bluuebunny/crossref_metadata_2025 huggingface dataset:
Objective assessment of sentinel node tumor burden and its impact on sentinel node localisation in breast cancer
Authors: Goyal A. , Douglas-Jones A. , Newcombe R. G. , Mansel R. E.
Published: March 2020

605

Background: Extensive tumor infiltration of the draining lymph nodes may prevent the migration of tracer to the sentinel node(SN), adversely affecting SN identification. Methods: A total of 202 breast cancer patients underwent SN biopsy using 99mTc albumin colloid and Patent Blue V injected peritumorally. This was followed by standard axillary clearance in all patients at the same operation. Tumor burden in the SN was assessed by measuring the size of metastasis, percentage replacement(PR) of the SN by tumor and by documenting extranodal invasion(EI). Digital images of the marked slides were acquired and measurements were made using Image Pro Plus software. Results: The overall SN identification rate was 94.6% (191/202), of which 5 were false negatives. Only 18% (2/11) of patients with failed SNB had evidence of nodal metastases on completion axillary clearance. A total of 83 positive SNs were removed from 64 patients. Radioisotope count in the SNs decreased with increasing PR of the SNs by tumor (p=0.005). 30% (24) of the nodes removed were not hot (counts<10 times the background count). The mean PR by tumor of these nodes was 55% (SD 36) as compared to 33% (SD 33) for hot nodes (p=0.009). 20% (16/81) of the positive SNs showed EI. 69% (11) of nodes with EI were not hot (radioisotope count ratio <10) and would not be localised if the radioisotope was used alone. SNs with EI had a lower radioisotope count compared to SNs without EI (p<0.0001). The mean PR by tumor of nodes with EI was 70% (SD 26) compared to 32% (SD 33) of nodes without EI. This shows that extranodal growth of the tumor would occur once the node is >50% replaced with tumor. There was no correlation between radioisotope uptake and size of metastasis in the SN. There was no correlation between blue dye uptake and tumor burden in the positive SN. Conclusion: In an individual SN, the PR by tumor and EI are markers of lymphatic obstruction and significantly associated with reduced radioisotope uptake. These results suggest that >50% replacement of the node by tumor will compromise the lymphatic flow and may lead to failed localisation of the node if the radioisotope is used alone. However, the SN tumor burden does not affect blue dye uptake. This result provides an argument for using a combination of blue dye and radioisotope for SN biopsy.

No significant financial relationships to disclose.
Adjuvant axillary radiotherapy for breast cancer: Is CT planning with nodal contouring better than traditional planning?
Authors: Chung C. , Keyes M. , Kwa W. , Weir L. , Parsons C.
Published: March 2020

606

Background: Historically, adjuvant radiotherapy planning for breast cancer has been based on clinical mark-up then subsequently bony landmarks. The objective of this study is to investigate whether individualized CT-based nodal contour guided planning of axillary fields in breast cancer improves nodal coverage and minimizes dose to normal tissues. There have been no previous studies addressing this issue. Methods: Thirty 4-field radiotherapy plans were selected as ‘traditional’ plans: 15 without nodal contours (traditional field placement) and 15 with radiation oncologists’ nodal contours. The following structures were contoured on each patient CT, regardless of previously contoured structures: level I, level II/III, supraclavicular(SCV)/infraclavicular(ICV) lymph nodes, ipsilateral brachial plexus and lung. Dose volume histograms (DVHs) of the listed contoured structures were obtained for the 30 original plans. All 30 patients were then re-planned with the same anterior dose prescription as the original plan (4000cGy/16 fractions (#) or 4500cGy/25#) but adjusted depth of midplane dose prescription based on nodal depth; MLC blocking was adjusted to the ‘study’ nodal contours. DVHs of the contoured structures for the new nodal-based plans were compared with the DVHs of the original plans, using two-tailed paired t-tests. Results: Volume receiving 90% dose (V90) was significantly improved for SCV nodes: original plan 84.67% vs nodal plan 95.76%(p=0.0005). V90 were similar for level I and level II/III nodes, but hot spots in these nodal groups were significantly hotter in the original vs nodal plan: mean hot spot for level I 120.8% vs 116.3%(p=0.0008), mean hot spot for level II/III 118.1% vs 113.2% (p=0.000003). Dose to 90% of the brachial plexus (D90) was significantly higher in the original vs nodal plan: 79.92% vs 40.92%(p=0.0028). V20 lung were not significantly different. Mean total body dose was significantly higher in the original vs nodal plan 831.8cGy vs 677.7cGy (p=0.0015). Conclusions: CT-based nodal contour guided planning significantly improves coverage of the nodes, particularly supraclavicular nodes, while markedly reducing the dose to critical normal structures, such as brachial plexus.

