bluuebunny/crossref_metadata_2025_split huggingface dataset:
Timeliness of breast cancer diagnosis and initiation of treatment in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP)
Authors: Richardson L. C. , Royalty J. , Howe W. , Helsel W. , Kammerer W. , Benard V. B. 
Published: March 2020

6571 Background: To examine intervals between breast cancer screening, diagnosis, and treatment initiation among low income and uninsured women in the National Breast and Cervical Cancer Early Detection Program during two time periods. Methods: We examined diagnostic and treatment intervals for the time periods of 1996–2000 and 2001–2005 to evaluate program progress. The intervals were defined as: (1) time between mammography and final diagnosis for all women receiving an abnormal mammogram result (including suspicious abnormality (SA), highly suspicious for malignancy (HSM) and assessment is incomplete (AI)) or abnormal clinical breast exam and; (2) time between diagnosis and treatment initiation among those diagnosed with cancer. Covariates including mammography result, age at screening, race/ethnicity, and metropolitan/urban/rural classification of residence were included in the analysis. Results: For the entire study period, 369,557 women screened for breast cancer through the NBCCEDP had abnormal screen results. For 1996–2000 and 2001–2005 time periods, the median interval to diagnosis after screening was 25 days and 23 days respectively. For those 22,302 women found to have cancer, the median interval from diagnosis to treatment increased from 12 days in the first time period to 14 days in the later time period. Overall, time to diagnosis improved from 1996–2000 compared to 2001–2005. However, time to treatment initiation was slightly longer (median increased by 2–3 days). Using data from the most recent period of 2001–2005, 93% of women with cancer initiated treatment within 120 days of screening. Conclusions: The goal of the NBCCEDP is to assure that women receive timely, quality breast cancer screening and diagnostic services and initiate treatment. Our data show that the program is meeting these goals. Disparities in breast cancer incidence, mortality and survival should diminish once all women have access to breast cancer early detection and treatment services. No significant financial relationships to disclose.
Patient attitudes regarding payment for participation in a phase I cancer clinical trial
Authors: Gibbs A. , Merz J. F. , Gore L. , O'Bryant C. L. 
Published: March 2020

6573 Background: Research industry practice reimburses healthy phase 1 study subjects and yet cancer patients who participate in a phase 1 study are rarely reimbursed. The ethical problems of disproportionate risk/benefit ratio and coercive informed consent are cited as reasons for not paying cancer study subjects. The purpose of this study is to determine if payment to participate in a phase 1 clinical trial affects a cancer subject's willingness to participate (WTP) in a clinical trial and to determine if any payment would reduce the therapeutic misconception. Methods: Eligible adults had consented to participate in a phase 1 clinical trial of an investigational drug at UCCC but had not yet initiated treatment. Subjects were identified by UCCC staff, consented to participate in this study, and then administered a questionnaire by phone. Primary analyses were descriptive in nature. Results: Thirty subjects were enrolled. The median age was 57 years (range 30–76); 53% were female; 97% were Caucasian; 77% had at least some college education; 47% had an annual household income of < $50,000. When asked an open-ended question, 53% of subjects stated that the main purpose of the phase 1 trial in which they consented to participate was efficacy. The majority of subjects (80%) did not think they should be paid to participate in a phase 1 cancer trial. Most subjects (73%) expected to benefit from phase I study participation and greater than 80% of subjects stated that payment would not change their perception or hope of benefit. There was a minor trend towards increased WTP with increased reimbursement or payment. Thirty-seven percent of subjects acknowledged that payment might affect what side effects they report. Conclusions: While payment appeared to have little or no affect on a cancer subject's expectation of benefit from a phase 1 trial, WTP increased slightly with increasing payment. Given these results, it seems that payment would not reduce the therapeutic misconception related to participation in phase 1 cancer trials. This study should be expanded to confirm these findings. No significant financial relationships to disclose.
Cost-utility of adjuvant trastuzumab in Her-2/neu positive breast cancer: A Canadian perspective
Authors: Skedgel C. , Rayson D. , Younis T. 
Published: March 2020

