bluuebunny/crossref_metadata_2025 huggingface dataset:
Quality of breast cancer care in NCCN centers as assessed by the ASCO/NCCN quality measures: Overall performance and reasons for nonconcordance
Authors: Hughes M. E. , Ottesen R. , Niland J. C. , Edge S. B. , Theriault R. L. , Wilson J. , Blayney D. W. , Wong Y. , Weeks J. C.
Published: August 2020

6506

Background: To assess the quality of breast cancer care in the National Comprehensive Cancer Network (NCCN), we compared practice against the ASCO/NCCN quality measures (QM). Methods: Using the NCCN Outcomes Database, we studied the care of women with newly diagnosed stage I-III breast cancer treated at 8 NCCN centers in 2003–6 to determine the proportion whose care was consistent with the 3 QMs (tamoxifen or anastrozole within 1 year of diagnosis for HR+ >1 cm tumors [HT]; post- lumpectomy radiation within 1 year of diagnosis for women <70 yo [RT]; and chemotherapy within 120 days of diagnosis of HR- >1 cm tumors for women <70 yo). Based on chart review, reasons for non-concordant care were classified as: 1) treatment recommended, but declined; 2) MD recommended against treatment; 3) non-recommended treatment administered; or 4) system problem (referral to the relevant specialist not documented or specialist not seen, delayed treatment initiation, or no relevant documentation in the chart). Results: 5,175 women were analyzable on at least one QM. Overall, treatment was consistent with the QM for 6,628/7,265 (91%) of the unique patient-recommendation pairs. Non-concordant care was received by 11% of patients eligible for the HT QM, 5% for the RT QM, and 13% for the chemotherapy QM. The reasons for non-concordance are shown in the table. Conclusions: Overall, breast cancer care in the NCCN is highly concordant with the ASCO/NCCN quality measures. System problems rather than patient refusal or physician recommendations account for the majority of care that deviates from the QM recommendations. This suggests that quality improvement targeting systems rather than physicians would be especially efficient and effective.

[Table: see text]

No significant financial relationships to disclose.
Absolute benefits of experimental medical therapies in phase III randomized clinical trials (RCTs) in breast and colorectal cancer
Authors: Seruga B. , Hertz P. C. , Wang L. , Booth C. M. , Krzyzanowska M. , Cescon D. W. , Tannock I. F.
Published: August 2020

6513

Background: New treatments are approved based on results of RCTs, which have become larger and powered to detect smaller absolute benefits (Booth et al, J Clin Oncol 26, 2008).The purpose of this study was to evaluate temporal trends in absolute benefits of experimental medical therapies in RCTs. Methods: RCTs with 200 or more participants evaluating medical therapies for breast and colorectal cancer were identified by searching Medline from 1975 to 2007. For each trial, absolute benefits were determined as: (i) the difference in either 3-year event-free survival (EFS) or 5-year overall survival (OS) for adjuvant trials, or in median survival for metastatic trials, as per usual practice; and (ii) the area between time-to-event curves for the treatment arms relative to total area, up to a given time. Monthly incremental cost of new therapies approved by the FDA between 1995 and 2007 were determined for treatments for metastatic disease. Results: We identified 236 eligible RCTs, with 57% evaluating adjuvant treatments for breast (N=102) and colorectal cancer (N=33). Median absolute benefits of experimental treatments decreased substantially in the last decade (Table) and were in the range of only 1.3 to 2.7% when analyzed as the relative area between time-to-event curves. Among RCTs evaluating treatment for metastatic cancer there was no change in absolute benefits with time, but incremental monthly cost of new approved treatments increased with time (1995: median $U.S. 65; 2007: median $U.S. 6560, p<0.0001). Conclusions: Evaluating absolute benefit as the relative area between time-to-event curves does not depend on the shape of the curves and is preferred. Over time, RCTs evaluating adjuvant treatment for breast and colorectal cancer show decreasing absolute benefit. New costly treatments may not assure meaningful clinical benefits.

[Table: see text]

No significant financial relationships to disclose.
Pharmacoeconomic study in head and neck cancer patients: Impact of prospective DPD deficiency screening with 5-fluorouracil (5-FU) dose tailoring on toxicities-related costs
Authors: Mercier C. , Brunet C. , Yang C. , Dupuis C. , Bagarry-Liegey D. , Duflo S. , Giovanni A. , Zanaret M. , Lacarelle B. , Duffaud F. , Ciccolini J.
Published: August 2020