No significant financial relationships to disclose.
Cancer clinical trials (CCT) awareness and attitudes in cancer survivors (Ca surv)
Authors: Comis R. L. , Colaizzi D. , Miller J. D.
Published: March 2020

6061

Background: A web-based survey of attitudes and awareness of Ca surv towards CCT was performed from 3–4, 2005. The survey instrument was developed jointly by the Coalition of Cancer Cooperative Groups (CCCG) and Northwestern Univ (NU) and executed by NU and Knowledge Networks (KN). Methods: Ca surv were obtained from a panel of 40,000 adults through KN, based on a US households national probability sample who agree to weekly surveys in exchange for a free WebTV box and ISP service. 2,029 panel members reported a cancer diagnosis. 1,788/2,029 (88%) agreed to participate. Results: Ten-percent of Ca surv were aware that CCT participation was an option. In 73%, a physician was the source of the CCT awareness. Awareness was related to time since diagnosis (< 9 yrs vs > 9yrs); gender (females > males); age (younger > older), and education (baccalaureate vs less). Awareness varied according to cancer type: leukemia, 26%; breast, 15%; lymphoma and lung, 14%; prostate, 12%; melanoma and renal cell, 10%; colorectal and bladder; 6–3%. Awareness was dependent (p < .01) on type of treatment: surgery 5% (n, 880); surgery and RT, 7% (n, 181); RT, 10% (n, 107); chemotherapy, 18% (n, 488). Of the last group, 44% enrolled into CCT; 33% declined and 11% were either ineligible or not offered a CCT. Those who declined were concerned that the new approach might be “less effective” (40%) and about “randomization” (18%). CCT Ca surv reported a high level of satisfaction on a 0 (worst) to 10 (best) scale: “treated with dignity and respect”, 9.6; “overall very positive experience”, 9.3; “recommend to a family member or friend”, 8.8. Conversely, the response to “I felt like a guinea pig” was 1.7. Conclusions: In summary, assessing issues such as awareness, participation and accrual onto CCT must adjust for key demographic, disease and treatment related factors. The CCT experience is valued and appreciated by Ca surv as they move the field forward.

No significant financial relationships to disclose.
Cost of chemotherapy-related febrile neutropenia
Authors: Weycker D. , Malin J. , Glass A. , Oster G.
Published: March 2020

6068

Background: Febrile neutropenia (FN) is a serious complication of myelosuppressive chemotherapy that typically necessitates hospitalization. While the costs of FN have been reported to be substantial, previous studies may have underestimated these costs due to failure to account for follow-on care. Methods: A retrospective cohort study was undertaken using a US healthcare claims database. The source population included adult cancer patients who received a course of chemotherapy between 2001 and 2003. For each such patient, each unique cycle of chemotherapy was identified, and patients who developed FN within these cycles were further identified based on hospitalization for neutropenia, fever, and/or infection. Patients with FN in a given cycle (“cases”), starting with the first, were matched–on tumor type, number of cycles, chemotherapy characteristics, and propensity score–to those not experiencing FN in that cycle (“controls”), regardless of occurrence of FN in subsequent cycles; once matched, patients were removed from their respective pools. FN-related healthcare charges–including inpatient, outpatient, and drug treatment for neutropenia, fever, and infection–were tallied for each such pair of patients from the cycle day on which cases developed FN through the last chemotherapy cycle. Healthcare charges were used as a proxy for costs, as the latter were unavailable. Results are reported as means and 95% confidence intervals. Results: The study population consisted of 746 patients; 38% had breast cancer, 21% had lung cancer, and 11% had non-Hodgkin’s lymphoma. Cases and controls were similar in terms of baseline characteristics. FN-related charges totaled $40,928 (95%CI $28,783-$62,586) among cases versus $3,933 ($2,890-$5,119) for controls, a difference of $36,995 ($25,283-$58,776). Non-FN-related charges were similar in the two groups ($32,774 [$28,587-$36,061] vs. $32,253 [$29,248-$36,066]). Care subsequent to initial hospitalization accounted for $9,872 (or 27%) of the higher FN-related charges among cases. Conclusions: Costs of care during chemotherapy are twofold higher among patients who develop FN; follow-on care represents more than one-quarter of the difference.

[Table: see text]
Measurement of quality of care for adjuvant chemotherapy of colorectal cancer
Authors: Morse M. , Prosnitz R. , Mantyh C. , Fisher D. , Samsa G. , McCrory D. , Cline K. , Gray R. , Patwardhan M.
Published: March 2020

6071

Background: Although adjuvant chemotherapy (CT) is a crucial component of the therapy for stage III colon cancer and stage II and III rectal cancer patients, little is known about how best to measure whether quality care is being delivered. We sought to provide policy-makers and stake-holders with an inventory of the available measures and their usefulness. Methods: The MEDLINE and Cochrane databases were searched for all publications which might contain quality measures (QMs) pertaining to the diagnosis and treatment of patients with colorectal cancer (CRC). Our analysis was confined to QMs pertaining to adjuvant CT for CRC, based on US data, and published after 1990. Identified QMs were quantitatively rated based on the concepts of importance/usability, scientific acceptability, and validity or how well they had been tested. Results: 3,429 abstracts were reviewed, of which 843 articles underwent full text evaluation. Ultimately 74 articles met the established inclusion criteria for containing QMs, 32 of which pertained to adjuvant CT. These 32 articles contained 10 QMs, 8 of which had major flaws limiting their applicability. The two most ideal measures are presented in the table . Among the reasons some measures did not rate highly was the failure to utilize standard staging definitions or reliance on administrative inpatient databases, which do not account for chemotherapy administered on an out-patient basis. Conclusions: Very few measures of the quality of adjuvant CT for CRC have been published to date and fewer rate highly with regard to the concepts of importance/usability, scientific acceptability, and validity. Future research should focus on refining existing QMs and on developing new QMs which target important leverage points with respect to the provision of adjuvant therapy for CRC.

