bluuebunny/crossref_metadata_2025_split huggingface dataset:
Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT
Authors: Pagani Olivia , Francis Prudence A. , Fleming Gini F. , Walley Barbara A. , Viale Giuseppe , Colleoni Marco , Láng István , Gómez Henry L. , Tondini Carlo , Pinotti Graziella , Di Leo Angelo , Coates Alan S. , Goldhirsch Aron , Gelber Richard D. , Regan Meredith M. ,   for the SOFT and TEXT Investigators and International Breast Cancer Study Group
Published: October 2019

PURPOSE The Tamoxifen and Exemestane Trial (TEXT)/Suppression of Ovarian Function Trial (SOFT) showed superior outcomes for premenopausal women with hormone receptor (HR)–positive breast cancer treated with adjuvant exemestane plus ovarian function suppression (OFS) or tamoxifen plus OFS versus tamoxifen alone. We previously reported the magnitude of absolute improvements in freedom from any recurrence across a continuous, composite measure of recurrence risk to tailor decision making. With longer follow-up, we now focus on distant recurrence. METHODS The TEXT/SOFT HR-positive/human epidermal growth factor receptor 2 (HER2)–negative analysis population included 4,891 women stratified by predetermined chemotherapy use. Kaplan-Meier estimates of 8-year freedom from distant recurrence were analyzed using subpopulation treatment effect pattern plot (STEPP) methodology across subpopulations defined by the continuous composite measure of recurrence risk. For each patient, the composite risk value was obtained from a Cox model that incorporated age; nodal status; tumor size; grade; and estrogen receptor, progesterone receptor, and Ki-67 labeling index expression levels. RESULTS The overall rate of 8-year freedom from distant recurrence was 91.1% and ranged from approximately 100% to 63% across lowest to highest composite risks. TEXT patients who received chemotherapy had an average absolute improvement with exemestane plus OFS versus tamoxifen plus OFS of 5.1%, and STEPP analysis showed improvements from less than 1% to more than 15% from lowest to highest composite risks. SOFT patients who remained premenopausal after chemotherapy had an average 5.2% absolute improvement with exemestane plus OFS versus tamoxifen and reached 10% across composite risks; for tamoxifen plus OFS versus tamoxifen, the maximum improvement was approximately 3.5%. Women who did not receive chemotherapy had a more than 97% rate of 8-year freedom from distant recurrence, and improvements with exemestane plus OFS ranged from 1% to 4%. CONCLUSION Premenopausal women with HR-positive/HER2-negative breast cancer and high recurrence risk, as defined by clinicopathologic characteristics, may experience a 10% to 15% absolute improvement in 8-year freedom from distant recurrence with exemestane plus OFS versus tamoxifen plus OFS or tamoxifen alone. The potential benefit of escalating endocrine therapy versus tamoxifen alone is minimal for those at low recurrence risk.
Financial toxicity among veterans with cancer.
Authors: Parikh Divya Ahuja , Ragavan Meera Vimala , Khateeb Sana , Patel Manali I. 
Published: October 2019

103 Background: Financial toxicity of cancer care has not previously been studied within the Veterans Health Administration (VHA). The VHA provides health care for veterans in VA hospitals across the United States (US). It is a single-payer system and the largest integrated health system in the US and in this study we sought to assess financial toxicity experienced by veterans at a VA hospital. Methods: We asked veterans with oncology clinic visits at the VA Palo Alto to complete a survey that included an 11-item validated questionnaire called the COST tool. The COST tool calculates a score 0-44 with higher scores suggestive of higher financial toxicity. We also assessed demographic factors including gender, education, race, income, and insurance status as well as monthly out of pocket costs (OOPC) and suggested resources to reduce burden. We coded responses and calculated descriptive statistics with proportions. Results: A total of 84 veterans completed the survey and demographic factors are depicted in Table. Veterans were predominantly male (96%), high school or less educated (46%), white (61%), with annual income less than $50,000 (81%), and VA insurance (95%). The mean COST score was 21. The majority of veterans (63%) reported less than $100 of monthly OOPC and many (56%) reported transportation as a major expense and requested transportation resources. Conclusions: Financial toxicity is an unmet concern among veterans. Despite low monthly OOPC in the VHA single-payer system, financial toxicity as measured by the COST score at a VA hospital was as high as a nearby academic center. Transportation was the most significant expense and future studies should evaluate interventions to reduce the financial burden of transportation for veterans. [Table: see text]
Lost productivity and time in patients with metastatic breast cancer receiving treatment.
Authors: Ingram Stacey A. , Williams Courtney , Gilbert Aidan , Lawhon Valerie , Davis Jasmine D. , Wan Clara , Dekle Kendal , Lowman Janel , Jones Jonathan , Rocque Gabrielle Betty 
Published: October 2019

