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## Complete Summary

#### GUIDELINE TITLE

Management of stage I nonseminomatous testicular cancer: guideline
recommendations.

#### BIBLIOGRAPHIC SOURCE(S)

Hotte S, Mayhew LA, Jewett M, Chin E, Winquist E, Genitourinary Cancer
Disease Site Group. Management of stage I nonseminomatous testicular
cancer: guideline recommendations. Toronto (ON): Cancer Care Ontario
(CCO); 2008 Feb 14. 30 p. (Evidence-based series; no. 3-19). \[79
references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline,
over time will expand to contain new information emerging from their
reviewing and updating activities.

Please visit the [Cancer Care Ontario Web
site](http://www.cancercare.on.ca/pdf/pebc3-19f.pdf) for details on any
new evidence that has emerged and implications to the guidelines.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Stage I (CS I) nonseminomatous testicular cancer (NSGCT)

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Management\
Treatment

#### CLINICAL SPECIALTY

Oncology\
Radiation Oncology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To evaluate the optimal management of patients with clinical stage I (CS
I) nonseminomatous testicular cancer (NSGCT) after orchidectomy and
staging

#### TARGET POPULATION

Adults with clinical stage I (CS I) nonseminomatous testicular cancer
(NSGCT)

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Surveillance with computerized tomography scans (CTs) of the abdomen
    and pelvis and measurement of blood tumor markers

2.  Adjuvant chemotherapy with bleomycin, etoposide, and cisplatin (BEP)
    or other cisplatin-based regimen

3.  Retroperitoneal pelvic lymph node dissection (RPLND)

4.  Informing patients of risks and benefits of management options

#### MAJOR OUTCOMES CONSIDERED

-   Relapse-free survival

-   Cancer-specific survival

-   Overall survival

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**[Literature Search Strategy]{.underline}**

The MEDLINE and EMBASE databases were searched for evidence during the
month of May 2007 using the following text, medical subject headings
(MeSH), and Excerpta Medica tree terms: \'testicular neoplasms\',
\'testicular cancer\', \'neoplasms, germ cell and embryonal\',
\'germinoma\', \'dysgerminoma\', and \'germ cell tumo?r\'. The results
were combined with the terms \'lymph node excision\', \'plnd\', \'pelvic
lymph node dissection\', \'surveillance\', \'watchful waiting\',
\'wait-and-see\', \'chemotherapy\', and \'drug therapy\'. The search
results were limited to human studies published from 1981 through to May
2007. The complete MEDLINE and EMBASE search strategies are available in
Appendix A of the original guideline document. The proceedings of the
annual meeting of the American Society of Clinical Oncology (ASCO) were
hand searched for the years 1995 to 2007. The bibliographies of reports
were also searched for additional references.

**Selection Criteria**

*Inclusion Criteria*

Studies were selected for inclusion in the systematic review if they met
the following criteria:

[Patient Criteria]{.underline}

-   They included patients with clinical stage I nonseminomatous
    testicular cancer (CS I NSGCT) or a mixed seminoma/nonseminoma
    diagnosis.

-   They included patients who had multiple stages of NSGCT, but
    outcomes were reported separately for CS I patients.

-   They included seminoma patients, but outcomes were reported
    separately for CS I NSGCT patients.

[Patient Outcomes]{.underline}

-   They reported survival (10 years or greater), recurrence, toxicity
    and/or quality of life.

[Year of Publication]{.underline}

-   They were published from 1981 to present.

[Study Designs/Types]{.underline}

-   They were clinical practice guidelines, systematic reviews,
    randomized controlled trials (RCTs), or non-randomized prospective
    studies.

*Exclusion Criteria*

Studies were excluded if they:

-   Were published in languages other than English, because of a lack of
    translation resources

-   Were conducted in narrow patient groups (e.g., human
    immunodeficiency virus \[HIV\]+)

-   Examined radiotherapy, as it is no longer used in the treatment of
    NSGCT

References identified by the literature search were reviewed by three of
the authors. All references were reviewed initially by one author, but
where there was a question concerning inclusion, advice was sought from
two authors.