[Table: see text]

[Table: see text]
Implementation of a direct patient callback system improves compliance for additional breast imaging and early breast cancer detection
Authors: Richard-Kowalski D. , Termeulen D. , Reed M. , Reyes R. , Kuliga M. , Sanjurjo D. , Hirsch A. E.
Published: March 2020

6073

Background: Existing patient recall systems usually involve contacting the referring physician who then notifies the patient to schedule a return visit for further imaging. We set out to determine whether a direct patient callback system would improve patient compliance in returning for additional imaging including magnification, spot compression, and ultrasound, and whether that would translate to an improvement in early breast cancer detection. Methods: Beginning on 4/1/2004, we prospectively identified all patients whose screening mammograms were read as having an incomplete assessment that required additional imaging (ACR BIRADS 0). Those patients were contacted directly via telephone to return for additional views. Results: Between 11/1/2002 and 3/31/3004, 1142 patients with incomplete screening mammography were identified and the referring physicians were contacted. 956 of 1142 (84%) patients returned and underwent additional breast imaging. Between 4/1/2004 and 12/31/2005, 1,336 patients with incomplete screening mammography were contacted directly to return for additional imaging. 1,307 of 1,336 (98%) patients returned and underwent additional breast imaging. (p < 0.0001, Fisher’s exact test). 125 of the 1,307 (8.5%) of the subsequent exams were found to be suspicious and biopsy was recommended (ACR BIRADS 4 or 5). Conclusions: Our new system of contacting patients with incomplete mammography has significantly increased our recall rate. Implementation of this system has enabled us to identify those patients whose mammograms are suspicious and ultimately diagnose breast cancer earlier. Direct patient callback has become standard policy and we are recommending this system for all radiology recall examinations.

No significant financial relationships to disclose.
Impact of organization of colorectal cancer screening: Results of EDIFICE study
Authors: Coscas Y. , Serin D. , Cals L. , Eisinger F. , Blay J. , Rixe O. , Pivot X. , Bouillet T. , Roussel C. , Morere J.
Published: March 2020

6078

Background: The EDIFICE study aimed to allow better understanding of population’s adhesion to the tests available for the 4 most frequent cancers: breast, colorectal, prostate and lung. In 1998 the French National Consensus Conference advocated for mass cancer screening (CS) using Hemoccult II. The departments are divided according to the existence or not of an organized program: this screening was organized in 22 departments (3 “scout” started in 1998, 9 “first wave” in 2003 and 12 “second wave” in 2004). Results are reported hereunder. Methods: This first nationwide observational study was carried out in France from January 18th to February 2nd, 2005 among a representative sample of 1504 subjects aged between 40 and 75 years and a representative sample of 600 general practitioners (GPs). Information about participating subjects included socio-demographic characteristics, attitude towards CS, and about GPs’ medical practice regarding CS. Results: Only 25% of the 970 subjects aged between 50 and 74 years had undergone a colorectal screening test. In the organized departments (OD), the rate of persons who self-report any colorectal cancer screening was 34% vs 20% in unorganized departments (UD) (OR=1.99, CI95% 1.47- 2.69, p<0.001). The rate of recent screening within a range of 2 years was 24% for OD vs 8% for UD (OR=3.35, CI95% 1.91- 5.88, p<0.01). The rate of “fear of the test and/or its results” was higher in OD: 11% versus 6% (OR=1.97, CI95% 1.11–3.49). The rate of GPs who advocated systematically for screening was 40%, 29%, 26% and 13% for scout, first wave, second wave OD and baseline UD respectively. Organization reduced the rate of screening based on colonoscopy alone from 69% persons in UD to 35% in the OD. Conclusions: The main result of this survey comparing data in the same frame of time, in the same country, is that organized programs for colorectal cancer impact of health outcomes.

No significant financial relationships to disclose.
The Registry Case Finding Engine (CaFE): An automated approach for cancer patient identification from unstructured, free-text pathology reports
Authors: Hanauer D. A. , Chinnaiyan A. M. , Miela G. , Blayney D. W.
Published: March 2020