106 Background: Costs for cancer patients are not all monetary. For patients with limited life expectancy, such as metastatic breast cancer (MBC) patients, time spent in the hospital or clinic setting can become burdensome. The goal was to evaluate time spent on healthcare among patients receiving treatment for MBC. Methods: This survey-based, cross-sectional study included women ≥18 years with MBC who received treatment at two academic medical centers in Alabama from 2017-2019. Questions regarding employment status, MBC-related hours missed from work, and time spent on healthcare-related activities were used to quantify lost productivity and time. Descriptive statistics included means and standard deviations (SD) or medians and interquartile ranges (IQR) for continuous variables and frequencies for categorical variables. Effect sizes were calculated using Cohen’s d or Cramer’s V. Results: We surveyed 83 female MBC patients with a median age of 59 years (IQR 50-66). Among all respondents, 34% were African American, 41% held a college degree, and 52% had a household income of < $40,000. Patients spent a median 60 minutes (IQR 30-110) traveling from their home to clinic and a median 120 minutes (IQR 60-180) receiving care at a clinic visit. Though not statistically significant, modest differences were found for patients with differing insurance types in travel time. Patients with Medicare had the shortest travel time (median 45 minutes [IQR 30-75]) compared to Medicaid (60 minutes [IQR 60-80]) and private insurance (60 minutes [IQR 30-120]; d = .06).). Patients spent a median 30 minutes (IQR 0-60) on cancer care related activities outside of a clinic visit. Most patients were retired (31%); however, 15% worked full-time, 6% worked part-time, and 20% were on disability. For working women, a median of 8 hours (IQR 1-11) were missed from work in the week. Conclusions: This study highlights productivity losses uncaptured by current patient healthcare cost calculations. Further work is needed to identify and minimize these additional patient costs related to lost productivity during cancer treatment.
A cost-effectiveness analysis of primary prophylaxis (PP) versus secondary prophylaxis (SP) with biosimilar myeloid growth factors (MGFs) for preventing chemotherapy-induced febrile neutropenia (FN) in non-Hodgkin lymphoma (NHL) patients at intermediate risk.
Authors: Lyman Gary H. , Mezzio Dylan , Li Edward C. , Campbell Kim , Balu Sanjeev 
Published: October 2019

107 Background: Historically, PP with a MGF was recommended in patients with a ≥40% risk for developing chemotherapy-induced FN, based on clinical and regimen-related factors. Previous economic studies provided evidence to lower the threshold to 20%, the current high-risk threshold listed by practice guidelines. Biosimilar MGFs, such as filgrastim-sndz or LA-EP2006 (a proposed pegfilgrastim biosimilar), offer an opportunity to evaluate whether it is cost-effective to further lower the threshold for intermediate-risk regimens (i.e., 10-20% FN risk). Methods: A Markov model was constructed to evaluate the total costs and clinical outcomes of biosimilar or reference MGFs when used as PP vs. SP in patients 55 years old with NHL receiving 6 cycles of R-CHOP chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) with no additional FN risk factors. Model inputs, including MGF efficacy and acquisition costs, were estimated from publically available data and literature, as were FN hospitalization costs and clinical utilities. Incremental cost-effectiveness ratios (ICERs) were calculated for cost per FN event avoided, life-year saved (LYS), and quality-adjusted life-year (QALY) gained from a payer perspective within the United States. Deterministic and probabilistic sensitivity analyses were conducted. Results: Use of filgrastim-sndz as PP vs. SP provided an additional 0.130 QALYs (0.144 LYS) at an incremental cost of $5,999. The ICERs were $50,676, $41,761, and $46,207 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. Using LA-EP2006 as PP vs. SP provided an additional 0.166 QALYs (0.184 LYS) at an incremental cost of $17,648. The ICERs were $123,840, $95,963, and $106,265 for cost per FN event avoided, cost per LYS, and cost per QALY gained, respectively. Conclusions: Within NHL patients receiving R-CHOP at an intermediate risk for FN, PP with filgrastim-sndz and LA-EP2006 are cost-effective compared to their respective use as SP based on a cost-effectiveness threshold of $150,000/QALY.
Cost implications of growth in new cancer drugs in a comprehensive cancer center.
Authors: Venkatesan Sukanya Murali , Chaudhuri Anamika , Fraile Belen 
Published: October 2019