6515

Background: Dihydropyrimidine dehydrogenase (DPD) plays a pivotal role in the detoxification of 5-FU. We studied the impact of screening DPD impairment in head and neck cancer (HNC) patients, both on reduction of drug-related toxicities and as a pharmacoeconomic endpoint. Methods: A total of 148 consecutive patients with HNC treated with 5-FU+platinum were monitored. Seventy-four patients (Arm A - before 2006) were treated with standard dosage, whereas 74 other patients (Arm B - after 2006) had their DPD status phenotypically evaluated prior to receiving 5-FU, with subsequent dose reduction if DPD deficiency were suspected. Severe toxicities and response were compared. Additionally, direct and indirect costs required to manage the treatment-related toxicities and to establish DPD status were calculated. Results: Sepsis was observed in 16.2% of patients treated with standard dosage. In Arm B, DPD deficiency was suspected in 35% of the patients and 5-FU dosage was subsequently reduced. Consequently, only 1.8% of them experienced sepsis. Of note, response rates were comparable between Arm A and B (62 vs 61%, p>0.05), thus demonstrating that 5-FU dose tailoring did not negatively impact on treatment efficacy, while reducing the occurrence of severe toxicities. Managing toxicities required an average 23-days of extra-hospitalization (4–96 days), including an average 1.6-day stay in ICU. No patients from Arm B had to stay in ICU. Drugs required for managing toxicities cost an average of $339 per patient (Arm A) and was reduced down to $38 per patient (Arm B). Similarly, mean extra-hospitalization cost was $5,940/patient in Arm A and $245/patient in Arm B. Testing DPD cost $49/patient in Arm B. Conclusions: Developing an adaptative dosing strategy based upon DPD status evaluation led to a dramatic reduction of the incidence of 5-FU-related severe toxicities, while maintaining optimal efficacy. Subsequently, extra-cost (medication + hospitalization costs) required to manage the toxicities fell down from $6,279 to $294/patient. Overall, this study advocates that systematic screening for DPD deficiency could be cost-efficient in the setting of 5-FU-based chemotherapies, with a reduction of 95% of the extra-costs.

No significant financial relationships to disclose.
The impact of obesity on adherence to the National Comprehensive Cancer Network (NCCN) guidelines recommending chemotherapy for patients with operable breast cancer
Authors: Brewster A. M. , Etzel C. , Zhou R. , Wong Y. , Edge S. B. , Blayney D. W. , Wilson J. , Hudis C. , Weeks J. C. , Theriault R. L.
Published: August 2020

6517

Background: Obesity (measured using body mass index [BMI]) is regarded as a prognostic factor for worse breast cancer survival. We hypothesized that obesity may influence adherence to NCCN guidelines recommending chemotherapy for patients with operable breast cancer at NCCN centers. Methods: We identified women < 70 years diagnosed with stage I, II, or III breast cancer from 1997 to 2006 at 8 NCCN centers for whom guidelines recommended chemotherapy. Body mass index was assessed in categories (<25 kg/m2 [normal], 25 to <30 kg/m2 [overweight], 30 to 39kg/m2 [obese], ≥40 kg/m2 [morbidly obese]) and in 5 kg/m2 increments. Multivariable logistic regression analysis adjusting for center, age at diagnosis, ethnicity, comorbidity score, and guideline was used to examine the association between BMI at diagnosis and non-receipt of chemotherapy. Results: 9,389 women were eligible for the study: 38% normal weight; 30% overweight; 23% obese; 5% morbidly obese; and 4% unknown. In multivariable analysis with BMI as a categorical variable, there was no association between weight status and non-receipt of chemotherapy (p = 0.35). When BMI was assessed in 5kg/m2 increments, weight status was a statistically significant predictor of non-receipt of chemotherapy (p = 0.02), but the odd ratios exceeded 1.0 only for BMIs ≥42.6kg/m2. Other patient-related factors associated with non-receipt of chemotherapy included older age at diagnosis (p < 0.01), presence of comorbidities (p < 0.01) and center (p < 0.01). Conclusions: Overall, the quality of breast cancer care as measured by adherence to NCCN guidelines recommending chemotherapy was not affected by patient overweight or obese status. Chemotherapy use was lower among patients with extreme morbid obesity, which may represent appropriate clinical decision-making. Evaluating factors that may contribute to worse prognosis among obese patients is essential for individualizing care and improving breast cancer outcome.

No significant financial relationships to disclose.
Differential survival after prostate cancer by race: Role of NCI-designated comprehensive cancer centers
Authors: Sun C. , Kurian S. , Washington G. , Nielsen-Menicucci K. , Wilson T. , Crocitto L. , Donald S. , Hanby C. , Landier W. , Smith S. , Bhatia S.
Published: August 2020

6520

Background: A significant gap exists between Caucasians and African-Americans (AAs) in prostate cancer mortality, possibly due to sociodemographics, disease biology, or treatment. Furthermore, differential access to care at NCI-designated Comprehensive Cancer Centers (NCICCCs) conceivably contributes to this difference. Methods: Using data from the Los Angeles Cancer Surveillance Program, we studied the underlying causes of differences in mortality in 18,790 men (AAs: 4,211; Caucasians: 14,579) diagnosed with prostate cancer between 1998 and 2003, and followed until 2006. Three NCICCCs serve this area: USC-Norris, UCLA-Jonsson, and City of Hope. Results: Median age at diagnosis was 67.5 yrs; AAs were significantly more likely to have lower SES; carry no insurance; have distant disease; and be managed with “watchful waiting.” The overall and prostate-specific survival was significantly superior for patients treated at NCICCCs, and for Caucasians (Table). Multivariate analysis, after adjustment for sociodemographics, race, insurance, tumor-related factors, and treatment-modality, revealed that treatment at NCICCCs was associated with lower overall (HR=0.74, 95% CI=0.6–0.9) and prostate-specific mortality (HR=0.69, 95% CI=0.5–0.97). AAs were less likely to utilize NCICCCs (OR=0.42, 95%CI=0.4–0.5). Finally, adjustment for sociodemographic, tumor/treatment-related factors, and treatment site abrogated the racial difference in overall (HR=1.08, 95%CI=0.99–1.2) and prostate-specific (HR=1.11, 95%CI=0.9–1.3) mortality. Conclusions: Patients treated at NCICCCs have lower mortality compared with other facilities. AAs are less likely to utilize NCICCCs for prostate cancer. AAs and Caucasians have comparable overall and prostate-specific survival, after adjustment for sociodemographic, tumor/treatment-related factors, and treatment site. Future studies are needed to understand barriers and facilitators to utilization of NCICCCs for management of prostate cancer.