#### NUMBER OF SOURCE DOCUMENTS

Of the total 2934 references identified, 285 were obtained for full
review. Of those, 37 papers representing 32 unique reports met the
selection criteria and include eight clinical practice guidelines, one
systematic review, two randomized controlled trials (RCTs), and 21
non-randomized studies.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus (Committee)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis of Randomized Controlled Trials\
Review of Published Meta-Analyses\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Quality Appraisal of Clinical Practice Guidelines**

The Appraisal of Guidelines for Research & Evaluation (AGREE) tool was
used by two independent raters to evaluate the quality of all the
clinical practice guidelines identified by the literature search. While
all the AGREE tool domains were considered in the evaluation, the rigour
of development domain and the overall rating were considered to be most
relevant to this review.

**Synthesizing the Evidence**

A meta-analysis of overall and treatment-specific (i.e., type of
chemotherapy) recurrence rates, if appropriate, was planned. First, 0.5
was added to both the total number of recurrences and the total number
of patients for each study, to allow studies with zero recurrences to be
included in the meta-analysis. Then, a corrected recurrence proportion
was calculated as corrected total recurrences divided by corrected total
patients. This proportion was logit transformed, and the standard error
was calculated for the logit transformed proportion, as suggested by
Lipsey and Wilson and Brown (where *p* is the corrected proportion, *n*
the corrected number of patients, and L the transformed proportion):

*ES~l~* = log*~e~* \[*p*/1-*p*\]

and SE(L) the standard error:

*SE~l~* = sqrt \[(1/*np*) + (1/*n*(1-*p*))\]

The Generic Inverse Variance method of Review Manager 4.2 was used to
logit transform proportions. The resulting summary estimates and their
corresponding 95% confidence intervals (CI) were back-transformed into
proportions. The summary estimates were combined using a random effects
model. The meta-analysis results were assessed for heterogeneity by
calculating the Chi-square test for heterogeneity and the I^2^
percentage. A probability level for the Chi-square statistic of less
than or equal to 10% (p≤0.10) was considered indicative of statistical
heterogeneity, and I^2^ values of 25%, 50%, and 75% indicative of low,
moderate, and high degrees of heterogeneity, respectively.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

Few randomized controlled trials (RCTs) are available to inform
clinicians on the management of clinical stage I nonseminomatous
testicular cancer (CS I NSGCT). Guidelines based on expert opinion are
consistent in acknowledging the importance of microscopic vascular or
lymphatic invasion (MVI) as a prognostic factor and in stating that CS I
NSGCT can be managed with surveillance, adjuvant chemotherapy,
retroperitoneal pelvic lymph node dissection (RPLND), or combinations of
these approaches. It is generally agreed that all approaches ultimately
result in similar cancer cure rates. Cancer cure rates are excellent
regardless of the management option selected. Overall and disease-free
survival rates are over 95% for all management approaches, even though
recurrence rates are higher in the patients managed by surveillance.

To address the efficacy of adjuvant chemotherapy, a meta-analysis of
recurrence rate data from eligible trials was performed. These data must
be interpreted with caution, as a proportion of patients would be
expected to be cured by orchidectomy alone, and, by including them in
the calculation of recurrence rates, the true efficacy of chemotherapy
to eradicate micrometastatic disease is overestimated. The analysis also
does not account for differences in recurrence risk over time. While the
lack of statistical heterogeneity might imply a strong consistency among
the studies, it actually might more strongly reflect the fact that the
numbers of recurrences are very low in all the studies. Finally, there
are some limitations to the meta-analysis method used. First, the logit
method used to calculate the confidence intervals is a conservative one,
and likely overestimates these intervals. Second, the addition of 0.5 to
the number of recurrences and total patients, while necessary to perform
the meta-analysis, does inflate the resulting estimate of recurrence by
a small but not trivial amount, given the small number of recurrences. A
sensitivity analysis not reported here suggested that this inflation
might be in the order of 0.5%.