6080

Background: A vital component to maintaining an accurate cancer registry is the identification of patients with cancer. The University of Michigan Cancer Registry identifies more than 90% of all registry patients by manually reading free-text pathology reports and their associated SNOMED codes. This method is labor and time intensive and is subject to errors of omission. Methods: We created an application to scan free-text pathology reports to identify cases of interest to the registry. It uses a custom-made list of approximately 3,300 words, phrases, and SNOMED codes to positively identify relevant cases and to eliminate non-relevant cases, including those which may mention cancer-related terms. Experienced registrars reviewed 2,451 pathology reports and marked cases of interest to the registry; this served as the gold standard. These reports were also analyzed by the Registry CaFE. The time required for case identification was recorded for both processes. Results: Experienced registrars marked 795 (32.4%) cases as being of interest compared to the CaFE which marked 1,009 (41.1%). The sensitivity of the CaFE was 100% whereas the specificity was 87.1%. An analysis of the 214 errors made by the CaFE revelead that 30 cases (14%) were due to incorrect SNOMED codes assigned by our auto-coding system (Cerner Corporation, Kansas City, MO) and 89 (41.6%) were either skin squamous or basal cell carcinomas (most non-melanomatous skin cancers are not tracked in the registry). Registrars required an average of 21 seconds per pathology report whereas the Registry CaFE processed each report in less than a second. Conclusions: The Registry CaFE identified all relevant cases and correctly eliminated most cases that were not important; it is both effective and time-saving. Future efforts directed at improving the CaFE for squamous and basal cell carcinomas would yield the largest improvement in accuracy.

No significant financial relationships to disclose.
Estimating costs of care for patients with newly diagnosed metastatic colorectal cancer (mCRC)
Authors: Paramore L. C. , Thomas S. , Knopf K. B. , Cragin L. , Fraeman K.
Published: March 2020

6082

Background: The cost of treatment for patients with metastatic colorectal cancer (mCRC) has become a significant component of overall cancer care due to its high incidence and the increasing duration of patient survival. This study examines the resource use patterns and costs of care for patients with incident metastatic colorectal cancer (mCRC) based on analyses of retrospective claims data from selected health plans in the United States. Methods: A case-control analysis was performed using claims data from over 70 US health plans representing 40 million lives from years 1998–2004. Incident mCRC cases were identified based on evidence of a colorectal cancer diagnosis and a metastatic disease diagnosis. Incident mCRC cases could have no other evidence of cancer in the one-year period prior to the date of their first mCRC diagnosis. Cases were matched to non-mCRC controls based on age, gender, geographic region and duration of plan enrollment. Costs were evaluated by phase of disease: diagnosis, treatment, or death phases. Ordinary least squares regressions were performed to evaluate impact of covariates in each phase. Results: Total costs in the follow-up period averaged $97,031 higher for mCRC cases (N=) than for controls. The main cost drivers for mCRC were hospitalizations ($37,369) and specialist visits ($34,582) which included chemotherapy administration. Approximately 40% of the 672 mCRC patients who qualified for the phase analysis were identified with a fatal event during follow-up. Monthly costs were similar in the diagnostic phase ($12,394) and death phase ($12,069), but were significantly lower in the treatment phase ($4,653). Both mean/median monthly costs increased over time during the study period, regardless of disease phase. Conclusion: The economic burden of mCRC is substantial for patients in commercial health plans in the U.S., and costs of care have increased substantially in recent years. Further research is needed to assess the cost impact of newer targeted therapies for the treatment of mCRC.

No significant financial relationships to disclose.
Do specialized oncology units improve the detection and management of pain?
Authors: Goldberg G. R. , Litke A. , Morrison R. S.
Published: March 2020

6084

Background: Pain is a common complaint of cancer patients and has a significant impact on quality of life. The objective of this study was to compare pain management for cancer patients admitted to dedicated oncology vs. general medicine/surgery units. Methods: Design: Secondary analysis of data obtained from a controlled clinical trial evaluating a series of interventions to improve pain outcomes conducted from 4/2002–2/2003. Setting: 1,171 bed hospital. Patients: 445 hospitalized adult oncology patients; 239 patients admitted to a specialized oncology unit, 206 patients admitted to general medicine/surgery units. Main outcome measures: Pain assessment and severity, analgesic prescribing. Analysis: T tests and chi square were used to compare patient characteristics. Hierarchical linear modeling (HLM) was used to explore the effect of a specialized oncology unit on pain assessment, severity, and analgesic and laxative prescribing. Results: The two groups did not differ significantly in patient characteristics. Mean age was 59 years, 56% were men, 61% were white, 79% had solid tumors. In multivariate analysis, patients admitted to a specialized oncology unit had significantly less pain (mean pain score for patients on oncology unit was 1.24 vs 1.68 for non-oncology unit; parameter estimate = −0.42; p<0.01). There were no significant differences in the frequency of nursing assessment of pain, opiate prescribing, or laxative prescribing for those patients receiving opioids. Conclusion: In multivariate analysis, admission to a specialized oncology unit was associated with significantly less reported pain. These findings have implications for structuring medical units for patients at high risk for pain.