[Table: see text]

No significant financial relationships to disclose.
Integrating cancer care: Patient and practice management processes among surgeons who treat breast cancer
Authors: Katz S. J. , Hawley S. T. , Griggs J. J. , Morrow M. , Hofer T. P.
Published: August 2020

6526

Background: The Institute of Medicine has called for cancer care models that parallel those underway to integrate the management of patients with chronic conditions. The objective of this study was to evaluate patterns and correlates of such initiatives in the practices of surgeons treating women with breast cancer. Methods: We developed 5 multi-item scales to describe breast cancer patient and practice management processes based on the Chronic Care Model (multidisciplinary clinician communication; availability of clinical information; patient decision support; access to information technology; and practice management initiatives). We then performed a survey among attending surgeons of a population-based sample of patients diagnosed with breast cancer during a period from June 2005-February 2007 in metropolitan Los Angeles and Detroit (N = 312, response rate 76.1%). We evaluated the distribution of management process measures across selected characteristics of providers and practices. Results: About half of the surgeons devoted 15% or less of their total practice to breast cancer; while 16.2% of surgeons devoted 50% or more. The deployment of management processes varied markedly with most surgeons reporting low use. For example, only about 10% of surgeons indicated that half or more of their patients were exposed to multidisciplinary physician communication; while only 5% indicated that half or more of their patients were provided decision and care support services such as attending a presentation or viewing a video about breast cancer prior to surgery or attended a patient support group. Management process measures were positively associated with greater levels of surgeon specialization and the presence of a teaching program. Cancer program status (NCI center, ACS cancer program, neither) was weakly associated with any of the management process measures. Conclusions: The low uptake of patient and practice management processes observed in this study suggests that breast surgeons are not convinced that these processes matter or that there are logistical and cost barriers to implementation. More research is needed to understand how variation in patient and practice management processes may affect the quality of care for patients with breast cancer.

No significant financial relationships to disclose.
Costs of treatments for local/regional prostate cancer
Authors: Snyder C. F. , Frick K. D. , Blackford A. L. , Herbert R. J. , Neville B. A. , Carducci M. A. , Earle C. C.
Published: August 2020

6527

Background: Men with prostate cancer have a variety of treatment options, including surgery, radiation, hormonal therapy, combinations thereof, or active surveillance. Treatment choice may have important cost implications. Methods: Using the SEER-Medicare database, we examined the Inpatient, Outpatient, Emergency, and Other costs of men diagnosed with local/regional prostate cancer in the year 2000 who were 66+ years old and enrolled in the fee-for-service Medicare program. Based on the treatments received in the first 9 months from diagnosis, men were assigned to these treatment groups: active surveillance, radiation, hormonal, hormonal+radiation, surgery (might also include radiation and hormonal therapy). We matched the prostate cancer cases to noncancer controls on age, race, sex, SEER region, comorbidity, and survival. We estimated the costs of prostate cancer care from 1 month pre- to 12 months post-diagnosis by calculating the incremental costs of care for cases vs. controls. Costs of care were estimated using Medicare payments. Results: 13,769 prostate cancer cases were matched with 13,769 controls and allocated to these treatment groups: active surveillance (n=2,805), radiation (n=2,582), hormonal (n=2,190), hormonal+radiation (n=3,992), and surgery (n=2,200). The most expensive treatment group was hormonal+radiation, with cases having a total average incremental cost of $17,795 vs. controls, followed by surgery ($15,467), radiation ($12,326), and hormonal therapy ($10,804). Active surveillance was the least expensive ($4,152). Outpatient costs were the major driver of increased costs for the hormonal+radiation group. Increased costs for surgery patients were driven by both Outpatient and Inpatient costs. Emergency Department and Other costs were generally similar between prostate cancer cases and controls. Conclusions: The treatment choice of men with local/regional prostate cancer has important implications for cost in the year following diagnosis. Additional analyses exploring long-term costs are needed.

[Table: see text]

No significant financial relationships to disclose.
Prevention of hip fractures in older men receiving androgen deprivation therapy for prostate cancer: A cost-effectiveness analysis
Authors: Ito K. , Elkin E. , Morris M.
Published: August 2020

6530

Background: Androgen deprivation therapy (ADT) increases the risk of osteoporotic fractures. Our goal was to assess the cost-effectiveness of bone mineral density (BMD) screening followed by alendronate therapy at the onset of ADT in men with T2c-T4N0 prostate cancer. Methods: We developed a Markov model of prostate cancer progression and simulated the experience of 70-year-old men with T2c-T4N0 prostate cancer starting a 2-year course of ADT after radiation therapy. We compared four strategies: No BMD screening and no alendronate therapy; BMD screening with alendronate therapy for men with osteoporosis (a T-score ≤ -2.5); BMD screening with alendronate therapy for men with osteoporosis or osteopenia (a T-score ≤ -1.0); and universal alendronate therapy without BMD screening. The main outcome measure was cost per quality-adjusted life year (QALY) gained. Data sources were U.S. epidemiological studies and health care cost figures. A model-based estimate of median survival was 9.5 years. Proportions of men who had a T-score ≤ -2.5 and -1.0 were 10% and 45%, respectively. A model-based incidence of hip fractures with no therapy was 0.93 per 100 person-years. Alendronate reduced the risk of hip fractures by 10%. Results: Compared with no screening and no therapy, BMD screening with alendronate therapy for men with osteopenia or osteoporosis cost $66,100 per QALY gained. BMD screening with alendronate therapy only for those with osteoporosis was slightly more costly and more effective, but had a less favorable ICER. Universal alendronate therapy without screening cost $1,580,300 per QALY gained. These results were most sensitive to assumptions about the impact of alendronate on the rate of BMD loss during ADT and the price of alendronate. Conclusions: In men with T2c-T4N0 prostate cancer, BMD screening with alendronate therapy for men with osteoporosis or osteopenia is a cost-effective use of resources, compared with other medical interventions in oncology.