In this setting, clinicians expect adjuvant chemotherapy to provide at
least 95% efficacy in the eradication of micrometastatic disease. The
upper 95% confidence limits of the estimated recurrence rates exceed 5%
for all regimens reported. Closest to this benchmark are two cycles of
bleomycin, etoposide, and cisplatin (BEP) or cisplatin, vinblastine, and
bleomycin (PVB) with an upper confidence limit of 7%. The small numbers
of patients treated with each type of adjuvant approach certainly
accounts for much of this lack of precision; however, it must be
remembered that these estimates represent a \"best case\" scenario, and
inadequate antitumour efficacy cannot be ruled out. The limitations of
these data would support a default approach using three cycles of
adjuvant BEP, as this is considered adequate therapy for patients with
good prognosis metastatic NSGCT who are at higher risk of disease
recurrence compared to CS I patients. However, the case for two cycles
of adjuvant BEP is supported by the observation that two of the eight
recurrences in this group consisted of mature teratoma only. There is
also indirect evidence from another RCTl. Williams et al randomized 195
patients with PS II NSGCT to observation or two cycles of adjuvant BEP.
The relapse rate in observation patients was 49% compared to 6% in
patients treated with adjuvant chemotherapy. Five of the six recurrences
in the adjuvant chemotherapy arm occurred before adjuvant chemotherapy
was given. Evaluating only patients who received adjuvant chemotherapy,
the recurrence rate was 1.1% (95% confidence interval \[CI\], 0.15% to
7.31%). Based on these additional data, it was the consensus of the
Genitourinary Disease Site Group (GU DSG) that two cycles of BEP (with
etoposide 500 mg/m^2^/cycle) represented adequate adjuvant chemotherapy
in CS I NSGCT patients.

With respect to RPLND, because there is very little evidence concerning
its efficacy in CS I NSGCT patients, a recommendation cannot currently
be made. With respect to primary surveillance as a management option,
while surveillance regimes require much more rigorous follow-up than
does adjuvant treatment, including more frequent physician visits,
computerized tomography (CT) scans, chest x-rays, and serum tumour
marker tests, surveillance is generally associated with a lower level of
toxicity and has comparable cancer-specific survival. Alternatively,
some patients prefer adjuvant treatment, as they may find it difficult
to adhere to the strict follow-up regime required by surveillance, or
feel like they are waiting for a recurrence (\"sword of Damocles\"
syndrome).

As salvage chemotherapy is able to provide a cancer cure with prompt
detection of recurrence in virtually all patients, the Genitourinary
Disease Site Group (GU DSG) consensus was that all CS I NSGCT patients
be offered surveillance, provided they are considered appropriate for
this approach and do not prefer immediate adjuvant treatment. Although
not part of the scope of this review, there is evidence from a
randomized trial conducted in patients with metastatic disease showing
better survival rates among patients treated in multidisciplinary
centres of excellence compared to patients treated in community centres.
Therefore, it is suggested that primary surveillance be done in
collaboration with a cancer centre experienced in the treatment of
testicular cancer. The appropriate number of CT scans recommended with
primary surveillance is unclear, but two scans at three and 12 months
may be adequate in CS I patients without MVI. For patients who decline
or who are not candidates for surveillance, immediate adjuvant
chemotherapy with two cycles of BEP is recommended. RPLND may also be
considered for this subset of men, but its benefits as an alternative or
in addition to adjuvant chemotherapy are unclear. The philosophy
underpinning these recommendations is to avoid the overtreatment of men
cured by orchidectomy while maintaining the highest possible cancer cure
rate in those destined to experience a recurrence.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

**Development and Internal Review**

This evidence-based series was developed by the Genitourinary Disease
Site Group (GU DSG) of Cancer Care Ontario\'s Program in Evidence-based
Care (CCO\'s PEBC).

**External Review**

This guideline was reviewed in draft form at the 1st Canadian Germ Cell
Cancer Consensus Conference on October 19-20, 2007 in King City,
Ontario. Conference attendees consisted of 39 Canadian experts in the
field from eight different Canadian provinces (there were no attendees
from Prince Edward Island or Newfoundland). The attendees included 14
medical oncologists, 13 radiation oncologists, 11 urologists/urological
surgeons, and one pathologist. Also present were one nurse practitioner,
one radiation technician, one methodologist from the CCO\'s PEBC, two
invited expert physicians from the United States, two invited expert
physicians from Europe, three patients, and the mother of a patient who
had passed away from testicular cancer.

