restage previous data.  Because CS collects the basic facts and derives final stage using an algorithm, it can restage previous data simply by changing the algorithm. 

CS also addresses tumors that can’t be staged when using strict AJCC criteria. For researchers, this may be an acceptable result of precise staging.  For practicing clinicians, it’s impractical for supporting treatment decisions or describing patient populations. CS comes to the rescue and allows mixing of the most accurate clinical and pathological information to derive a very practical and accurate description of the stage of the tumor, sometimes called the “best” stage available for that tumor.

## CS Logical Assumptions

**If status of regional nodes not mentioned, but treatment is appropriate for local disease, assume nodes not involved**
**If status of regional nodes not mentioned, but primary lesion is in situ, assume nodes not involved.**
**If status of distant metastases not mentioned but treatment is appropriate for local disease, assume no distant mets**

**Notes:**
In deriving stage of disease, Collaborative Staging allows some practical and logical assumptions based on how physicians practice.  Physicians tend to not schedule tests if they think the results will be negative. They also tend to report positive findings but not negative findings.

For example, (because some GYN sites are inaccessible) when neither physical exam nor CT scans mentions regional lymph nodes and treatment is standard for local disease, registrars can assume nodes are negative for the purpose of CS.  If there is reason to believe the cancer may have spread, regional nodes should be coded as unknown.

By definition, in situ lesions have not spread beyond the organ of origin.  If regional nodes aren’t mentioned, assume they are not involved.  However, if the primary lesion is in situ and regional nodes are diagnosed as involved, then regional nodes can be recorded as positive and the extension is no longer in situ.  The assumption is that an area of invasion was missed. 

If distant metastases are not mentioned but treatment is appropriate for local disease, assume there are no distant mets.  Assume no mets also if the physician assigns a tumor stage that is appropriate only when there is no distant disease and there is no contradictory documentation.

## CS Cautions: GYN

**Some histologies have their own schema**
**Lymphoma**
**Kaposi’s sarcoma**
**Skin of vulva**
**Melanoma uses melanoma schema**
**Mycosis fungoides and Sezary disease use their own schema**
**Other “skin” histologies use vulva schema**
**GTT of non-placenta site uses schema for site**

**Notes:**
Some histologies have their own CS schemas. Lymphomas of any site use the CS lymphoma schema.  Kaposi sarcoma of any site uses the Kaposi schema.  Kaposi is usually a skin malignancy but does occasionally arise in a non-skin site.

Skin of the vulva uses the vulva CS schema with a few exceptions.  Melanoma of the vulva uses the melanoma schema.  Mycosis fungoides and Sezary disease of the skin of the vulva use their own schemas. All other histologies occurring in the skin of the vulva use the vulva schema.

Gestational trophoblastic tumors may occasionally arise in a non-placenta site, for example ovary. If the physician indicates a non-placenta site of a GTT tumor, use the CS schema for that site. For a placenta site, use the CS placenta schema. AJCC TNM staging follows this same rule.

## Other GYN CS Schemas

**Specified sites (C57.1-C57.4)**
**Broad and round ligaments**
**Parametrium**
**Uterine adnexa**
**Other and unspecified sites (C57.7-C57.9)**
**Other specified sites not previously named**
**Overlapping lesion of GYN organs**
**Female genital tract, NOS**

**Notes:**
Collaborative staging has two staging schemas for GYN cancers that don’t fit in the schemas for the major GYN sites.  One covers specified sites that only rarely develop cancers. 
The broad ligament is a sheet of folded peritoneum that attaches to the posterior surface of the uterus and uterine adnexa, the pelvic sidewalls and the bottom of the pelvic cavity to provide support to the uterus and GYN organs.
The parametrium is the serosa that covers the corpus.
The uterine adnexa are the fallopian tubes and the ovaries.  If a primary site of cancer is described only as adnexa, use this staging schema.

The second CS schema is for other female genital sites not previously specified for CS schemas and, more importantly, for lesions that involve more than one GYN site and a specific site of origin cannot be established.  This schema is used also for GYN, NOS, when no primary site is established but the tumor is thought to have a GYN origin. 

## CS Evaluation: Size/Extension

**Evaluation based on...**
**0 ****	****Clinical information only**
**1**** ****	****Clinical and biopsy and/or surgical observations**
**2**** ****	****Autopsy (cancer suspected/dx’d prior to death)**
**3 ****	****Resection without pre-operative treatment**
**5 ****	****Pre-op tx, coding based on clinical information**
**6**** ****	****Pre-op tx, coding based on pathological information**
**8**** ****	****Autopsy (cancer not suspected prior to death)**
**9 ****	****Unknown if done, not documented**

**Notes:**
The Evaluation fields document how primary site extension, lymph node involvement and distant mets were determined.  They follow a similar pattern for all sites.  The Collaborative Staging System (CS) determines if a staging component is clinical or pathological based on the evaluation data items.  If invasive techniques were limited to incisional biopsies and/or observations during surgery, the staging information is clinical.  Endoscopies of cervix or uterus are evaluation code 1 even without biopsies because endoscopy is an invasive procedure.
Note that code 5 is based on evaluation when the patient has pre-operative treatment, but the evaluation itself was based on clinical information known prior to the start of any treatment.  CS requires recording the most extensive disease, which is sometimes prior to resection.  For example, record the clinical tumor size if larger than the pathologic tumor size after neoadjuvant chemotherapy shrank the tumor.
Code 6 is the same situation of neoadjuvant treatment, but the pathological tumor size was used either because it was larger than the pre-treatment size or because the clinical size was unknown.

## CS Evaluation: LNs and Mets

**Codes 5, 6 similar to TS/Ext Eval**
**Lymph nodes**
**Code 1 states FNA instead of biopsy**
**At least one LN must be “removed” to use code 3**
**Mets**
**Code 1 excludes any biopsy**
**Code 3 requires only tissue be examined**

**Notes:**
The Evaluation fields are slightly different for lymph nodes and metastases. 
Code 1 for lymph nodes (clinical evaluation using invasive techniques) omits the word biopsy and includes only FNA for tissue examination.  The other invasive techniques, such as endoscopy, are the same. 
Code 3 (pathological evaluation) for lymph nodes requires the removal and examination of at least one node. 
Code 1 (clinical evaluation) for evaluating metastases excludes any tissue examination. Endoscopy and other invasive techniques are the same.
Code 3 (pathological evaluation) requires only that metastatic tissue be microscopically examined.  Biopsies were not included with code 1 because biopsies are sufficient to evaluate metastatic sites.
Definitions for the remaining codes are pretty much the same as used for evaluating primary site size and extent.

## CS Extension

**Extension of the primary site**
**Note: Code as “local” if in situ lesion with involved lymph nodes**
**Direct extension into adjacent organs**
**Ovarian cancer – discontinuous  extension**
**Farthest extension clinical or pathological**

**Notes:**
The purpose of the CS Extension field is to record how far the primary-site tumor directly extends. In the unlikely event of an in situ lesion with positive regional nodes, use the code for localized, NOS.  