No significant financial relationships to disclose.
Systemic therapy (ST) in cancer patients ≥ 80 years of age: A Manitoba population-based assessment
Authors: Gingerich J. R. , Turner D. , Xiaoyun S. , Czaykowski P.
Published: March 2020

6090

Background: Little is known about the cancer characteristics, treatment options and outcomes in the oldest subset of the elderly, those ≥ 80, who develop cancer. Methods: We employed a population-based, cross-sectional design utilizing the provincial cancer registry and administrative data augmented by clinic-specific retrospective chart review to study the demographics, treatment and outcomes of patients ≥ 80 diagnosed with cancer in the years 2002–2003 in Manitoba, Canada. We assessed treatment patterns for various subgroups (analyzed using chi-square and Fisher’s exact tests to determine association, as appropriate) and associated survival. Results: Our cohort included 2,194 patients. This represented 20.8% of all incident cases. The median age was 84 (range: 80–102), with a slight preponderance of females (53%). As expected, prostate, lung, and colorectal cancers were most common for males with breast, lung, and colorectal cancer being most common for females. Only 241 (10.9%) of the cohort were referred to the central cancer centre for consideration of ST which was less than the overall referral rate of 33%. Of those referred, 57% did not receive ST, 20% received palliative ST, and 23% received adjuvant/curative ST. The two year survival rates were statistically significant by treatment categories (not referred = 39%, referred but who did not receive ST = 39%, palliative ST = 27%, and adjuvant/curative ST = 76%,) (p<0.0001). The Charlson score for those patients referred who received ST was lower than those who did not receive ST (p<0.0001) Conclusions: Our data indicate that in patients ≥ 80 years of age with cancer, few are referred to the central cancer clinic for ST. Of those referred, patients who receive adjuvant/curative intent ST live longer then those not receiving ST. Lower Charlson scores (indicative of fewer comorbidities and better general health) were found more often in patients receiving ST.

No significant financial relationships to disclose.
Cancer screening tests in France: First results of EDIFICE study
Authors: Pivot X. , Serin D. , Coscas Y. , Eisinger F. , Rixe O. , Roussel C. , Morere J. , Blay J.
Published: March 2020

6092

Background: The EDIFICE study was the first which aimed to allow better understanding of population’s adhesion in France to the screening tests available for the 4 most frequent cancers: breast, colorectal, prostate and lung. Methods: This nationwide observational study was carried out in France from January 18th to February 2nd, 2005 among a representative sample of 1,504 subjects aged between 40 and 75 years and a representative sample of 600 general practitioners (GPs). Information collected about participating subjects included socio-demographic characteristics, attitude towards cancer screening and actual experience of cancer screening, and about GPs’ medical practice regarding screening. Results: A striking result observed is that screening for colorectal cancer that USPSTF rates as an “A” Recommendation (strongly recommended) deserves less attention: reported rate 25% than prostate cancer screening (either with digital rectal examination and/or PSA): reported rate 36%. In the same way, GPs’ are recommended more often prostate cancer screening (58%) than colorectal cancer screening (18%). Another key result of that EDIFICE national representative survey is the high attendance rate of women at mammography screening. Conclusion: With respect to the cost of such programs, utilization must be monitored and compared among different countries/organization. Additional data will be presented about reasons to do or not cancer screening and about regularity of screening.

[Table: see text]

No significant financial relationships to disclose.
A new model for training patient advocates to advance the adoption of research results in community oncology practices
Authors: Railey E. , Smith M. , Perotti J.
Published: March 2020

6094

Background: The advocate community has been identified as an influential component in disseminating the results of research reported at ASCO. A pilot program offered by Research Advocacy Network prepared advocates to better understand the common concepts in oncology, improve statistical skills to interpret the presentations and identify the influencers and barriers to adoption of research results in clinical practice. Methods: Advocates were selected based on their ability to disseminate results reported at ASCO to a patient constituency. Pre-ASCO webconference lecture topics included: targeted therapies, drug safety and approval process, statistics for advocates. Post ASCO webconferences explored evidence-based medicine principles with case presentations and discussions. Participants were responsible for reporting their efforts in disseminating the results that could change clinical practice in their disease site. Results: Fifteen advocates representing six cancer sites participated in the program. Six of the participants were first time attendees. Participants reported an increased 1) understanding of scientific concepts and language; 2) increased confidence in dialoguing with researchers; and 3) improved ability to translate research results for their constituencies. Research results were provided by the participants to staff and volunteers, via teleconferences, web sites and individually to newly diagnosed patients, caregivers, support groups, survivor hotlines and in newsletter articles with a combined circulation of over 125,000 readers. Conclusions: Preparatory lectures help advocates maximize the experience of interpreting and translating the results from the ASCO meeting. More prepared advocates help to advance the dissemination of research results through their formal and informal distribution channels and are able to translate the information more rapidly to their constituencies.