[Table: see text]

No significant financial relationships to disclose.
The effect of a cancer diagnosis on disability status
Authors: Habermann E. B. , Virnig B. A. , McGovern P. M. , McBean A. M. , Alexander B. H. , Baxter N. N.
Published: August 2020

6531

Background: Although cancer and cancer treatments may lead to an inability to work, working-age adults eligible for Medicare benefits on the basis of disability face a 29-month waiting period between initial application due to disability and enrollment in the program. In this study we evaluated patterns of Medicare enrollment for working-age adults with cancer and determined factors predicting enrollment. Methods: The Surveillance, Epidemiology, and End Results (SEER) and SEER-Medicare data were used for this retrospective cohort analysis. We included patients age 21 to 59 diagnosed with lung, prostate, colorectal, and breast cancer (female) cases from 1992 through 2002. Patients were followed until 2005 or death. We constructed line plots of time from cancer diagnosis to enrollment in Medicare due to disability, anticipating a spike in enrollment around 29 months post-diagnosis. We compared demographic and tumor characteristics in the disabled to the all similarly aged patients included in SEER. We used logistic regression to determine factors associated with enrollment in Medicare due to disability 29 to 35 months post-diagnosis including demographic characteristics, stage at diagnosis, and type of surgical treatment. Results: We identified 359,049 working-age adults who were diagnosed with prostate, lung, colorectal, or female breast cancer. Within 5 years of diagnosis, 4.4% had enrolled in Medicare due to disability, most between 29 and 31 months post-diagnosis (the earliest time period of eligibility on the basis of cancer diagnosis). Later stage at diagnosis, lack of surgical treatment, aggressive surgical treatment, unmarried marital status, Hispanic or African American race/ethnicity, older age, and male gender were associated with statistically significantly higher odds of enrollment in Medicare due to disability. Conclusions: A significant number of working-age cancer patients become eligible for enrollment in Medicare due to disability. Most become eligible between 29 and 31 months after diagnosis indicating that cancer and/or treatment had a substantial permanent impact on ability to work from the time of diagnosis. Federal policy offering Medicare benefits only 29 months after application should be reevaluated.

No significant financial relationships to disclose.
Cardiometabolic risk in survivors of childhood cancer who received hematopoietic cell transplant (HCT)
Authors: Baker K. S. , Kelly A. S. , Petryk A. , Sinaiko A. R. , Steffen L. M. , Moran A. , Mulrooney D. , Dengel D. R. , Gujral K. , Zhou X. , Steinberger J.
Published: August 2020

6532

Background: Evidence suggests that survivors of childhood cancer are at increased risk for cardiovascular disease (CVD) and type 2 diabetes with even higher risk in those who received HCT. The purpose of this study was to compare the cardiometabolic risk factor profile in HCT patients and healthy sibling controls. Methods: Measures of insulin resistance (euglycemic hyperinsulinemic clamp adjusted for lean body mass [Mlbm], low Mlbm represents insulin resistance), fasting glucose, insulin, lipids, anthropometry, blood pressure (BP), and carotid artery compliance and distensibility (lower values represent arterial stiffness) were determined in 87 children and young adults (current age 27.3 yr, 57% male) who had received HCT for hematologic malignancy during childhood (mean age at HCT 11.8 yr) and 55 healthy sibling controls (current age=25.2 yr, 51% male). Linear regression models were used to evaluate risk factors between groups after adjusting for age, gender, pubertal stage, body mass index (BMI), and carotid lumen diameter (stiffness measures only). Results: Metabolic syndrome (ATP III criteria for adults, modified criteria for children) was present in 13 (14.9%) HCT survivors and 4 (7.3%) controls (p=0.19). Thirty-one (35.6%) survivors and 9 (16.4%) controls had two or more components of the metabolic syndrome (p=0.11). There were no differences between groups for BMI, waist circumference, percent body fat, or BP. HCT survivors had higher triglycerides, fasting glucose and insulin, lower HDL cholesterol, arterial distensibility, and were more insulin resistant (Table). Conclusions: HCT survivors have increased cardiometabolic risk factors independent of obesity suggesting that cancer itself and/or associated treatment exposures have a direct influence on CVD risk and that early screening and management of cardiometabolic risk factors should be considered in HCT survivors.