The corpus uteri, ovary and fallopian tube extension fields are exceptions to the usual rules for CS Extension.  All three have codes for discontinuous extension, including peritoneal implants on pelvic and abdominal organs.  Positive peritoneal washings and ascites are also included in these extension codes.

CS requires that the farthest extension of tumor be coded.  If neoadjuvant therapy shrinks tumor from tissues that were clinically positive, the farthest clinical extension should be coded.  The extension evaluation code would be 5 (surgical resection performed with pre-surgical systemic therapy and tumor extension based on clinical evidence).

## CS Lymph Nodes

**Terms that mean clinical LN involvement**
**Fixed or matted**
**Mass in node bearing area**
**LNs may be regional or distant depending on GYN site**
**GTT placenta – no regional LNs**
**Code farthest LNs even if clinical **

**Notes:**
Terms like lymphadenopathy, enlarged nodes or palpable are not evidence of lymph node involvement unless there is also a statement by a physician that the nodes are involved. Terms such as fixed, matted or mass in retroperitoneum or mesentery are acceptable as evidence of nodal involvement.  Since some GYN sites are inaccessible and few regional nodes are palpable, some of these terms would also be used as evidence of distant metastases.

GYN sites do not all have the same primary lymph node drainage pattern.  Inguinal and femoral nodes are regional for the vulva and lower third of the vagina, but all pelvic nodes are distant.  Pelvic nodes are regional for the upper two-thirds of the vagina, but para-aortic nodes are distant. Para-aortic nodes are also distant for cervix uteri but regional for corpus uteri.  The placenta has no regional nodes; all nodes are distant.  Confirming whether involved nodes are distant or regional for specific GYN sites will be important for ensuring accurate data. Use your manuals.

Collaborative staging requires using clinical and pathological information to code the farthest extent of regional node spread.  If neoadjuvant therapy makes some nodes negative that were clinically positive, code node involvement for the farthest clinically involved nodes and enter code 5 for CS regional node method of evaluation. 

## CS Mets at Dx

**Code farthest metastases**
**Disregard metastases arising after dx**
**Code mets 00 **
**If treatment standard for early stage disease**
**If MD stage does not indicate mets**

**Notes:**
Use the numerically highest code that applies in the CS Mets at Dx table for the site, whether the mets were clinically or pathologically diagnosed. If mets resolved with neoadjuvant therapy, code the clinical extent.

If it is known that metastases developed after the diagnosis was made, this represents progression of disease and should be disregarded in the CS fields. 

If no mets are identified and treatment is appropriate for early stage disease, code mets as 00 (no mets) rather than 99 (unknown if mets). Also code mets as 00 if the physician assigns a stage that indicates there was no distant spread of disease.

## CS Site-Specific Factors

**None applicable for most GYN sites**
**SSF 1 applicable for two sites**
**Ovary – CA-125 testing**
**Placenta – low/high risk score**
**SSF 2 – 6 are not used for any GYN site**
**Code as 888**

**Notes:**
Site specific factor 1 applies to just two GYN sites: ovary and placenta.  No other site specific factors apply to any GYN sites. Site-specific Factor 1 asks for information on CA-125 tumor marker for ovarian cancers.  For GTT, Site-specific Factor 1 asks for results of risk scoring of GTT tumors of the placenta. A table for calculating risk scores is included in the chapter on gestational trophoblastic tumors in the AJCC Cancer Staging Manual, 6th ed. and in the placenta section of the CS Manual.

## CS Valuable for QA

**Compare CS derived TNM stage to TNM stage assigned by MD**
**Caution: **
**CS mixes clinical and pathological**
**Assigned TNM must be one or the other**
**Check your work first**
**Work with MD to resolve differences**

**Notes:**
Collaborative Staging (CS) derived stages are valuable for doing quality assurance (QA) on physicians’ assigned stages and on the registrar’s selection of CS data items.  However, there are some guidelines you should follow:
When comparing derived TNM stage to assigned TNM, remember that derived stages are often a mix of clinical and pathological components.  Assigned TNM staging must still follow rules for pure clinical and pure pathological stages. If there is a difference, the difference could be the result of mixing clinical and pathological elements to get the derived stage. If so, there is no error.
If there is a discrepancy, check the individual CS data items entered.  An incorrect code could make a big difference in the derived stage.  If the difference is your error, correct the error and compare stages again.
If there is an actual discrepancy between the physician’s assigned stage and the derived stage, work with the physician to resolve the differences. Be diplomatic and your discussion should be a learning experience for both you and your physician.

## “Fixing” Collaborative Stages

**Don’t change data just to get a match**
**If CS stage unexpected, look for reasons**
**Review stages in appropriate manuals**
**Review each CS data item you entered**
**Change data ****ONLY**** if a true error **

**Notes:**
This cautionary slide is here because registrars have been known to make changes in their codes just to make the derived stage come out “right”; in other words, to make the derived stage match the physician’s stage or satisfy an edit check.
Don’t assume your data is wrong.  Avoid “fixing” CS data items just to get a match.
Again, sometimes the difference between an assigned stage and a derived stage is due to CS being able to mix clinical and pathological staging components.  This is another reason for being familiar with AJCC TNM staging guidelines and SEER summary staging as well as Collaborative Staging.

Suggested procedure:
When derived CS stage is not what was expected, look for reasons
Review the AJCC and/or Seer Summary staging manuals 
Review accuracy of each CS data item you entered
Only after finding an actual error should any data be changed

## CS Manual Updates

**Examples:**
**CS Mets at Dx**
**Tumor size for multifocal primary**
**Clarifications**
**Use the correct version of all manuals**

**Notes:**
The Collaborative Staging Manual has been updated several times since the original manual was published.  The updates may include changes to some of the data items and/or clarifications.  This slide lists three examples from the Version 1.03 updates.
Manuals are updated every year and clarifications are published whenever necessary within the year.  Make sure that you are always using the correct version of all manuals.

## CS Update: Mets at Dx

**Code Mets at Dx as 00 when treatment is appropriate for early-stage disease**
**Code Mets at Dx as 99 when reason to doubt tumor is localized**

**Notes:**
This update was covered earlier.  Code Mets at Dx as 00 instead of 99 when the treatment given is appropriate for early stage disease. Code Mets at Dx as 99 if there is reason to doubt that the tumor is localized. Doubts regarding local disease could be the result of an ambiguous CT, a large primary tumor, elevated tumor markers or doubts expressed by the physician. 

## CS Update: Multi-focal

**Do not add several foci or tumors together to get size **
**Use largest focus of a multifocal tumor to determine tumor size**
**Use largest tumor to determine tumor size when multiple tumors are being reported as a single primary**

**Notes:**
These were also covered earlier in the discussion on tumor size. Do not add pieces of tumor to get size. Use the largest focus of a multifocal tumor as tumor size. Use the size of the largest tumor for tumor size when multiple tumors are reported as a single primary.