No significant financial relationships to disclose.
Knowledge of cancer clinical trials in a population being screened for cancer
Authors: Walsh J. H. , Sahasrabudhe D.
Published: March 2020

6095

Background: Only 2.5 percent of adult cancer patients enrolled in cooperative group clinical trials between 1998 and 1999. Increasing participation in clinical trials is important in efforts to improve cancer care. Methods: We administered an anonymous true/false questionnaire that assessed knowledge of clinical trials to 117 men seeking prostate cancer screening. Questions involved the rationale for conducting clinical trials, regulatory oversight of clinical trials, informed consent, randomization, blinding, use of placebos, and safeguards built into clinical trial design. We performed multi-way ANOVA and t-test analyses to compare the average proportion of correct responses by group. Results: On 71 percent of test questions, participants chose the correct answer 80 percent or more of the time. Descriptive general statements about the conduct of clinical trials were answered correctly 88 percent of the time. Questions in which participants scored less than 80 percent involved randomization, blinding, and the use of clinical trials to improve cancer treatments. 45 percent incorrectly answered a question about placebo use. Results of the univariate t-tests and multi-way ANOVA suggest that white men and employed men are significantly more knowledgeable about clinical trials. College educated men also appear somewhat more knowledgeable about clinical trials, although this effect does not attain statistical significance when other predictors are controlled. Marital status, age, health insurance status and income do not have a significant effect on men’s knowledge. Conclusions: Percent of participants answering correctly decreased for concepts such as randomization, placebo use, and blinding. A belief persists that placebos will be used in cancer clinical trials. This may play a role in low accrual, and may be an area in which educational interventions could improve accrual. This study identifies specific concepts, beliefs, and populations that have to be addressed to improve enrollment on cancer clinical trials.

[Table: see text]

No significant financial relationships to disclose.
Extending the patient navigator research program from Harlem to the nation
Authors: Garcia R. , Freund K. M. , Dudley D. , Fiscella K. , Jones J. D. , Patierno S. R. , Raich P. C. , Roetzheim R. G. , Paskett E. , Bennett C. L.
Published: March 2020

6096

Background: Low-income persons face barriers when attempting to seek cancer diagnostics tests and treatment. In 1990, Harold Freeman implemented a novel patient navigator program for women with abnormal mammograms, resulting in earlier presentations and better survival. Identified barriers included lack of insurance, poor social support, coping styles, health beliefs such as fatalism, and poor health literacy skills. Single-site navigator programs have been subsequently implemented. Building on these experiences, the National Cancer Institute is supporting navigator programs at 9 sites. Methods: At 9 sites, the skill set of the navigators, community partnerships, target patient populations were reviewed for information regarding cancer type, number of patients seen, and navigator type. Common data elements include time to diagnosis and time to initiation of treatment, navigation costs, cost-effectiveness of the intervention (in order to address sustainability), and navigation satisfaction. Results: See Table . Conclusions: While programs such as the Breast and Cervical Cancer Treatment Act, the Department of Veterans Affairs, and the Indian Health Board provide financial support to pay for diagnostic/treatment services, the Patient Navigator Research Program will provide medical, social, and psychosocial services for 5,295 patients with positive breast cancer screens, 3,528 patients with positive cervical cancer screens, 5,507 patients with colorectal cancer screens, and 1,167 patients with prostate cancer screens. Diversity of sites, navigator skill sets, patient eligibility, sociodemographics, and study design in conjunction with common data elements, outcomes, and analytic plans will allow us to assess the efficacy and costs of a range of navigation programs.

[Table: see text]

No significant financial relationships to disclose.
Surgical oncology outcomes: The role of nurse practice environments
Authors: Friese C. R. , Aiken L. H.
Published: March 2020

6105

Background: Increased attention has focused on the role of hospital characteristics on cancer patient outcomes. We examined two cancer-specific credentials, as well registered nurse practice environments, on outcomes of care. Methods: Through secondary analysis of existing data from hospital claims, the tumor registry, and a statewide of survey of nurses (RNs), we studied 30-day mortality (D) and failure to rescue (death given a complication) (FTR) for surgical oncology patients treated in 164 Pennsylvania hospitals from 1998–1999 (N=24,618). We compared D and FTR rates by a hospital’s NCI cancer center designation, American College of Surgeon’s (ACoS) cancer program approval and categorized scores on the Practice Environment Scale of the Nursing Work Index (PES-NWI). The PES-NWI scales measure RN participation in hospital affairs, RN foundations for quality of care, nurse manager leadership/support, staffing/resource adequacy, and RN-physician relations. Multivariate logistic regression models examined predictors of D and FTR, controlling for 25 patient variables. Standard errors were corrected for patient clustering in hospitals. Results: NCI centers had lower D and FTR rates (p < .01). ACoS hospitals had lower D and FTR rates (ns). Hospitals with low scores on PES-NWI scales had the poorest outcomes (p < .01). In logistic regression models, significant predictors included unfavorable PES-NWI Scores for D (OR=1.32, 95% CI: 1.06–1.65) and FTR (OR=1.39, 95% CI:1.03–1.88), and NCI centers for D (OR=0.64, 95% CI: 0.50–0.83) and FTR (OR=0.67, 95% CI: 0.47–0.96). The NCI effect lost significance when environment was included. ACoS program effects were small (OR= 0.99, p = .90) for both outcomes. Conclusions: Favorable outcomes in NCI centers may be partly explained by practice environments. The practice environment of RNs significantly predicts surgical oncology patient outcomes, and should be a focus of quality improvement activities.