112 Background: Rising costs of cancer therapies calls for strategizing towards sustainable care delivery models from a hospital planning, payer as well as policy-making perspective. This topic becomes increasingly significant as there is exponential growth of novel, high-cost immunotherapy drugs making it imperative for players to adopt and practice value-based oncology. Objective: This study aims to evaluate increasing trends in use of new and transformative cancer therapies, and associated drug costs in a comprehensive cancer center in Massachusetts. Methods: Study period was fiscal year (FY) 2015-2018. Utilization was defined by the number of patients receiving infusion and number of visits made by them to the center during the FY. Cost was defined as expense to hospital. Data source was hospital billing database. ASP (Average Sales Price) of drug was obtained from CMS website and was used as an indicator for cost per unit of the drug. Results: Top 10 drugs were identified based on total cost incurred in the study period and contributed to almost a third of center’s total cost. Over the three years, number of visits for these drugs grew up to 700% and treated patients grew up to 350%. Use of chemotherapy in isolation decreased from 35% of treated patients in FY15 to 26% in FY18, whereas its use in combination with immunotherapy increased from 22% in FY15 to 28% in FY18. Average drug cost to hospital per patient for the study period ranged as high as $120,000 (excluding non-drug treatment costs). Conclusions: While clinical value of the new cancer therapies is unquestionably significant, there is a dire need for policy-makers, providers and payers alike to pay continued attention towards its high cost implications as observed in this study and, continue striving towards establishing more sustainable pricing policies through alternative payment models.
Community oncologists' perceptions three years after the Oncology Care Model.
Authors: Kish Jonathan Karl , Yeh Ting-Chun , Gajra Ajeet , Smith Yolaine , Feinberg Bruce A. 
Published: October 2019

113 Background: The Oncology Care Model (OCM) is a Medicare-sponsored delivery and payment innovation pilot under the broader concept of value-based care (VBC). OCM aims to provide better quality and coordinated cancer care at reduced cost. The OCM participants, 176 practices and 10 payers who provide care to nearly half of Medicare beneficiaries, entered into payment arrangements based on financial and performance accountability for episodes of care surrounding chemotherapy administration. We sought to understand the impact of OCM adoption on community physicians 3 years into the pilot. Methods: A live meeting in April 2019 convened a sample of US-based community oncologists to discuss “The OCM Experience”. Audience response survey methodology addressed: participation in OCM and/or related commercial programs, implementation, operation and perceptions of outcomes to patient care and practice. Results: Regarding VBC initiatives at the practices (n = 48) of 57 providers: 61% identified their practice participated in OCM, 31% in other commercial payer pathway program, and 17% in other commercial payer VBC reimbursement (not mutually exclusive). Regarding impact of OCM on improving access to care: 60% indicated having same-day appointments, 45% 24/7 HCP access, 22% weekend hours and 18% evening clinic hours. Regarding changes to patient care: 58% stated OCM driven initiatives reduced ER visits, 48% reduced hospitalizations, 62% increased palliative care referrals, and 54% increased hospice referrals. Regarding impact on practice: 41% felt an increased administrative burden with 50% hiring administrative staff, advanced practice providers, and patient navigators, but only 11% hiring physicians. The 13-component oncology care plan was reported by 53% as “not easy” to devise. The “most challenging” components included estimating total out of pocket expenses (61%) and creating a plan to address psychosocial needs (16%). 49% respondents found their practices’ OCM transformation meaningful and 46% found it not very/not at all meaningful. Conclusions: The impact of OCM/VBC transformation upon community oncologists and their practices appear to be quite profound, while the precise impact on their patients remains to be determined.
Cost implications of potentially avoidable hospitalizations among Oncology Care Model patients with prostate cancer.
Authors: Smith William H. , Parikh Anish B , Li Lihua , Sanderson Mark , Liu Mark , Mazumdar Madhu , Isola Luis M. , Dharmarajan Kavita Vyas 
Published: October 2019