6574 Background: Recent RCTs have demonstrated a significant disease-free and overall survival advantage with adjuvant trastuzumab (aTZ) compared to chemotherapy alone in women with Her2/neu positive breast cancer. However, as aTZ is also associated with considerable costs and an increased risk of cardiotoxicity, an economic evaluation was undertaken to estimate the cost-utility (CU) of aTZ in terms of cost per quality-adjusted life year (QALY) gained relative to chemotherapy alone. Methods: A Markov model was developed to calculate the incremental costs and outcomes of 12 months of aTZ following chemotherapy in a hypothetical cohort of 1,000 women with Her2/neu positive breast cancer over a lifetime horizon. The model consisted of four broad health states: 1) disease-free, 2) local recurrence, 3) distant recurrence and 4) death. Each survival state was stratified as experienced with or without cardiotoxicity. The baseline rate of recurrence, the hazard ratio (HR) of recurrence with aTZ and the rate of adverse cardiac events were taken from recent RCTs. Age-sex specific background mortality, based on Statistics Canada life tables, was also incorporated. The cost of aTZ was based on our previous cost study (Drucker et al, ASCO 2006). Costs of local and distant cancer recurrence were derived from the literature, with an adjustment for the cost of palliative TZ (Potvin et al, ASCO 2005). Utility weights were taken from the literature. The model took a direct payer perspective, with costs reported in 2006 Canadian dollars (CDN$). Costs and QALYs were both discounted by 3% annually. The primary analysis assumed 5 years of benefit with aTZ therapy and an HR=1.0 over the remainder of the horizon. Results: Per 1,000 treated patients, aTZ was associated with a lifetime gain of 1,267 QALYs and an incremental cost of CDN$38.8 million. Lifetime CU was CDN$30,630 per QALY gained. aTZ met a CDN$50,000/QALY threshold at year 17. CU results were particularly sensitive to changes in the analysis horizon and assumptions regarding the long-term HR of aTZ. Conclusions: The lifetime CU of aTZ appears reasonable. However, further clinical follow-up is required to clarify the long-term outcomes of aTZ and confirm these CU estimates. No significant financial relationships to disclose.
Revolutionizing oncology patient enrollment in clinical trials: Just-in-time approach
Authors: Wiener M. B. , Newman H. M. , Spradley E. A. 
Published: March 2020

6577 Background: In the US, adult oncology patient enrollment in clinical trials is estimated at 4% (Cancer 2006; 106(2):426–33). This is a major bottleneck in the development of new cancer treatments, especially for rare indications, like stage IV pancreatic cancer in treatment-naive patients. To overcome the challenge of low enrollment in clinical trials, Pharmatech developed the Just-In-Time (JIT) approach. JIT expands the potential patient population and allows research sites to pre-identify patients using standard of care information prior to site activation. This differs from a traditional approach where sites are activated prior to screening for patients. We postulated the JIT approach would impact patient accrual. Methods: With the JIT approach, a central IRB-approved protocol was presented to 38 research-ready sites but only 8 sites with a potential patient obtained IRB-site approval over a 6 month period. Within 5–10 business days after identifying a potential patient, sites obtained IRB approval, investigators at the site were trained, received study materials, and dosed the first patient. We compared traditional site activation conducted by the sponsor to JIT approach in this study. Results: Traditional approach vs JIT approach: No.of patients enrolled: 42 vs 18; No.of months open: 19 vs 6; No. of sites open: 13 vs 8; No. of non-enrolling sites: 2 vs 0; Patient accrual rate (pts/mo/site): 0.17 vs 0.38. Sites participating in the JIT approach accrued subjects at >2x the rate of traditionally activated sites. The JIT approach eliminated non-enrolling sites, increasing sites’ and sponsor's satisfaction with enrollment. JIT also enhanced patient options by providing access to a novel treatment alternative for this rare indication even at smaller research sites. Conclusions: With JIT, patient accrual rate, enrollment success and trial-related cost in a pancreatic cancer study were markedly better than with the traditional approach. Expanding JIT to other rare indications and to trials requiring specific genetic tumor-profiles will show whether these results are reproducible and whether JIT is a viable approach for trials with challenging eligibility criteria. No significant financial relationships to disclose.
Cost-effectiveness of rituximab plus CVP for first-line treatment of advanced indolent lymphoma
Authors: Hornberger J. , Reyes C. , Verhulst E. , Lubeck D. , Valente N. 
Published: March 2020