## CS Update: Clarifications

**Tumor size note revision: for incisional bx, code 999 in absence of clinical size**
**Core biopsy was added to aspiration for regional LN positive and regional LN examined code 95**
**Phrasing was clarified in several areas**

**Notes:**
Some of the changes in version 1.03 of the Collaborative Staging Manual were just clarifications and are mentioned here because the list of changes looks long at first glance.

##  IV. TREATMENT

** ****IV. TREATMENT**

**Notes:**
This section of advanced abstracting for gynecologic cancers discusses treatment of various gynecologic cancers as well as Collaborative Staging for the various GYN sites.

## Treatment Issues

**Determining timing of therapy**
**Initial therapy**
**Subsequent therapy**
**Deciding how much data to collect**
**Basic required data set**
**Extended data set**
**Additional special data items**

**Notes:**
Besides recording what types of treatment were provided, the two biggest issues for cancer registries are figuring out which treatments are initial therapy and how much data to collect. Sometimes it isn’t very clear when treatment becomes subsequent.  Sometimes it becomes a matter of setting policies for your registry on how to handle certain ambiguous situations.

Registries always face the problem of how much data to collect.  That’s why software vendors include additional data items in their abstract and supply a number of data fields that can be defined by the user.

## Treatment: First Course

**Initial plan of therapy**
**Best chance for cure**
**Best chance for long-term control**
**Frequently an algorithm**

**Notes:**
By definition, first-course therapy is the initial plan for treating a patient after a diagnosis of cancer is established.  Treatment in the context of this presentation is therapy directed at removing, controlling, destroying or modifying an area of proliferating malignant cells. A decision not to treat is also a treatment option according to registry guidelines. The first and only course of treatment could be palliative.

The initial plan of therapy is the clinician’s best attempt at cure or long-term survival.  If these are not thought possible because of the medical condition of the patient or the extent of the cancer, then the initial plan may be directed at palliation and maintenance of quality of life.

Determining first-course of therapy used to be simple.  Some of you may remember the guideline that first-course therapy was all treatment initiated in the first four months after diagnosis.  Now first-course therapy is an algorithm with changes in therapy implemented based on every newly discovered characteristic of the cancer.  With inaccessible GYN sites, whether surgical resection is done may depend on what is found during surgical exploration. For example, the plan to do a D&C for a gestational trophoblastic tumor may include the option of a total hysterectomy and chemotherapy if the D&C is unable to remove all the tumor or if choriocarcinoma is found in the specimen.

## End of First Course Treatment

**Completion of initial plan **
**Note: ****Ovarian Ca may include a 2****nd**** surgery**
**Cancer progresses on treatment**
**Therapy changed to other type Modality not in initial algorithm**
**Drug with different type of activity**

**Notes:**
Knowing when first-course therapy ends is an important question, not only for accuracy and completeness of data collection, but also because some registries do not collect subsequent therapy.

First-course therapy ends when the initial plan of treatment is completed and the cancer has not recurred or progressed.  Treatment for ovarian cancer is often surgery followed by chemotherapy, followed a year or so afterwards by a second-look laparotomy. Once the second surgery is done, the plan is completed.

First-course therapy ends when the cancer progresses, but common sense must apply.  Example: The plan to treat a cervical cancer with lymph node metastases may be to excise the cervical lesion and then treat the lymph nodes with radiation therapy.  After surgery, when the patient presents for radiation, the node metastases are found to have progressed.  The radiation isn’t subsequent treatment; it was part of the planned first course.  However, if the nodes had progressed on chemotherapy, that would indicate failure of the chemotherapy to control the disease and any additional treatment would be subsequent.

First-course therapy is over when the treatment is changed to another type. If the modality wasn’t in the original plan and especially if the cancer hasn’t responded, then further therapy is no longer first-course.

## Treatment: Subsequent

**Begins after first course ends**
**Not included in initial treatment algorithm**
**A planned change in treatment is not  subsequent treatment**
**Subsequent treatment may still result in cure**

**Notes:**
Subsequent therapy begins when  first course treatment ends. The separation between first course and subsequent isn’t always clearly defined. If cancer recurs after a disease-free interval, the therapy for the recurrence is clearly subsequent treatment.  However, the lines become blurred, usually in late-stage cases, when subsequent therapy starts before the documented initial treatment plan is completed or when changes in treatment occur and there’s no documentation that the cancer has progressed.

Looking at some specific situations on the following slides may help:

(Presenter should press ”enter” on the keyboard when ready for the answer on the following slides. The correct answer should fade in on the slide. Other triggers may work)

A change to subsequent treatment because the initial plan doesn’t work as expected can still result in a cure.  A cervical cancer could recur locally after limited surgery and radiation therapy.  A hysterectomy  as subsequent therapy may still offer a high chance of cure.

## Q. 1: Is it subsequent treatment?

**The radiation oncologist had planned to use photons to treat lymph nodes but decided to use electrons instead.**
**No, it is still first-course**

**Notes:**
(Press enter when ready for answer to appear)

It’s still first-course if the radiation oncologist decides to use electrons instead of photons to radiate regional lymph nodes. They are both external beam and the cancer has not progressed.

## Q. 2: Is it subsequent treatment?

**Chemo was changed from one type, Platinol, to another type, Taxol, because the patient didn’t respond as much as expected.**
**Yes, treatment is subsequent**

**Notes:**
(Press enter when ready for answer to appear)

Treatment is subsequent when chemotherapy is changed from one type of chemo drug to another because the cancer didn’t respond as much as expected.  

Recommendation: Check the SEER*Rx drug subcategory field for type of chemotherapy.  SEER*Rx can be downloaded free from the SEER web page www.seer.cancer.gov/seerrx. Web site is on slide during chemo section later.

## Q. 3: Is it subsequent treatment?

**The surgeon had planned a local excision but the cancer extended deeper than expected and she had  to do a reexcision to get clear margins.**
**No, it is still first-course**

**Notes:**
(Press enter when ready for answer to appear)

It’s still first-course if the surgeon has to do a more extensive surgery than first planned in order to get negative margins. The more extensive surgery wasn’t specifically planned, but it was always a consideration in the physician’s mind and part of the treatment algorithm.

## Amount of Data: Basic

**Required (basic) data set**
**NPCR-required data set**
**COC Approved programs require additional data**
**OK for facilities with minimum data needs**
**Still provides useful and interesting graphs**

**Notes:**
The amount of treatment data required by state registries might differ from state to state. Each state registry could require data items additional to the NPCR data set.  Facilities must comply because state laws mandate reporting of cancer in all states. The Commission on Cancer requires additional treatment data as defined in FORDS. Collecting only the basic, required data sets is fine for facilities that have minimum data needs.  The required data sets provide enough data to create statistical graphs and tables interesting and useful to physicians, administrators, and other staff.