114 Background: Hospital-based care remains a major contributor to cost in oncology and thus represents an important cost-saving opportunity. We previously developed a rigorous two-stage consensus driven review process to identify potentially avoidable hospitalizations (PAHs) among oncology care model (OCM) patients with prostate cancer and reported a 28% rate of PAHs between 1/2012-6/2015. Our current objective was to estimate the magnitude of any expected cost savings generated if inpatient care from these PAHs were shifted to an acute care model in the outpatient setting. Methods: Costs for ambulatory acute care management among a separate but characteristically similar cohort of cancer patients were obtained from our institution’s recently established Oncology Care Unit (OCU), where acute clinical issues are managed in an enhanced ambulatory setting. We used an exact-matching algorithm to match previously identified PAHs to OCU visits based on strata of age (≤ 70 years vs. > 70 years), categorically defined chief complaint (infusion/transfusion, lab abnormalities, symptom control, and diagnostic work-up), and the presence of “systemic disease” (metastatic disease or hematologic malignancy). PAH costs obtained from OCM data were compared to costs from these matched OCU encounters. Results: We identified 89 acute care OCU visits occurring from 5/2017-12/2018, of which 48 were fully evaluable based on documentation. Twenty-five of our initial 28 PAHs (89%) matched to 29 OCU acute care visits. The mean inpatient cost among matched PAHs was $15,879 compared to $975 for matched OCU visits. Boot strapping within each match produced a mean estimated cost savings of $15,120 (95% CI $13,682 to $16,557) per PAH. We estimate this per event savings to yield an overall spending decrement of 5.7% for OCM prostate cancer episodes. Conclusions: PAHs contribute substantially to costs of care in oncology. Investment in specialized ambulatory acute care services for oncology patients could lead to meaningful cost savings by shifting avoidable inpatient care to the outpatient setting.
ICU utilization among oncology patients at the end of life.
Authors: Hong Jennifer , Kurian Christine , Minetola Jared , Csik Valerie Pracilio , Binder Adam 
Published: October 2019

118 Background: Patients with advanced cancer have high rates of hospitalizations as a result of their oncologic care. Furthermore, these patients receive aggressive end of life care despite evidence that aggressive end of life care does not improves quality of life or outcomes for patients and is associated with worse bereavement adjustment for caregivers. The American Society of Clinical Oncology has endorsed several indicators of aggressive end of life care, but most striking is intensive care unit (ICU) admission within 30 days before death. Methods: Adult oncology patients who died within 30 days of hospitalization and/or admitted to the ICU from 10/2018-3/2019 at an academic medical center were evaluated. The cohort was identified using ICD-10 codes, EMR systems support, and manual chart review. Patient demographic data, cancer type, stage, line of therapy, code status, advanced care plan, prior admissions as well as other clinical characteristics were collected. Results: In total, 180 patients were included for analysis; 106 of which were admitted to the ICU. Of patients admitted to the ICU, 58 patients died (54.7%). Mean ECOG performance status was 1.24. Average number of admissions 3 and 6 months prior to death was 0.71 and 1.26. Thirty six percent of patients were on first or second-line chemotherapy. 41.37% of patients who died in the ICU had prolonged length of stay (>1 week). Only 34.48% were known to palliative care prior to admission and 12.06% of patients had advanced care plans in place at time of hospitalization. Palliative care was consulted on 32.75% of patients who died in the ICU. Ninety Three percent had their code status changed prior to death. Conclusions: Despite established recommendations to support otherwise, at our institution there continues to be high utilization of ICU care near the end of life. Previous admissions and ECOG status are poor predictors of death in this cohort. The majority of patients had relapsed and refractory disease. There was a low rate of advanced care planning or palliative care involvement prior to the patient’s hospitalization. Further interventions are underway to improve end of life planning in order to improve our quality of care.
Patients enrolled in clinical trials with Medicaid or no insurance and overall survival benefits from new interventions.
Authors: Unger Joseph M. , Blanke Charles David , LeBlanc Michael Leo , Barlow William E. , Hershman Dawn L. 
Published: October 2019