Conference attendees were given a presentation on the Ontario draft
guideline, as well as presentations on guidelines from Europe and the
United States. Conference attendees were given the opportunity to
discuss the different guidelines and ask questions of the presenters,
and were presented with paper copies of the guidelines. The following
day, attendees were asked to come to a consensus concerning
recommendations for treatment.

As the conference attendees included a majority of those who would be
approached for practitioner feedback, using the PEBC\'s standard
external review methods, no additional practitioner feedback was
solicited for this report beyond that obtained at the conference.

**Report Approval Panel Review**

The draft report was reviewed by the PEBC Report Approval Panel, which
consists of three members, including an oncologist, with expertise in
clinical and methodology issues.

This report reflects the integration of feedback obtained through the
external review process with final approval given by the Genitourinary
Disease Site Group and the Report Approval Panel of the PEBC.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

-   Patients should be made aware of all treatment options and the risks
    and benefits surrounding each of these options.

-   The consensus opinion of the Genitourinary Disease Site Group (GU
    DSG) is that primary surveillance is recommended for all patients
    with clinical stage I nonseminomatous testicular cancer (CS I
    NSGCT), with treatment at relapse. When a primary surveillance
    approach is adopted, patients should be informed of their estimated
    risk of recurrence and the need for frequent ongoing investigations,
    including blood tumour markers and computerised tomography (CT)
    scans of the abdomen and pelvis, to monitor for recurrence.

-   Patients with CS I NSGCT should be assessed and have management
    plans developed at multidisciplinary centres with experience in the
    treatment of testicular cancer.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by clinical practice guidelines, one
systematic review, randomized controlled trials (RCTs), and
non-randomized studies.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Eight clinical practice guidelines were reviewed and their
    recommendations for management of clinical stage I nonseminomatous
    testicular cancer (CS I NSGCT) compared.

    -   One guideline reported that consensus was not achieved. There
        was general agreement that adjuvant radiotherapy should not be
        used and that appropriate management options included primary
        surveillance, adjuvant chemotherapy, and retroperitoneal
        lymphadenectomy (RPLND).

    -   All the guidelines recognized the importance of the presence or
        absence of microscopic vascular or lymphatic invasion (MVI) in
        the primary tumour as a prognostic factor, and three recommended
        a risk-stratified approach to management based on this.

    -   For low-risk patients (MVI absent), all the guidelines
        recommended surveillance for patients considered appropriate and
        motivated for this approach. Some variability in recommended
        surveillance schedules was present.

    -   For high-risk patients (MVI present), three guidelines
        recommended adjuvant chemotherapy with two cycles of bleomycin,
        etoposide and cisplatin (BEP), three recommended primary
        surveillance, and three recommended adjuvant chemotherapy or
        RPLND.

    -   Five guidelines recommended that all patients be treated
        similarly regardless of risk factor.

-   There are no randomized controlled trials (RCTs) that compare the
    most relevant treatment options for the management of CS I NSGCT.

-   Two RCTs were identified that addressed the management of CS I
    NSGCT:

    -   In the trial of chemotherapy (one cycle of adjuvant BEP) versus
        RPLND, the authors concluded that, while BEP was more
        efficacious, the follow-up period was short, and
        generalizability to patients with high-risk features remained
        uncertain.

    -   In the trial of two computerized tomography (CT) scans versus
        five CT scans in primary surveillance, the authors concluded
        that the lower frequency of CT scans did not increase the risk
        of relapse among patients with poor-prognosis disease.

-   Twenty-one additional non-randomized studies were reviewed,
    including eight chemotherapy, 11 surveillance, and two RPLND
    studies, and three risk-adapted studies that reported findings for
    more than one treatment type. Patients managed by primary
    surveillance were found to have equivalent cancer-specific survival
    rates to those given adjuvant treatment.

-   Although not part of the focus of this report, a randomized trial
    conducted in patients with metastatic disease showed that patients
    treated in multidisciplinary centres of excellence had better
    survival rates than those treated in community centres.