[Table: see text]

No significant financial relationships to disclose.
Adequacy of published oncology randomized controlled trials to provide details needed for clinical application
Authors: Duff J. M. , Leather H. L. , Walden E. O. , LaPlant K. D. , George T. J.
Published: August 2020

6536

Background: Randomized control trials (RCTs) provide evidence for life-saving and supportive therapies. Although manuscript submissions follow a standard scientific format, major oncology journals have minimal standards for reporting treatment administration. Published data investigating chemo and biologic therapy often lack details needed for effective and safe clinical application. Methods: All therapy-based phase III oncology RCTs published between 2005–2008 in the Journal of Clinical Oncology (JCO), The New England Journal of Medicine (NEJM), Journal of the National Cancer Institute (JNCI), Blood, and Cancer were eligible for inclusion. Physicians and oncology pharmacists were surveyed for details needed for clinical practice. Each article was evaluated for these mandatory elements ( Table ). Differences were calculated using the Chi-squared test. Results: Literature search identified 339 eligible articles, 77 were reviews or meta-analyses. 262 were included in the final analysis (165 JCO; 31 NEJM; 27 Cancer; 20 JNCI; 19 Blood). Only 31 (12%; median score 7.3) met the main objective of complete data reporting. The most consistently reported and missing elements are described in Table 1. Premedications, growth factor support, and dose adjustments for hematologic or organ toxicity were reported less than half the time (p<0.0001). The presence of an online appendix did not significantly improve the results (data not shown). Conclusions: RCTs published in top tier oncology journals fail to consistently report full details needed for clinical application. Manuscript submission guidelines should be modified to promote consistent reporting with potential use of online appendices. Standardized editorial policy may allow safe and effective translation of trial drug findings into clinical practice.

[Table: see text]

No significant financial relationships to disclose.
Racial differences in the use of contralateral prophylactic mastectomy among women undergoing BRCA1/BRCA2 genetic testing
Authors: Ready K. , Gutierrez-Barrera A. M. , Litton J. , Meric-Bernstam F. , Gonzalez-Angulo A. M. , Hortobagyi G. , Arun B.
Published: August 2020

6542

Background: Patients often use both positive and negative BRCA1/BRCA2 genetic test results to aid in surgical management decisions, but little is known about the existence of racial/ethnic differences in the use of genetic test results. The objective of this study was to evaluate differences in rates of contralateral prophylactic mastectomy (CPM) by race. Methods: A retrospective chart review was performed. Women with a personal history of breast cancer who underwent genetic testing for the BRCA1 and BRCA2 genes at our institution between 1996 and 2008 and were eligible for CPM were included in the study. Genetic test result, race/ethnicity as reported by the patient, years of follow-up since receipt of test result, and decision regarding CPM were recorded. Pearson chi square analyses and Fisher's exact tests were performed to test for significance. Results: 881 women were included in the study. Twenty percent (n = 180) were found to have a BRCA1 or BRCA2 mutation, while 80% (n = 701) were found to have an uninformative negative result. The study population was 87% (n = 771) Caucasian; 7% (n = 58) African American; and 6% (n = 52) Hispanic. Median follow up time was 3 years. There were no significant differences in either follow up time or percentages of BRCA positivity, based on race/ethnicity. Among those with a positive result, 45% (67/149) of Caucasians, 33% (5/15) of African Americans, and 50% (8/16) of Hispanics underwent CPM, but this was not statistically significant. Caucasians and Hispanics with positive results were significantly more likely than their counterparts with negative results to undergo CPM (Caucasians, 45%; 67/149 vs. 16%; 101/622; p<.001; Hispanics, 50%; 8/16 vs. 11%; 4/36; p = 0.004), but this same trend was not observed among African Americans (positive results, 33%; 5/15 vs. negative results, 14%; 6/43; p = 0.10). Conclusions: Among those with a BRCA1/BRCA2 mutation, there does not appear to be any significant difference in the use of CPM based on race/ethnicity. However, Caucasians and Hispanics appear to be more likely than African Americans to use the results of genetic testing to make surgical management decisions.

No significant financial relationships to disclose.
Quality of care for breast cancer patients in Japan: An analysis of the Japanese Breast Cancer Registry
Authors: Mukai H. , Higashi T. , Iwase T. , Sobue T.
Published: August 2020

6547

Background: In Japan, growing concern that patients do not receive optimum care led to the enactment of the Cancer Control Act in 2006, which mandates the government to undertake initiatives in ensuring the quality of cancer care. Here, we evaluated the current status of breast cancer care in Japan using process-of-care quality indicators (QIs) for breast cancer care. Methods: Combining clinical evidence and expert opinion, we developed 45 QIs covering the continuum of breast cancer care from initial evaluation to follow-up. Each QI describes standards of a particular aspect of care, and its score is calculated as the percentage of applicable patients who received the recommended care (adherence score). Of the 45 QIs, 7 could be scored using data in the Japanese Breast Cancer Registry, which covers about 40% of all Japanese breast cancer patients and has been continuously maintained since 1975. Results: The study population included 15,227 patients registered by 224 facilities in 2005. On average, patients received 72.1% of recommended care. However, substantial variation in adherence was seen across QIs (21–98%). Adherence score was less than 85% in five of seven QIs. Variation across facilities was observed in six QIs. Conclusions: The quality of breast cancer care in Japan has room for improvement in many aspects of care. Although the amount of data in the cancer registry suitable for quality assessment is limited, it is useful in detecting quality problems.

