bluuebunny/crossref_metadata_2025 huggingface dataset:
A machine learning approach to predicting short-term mortality risk for patients starting chemotherapy.
Authors: Parikh Ravi Bharat , Elfiky Aymen , Pany Maximilian J. , Obermeyer Ziad
Published: September 2018

6538

Background: Patients who die soon after starting chemotherapy incur symptoms and financial costs without survival benefit. Prognostic uncertainty may contribute to increasing chemotherapy use near the end of life, but few prognostic aids exist to guide physicians and patients in the decision to initiate chemotherapy. Methods: We obtained all electronic health record (EHR) data from 2004-14 from a large national cancer center, linked to Social Security data to determine date of death. Using EHR data before treatment initiation, we created a machine learning (ML) model to predict 180-day mortality from the start of chemotherapy. We derived the model using data from 2004-11 and report predictive performance on data from 2012-14. Results: 26,946 patients initiated 51,774 discrete chemotherapy regimens over the study period; 49% received multiple lines of chemotherapy. The most common cancers were breast (23.6%), colorectal (17.6%), and lung (16.6%). 18.4% of patients died within 180 days after chemotherapy initiation. Model predictions were used to rank patients in the validation cohort by predicted risk. Patients in the highest decile of predicted risk had a 180-day mortality of 74.8%, vs. 0.2% in the lowest decile (area under the receiver-operating characteristic curve [AUC] 0.87). Predictions were accurate for patients with metastatic disease (AUC 0.85) and for individual primary cancers and chemotherapy regimens—including experimental regimens not present in the derivation sample. Model predictions were valid for 30- and 90-day mortality (AUC 0.94 and 0.89, respectively). ML predictions outperformed regimen-based mortality estimates from randomized trials (RT) (AUC 0.77 [ML] vs. 0.56 [RT]), and National Cancer Institute Surveillance, Epidemiology, and End Results Program (SEER) estimates (AUC 0.81 [ML] vs. 0.40 [SEER]). Conclusions: Using EHR data from a single cancer center, we derived a machine learning algorithm that accurately predicted short-term mortality after chemotherapy initiation. Further research is necessary to determine applications of this algorithm in clinical settings and whether this tool can improve shared decision making leading up to chemotherapy initiation.
Implementation of a telechemotherapy center in the Peruvian jungle to improve patients' quality of life.
Authors: Vidaurre Tatiana , Valencia Fernando , Alcarraz Cindy Elizabeth , Vasquez Chavez Jule Franve , Becerra Litol , Sanchez Obeth , Mas Luis , Neciosup Silvia P. , Gómez Henry L.
Published: September 2018

6547

Background: Instituto Nacional de Enfermedades Neoplásicas (INEN) is located in Lima (capital of Peru). There are no oncologists in regions like Peruvian jungle. Approximately 6% of medical attentions at INEN are people from this cities; so they must spend money and time to receive their treatment far from their cities. The purpose was to implement a module of outpatient chemotherapy in a non-specialized hospital, located in Peruvian jungle, for chemotherapy administration monitored by oncologists from INEN through the use of information and communication technologies (ICT). Methods: Two working teams were organized by formal agreement between INEN and local authorities to properly implement the infrastructure and to train local staff from December 2014 to November 2015. Questionnaire EORTC QLQ-C30 (v3) was used to assess QoL at the beginning and 3 months later. Results: A chemotherapy room with 18 armchairs, an area with a laminar flow hood to mix drugs at pharmacy, and videoconferencing equipment were implemented in Lamas, San Martin (1100 Km from Lima). Two general practitioners, 3 nurses and a pharmacist from Lamas, were trained during 3 months at INEN. Since November 2015, 31 patients were admitted. They received 181 cycles of chemotherapy in 248 rounds of administration, monitored by teleconference. Additionally 227 videoconference meetings to evaluate patients and to coordinate with local team were performed. Global health status improved from 76.67% to 83.33%. We observed benefit in functional scales, likewise symptoms related to disease did not vary, nevertheless financial difficulties decreased from 33.3% to 6.67%. In terms of money and time, this meant an average saving of $150.00 and 4 hours of travel time. Conclusions: Using ICT, we successfully implemented a tele-chemotherapy module in the heart of Peruvian jungle without harming patients quality of life. They will not need to travel to Lima for receiving their treatment.
Forecasting financial impact of alternative payment models to cancer drug manufacturers.
Authors: Hinkel Jennifer M. , Sexton Daniel B. , McGivney William T
Published: September 2018