No significant financial relationships to disclose.
Treatment efficacy and tolerance in geriatric oncology
Authors: Kumar A. , Soares H. P. , Balducci L. , Djulbegovic B.
Published: March 2020

6115

Background: Elderly patients share the majority of the disease burden in cancer. Although 61% of new cancer cases occur among elderly, yet elderly comprise only 25% of the patients enrolled in clinical trials. A systematic review to assess the accurate participation of elderly in randomized clinical trials (RCT) has not been done. Methods: We reviewed all consecutively completed phase III RCTs conducted by 5 National Cancer Institute sponsored cooperative groups. Published papers and study protocols were used to ensure the accuracy of the data extraction. We used a cut-off of age ≥65 to define elderly patients. For trials that did not have an exclusive ≥65 age criteria for enrollment, data were extracted on number of participants ≥65. Outcome between the innovative and the standard treatment was compared. Data were extracted as per the methods recommended by the Cochrane Collaboration. Results: Out of 413 studies, only two trials exclusively enrolled elderly patients (0.5%). 57% (n=235) of the trials did not have any stratification by age. Only 10% of the studies had a stratification age at ≥65 (n=42). Contrary to the general notion that elderly may not respond well to newer chemotherapy combination treatments, overall survival in these two trials exclusively enrolling elderly favored the newer treatments [Hazard ratio (HR) 0.62(95%CI 0.44, 0.87)]. In addition, trials enrolling >40% of elderly had favorable outcomes involving innovative treatments for survival and event-free survival [HR survival 0.85(95%CI 0.77, 0.94), HR event-free survival was 0.76(95%CI 0.64, 0.92)]. Treatment related mortality was similar in the innovative and the standard arms [HR 0.87(95%CI 0.39, 1.96)]. Conclusions: Our data indicate that enrollment of elderly in experimental RCTs is not associated with increased harms to this patient population. Increased participation of elderly may help in finding new treatments that are clinically applicable specifically to this cohort of patients.

No significant financial relationships to disclose.
A prospective evaluation of the attitudes of patients, physicians and nurses using a computer-assisted quality of life instrument (LCSS-QL) in a multicenter clinical trial in non-small cell lung cancer (NSCLC)
Authors: Gralla R. J. , Hollen P. J. , Leighl N. , Meharchand J. M. , Krieger H. , Solow H.
Published: March 2020

6123

Background: The LCSS has been computerized (LCSS-QL) for inexpensive hand-held devices (pocket-pc) to enhance feasibility, provide immediate results, and automatically record data. Correlation coefficient between paper form and electronic version is excellent (r=0.93). This analysis determines the acceptability and value of LCSS-QL assessed by patients and health care professionals. Methods: NSCLC patients utilized LCSS-QL in a clinical trial and also completed a form evaluating their experiences after their first and third treatment cycles. All received docetaxel and platinum. Eleven physicians and nurses administered LCSS-QL and completed an evaluation form. The evaluation included: time required, satisfaction with the process, value of assessment, impact on communication, resource utilization. Results: The evaluation form was completed by 126 patients (cycle 1) and 94 (75%) completing cycle 3. Baseline characteristics: Stage III/IV 29/71%; median KPS 80%; 56% male; median age 69 yrs. Results are in the table : All physicians considered their time per patient was not lengthened and 80% felt that QL evaluation could save time. 67% of nurses felt the instrument could save time, while 83% felt that their time with patients was lengthened. Utilization: 67% of professionals reported QL evaluation would identify earlier patients not benefiting from chemo; 91% were more aware of pain issues. Conclusions: Patients and health-care professionals found using a validated QL instrument in a computerized form via a hand-held device was easy, added value and satisfaction while enhancing communication and awareness of PRO issues. This electronic format added no physician time. These results indicate that this QL evaluation method should be used more frequently in clinical trials and patient management. Supported in part by a grant from Sanofi-Aventis Canada, Laval, QC.

[Table: see text]

[Table: see text]
Survey amongst health care professionals—Willingness to pay for novel therapies
Authors: Chia W. K. , Hee S. W. , Toh H. C.
Published: March 2020

6138

Background: Singapore’s state sponsored healthcare system provides subsidies for “standard” oncology drugs (patients co-pay). Patients pay full cost for access to newer therapies prior to Government assessment for subsidy eligibility. Methods: A questionnaire-based study was performed to determine willingness to pay (WTP) for newer anti-cancer therapies (Herceptin, Avastin, Iressa). In addition to absolute dollar cost, patients were asked to tradeoff material goods (cars, house, electronic goods) to purchase such drugs. Face to face interviews were conducted amongst HCP by a single interviewer at Singapore National Cancer Centre from 24 Nov to 16 Dec 06. The questionnaire provided didactic information of such drug benefits in either the appropriate adjuvant or palliative setting. Results: Population: 70 out of 76 HCP responded to the survey—36 doctors (radiation and medical oncologists) and 34 oncology nurses. 60% were female, 61% married and 48% had dependent children. 71% supported parents financially. Median length of practice for doctors(drs) was 10 years (range 2 to 35) and 9 years (range 2 to 29) for nurses(nrs). Median income bracket was USD 3000–5000/mth and USD 1200–3000/ mth respectively. Findings: 69% of respondents reported WTP for herceptin (97% for drs and 38% of nrs). Although drs were most able to afford herceptin, they also demonstrated the highest willingness to trade off material goods to pay for treatment. 57% would sell their houses and 71% sell their cars to pay for herceptin. Almost the entire cohort reported willingness to forego discretionary spending on restaurant dining, clothes and electronics. Only 20% of respondents were WTP for palliative avastin for advanced colon cancer. 53% were willing to pay for a trial of Iressa (for advanced non-small cell lung cancer). If response was favorable, 68% were willing to sell their house to pay to continue palliative treatment. This survey must be interpreted in the context of a relatively affluent Asian population. Conclusions: Government healthcare programs worldwide will find increasingly difficulty paying for expensive novel therapies. At an individual level, respondents demonstrate a high WTP and forego substantial material goods for access to such novel agents.