## Amount of Data: Extended

**Used by research and teaching facilities**
**Support higher outcomes data demand**
**Common non required data items**
**Names of drugs and regimens**
**Types of radioisotopes**
**Family history of cancer **

**Notes:**
Research and teaching health care facilities might extend the required data set with additional data items because of a greater emphasis on outcomes information beyond the end-of-life survival studies that are standard for all registries. State registries could be involved in patterns of care studies that require additional data items. Some community health care facilities desire an expanded data set that helps them plan, evaluate, and assign resources more effectively.  As a cancer registrar, you might identify areas where additional data might be useful to your facility.  Sometimes cancer registry data are not well utilized simply because no one realizes the quantity and types of data collected.

Common types of data collected in addition to the required data set include the names of chemotherapy regimens, hormone drugs, and drugs used in clinical trials.  Additional dates might be collected for all types of systemic therapy, instead of just one date for the start of systemic therapy, NOS. A simple field for family history of cancer might be collected, or a group of fields might collect more detailed information such as the type of cancer in a family member and relationship to patient. 

## Amount of Data: Special Data Items

**Collected for a specific purpose**
**Track surgical populations over time**
**Evaluate a unique service or procedure**
**Collected for a limited time**
**Special studies**
**Track usage of new equipment**

**Notes:**
Special data items might be collected for a specific purpose or for a limited time.  What information does your facility need? What will it potentially need in the future?  You could be the person to suggest additional data items to your facility.  

Is your facility concerned because it is not attracting cancer patients in minority groups?  In addition to collecting race and ethnicity, you might want to also collect and retain the county where the patient resided at the time they came to your facility.  You already collect address at diagnosis and current address, but these could be different from where the patient lived when they first came to your facility. This is especially true of non analytic patients, but even analytic patients might have been diagnosed away from home.  

Does your facility perform any new or unique procedures?  An example of new or unique procedures a few years ago was sentinel node biopsies. Identify the procedure in a user-defined field.  Compare numbers of patients using the unique or new procedure to numbers of patients who had a more standard procedure. Run reports comparing outcomes between the groups.
Special items might be needed for a study.  Discontinue collection of special fields when the study is complete. Perhaps your facility wants to know how many patients have been treated with radioactive microspheres for liver mets. The radiology department can possibly provide the raw number of patients, but it is doubtful they could break them out by county of residence, gender, stage of disease, and disease-free survival.

## Surgery

**Many GYN sites require surgery**
**Extent of surgery depends on stage**
**Intent of surgery depends on stage**
**Often part of multi-modality treatment**

**Notes:**
Standard therapies for most GYN cancers typically include some type of surgical procedure. The extent of the surgery depends on the extent of the cancer. A small tumor can be removed with an excisional biopsy, a minimally invasive tumor with a D&C.  A large tumor might require more extensive surgery.  Cancer that has spread to regional nodes might require lymph node dissection.  

The purpose of the surgery also depends on the extent of the cancer.  Most cervical cancers are diagnosed at a very early stage and the purpose of surgery is for cure.  If the cancer is advanced, the purpose could be palliation or debulking.

Cancer treatment for several GYN sites is often multi-modality.  Surgery is the foundation, but treatment can routinely include radiation and some type of systemic therapy. Some late-stage cases may be treated with non surgical modalities only. 

## Radiation Therapy	

**Adjuvant**
**Neoadjuvant**
**Brachytherapy**
**Intracavitary**
**Interstitial**
**Primary**

**Notes:**
Adjuvant and neoadjuvant radiation therapy are terms related to the timing of the radiation procedure.  Neo-adjuvant occurs prior to surgery. Adjuvant occurs after surgery. 

Brachytherapy involves placing a radioactive source in close proximity to the tissues being treated. Brachytherapy is frequently used to treat GYN cancers. There are two main types. 
Intracavitary is the most common type of brachytherapy for GYN cancers. A radiation source is placed inside the vagina, cervix, or corpus uteri, organs which have natural body cavities. 
Interstitial is brachytherapy that is inserted into tissue. Vaginal cancer is sometimes treated with interstitial brachytherapy.

Primary radiation therapy is radiation used alone or with chemotherapy as the main treatment procedure. No definitive surgery is done before or after primary radiation therapy.  It’s not uncommon to have adjuvant brachytherapy after primary radiation therapy.  

## Chemotherapy

**Adjuvant**
**Neoadjuvant**
**Both **

- Image source: National Cancer Institute

**Taxol Molecule**

**Notes:**
Chemotherapy has a major role in some GYN cancers, specifically ovarian, fallopian tube, and GTT.  It is also used for advanced cancers of the other GYN sites. Adjuvant therapy is given after surgery. Neoadjuvant therapy is given before surgery in an effort to reduce the tumor to a size that can be resected. Occasionally, chemotherapy is given both before and after surgery for the same cancer.

Source of instant information on cancer treatment drugs is provided on next slide.

## SEER*Rx Interactive Drug Database

**Excellent source of chemo information**
**Download free from SEER**
**http://seer.cancer.gov/tools/seerrx**
**Keep on desktop for quick access**

## Hormone Therapy

**Little used in GYN cancers**
**Caution: do not code estrogen replacement as hormonal treatment**

**Notes:**
Per NCCN uterine treatment guidelines, hormone therapy is recommended for late-stage endometrial cancer with distant metastases and recurrent disease. This is the only situation among GYN cancers when hormone therapy is standard treatment.  Because of the extensive surgery that sometimes removes most of the female genital organs, estrogen replacement therapy is sometimes prescribed. Registrars should be careful not to get the two uses of hormones confused. Estrogen replacement therapy is not cancer treatment. 

## Treatment: Vulva

**Localized**
**Wide excision for early malignancies **
**Radical vulvectomy with bilateral lymph node dissection (LND) or RT to nodes**
**Regional**** **
**Radical vulvectomy with bilateral LND**
**Primary RT with or without chemotherapy**
**Distant**
**Radical vulvectomy and pelvic exenteration **
**Neo-adjuvant or adjuvant RT with or without chemotherapy**

**Notes:**
Per NCI Cancer Topics: 
VIN III, in situ and minimally invasive vulvar lesions are treated with conservative surgery, but watched carefully for recurrence.  Fortunately, most vulvar lesions are discovered while still at an early stage. If invasion is deeper into vulvar tissues, radical vulvectomy can be performed along with inguinal and femoral bilateral node dissections. Disfigurement is minimized by dissecting the lymph node chains through separate incisions. Research is currently underway to see if sentinel lymph node mapping and biopsy might be appropriate for vulvar cancers. There is some evidence that radiation therapy is as effective as node dissections for controlling lymph node involvement.

Vulvar cancers with regional spread to tissues or nodes are treated with radical vulvectomy and bilateral node dissections. If surgery is contraindicated, primary radiation therapy with or without chemotherapy has shown some long-term survivals. 

Late-stage vulvar cancers could require pelvic exenteration (all involved pelvic organs removed) in conjunction with neo-adjuvant radiation or adjuvant radiation.  Again, chemotherapy might or might not be used.  