6583 Background: The addition of rituximab (RTX) to CVP (cyclophosphamide, vincristine, prednisone) in the treatment of advanced follicular lymphoma increases median time to progression by 17 months (15 month v 32 months; p < 0.0001) (Marcus et al, Blood 2005). A societal cost-effectiveness analysis was performed to estimate projected lifetime clinical and economic implications of this treatment. Methods: The cost-effectiveness (CE) of RTX + CVP versus CVP was estimated for a 50 yr old patient. Kaplan-Meier estimates of progression-free and overall survival, up to 4 years, were obtained from the M39021 trial. After 4 years, transition rates from initiation of treatment to progression or death were assumed to be the same in both arms. The clinical and economic implications of relapse and its treatment were included in the model. Incremental costs associated with addition of RTX were estimated using Medicare reimbursement rates and published retail price data. Costs included drug and administration costs, adverse events, treatment of relapses, and end-of-life costs. Utility estimates were derived from the literature and a 3% discount rate was employed. Results: Projected mean overall survival is 1.5 yrs longer for patients assigned to RTX+ CVP versus only CVP (13.7 v 12.2 yrs). The addition of RTX to CVP is estimated to cost an additional $26,439 on average, with an expected gain of 0.85 year of quality-adjusted survival. Over a lifetime, the cost per QALY gained is $31,329. Sensitivity analyses revealed that the variables that most influenced cost-effectiveness were the time horizon (range: $18,800- $31,240) and the unit drug cost of RTX (range: $24,000-$38,000). Conclusion: The model estimates a cost-to-QALY gained ratio that is below that of many treatments used for oncology patients. The use of RTX + CVP for first-line treatment of advanced follicular lymphoma is projected to be cost-effective compared to CVP alone under a range of sensitivity analyses. No significant financial relationships to disclose.
Evaluation of quality indicators (QIs) for colorectal cancer care in a community setting
Authors: Frisby K. , Meyer L. , Lee J. , Mathiason M. , Dietrich L. 
Published: March 2020

6585 Background: We compared two existing sets of QIs for colorectal cancer care to evaluate our performance as compared to published data. We also explored reasons for non-adherence to these QIs to determine how we could increase our compliance. Methods: Chart review of all patients who were newly diagnosed with colorectal cancer at our institution in 2004 and 2005 for compliance with QIs for colorectal cancer care as presented by National Initiative for Cancer Care Quality (NICCQ) and Moffitt Network Initiative on Practice Quality (MNIPQ). When 85% compliance was not observed, charts were reviewed as to why care differed from QI. Results: Adherence rate was less than 85% in 5 of 25 NICCQ colon cancer measures and patients overall received 83% of recommended care. Reasons for <85% adherence on NICCQ were most often due to patient decision (patient decision after informed discussion, refusal of treatment, patient initiated delay) or co-morbidity (poor wound healing, infection, medical co-morbidity). In one item regarding counseling of family members about colorectal screening we were truly noncompliant without documentation of reason. Review of MNIPQ items observed less than 85% adherence rate in 2 of 9. Reason for non-adherence in MNIPQ review was due most often to co- morbidity, and true noncompliance (no reason documented for lack of pretreatment CEA). Conclusions: Our adherence rates for NICCQ and MNIPQ measures compare favorably with published values. Lower compliance rates on NICCQ and MNIPQ measures were most often due to patient choice or co-morbidities. In setting benchmarks for these individual QIs it should be noted that for some indicators (such as those regarding adjuvant therapy) higher percent adherence does not always reflect better care. Higher compliance may actually mean that thoughtful consideration of patient co-morbidity and complications, or including patients in decision making is not occurring or that the population being served is younger or has fewer co-morbidities. Other indicators such as those regarding staging documentation, documentation of chemotherapy, and patient education factors the higher the compliance the better. We conclude that some sampling of reason for non- adherence is necessary when assessing quality of care. No significant financial relationships to disclose.
Adjuvant chemotherapy in non-small cell lung cancer (NSCLC): Referral and utilization patterns
Authors: Al-Fayea T. , Saint-Jacques N. , Virik K. , Morzycki W. , Younis T. 
Published: March 2020