119 Background: Very few new treatments tested in randomized phase III cancer clinical trials show an overall survival (OS) benefit. Understanding whether the benefits are consistent among all patient groups is critical for informing guideline care. However, within trials, there is limited power to examine demographic or insurance subsets, especially in under-represented groups. Here we systematically examine whether positive treatment effects apply to all demographic and insurance groups. Methods: We examined all SWOG treatment trials completed from 1985-2014, and pooled data from trials with a statistically significant (p < .05) OS benefit for the experimental treatment. We conducted multivariable Cox regression analyses adjusting for clinical risk level and stratifying by study-specific 2-year OS probability ( < 25% vs. 25-75% vs. > 75%). Interaction tests determined whether OS hazard ratios (HRs) differed by 5 prespecified factors including age ( < 65 vs. ≥65), race (black vs. other), sex, ethnicity (Hispanic vs. non-Hispanic), and insurance status in patients < 65 years (private insurance vs. Medicaid/no insurance). Results: We identified 16 trials, containing 9,328 patients, with statistically significantly better OS in the experimental arm. The OS HR did not differ by sex (p = .60), race (p = .68), or ethnicity (p = .66). However, patients ≥65 years had a smaller treatment benefit than patients < 65 (HR = 1.24 vs HR = 1.37, p = .03), and patients with Medicaid/no insurance had a smaller treatment benefit than private insurance patients (HR = 1.22 vs. HR = 1.70, p = .03). Conclusions: The magnitude of the OS benefit from experimental treatments may not be uniform among demographic and insurance status groups. Older age patients and those with suboptimal insurance are at greater risk of experiencing competing risks of death, which can reduce power to identify the benefits of new experimental therapies. Trial designs should account for the risk of non-cancer deaths in important patient groups. Future research should examine whether reduced treatment impact is due to a higher comorbid burden in older patients, and to worse adherence to protocol care in those with limited financial resources.
Improving patient access in radiation oncology from referral to consult.
Authors: Baracena Daphne , Jaboin Jerry Jeff , Bednar Michelle 
Published: October 2019

122 Background: To increase patient access, Oregon Health & Science University set an institution-wide metric for ambulatory clinics to contact the patient within a specified time frame. For our study, we utilized targets of patient contact within three days from the date of referral and of scheduling and resolving referrals within six days. Since the reports for these metrics did not provide detailed reasons for the consult delays, we were unable to assess if these delays were due to pending patient action, provider recommendations, providers’ overbooked schedules, and/or an inefficient intake process. Methods: We targeted two providers’ schedules with the highest consult-to-treatment turnover and determined that 45% of consult delays were due to intake processing. The Department implemented two PDSA cycles: internal metrics were set for 97% of the patients to be contacted within three days and for 100% within six days; and a standardized workflow for the providers’ patient list was provided. Results: After the first PDSA cycle, patient contact within three days declined from 80% to 62% and within six days from 57% to 45%. However, the percent of patients scheduled within six days increased from 61% to 64%. After the second PDSA cycle, patient contact within three days increased to 70% and within six days to 68%. About 76% of referrals were scheduled within those six days. Conclusions: Although patient contact within three days declined from the baseline data for both PDSA cycles, we found that there was a gradual increase in patients being contacted and scheduled within six days, especially after the second PDSA cycle. Despite the progress observed, we did not hit our internal metrics and intend to launch an automated patient list to further improve intake processing.[Table: see text]