## Treatment: Vagina

**In situ and VAIN III**
**Laser therapy or intravaginal chemo**
**Localized**
**Surgery or brachytherapy or intravaginal chemo**
**Regional**
**Brachytherapy and external beam radiation therapy (EBRT)**
**Distant**
**Brachytherapy and EBRT**

**Notes:**
Per NCI Cancer Topics: 
For VAIN or in situ lesions, there are several options, including wide local excision, laser therapy, partial or total vaginectomy, intracavitary brachytherapy, and intravaginal chemotherapy. 

Superficially invasive squamous cell carcinomas are usually treated with wide local excision or total vaginectomy depending on the extent and location of the cancer. Narrow margins or a lower vaginal site might require adjuvant external beam radiation therapy (EBRT). Another option is intracavitary brachytherapy.  Bulkier lesions might require external beam radiation therapy. Adenocarcinomas have a tendency to be more aggressive, and consequently are treated like deeply invasive lesions.

Lesions that have invaded more deeply are treated with radical vaginectomy and regional node dissection. Narrow margins might require adjuvant radiation therapy. Another option is combination interstitial and intracavitary brachytherapy.  EBRT is used when there is a risk of regional node involvement. Adenocarcinomas are more likely to get combination surgery plus interstitial brachytherapy.

For regional-stage vaginal cancers, brachytherapy and external beam to the vagina and nodes is standard. An alternative is radical vaginectomy or pelvic exenteration with bilateral node dissections, and possibly adjuvant radiation. When extension includes the pelvic wall or nodes, surgery is less likely. Instead, combination radiation therapy of interstitial, intracavitary, and external beam is used.

Distant vaginal cancers are usually treated with interstitial and intracavitary radiation, plus external beam radiation. Surgery is rarely done. 

## Treatment: Cervix

**In situ lesions and minimal invasion**
**Limited surgery**
**Localized**
**Radical hysterectomy with or without LND**
**Intracavitary brachytherapy**
**Regional**
**Brachytherapy and EBRT and chemo**
**Distant**
**Brachytherapy and EBRT and chemo**

**Notes:**
Per NCI Cancer Topics:
In situ and minimally invasive cervical cancer (up to 3 mm) can be treated effectively with surgery, such as cold-knife conization, LEEP, laser therapy, cryotherapy or total hysterectomy. Surgical decisions are based on depth of invasion. When surgery is contraindicated for medical reasons, intracavitary brachytherapy is another option. Localized tumors that have invaded deeper into the wall of the cervix require more extensive surgery, specifically radical hysterectomy and pelvic node dissection. 

Treatments for regional spread outside of the cervix or regional node involvement range from radical hysterectomy and lymph node dissection for minimal regional disease to combination therapy of intracavitary brachytherapy plus external beam radiation, which might be followed by chemotherapy for more extensive spread or bulkier tumors. 

Late-stage cervical cancer still confined to the pelvis is treated like regional cervical cancer except that the radiation could be more extensive and the chemotherapy more intense. Cervical cancer with distant spread outside the pelvis might receive palliative radiation to the primary and/or distant mets with or without chemotherapy.

## Treatment: Endometrium

**Localized**
**TAH-BSO with or without adjuvant EBRT**
**Neoadjuvant brachytherapy and EBRT with TAH-BSO for deeper or high-grade tumors**
**Regional**
**Surgery and adjuvant EBRT**
**Intracavitary brachytherapy and EBRT**
**Distant**
**Pelvic tumor – Intracavitary brachytherapy and EBRT**
**Distant mets – hormone therapy**

**Notes:**
Per NCI Cancer Topics: 
Early low grade endometrial cancer can be treated with hysterectomy alone with good results. When invasion is greater than 50% of the myometrium, the cell type is high grade or there is a concern for regional node involvement, adjuvant external radiation with or without node dissection could be done. For local tumors that have invaded deeper into the myometrium, treatment could be neoadjuvant brachytherapy followed by external beam radiation and TAH-BSO.

Patients with regional spread usually have two options:  (1) total hysterectomy and bilateral salpingo-oophorectomy with adjuvant external radiation, or (2) intracavitary brachytherapy and external beam radiation followed by TAH-BSO. 

Distant disease that is confined to the pelvis is treated with intracavitary brachytherapy and external beam. When the disease has distant metastases outside the pelvis, palliative chemotherapy could be helpful.  Clinical trials should be considered for all advanced endometrial cancers.  NCCN clinical practice guidelines also suggest hormone therapy, usually with progestational agents, for metastatic endometrial cancer.

## Treatment: Sarcoma of Corpus

**Localized**
**TAH-BSO and lymphadenectomy and adjuvant pelvic RT**
**TAH-BSO and adjuvant chemotherapy**
**EBRT alone**
**Regional**
**Same as for localized but with resection of all gross disease**
**Distant**
**Clinical trials (no standard therapy)**

**Notes:**
Per NCI Cancer Topics: 
Uterine sarcomas are very aggressive. Even when confined to the muscular wall or endometrial stroma, TAH-BSO is recommended along with selective lymphadenectomy to confirm that nodes are negative. Adding adjuvant radiation or chemo are other options.

Treatment of regional sarcomas is essentially the same as for localized sarcomas, with the addition of further surgery to resect all gross disease.

There is no standard therapy for late-stage sarcomas of the corpus. Clinical trials are strongly recommended. Per NCCN treatment guidelines, hormone therapy with or without radiation is an option for late-stage, low-grade endometrial stromal sarcomas (different hormone agents than those used for late-stage endometrial carcinomas). Chemotherapy with or without radiation is an option for other late-stage uterine sarcomas, including high-grade endometrial stromal tumors.  Ifosfamide is the most active agent against carcinosarcomas and doxorubicin is the most active against leiomyosarcomas.  Realistically, any chemo that has activity against soft tissue sarcomas could have activity against uterine sarcomas.

## Treatment: Ovary

**Localized**
**TAH-BSO or TAH-USO and omentectomy**
**Exploration of peritoneal cavity**
**Regional**
**TAH-BSO, omentectomy, cytoreduction and intraperitoneal chemotherapy**
**Intraperitoneal radioisotope or EBRT**
**Distant**
**TAH-BSO, omentectomy, cytoreduction, debulking and chemotherapy**

**Notes:**
Per NCI Cancer Topics: 
Ovarian cancer is seldom found while still localized. When it does happen, treatment is usually surgery alone.  If only one ovary is involved, the other healthy ovary could be left for women of childbearing age. Otherwise, TAH-BSO with omentectomy is fairly standard. At the time of surgery, exploration of the peritoneal cavity should be performed to confirm that there is no regional or distant spread.

Ovarian cancer that has spread to the peritoneal cavity requires radical hysterectomy and BSO, as well as cytoreduction of any pelvic implants or other tumors to < 1 cm. Surgery is then followed by chemotherapy. Recent evidence has indicated greater benefit with intraperitoneal chemotherapy for optimally debulked tumors and is now recommended over systemic chemo for ovarian cancer limited to the peritoneal cavity.  An alternative is intraperitoneal radioisotope or external beam radiation.