[Table: see text]

No significant financial relationships to disclose.
Trends in the application of dynamic allocation methods in multiarm cancer clinical trials
Authors: Pond G. R. , Tang P. A. , Welch S. A. , Chen E. X.
Published: August 2020

6550

Background: In multiarm oncology clinical trials there is always a risk that the treatment groups could be imbalanced for a prognostic factor, potentially biasing treatment comparisons and compromising the validity of the results. Stratified randomization (SR) is frequently used to reduce imbalances. Dynamic allocation (DA), also known as minimization, is a controversial and largely nonrandom method of treatment allocation that can incorporate more prognostic factors than traditional SR methods. Proponents argue that results from clinical trials implementing DA are potentially more credible, while opponents claim there is little added benefit, increased complexity, and the statistical properties are not fully understood. We reviewed multi-arm cancer trials published between 1995–2005 to describe trends in the application of DA methods. Methods: 476 clinical trials with at least 100 patients in each arm, published in 13 major journals were reviewed. Manuscripts were grouped by impact factor (IF) of the publishing journal into low (<10), medium (10–20) and high (20+) categories. Trial-specific factors associated with publication were collected along with details of allocation method. Results: 112 (24%) trials described using DA for assigning patients to treatment. 79% of trials employing DA methods included 3 or more stratification factors, compared with only 36% of other trials (p < 0.001). Reported use of DA was similar between industry and non-industry sponsored studies (p = 0.85) and by geographical region (p = 0.73). Of 364 trials which did not describe using DA, 103 (28%) reported using SR, but a statement describing stratification on at least one factor was included in 291 (80%) trials. A trend was observed that reported use of both DA (p = 0.072) and SR (p = 0.067) methods increased over time. DA was associated with publication in higher IF journals univariately (OR = 1.67, 95% CI 1.11–2.52, p=0.014) and after adjusting for identified prognostic factors (OR = 1.70, 95% CI 1.06–2.73, p = 0.028). No association between SR and higher IF journal publication was observed (p = 0.52 univariately and p = 0.44 adjusting for other factors). Conclusions: DA is frequently used in cancer clinical trials. Reported use of DA, but not SR, is associated with publication in high IF journals.

No significant financial relationships to disclose.
Metastatic breast cancer treated by chemotherapy: Trends in survival and costs in two patient cohorts treated in 1994–1998 and 2003–2006
Authors: Galy G. , Labidi S. , Perol D. , Carol C. , Guastalla J. , Favier B.
Published: August 2020

6552

Background: Although new chemotherapy agents have been approved during the past decade for the treatment of metastatic breast cancer (MBC), it is unclear whether their use has changed the outcome of patients. This study assessed the clinical and economic impacts of these drugs. Methods: We undertook a retrospective study of women diagnosed with MBC during two periods of time, 1994–1998 and 2003–2006 and compared overall survival data between the two groups. Female patients with MBC were identified from the Centre Léon Bérard (Lyon, France) database. Tumor and treatment characteristics, costs of chemotherapy, and patient outcome were compared using the X2 test, the log rank test, and Cox regression analysis. Overall survival was calculated from the date of MBC diagnosis to the date of death or last follow-up. Chemotherapy-related costs were calculated according to the 2008 pricelist of French cancer centers. Results: A total of 301 MBC cases were identified. The median follow-up of living patients was 3.87 years. No survival difference was observed between the two periods, with a median overall survival of 2.76 years for the 1994–1998 cohort (149 patients) and 2.68 years for the 2003–2006 cohort (152 patients) (HR 1.04, 95%CI 0.70–1.55; p = 0.83). The median number of lines of chemotherapy was similar in the two groups (=3). The median cost of chemotherapy per MBC patient was 3 times higher in 2003–2006 (25,320 €) than in 1994–1998 (8,865 €; p < 0.001). In multivariate analysis, prognostic factors for overall survival were the number of metastatic sites (HR 2.06; p < 0.0001), bone metastases (HR 0.67; p = 0.007), and hormone receptors (HR 0.56; p = 0.002). Survival was identical in HER-2 positive and HER-2 negative patients (HR 0.99; p = 0.99). Conclusions: Despite the implementation of numerous novel chemotherapeutic agents, the overall survival of patients with metastatic breast cancer has not improved over the last decade on the scale of our institution, whereas the costs of chemotherapy have significantly increased.

No significant financial relationships to disclose.
Trends in chemotherapy and biologic treatment of U.S. metastatic colorectal cancer patients
Authors: Foley K. M. , Wang P. F. , Long S. , Barber B. , Bagalman E. , Zhao Z.
Published: August 2020

6553

Background: Several long-standing chemotherapy regimens are available to treat metastatic colorectal cancer (mCRC) including: oxaliplatin plus 5-fluorouracil (5-FU) and leucovorin (FOLFOX); and Irinotecan plus 5-FU and leucovorin (FOLFIRI). More recently, new biologic therapies were approved for use in mCRC. This cohort study examines trends in first-line chemotherapy treatments for newly diagnosed mCRC patients after the introduction of capecitabine (CAP) in 2001 and the biologic therapies in 2004. Methods: Using a large, US-based administrative medical claims database of a national commercially insured population, patients with newly diagnosed mCRC were identified from 2001 to 2005. At least 6-months of patient history prior to mCRC diagnosis were required to confirm patients were newly diagnosed. Patients were followed from initial mCRC diagnosis to death, disenrollment, or 12/31/2006. Results: Total of 3,781 newly diagnosed mCRC patients were identified between 2001–2005. On average over the 5 years, 58% of patients (with annual variation ± 4% points) received chemotherapy/biologic treatment in the year following their mCRC diagnosis; mean days to initiation of chemotherapy treatment decreased from 135 to 62 between 2001–2005. In 2001, FOLFIRI (40%), 5-FU (30%), and CAP (20%) were the most prevalent first-line treatments. In 2005, first-line treatment regimens were more diverse: FOLFOX plus bevacizumab (35%), FOLFOX alone (15%), 5-FU (15%), and CAP (15%) were the most prevalent, while 33% of patients used other treatment combinations. Among mCRC patients diagnosed in 2005, 63% were treated with at least one biologic therapy in the first year after diagnosis (57% received bevacizumab; 26% received cetuximab). Conclusions: While rates of chemotherapy use remained relatively constant between 2001–2005, patients initiated chemotherapy treatment sooner after their initial diagnosis and the standard course of therapy shifted from being FOLFIRI-based to FOLFOX-based. A rapid uptake in biologic therapies occurred. The majority of newly diagnosed mCRC patients were users of biologic therapy within one year following their introduction.