6590 Background: Adjuvant chemotherapy in Non Small Cell Lung Cancer (NSCLC) has become a new standard of care. However, referral and utilization patterns for adjuvant chemotherapy outside of clinical trials remain unknown. Methods: All patients with NSCLC who underwent curative-intent surgery in Nova Scotia, Canada, in year 2005 were identified. Data were abstracted from the provincial cancer registry, and the patients’ charts at the two provincial cancer centers. A retrospective exploratory analysis was conducted utilizing logistic regression models to determine the statistically significant variables associated with referral to medical oncology and/or utilization of adjuvant chemotherapy. Results: 108 patients who underwent curative-intent surgery (67% lobectomy, 15% pneumonectomy, and 19% wedge resection) for NSCLC (38% IA, 23% IB, 4% IIA, 21% IIB, 12% IIIA, and 2% IIIB) were identified. The median age was 66 years, and 56% were males. Common histologies included adenocarcinoma (43%), squamous cell carcinoma (32%), large cell carcinoma (7%), and broncheoalveolar carcinoma (7%). A referral to medical oncology for consideration of adjuvant chemotherapy was observed in 41% (44/108) of all patients including 62% (41/66) of those with stage > IA. Lower referral rate was associated with older age, stage I, and wedge resection while higher referral rate was associated with younger age, more advanced stage, large cell carcinoma subtype, and pneumonectomy. Adjuvant chemotherapy was prescribed in 27% (29/108) of all patients, including 41% (27/66) of those with stage > IA, and in 66% (29/44) of the patients referred to medical oncology. Of those referred to medical oncology, older patients and those who underwent wedge resection were less likely to receive chemotherapy. Of all patients, higher chemotherapy utilization was associated with younger age and more advanced stages. Conclusions: Adjuvant chemotherapy utilization in patients with resected NSCLC is low overall, especially among older patients and those with early-stage disease. However, a high proportion of the patients referred to medical oncology receive chemotherapy. Improved referral rates to medical oncology may increase the overall utilization rates of adjuvant chemotherapy in NSCLC. No significant financial relationships to disclose.
Barriers to participation in breast cancer trials
Authors: Herasme O. , Goldberg J. , Sandoval R. , Harris C. , Ortiz-Pride Y. , Jacobson J. , Schmitt K. , Kumah C. , Hershman D. , Grann V. 
Published: March 2020

6593 Background: Clinical cancer trials allow investigators to test the effectiveness and safety of new cancer drugs and treatments. Historically, fewer that 5% of cancer patients have participated in clinical trials. The purpose of this study was to assess attitudes, beliefs, and practical barriers to clinical trial recruitment. Methods: Women were recruited in the Herbert Irving Comprehensive Cancer Center while waiting for routine breast screening or for oncology care in connection with a diagnosis of breast cancer. The 29-item survey questionnaire covered demographic factors, prior cancer diagnosis or risk factors, past experience with clinical trials if any, willingness to participate in different types of trials, and attitudinal and practical barriers to participation. Results: Of 329 respondents, 48.9% were non- Hispanic white, 10.9% non-Hispanic black, 34.9% Hispanic, and 5.30% other/unknown. The mean age of participants was 52.5 (SD=12.1). Of 131 (39.8%) participants reporting that they had been asked to participate in clinical trial, 82 were white, 17 black and 32 Hispanic. Of those who enrolled, 64 were white, 14 were black, and 19 Hispanic. Of those asked to participate 56/63 breast cancer patients (88.9%) and 44/68 others (64.7%) enrolled (P=0.002). Of 48 who reported that they had child care responsibilities, 33 enrolled (68.8) compared to 67/83 (80.7%) of those without such responsibilities (P=0.07). Of the total sample, 88/220 (40.0%) of those without childcare responsibilities but only 32/109 (29.4) said they would be willing to participate in a placebo-controlled trial. Respondents were twice as likely to say they would participate in a trial comparing two active agents as a placebo-controlled trial. Conclusion: Our findings suggest that being asked to participate in a clinical trial may be associated with demographic factors, and that specific circumstances, such as child care responsibilities, may also affect trial participation. Awareness of these barriers may help investigators to develop effective strategies for overcoming them and for improving trial participation overall. No significant financial relationships to disclose.
A clinical pathways project to promote evidence-based medicine in a large community oncology practice
Authors: Neubauer M. A. 
Published: March 2020