Distant-stage ovarian cancer (mets outside the peritoneal cavity) requires extensive surgery including radical hysterectomy and BSO, omentectomy, cytoreduction, debulking, and adjuvant chemotherapy. Systemic chemo is still recommended as the standard for this stage, but intraperitoneal chemo is an option. 

## Prophylactic OophorectomyHigh-Risk Patients

**Code the surgery only if removed at same time as involved ovary**
**Ovaries removed as preventive measure**
**Unilateral or bilateral**
**Not involved with cancer**
**Slight risk of primary peritoneal carcinoma**

**Notes:**
A prophylactic oophorectomy is the removal of an uninvolved ovary for the purpose of eliminating the risk for a high-risk patient of getting ovarian cancer. High-risk patients are those who have a strong family history of ovarian cancer or who are identified as being high risk through genetic counseling.  Patients might choose to have bilateral salpingo-oophorectomy (BSO) before ovarian cancer has occurred. 

A unilateral salpingo-oophorectomy (USO) is usually performed when a patient is diagnosed with early-stage ovarian cancer in one ovary.  The patient might choose to have the uninvolved ovary removed at the same time.  Code the surgery as a bilateral salpingo-oophorectomy. There are no codes for collecting information on prophylactic BSO because neither ovary is involved with cancer at the time of the surgery. 

Even after both ovaries are removed, there is still a 1% - 2% risk of developing primary peritoneal carcinoma (AJCC Staging Manual, chapter on ovarian cancer). The histology, pattern of spread and treatment are similar to ovarian cancer.

Reminder: primary peritoneal carcinoma is coded to C48.1, peritoneum.

## Treatment: GTT

**Local**
**Single-agent chemotherapy**
**TAH an option**
**Metastatic—low-risk score**
**Single-agent chemotherapy**
**TAH and single-agent chemotherapy**
**Metastatic—high-risk score**
**Multi-agent chemotherapy and radiation to CNS mets (if any)**

**Notes:**
Per NCI Cancer Topics: 
GTT is highly sensitive to chemotherapy and curable even when it has spread to distant sites. Hydatidiform moles are 100% curable.  When confined to the uterus, D & C or hysterectomy both offer potential cure. The choice is usually based on whether the patient still wants to bear children. About 20% will also require chemotherapy. Cancer registries are not required to collect hydatidiform mole cases.

Non-mole malignant GTT tumors, such as choriocarcinoma, are also highly  curable with chemotherapy although not quite 100%. Choriocarcinomas are very aggressive and metastasize early. Even when metastatic at diagnosis, the risk scores are the main determinants of treatment. If the risk score is low – seven or less – single-agent chemotherapy is usually given.  An alternative would be hysterectomy and single-agent chemotherapy.

When the risk score is eight or higher, multi-agent chemo is given.  Chemotherapy is not as effective in treating metastases to the brain or liver, either of which indicate a poorer prognosis.  Radiation can be used to treat brain mets, but radiation is not effective in treating liver metastases.

## Palliative Care

**Intended to relieve symptoms**
**May use cancer-treatment modalities**
**Surgery**
**Radiation**
**Chemotherapy**
**May require coding in more than one  data field**
**Code pain management only in palliative care field**

**Notes:**
Palliative care is provided when the cancer is incurable or when the patient is too debilitated to tolerate definitive treatment.  The goal of palliative care is to optimize quality of life and the comfort of the patient.  

Palliative therapies for GYN cancers include surgery, radiation and chemotherapy.  These treatments, when provided for palliation, must be coded both as palliative care and in the appropriate treatment fields. They not only control pain and other symptoms, but also work directly on cancer cells. For example, radiation for bone metastases targets cancer cells in bones for the purpose of reducing pain. This procedure would be coded to palliative radiation in the palliative care fields and would also be coded under radiation therapy in the treatment fields. Pain management procedures that don’t involve these types of palliative, cancer-directed treatments are coded only in palliative care. 

Registries might consider collecting hospice care as a special user-defined data field for palliative care. 

##  V. FOLLOW-UP AND OUTCOMES

** ****V. FOLLOW-UP AND OUTCOMES**

**Notes:**
This final section of advanced abstracting for GYN cancers discusses registry follow-up procedures, and anticipated data needs to serve the facility and the central registry.

## Follow-up

**Plan ahead**
**Anticipate future health care needs**
**Collect contact information**
**Anticipate data needs**
**Determine amount of data to collect**

**Notes:**
Planning for follow-up while you are abstracting might take a little more abstracting time, but it will save much more time later when following those patients.  Anticipate checking for incomplete treatment.  Write notes about anticipated care the patient might need in the future. Taking time for this extra step is more justified and practical for patients who are diagnosed with extensive disease.  

Anticipate data needs that will depend on follow-up information. Needing data to calculate survival is obvious, but there are other measures of outcome your facility or medical staff might be interested in.  Determine up front the amount of data you will collect at follow-up. 

Data accuracy is also important for follow-up.  Having the correct social security numbers and dates of birth are vital for future lookups. Always check name, SSN, sex, race, DOB, etc., entered on the admissions screens with what is documented within the actual patient record. Try to check discrepancies against a third information source.  Dates of birth are on drivers licenses that are often scanned into the record for insurance purposes.  Scanned patient signatures will give you the correct spelling of patient names.

## Plan Follow-up

**Set up follow-up when abstracting**
**Identify likely contacts**
**Collect list of helpful Web sites **
**Make notes in abstract**

**Notes:**
Steps in planning ahead include:
 Enter correct zip codes to facilitate auto-letter generation for follow-up, even if you have to look them up yourself.
 Collect the following types of useful Web sites and add them to your favorites file:
Social Security death index
U.S.P.S. zip code site
Property tax collector’s site
Physician locator for your state
 Collect complete contact information
Note any communication difficulties in talking to the patient or patient’s family (e.g., hard of hearing, doesn’t speak English.)
Also document any contacts that should not be contacted again and the reason.
 Record the method you used to get the last contact information.
 Enter the best method for getting information on the next follow-up.
Record notes with information that might impact the next follow up (“Patient is planning to move to Wisconsin”.)

## Collect Follow-up Contacts

**Complete patient address**
**Spouse name and work number**
**Identify healthcare surrogate**
**Other family**
**Other contacts**

**Notes:**
Have a complete and current address and phone number for the patient; check for a new address whenever you use a new admission for follow up.
If the patient has more than one residence, collect contact information for all.
Add the spouse’s name and work number to your contact file.
Identify the patient’s health care surrogate. This saves time if you know you can discuss the patient’s cancer, per HIPAA guidelines.  A health care surrogate can be formally identified on a signed legal form or a health care surrogate can be implied, if they accompany the patient to appointments and talk to the doctor along with the patient.
Add family members to your contact file, but remember being family doesn’t automatically make them health care surrogates.
Add other contacts who might keep track of the patient, like friends and neighbors.
Document any contacts that are no longer relevant or were not cooperative – so that you will not contact them again.
Don't forget to document how to contact your central or state cancer registry; they usually provide facilities with death lists, or your CCR can provide info for current address or names of other facilities who see the patient.