[Table: see text]
Breast cancer patients' perceived quality of care: The importance of trust and communication
Authors: Franco R. , Joseph K. P. , Fei K. , Bickell N.
Published: August 2020

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Background: As insurers consider paying for performance and quality measures grow in importance, factors that affect patients’ perceived quality of cancer care matter. We undertook this study to assess predictors of women's ratings of the quality of their breast cancer care. Methods: 210 of 300 eligible women with stage I or II breast cancer at 1 of 8 participating NYC hospitals were enrolled in our survey: 43 (20%) were African-American (AA), 85 (40%) were white, and 63 (30%) were Hispanic and 19 (9%) were other races. All patients were telephone-surveyed to assess care experiences, knowledge, attitudes & beliefs about breast cancer and its treatment. Trust is based on a validated instrument and calibrated to a 100 point scale (Cronbach α = 0.73). A scale of 5 items assessing physician communication was created and calibrated to100 points (Cronbach α = 0.83). Results: Only 55% of women rated their quality of cancer care as excellent. Compared to women who did not rate their care as excellent, those who did had greater trust in their physician (p < 0.0001), better communication with their physician (p < 0.0001), indicated that were treated well by their physicians’ office staff (p = 0.01), and knew which physician to ask when they had questions (p = 0.0001); age, education & income were not significantly related to patient report of excellent care. AA women were least likely to rate their care as excellent (p = 0.004). AA women had lower levels of trust in their physician (p = 0.02). Patients reporting greater levels of communication also had greater trust (r = 0.38; p < 0.0001). Multivariate models evaluating the role of patient race, education, income, knowing which physician to talk to and how well the staff treated the patient found that being AA (aRR = 0.47; 95% CI: 0.21–0.88), having greater trust (aRR = 1.72; 95% CI:1.49–1.85) and better communication (aRR = 1.38; 95% CI: 1.03–1.65) were significantly associated with patient perception of excellent quality care (p < 0.0001). Conclusions: Greater levels of physician communication about treatment and patient trust of their physician affect women's ratings of excellent cancer care quality. Efforts should be made to improve physician communication about treatment, particularly among AA women, to improve levels of trust and ratings of cancer care quality.

No significant financial relationships to disclose.
Differences in uptake of postoperative adjuvant chemotherapy for lung cancer: Results from the Project for an Ontario Women's Health Evidence-Based Report Card (POWER) study
Authors: Barbera L. C. , Krzyzanowska M. , Elit L. , Saskin R. , Bierman A.
Published: August 2020

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Background: The goal of the POWER study is to improve health and reduce inequities among women of Ontario using performance measurement. Indicators are selected to facilitate assessment of care by sex and neighbourhood income. Results pertaining to the uptake of postoperative adjuvant chemotherapy for non-small cell lung cancer (NSCLC) are presented. Methods: An expert panel process was used to identify performance measures feasible to be evaluated from administrative data. Recent evidence suggests that adjuvant chemotherapy after resection of NSCLC is associated with improved survival. This measure was selected the by the expert panel. Data from Ontario Cancer Registry, Registered Persons Database as well as provincial billing and hospital databases was used to evaluate this measure stratified by age, sex, income and region. All adult patients who underwent resection of NSCLC between April 2003 and May 2004 were included in the cohort. Claims indicating chemotherapy administration within 6 months of surgery were considered adjuvant chemotherapy. Results: Overall in Ontario, the use of postoperative chemotherapy in NSCLC was 17.6% (95% CI 15.3%-20.2%) in April 2003 increasing to 32.9% (95%CI 29.8%-36.3%) in May 2004. In May 2004. use of chemotherapy decreased with increasing age: 47% of patients <65 years received chemotherapy versus 27% of patients aged 65–79. There was significant variation by region: in those under 65 years the rate of chemotherapy use among 14 regions ranged between 24–70 percent; in those 65–79 years it ranged between 18–35 percent. There was no difference in chemotherapy use between men or women or by neighbourhood income quintile. Conclusions: Rates of chemotherapy use almost doubled from April 2003 to May 2004, suggesting uptake of the new evidence in the treating community. Age and region-related, rather than sex or income, differences exist in the uptake of this new evidence. Further work is necessary to determine how these differences in uptake affect outcomes.