#### POTENTIAL HARMS

Toxicities of treatment

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   As cancer cure rates appear equal with primary surveillance,
    adjuvant chemotherapy, and retroperitoneal lymphadenectomy (RPLND),
    patient preference with respect to the risk of recurrence and the
    timing and toxicities of treatment must be considered.

-   For patients who prefer immediate treatment, or who are unsuitable
    for primary surveillance, adjuvant chemotherapy with two cycles of
    bleomycin, etoposide (500 mg/m^2^/cycle), and cisplatin (BEP) is
    recommended.

-   Surgeons involved in the development of this guideline suggest RPLND
    may be a useful option for patients at high risk of relapse. There
    is currently not enough evidence from prospective trials to support
    or refute this position. Patients who undergo RPLND should have
    their surgery performed by surgeons who are experienced with the
    procedure. Otherwise, RPLND should be offered in the context of a
    clinical trial.

-   Patients with no clinical evidence of nonseminomatous testicular
    cancer (NSGCT) after orchidectomy other than persistently elevated
    or rising serum tumour markers should be considered for management
    as if they have metastatic disease.

-   Patients undergoing surveillance could be investigated with only two
    computerized tomography (CT) scans at three and 12 months.

-   Care has been taken in the preparation of the information contained
    in this report. Nonetheless, any person seeking to apply or consult
    the report is expected to use independent medical judgment in the
    context of individual clinical circumstances or seek out the
    supervision of a qualified clinician. Cancer Care Ontario makes no
    representation or guarantees of any kind whatsoever regarding the
    report content or use or application and disclaims any
    responsibility for its application or use in any way.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Hotte S, Mayhew LA, Jewett M, Chin E, Winquist E, Genitourinary Cancer
Disease Site Group. Management of stage I nonseminomatous testicular
cancer: guideline recommendations. Toronto (ON): Cancer Care Ontario
(CCO); 2008 Feb 14. 30 p. (Evidence-based series; no. 3-19). \[79
references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2008 Feb 14

#### GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency
\[Non-U.S.\]

#### GUIDELINE DEVELOPER COMMENT

The Program in Evidence-based Care (PEBC) is a Province of Ontario
initiative sponsored by Cancer Care Ontario and the Ontario Ministry of
Health and Long-Term Care.

#### SOURCE(S) OF FUNDING

Cancer Care Ontario\
Ontario Ministry of Health and Long-Term Care

#### GUIDELINE COMMITTEE

Provincial Genitourinary Cancer Disease Site Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

For a current list of past and present members, please see the [Cancer
Care Ontario Web
site](http://www.cancercare.on.ca/english/toolbox/qualityguidelines/diseasesite/genito-ebs/genito-dsg/).

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The authors of this guideline were asked to disclose potential conflicts
of interest relating to this systematic review and declared there were
none.

#### GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline,
over time will expand to contain new information emerging from their
reviewing and updating activities.

Please visit the [Cancer Care Ontario Web
site](http://www.cancercare.on.ca/pdf/pebc3-19f.pdf) for details on any
new evidence that has emerged and implications to the guidelines.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[Cancer Care Ontario Web
site](http://www.cancercare.on.ca/pdf/pebc3-19f.pdf).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Management of stage I nonseminomatous testicular cancer: guideline
    recommendations. Summary. Toronto (ON): Cancer Care Ontario (CCO),
    2008 Feb. 6 p. (Practice guideline; no. 3-19). Electronic copies:
    Available in Portable Document Format (PDF) from the [Cancer Care
    Ontario Web site](http://www.cancercare.on.ca/pdf/pebc3-19s.pdf).

-   Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni
    A, et al. The practice guidelines development cycle: a conceptual
    tool for practice guidelines development and implementation. J Clin
    Oncol 1995;13(2):502-12.

#### PATIENT RESOURCES

None available

#### NGC STATUS

This summary was completed by ECRI on July 16, 2008. The information was
verified by the guideline developer on August 20, 2008.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please refer to the
[Copyright and Disclaimer
Statements](http://www.cancercare.on.ca/ontariocancernews/copyright.html)
posted at the Program in Evidence-based Care section of the Cancer Care
Ontario Web site.

### DISCLAIMER

#### NGC DISCLAIMER

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008