## Protect Patients’ Privacy

**HIPAA requirements**
**Facility’s privacy policy**
**Be careful**
**Watch what you say and to whom**
**Fax rather than email**

**Notes:**
Take steps to protect your patients privacy because it is the right thing to do; and because HIPAA says do it or else.

Be familiar with HIPAA privacy rules.
Know and follow your own facility’s privacy policies.
Don’t leave protected health information on a patient’s voicemail. 
Don’t mention a patient’s diagnosis to a friend or family member unless you are sure the patient identified that person as someone who can have that information.  Just because a patient lists their next door neighbor as an emergency contact on their hospital admittance form, doesn’t mean that person has permission to get or give medical information on the patient. The neighbor could be listed because they provide transportation for the patient or take care of the patient’s children. 
Don’t email patient information; faxing is much more secure.
Handle your patients’ medical information as you would want your own medical information handled.

## Health Care Contacts

**Following physicians**
**Other facilities that treated patient**
**Home health care agencies if appropriate**
**Hospice if appropriate**

**Notes:**
Collect contact information for the following:
The health care professionals that interact with your patient
Referring and following physicians
Treating physicians, especially physicians that are not on your facility’s medical staff.
Other facilities that treated the patient, including the cancer registrar’s name.
Home health care agencies (if the patient was referred to one).
Hospice, if the patient was referred to one.

## Anticipate Data Needs

**Survival and outcomes studies**
**Recurrences**
**Requirements for CoC approval**
**Your facility’s needs**

**Notes:**
Anticipate data needs for the future.
What data will you need to calculate survivals?
What type of outcomes studies can you expect to be asked for?
What types of data will your facility need?
Last, but not least, what outcomes data are required by your state and national standard setters (i.e., the Commission on Cancer and SEER)?
If you haven’t planned ahead and set up your contacts, how are you going to collect the following required data?
Date of first recurrence
Type of first recurrence
Current date of last contact 
Vital status 
Cancer status

You aren’t the only one using your data.  Data are collected by other agencies who depend on your outcomes data to make decisions about where to focus cancer care and cancer research.

## Amount of Data to Collect

**Abstract now for data requests**
**Determine data needs**
**Facility**
**Physicians**
**Research**
**Determine amount of data to meet needs**

**Notes:**
This is the same question discussed previously, but now apply it to follow-up data.  Abstract now for the data requests you will get later.  Be accurate with what you enter now and anticipate future data needs for your facility, staff physicians, and research (at whatever level your facility participates).  Determine, too, the amount and type of data needed to meet your needs.

Some examples of using follow-up data:
Studies of Stage 4 cases usually aren’t particular about whether the patient was Stage 4 when they first came to your facility or advanced to Stage 4 while you are following them. You won’t be able to track current stage for all the patients you are following, but those you can identify may be appropriate for this type study.
Your facility might treat a high number of Class 3 patients. Physicians could be interested in studying the effectiveness of subsequent therapies for a particular site. Your facility might want to track costs related to subsequent therapies and resources to assess upgrading services or equipment. Often only the registry can identify when a therapy is subsequent.
Sometimes the useful information is as simple as knowing how many of the patients who got first-course therapy at your facility returned for subsequent care at your facility if and when the cancer recurred.
Marketing and business development departments might be interested in data that identifies and defines the cancer patient populations receiving care at your facility. They can target those populations with marketing campaigns and development of services that best meet the needs of those populations.

If the data for these types of analyses were not recorded, the analyses could not be done and the services less likely to be provided.  Know the cancer data needs of your facility. 

## Facility Data Needs

**Cancer site distributions**
**Top cancer sites**
**Trends over time**
**Demographic distributions**

**Notes:**
Some common requests by administrators and staff in a community hospital include distributions of cancer sites seen at the facility, distributions of demographics (i.e., gender, age, race, ethnicity, zip code), the top cancer sites and trends over time (any cancer site increasing or decreasing in  numbers of cases more than expected).  Note in the pie chart that only five sites account for approximately 2/3 of all cancer patients. 

This information (five sites = 2/3 of all patients) directs resource needs and could indicate additional marketing of services for other cancers or perhaps an expansion to include services for other cancers.  Central cancer registries can provide you with data concerning the incidence of cancers, national, state and county, for comparison to the distribution of your top 5 sites.  NCDB data allow you to compare your facility to others in the same CoC Cancer Program Category.

## Physician Data Needs

**Number of certain procedures**
**Numbers of cancers by GYN site**
**Outcomes on certain therapies**
**Outcomes on certain stages**
**Other**

**Notes:**
Staff physicians want to know what kinds of procedures are being done at their facility.  When they discover you collect patient procedures done at other facilities, they might want to know if there is a pattern of patients going elsewhere for a particular procedure.  For example, although your facility has a good radiation therapy center, are patients having a hysterectomy at your facility and then going elsewhere for adjuvant radiation therapy? Decisions to acquire new RT and robotic surgical equipment, etc. are based in part on this type of information. 

Physicians could ask for the outcomes on certain stages or certain therapies.  Outcomes can include readmissions, recurrences, disease-free intervals and lifetime survivals as well as other information. Some of the data fields added to new editions of cancer registry data collection manuals are a result of physicians asking for these data.

## Research Data Needs

**Know what data your facility needs**
**Teaching hospitals do research**
**Hospitals participate in clinical trials**
**Studies required for CoC-approval**
**Special studies not limited to your facility**

**Notes:**
What research data does your facility need? Teaching hospitals do research. Community hospitals may participate in clinical trials. Some smaller hospitals may refer patients to other facilities for clinical trials but still want to track them. Any facility can do retrospective studies on cancer registry data. CoC-approved facilities are required to do studies of quality and outcomes and most cancer program categories are required to accrue patients to clinical trials. Studies may be prospective or retrospective.  

State registries and NCDB might use your data for special studies. Discuss data needs with your cancer program director and your cancer committee to determine current and future data collection needs for your facility.  Let them know the types of data you can provide. Registries that do annual cancer reports publish their data.  Annual reports are an effective way to make your registry and the types of data you collect visible to the administrative and medical staff at your facility.

The important point here is that others are using your data, making accuracy and timeliness of reporting extremely important.

## Recurrences

**Used for calculating disease-free survival**
**Per MPH rules, GYN cancers more than one year apart are multiple primaries **
**New occurrences within one year are same primary **
**Assumes same site or metastatic site**
**Assumes same histology and behavior**

**Notes:**
The date when a recurrence was diagnosed is important. The recurrence date establishes the length of the disease-free survival.  If the recurrence wasn’t diagnosed at your facility, it could be difficult establishing an accurate date. Your registry should have a policy on either estimating recurrence dates or using unknown values (i.e., 99/99/9999).  