No significant financial relationships to disclose.
Quality not quantity: Key success factors from the first decade of safety reports from the Research on Adverse Drug Events and Reports project (RADAR)
Authors: Bennett C. , Edwards B. J. , Tigue C. C. , Raisch D. W. , Courtney D. M. , McKoy J. M. , West D. P.
Published: August 2020

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Background: RADAR is the only independent academic pharmacovigilance organization funded exclusively by peer-reviewed grants. We describe the role of high quality case reports in the detection of drug safety signals. Methods: RADAR has identified 11 cancer-related adverse drug reactions (ADRs). Initial reports for small numbers of cases were obtained from our own institution, NU, (4 ADRs) or from referral centers (7 ADRs). Clinicians at these centers voluntarily provided brief case reports to RADAR, who submitted detailed case reports to the FDA/manufacturer. Clinicians were promised that patient/provider data would be kept confidential and that these data would be submitted as peer-reviewed manuscripts. Results: See Table. Conclusions: RADAR was successful at signal generation and amplification because it focused on quality, not quantity of case reports. Pharmacovigilance efforts that allow clinicians to complete brief forms, maintain confidentiality of patient and provider, and result in submission of collaborative manuscripts may improve early detection of drug safety signals initiatives in oncology.

[Table: see text]

No significant financial relationships to disclose.
Are cancer cost-effectiveness analyses presented at major conferences published timely without bias? A systematic review
Authors: Chan K. K.
Published: August 2020

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Background: Cancer cost-effectiveness analyses (CEA) should be published timely without publication bias of studies with more favourable incremental cost-effectiveness ratios (ICER) in order to be informative to policy makers and stakeholders. This study examined the publication pattern of CEA presented in the annual meetings of the American Society of Clinical Oncology (ASCO) and the international annual meetings of the International Society of Pharmacoeconomics and Outcome Research (ISPOR). Methods: Abstracts from ASCO and ISPOR from 1997 to 2007 were reviewed. CEA with primary outcomes as incremental cost per life year gained or quality-adjusted life year (QALY) were included. Data including ICER (adjusted to USD), cancer type, country, and quality indicators were extracted. Publication search was conducted using Medline, HealthStar and EconLit. Time-to-publication analysis was conducted with exploratory analyses on predictors of publication. Results: 137 abstracts were included. Only 48 were published. The actuarial 1-, 2-, 3-, 5-year publication rates were 12%, 25%, 33%, 42%, respectively. CEA using a lifetime horizon (HR = 2.3, p = 0.01) were more likely to be published. There were trends of CEA presented in ASCO (HR = 1.8, p = 0.07) or on breast cancer (HR = 1.7 p = 0.06) towards being published. Favourable ICER and country did not predict publication. Among the 77 cost-utility analyses, when using cutoff at $20,000, $50,000, and $100,000/QALY, 55%, 82%, and 87% were cost-effective, respectively. US abstracts were more likely to report ICER > $50,000/QALY (OR = 4, p = 0.05). Quality indicators such as the use of lifetime horizon, societal perceptive, and probabilistic sensitivity analysis were stated explicitly in only 22%, 17%, and 16% of abstracts, respectively. Conclusions: The publication rate of CEA abstracts was low and not timely for open discussions among stakeholders when making policy decision. While there was no direct evidence of publication bias of favourable ICER CEA on the abstract-to-publication level, very favourable ICERs were reported by most abstracts, which might suggest non-submission of unfavourable ICER CEA for abstract presentation. The overall quality of study design or reporting of CEA abstracts appeared suboptimal.

No significant financial relationships to disclose.
Preferences and knowledge gaps among pediatric oncologists regarding the care of childhood cancer survivors: A survey of nearly 1,200 physicians
Authors: Henderson T. O. , Hlubocky F. , Diller L. , Daugherty C.
Published: August 2020

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Background: Pediatric oncologists' attitudes and knowledge about the long-term follow-up (LTFU) care of childhood cancer survivors (CCS) have not been well described. Methods: We surveyed pediatric oncologists' self-reported attitudes and knowledge regarding the LTFU care of CCS. Following a pre-notification letter, surveys with a $5 gift card were mailed to 1,173 U.S. pediatric oncologists in November 2008. A second mailing for non-responders is planned. Results: With surveys still arriving, 536 have been returned (46% response rate). Median age of respondents is 47 years (range: 32–82 years); 56% men; 69% work in a children's hospital; 17% in a cancer center; 3% in a private practice. Respondents have practiced a median 14 years (range: 1–50 years) and see a median of 23 patients/week (range: 0–250 patients/week). 70% of respondents say their center has a LTFU clinic. Choosing from closed-ended responses: 37% say they prefer to follow CCS as long as possible, 21% prefer for the patients to be followed by a physician other than themselves, and 29% are willing to follow them in the absence of a more suitable physician. In describing comfort levels in caring for CCS (1 = very uncomfortable; 7 = very comfortable), respondents were most comfortable with survivors < 21 years (mean 6.2 + 1.4). For CCS >21 but <30 years, respondents were less comfortable (mean 5.0 + 1.5), and were uncomfortable caring for CCS > 30 years (mean 3.3 + 1.7). 84% of respondents report eventually referring CCS to a LTFU program (40%), to a primary care physician (23%) or to an adult oncologist (12%). In a clinical vignette of 29 year old women exposed to mantle radiation and anthracyclines (150 mg/m2) for Hodgkin's lymphoma at 16 years of age: 30% of respondents did not appropriately recommend yearly breast cancer surveillance (based on Children's Oncology Group LTFU guidelines); 41% of respondents did not appropriately recommend cardiac surveillance; and 15% of respondents did not appropriately recommend yearly thyroid screening. Conclusions: Pediatric oncologists express a range of preferences with regard to LTFU of CCS and CCS over 21 years of age. Many appear unfamiliar with LTFU surveillance recommendations.

No significant financial relationships to disclose.