No significant financial relationships to disclose.
Medical oncologists’ skill and understanding of epidemiology and statistical principles need to be strengthened to maximize their use of clinical trial results
Authors: Hoffman K. R.
Published: March 2020

6139

Background: Clinical oncologic practice is based on evaluating data from studies whose results are statistically defined, increasingly from interim analyses. How well the practicing oncologist understands the correct use of these statistical and epidemiologic methods is unknown. Methods: Twenty (20) board-certified community based medical oncologists agreed to take a ninety minute, twenty-five question exam on epidemiology and statistics to test their competence in evaluating current treatment data. This test was based on abstracts and articles presented within the last three years and basic statistical and epidemiology concepts taught to second-year medical students Results: Only 11/20 oncologists had a passing grade of 70% (range 92–24%, mean 72%). The recognition of different phased clinical trials was correctly identified by 17/20 doctors. While the identification between a retrospective vs. prospective study was perfect, only 7/20 respondents correctly identified what information can be obtained from a retrospective study. 11/20 respondents correctly explained a ‘p‘ value. Correct calculations and explanations of the sensitivity, specificity, positive and negative predictive value of screening test ranged between 8/20 and 13/20. The importance of a study’s sample size in defining statistical ‘significance‘ was recognized by 9/20 respondents. Only 5/20 oncologists could explain a ‘hazard ratio‘ while14/20 correctly found survival information off of a Kaplan-Meier survival plot. Only10/20 correctly explained a ‘forest plot.‘ Most doctors knew ‘incidence‘ and ‘prevalence‘ but not ‘lead time bias.‘ The identification of ‘absolute risk‘ vs. ‘relative risk‘ (6/20) and understanding the concept of a ‘Type I‘and ‘Type 2‘ error was poor (8/20). After completion of the exam all respondents agreed that CME opportunities in this field would be very helpful. Conclusions: A confirmatory study should be done. In the meantime, there seems to be a need to improve the competence of the practicing oncologist in evaluating data and clinical trials. ASCO should include this topic in future free (not ticketed) educational symposiums at our national meetings and as part of their regional programs.

No significant financial relationships to disclose.
A budget impact analysis of extended adjuvant letrozole following five years of tamoxifen in postmenopausal women with early breast cancer
Authors: Calabró A. A. , Portella M. S. , Garcia M.
Published: March 2020

646

Background: MA17 study wasa randomized double-blind placebo-controlled trial of 5 years of extended adjuvant therapy with letrozole (Femara) in 5187 postmenopausal women with early breast cancer after adjuvant tamoxifen. MA17 study demonstrated significant improvement in disease-free survival (93% vs. 87% at 4 yrs, HR 0.57) and a similar trend in overall survival (96% vs. 94% at 4 yrs, HR 0.76). Objective: To estimate the budget impact of adding extended adjuvant letrozole in the management of postmenopausal women with early breast cancer after 5 years adjuvant tamoxifen. Methods: A budget impact analysis over 4 years of letrozole vs. no extended adjuvant therapy was developed from the perspective of a health care payer in terms of total treatment costs following the introduction of letrozole. Model inputs included the overall survival, disease-free survival and probabilities of recurrence from the MA17 trial, additional cost of letrozole and the average annual cost to treat a given type of recurrence (contralateral, loncoregional, metastatic). Only direct medical costs were included using the consumer price index. Costs and cost-savings were reported as 2005 US dollars and discounted at 3%. The average annual cost to treat a recurrence was calculated through a retrospective analysis of a healthcare plan database with 147 postmenopausal women and data from published literature. The recurrence cost included chemotherapy in the first year (drug costs, dispensing fee, materials), health professional contacts, laboratory tests, diagnostic procedures, radiotherapy, bisphosphonate (metastatic recurrence), health professional contacts and hospitalization. Surgery costs were not considered in the study. Results: The average annual cost to treat a recurrence was estimated in US$83,064. For the base-case analysis of 100 patients, savings due to reduced recurrence were $1,006,446, in the letrozole patients. Subtracting the cost of letrozole treatment for 100 patients from savings yielded projected net savings of $36,314. Conclusions: In post-menopausal women who have completed 5 years adjuvant tamoxifen therapy, extended adjuvant letrozole is a cost-saving use of healthcare resources in additional to its clinical benefits.

[Table: see text]