The multiple primary and histology rules require that cancers of the same GYN site and same histology diagnosed more than one year apart are different primary cancers, even if the physician calls it a recurrence.  The old rule was to assume a new primary after two months, unless the physician called it a recurrence. A GYN cancer occurring one year or more later may be called a recurrence, but there must be documentation that a pathologist reviewed tissue from both tumors (current and original) and stated they were the same cancer.

GYN cancers diagnosed a year or less apart could be called a recurrence by a physician. The histologies must be the same, using the MPH Other Sites Table 2, pp. 79-80, and histology rules for determining single primaries. The site must be the same site, using the MPH Other Sites multiple primary rules, or a metastatic site.  

## Recurrences

**Invasive cancer following an in situ**
**MPH Other sites rule M18**
**Diagnosed within 60 days**
**Single invasive primary – one abstract**
**MPH Other sites rule M15**
**Diagnosed more than 60 days apart**
**Two primaries – two abstracts**
**	**

**Notes:**
Invasive GYN cancers that meet all the rules on the previous slide but follow an in situ cancer are single invasive primaries if diagnosed within 60 days (MPH Other Sites, Rule M18) and a separate primary if diagnosed more than 60 days later (MPH Other Sites, Rule M15). These were epidemiological decisions to ensure the inclusion of all invasive cancers in incidence data.

## Types of Recurrences

**Long list**
**First “match” may not be best match**
**Some specific to original behavior**
**Some specific to recurrence site**
**Check entire list until familiar w/ choices**

**Notes:**
You are also required to code the type of recurrence.  Become familiar with the long list of recurrence types. The first recurrence type you spot on the list that looks like a match may not be the most accurate. Check the entire list when you have a recurrence before selecting a code—at least until you become familiar with the choices. 

Per FORDS, cancers originally diagnosed as in situ tumors are coded to recurrences 06, 16, 17, 26, 27, 36, or 46. Note the definitions of these codes all include the phrase “recurrence of an in situ tumor.” Also note that you can record an invasive and even distant recurrence of an in situ tumor on the abstract of an in situ tumor.  You still need to abstract the invasive “recurrent” tumor as a new primary (previous slide).

Recurrence codes through Code 46 use general terms for sites of recurrence, such as local, regional, distant, etc. Codes 51 – 59 refer to specific sites of distant recurrence of invasive tumors only.  Use these when the only recurrence is to the distant site being described. Code 60 when an invasive tumor recurs to a single distant site described in Codes 51 – 59 and concurrently to a local or regional site (within two months). Code 62 when an invasive tumor recurs to more than one distant site described in Codes 51 – 59.

Codes 00, 70, 88 and 99 can be used for any cancer.

## Status at Last Contact

**Cancer status**
**Was cancer present at last contact?**
**Used to calculate disease-free survivals**
**Vital status**
**Was the patient alive or not?**
**Used to calculate life-time survivals**

**Notes:**
Along with recurrence information and the last contact date, vital status and cancer status are the most important data items you collect that allow you to calculate outcomes. Disease status at last contact is needed to calculate disease-free survival.  Vital status is required for calculating observed and relative life-time survivals. 

## Outcomes

**USE the data you’ve collected!**
**Outcomes studies are required by CoC**

**Notes:**
Even if your own facility is interested only in the minimum outcomes analyses to maintain Commission on Cancer approval status, your data goes to the larger state and national databases that will use it for analyses, allocating funds for research, providing information to improve public health, investigating disease clusters and hopefully finding a cure!

Sometimes it pays to become proactive in presenting data and not wait until it is specifically requested.

## QA Right Away

**Review as soon as you abstract**
**Did you enter what you thought?**
**Does it make sense?**
**Run edit checks**

**Notes:**
Cancer registries are required to have a plan for quality assurance of cancer registry data. The plan can include visual review or re-abstracting retroactively. Actually the best time to quality review your work is as soon as you finish the abstract. Check the data items subject to transpositions, such as SS # and DOB.  Check these while the chart is still open. Do quality review right away while the facts of the case are still fresh in your mind.  The main benefit is that the case is accurate before you close it, so you don’t have to revisit it later.

Can you code the case using the text that you’ve entered in the abstract? Does the abstract make sense? Is it logical? Have you documented any unusual information, such as the 45 y/o male with prostate cancer? Documented where you received additional information outside the facility?  This is very important for COC survey reviews of abstracts and questions from anyone about the quality of the information. Did you accidentally enter typos, or did you enter what you meant to enter.  Quality reports should be run often to scan for discrepancies, for example, tumor size versus stage of disease.  Run computer program edit checks.

When you tabulate data for a study, look for outliers (values out of range for the norm). An example would be a tumor size over 10 cm.  Maybe 10 mm was the actual size, or maybe 10 cm was really the actual size.  It’s worth checking the chart to be sure.  If you find a mistake in one case, do a QA report on that same field for all cases to ensure the error isn’t something done consistently. Run each year’s data through NAACCR and NCDB edits long before reporting the data.  That way mistakes are identified early, corrected and measures implemented to keep the same mistakes from happening again.

## Resources Used

***NCCN Clinical Practice Guidelines in Oncology*****, NCCN (**_**[nccn.org](http://nccn.org/)**_**)**
***Facts & Figures 2007 and Cancer Reference Information, *****American Cancer Society (**_**[www.cancer.org](http://www.cancer.org/)**_**)**
***Cancer Topics*****, National Cancer Institute (**_**[www.cancer.gov](http://www.cancer.gov/)**_**)**
***Cancer Stat Fact Sheets*****, SEER web site (****seer.cancer.gov/statfacts****) **
***SEER Self Instructional Manual for Cancer Registrars: Book Four, *****National Cancer Institute SEER Program**
***AJCC Cancer Staging Manual*****, 6****th**** ed., AJCC**
***FORDS*****, Commission on Cancer**
***ICD-O-3*****, World Health Organization**

**Notes:**
This presentation was compiled from a variety of sources.  You might be interested in reviewing some of these for further information.

## Additional Resources

**Images**
**A.D.A.M. Interactive Anatomy 4, A.D.A.M., Inc., 2004.  Used with licensed permission.**
***AJCC Cancer Staging Illustrations in PowerPoint***** from the AJCC Cancer Staging Atlas, sixth edition (2002). Springer-New York, 2007.  Used with permission.**

**Notes:**
These are some additional programs that provided pictures and information for this presentation.

## 

    The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.

**    ****The findings and conclusions in this presentation are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention.**

## For information about CDC’s  
Cancer Prevention and Control Programs
and the 
National Program of Cancer Registries

Please visit www.cdc.gov/cancer/npcr

**Cancer Prevention and Control Programs**
**and the **
**National Program of Cancer Registries**
**Please visit**_** **__**www.cdc.gov/cancer/npcr**_