6597 Background: Medical oncology therapy tends to vary widely due to a large number of drug choices and a wide array of reference sources for decision-making. It is assumed that this high variability reduces quality and efficient delivery of cancer care. We developed clinical pathways for common cancers in which we, after extensive review of seminal literature, distilled a succinct list of evidence- based regimens. We then instructed all physicians at KCCC (26 medical oncologists) to adhere to these pathways or write an exception to the pathway. Exceptions were reviewed by a practice peer-review committee before treatment was initiated. Methods: Included in this analysis is KCCC practice data on treatment choices for ALL patients who were started on treatment or had a change in treatment for breast cancer, non-small cell lung cancer, or colon cancer. All treatments required entry of patient information and staging information on a web-based pathway tool followed by selection of a pathway choice. If a physician preferred “off-pathway” treatment for his/her patient, then an exception sheet with an explanation for off-pathway therapy was submitted and reviewed before treatment. Data was collected from January 1, 2006 through October 31, 2006. The study endpoints were pathway adherence, pathway exception rate, and frequency of accrual to clinical trials. Results: Over a 10 month time period, there were 764, 624, and 326 patients treated for breast, non-small cell lung, and colon cancer, respectively. On-pathway treatment rates were 92.5%, 93.4% and 88.3%. Conversely, exceptions were utilized 7.5%, 6.6% and 11.7% of the time. Rate of accrual to clinical trials was 6.8%, 13.0% and 7.7% for breast, non-small cell lung and colon cancer. Conclusions: Strategies to support and enforce evidence-based medicine in a community based oncology practice can be successful in standardizing care, improving efficiencies, promoting clinical trial enrollment, and developing a practice profile. This pathway project is now being implemented throughout most of the US Oncology network. No significant financial relationships to disclose.
Characteristics of a phase II study that predict for a positive phase III trial—A study of 383 clinical trials
Authors: Ueda S. M. , Sugiyama V. E. , Stave C. , Shin J. Y. , Monk B. J. , Kapp D. S. , Sikic B. I. , Osann K. , Chan J. K. 
Published: March 2020

6604 Background: To identify the characteristics of a phase II study that predict for a subsequent positive phase III trial. Methods: All phase II studies and subsequent phase III clinical trials on biologics in advanced cancers published from 1985 to 2005 were extracted. Chi-square test and logistic regression models were used for analyses. Results: 383 phase III clinical trials and their preceding phase II studies were identified. 183 (47.8%) phase III trials were “positive” and 200 (52.2%) were negative. 220 trials (57.4%) used biologics alone and 162 (42.3%) used a combination of biologics and chemotherapy. Over the study periods 1985–1990, 1991–1995, 1996–2000, 2001–2005, the percentage of phase II studies that led to positive phase III trials increased from 37.7% to 33.3% to 56.0% to 76.8% (p<0.001). The interval between the publication of phase II and III studies, 0.5–5, 6–10, 11–15, and 16–20 years were also associated with the success of phase III trial, 55.6%, 42.2%, 32.6%, and 10.0%, respectively (p<0.001). Phase II studies from multiple rather than single institutions were more likely to have a successful trial (60.4% vs. 39.4%; p<0.001). The percent of successful trials from pharmaceutical companies was significantly higher compared to academic, cooperative groups, and research institutes (89.5% vs. 44.2%, 45.2%, 46.3%; p=0.002). The publication of the phase II studies in journals with an impact factor of 8 or greater compared to those less than 8 was also predictive (44.1% vs. 58.0%; p=0.024). Phase II studies with a lower attrition rate were also associated with a positive phase III trial (61.1% vs. 41.8%; p=0.025). On multivariable analysis, all factors, except for journal impact factor, were independent predictive factors for a positive phase III trial. Conclusions: In phase II biologic studies, characteristics such as larger number of patients, more recent year of study, multiple vs. single institution participation, shorter time period between publication of phase II to phase III trial, and lower rate of attrition were predictive factors of success in a phase III trial. Investigators need to be cognizant of these phase II study characteristics before designing phase III trials. No significant financial relationships to disclose.