6549

Background: Payers are moving from fee-for-service (FFS) reimbursement models towards value-based Alternative Payment Models (APMs). In Medicare, this trend has emerged via MACRA legislation and the Oncology Care Model (OCM). Reimbursement changes carry financial implications for payers, providers, and drug manufacturers. Methods: Financial impact of APMs was modeled as a function of Volume Factors and Price Factors in sales of a cancer drug product. Volume Factors included utilization patterns and market share. Price Factors included launch price, price increases, and both mandated and negotiated discounts. The model described three APM categories: Buy & Bill Plus (similar to OCM), Episode-Based Payment, and Third-Party Buy & Bill. The model included assumed timelines of APM implementation and the share of commercial insurer and Medicare markets implementing. Assumptions were generated in a multi-stakeholder workshop applying a modified Delphi method and Nominal Group Technique to arrive at consensus. The model included input ability for existing product forecast data including expected patient numbers, market share, payer mix, channel mix, price, 340B discount parameters, and additional concessions. Combinations of inputs and assumptions were run through the model as scenarios to generate results. Results: Across all scenarios, Episode-Based Payment resulted in revenues averaging 34% below baseline forecast at the ten-year mark. Third-Party Buy and Bill resulted in revenues averaging 100% of baseline at the ten-year mark. Buy and Bill Plus resulted in revenues averaging 66% below baseline at the ten-year mark. Market share as a function of clinical differentiation appeared to be a significant factor influencing revenue impact, with highly differentiated products outperforming others in all APMs. Conclusions: While much attention is paid to the impact of reimbursement reform on oncology provider economics, with subsequent impacts to patient access, less attention has been focused on impact to drug manufacturers. APM implementation could significantly impact manufacturer revenues, which in turn may impact both access to such therapies and research investment towards new anti-cancer therapies.
Factors associated with 21-gene assay receipt among women with lymph node positive breast cancer.
Authors: Roberts Megan , Kurian Allison W. , Petkov Valentina I.
Published: September 2018

6554

Background: The 21-gene Breast Recurrence Score (RS) assay predicts breast cancer (BC) recurrence and adjuvant chemotherapy benefit in select patients with lymph node-positive (LN+), hormone receptor-positive (HR+), HER2 negative BC. This study examines factors associated with assay uptake among women with LN+ BC in SEER databases. Methods: In this population-based study, incident BC cases in SEER registries (2010-2013) were linked to RS results from assays performed by Genomic Health. Our study sample included women with non-metastatic, LN+ (≥1 positive LN), HER2-, HR+, BC. We use logistic regression to identify demographic, SES, and tumor characteristics associated with having the 21-gene assay ordered. Results: A total of 4428 (14.0%) of 31520 women with LN+, HR+, HER2-, BC had the assay ordered. Uni- and multi-variate analyses identified key factors that were significantly associated with the proportion of women tested. In the multivariable analysis, age (aOR: 2.23, p<0.001, 65-74 v <45 years) and BC diagnosis year (aOR:1.75, P<0.001 2013 vs 2010) were positively associated with assay receipt; whereas number of positive LN (aOR: 0.14, p<0.001, 4+ positive LN vs 1 positive LN), tumor grade and size, low SES, being black, and being widowed were negatively associated with assay uptake (p<0.001). Having Medicaid was associated with lower odds of test receipt (p=0.01). Finally, we identified geographic variation in assay ordering. See univariate results (Table). Conclusions: Important demographic and SES variables were associated with test receipt in LN+ disease, and differed from those previously reported in node negative disease. Moving forward, increased awareness of these disparities, particularly among low SES, Medicaid, Black and widowed patients, along with targeted interventions may help to improve quality of care and equity in test receipt. [Table: see text]
Financial assistance for fertility preservation at cancer diagnosis: An analysis of the LIVESTRONG Fertility program.
Authors: Omesi Lenore , Narayan Aditi , Schear Rebekkah , Reinecke Joyce , Levine Jennifer
Published: September 2018

6555

Background: Fertility preservation (FP) is a critical component of comprehensive adolescent and young adult (AYA) cancer care that is discussed and/or offered to only a fraction of eligible patients. Barriers include lack of insurance coverage making FP prohibitively expensive for many patients. The Sharing Hope program, now known as LIVESTRONG Fertility, was created by Fertile Hope in 2004 and acquired by LIVESTRONG in 2009. LIVESTRONG Fertility provides financial assistance to AYA cancer patients through discounted FP rates and access to free medications through a pharmaceutical company. Our aims were to review demographic characteristics of patients served, identify geographic utilization patterns, and quantify the program’s financial impact. Methods: De-identified records maintained by Fertile Hope/LIVESTRONG from 2004 to 2011 were retrospectively reviewed. Patient population, treating institutions and cost savings/patient were summarized using descriptive statistics. Results: 1171 men and 1319 women were approved for financial assistance between 2004 and 2011. Median age was 24 years (range 12-67) for men and 30 years (range 13-49) for women. The most common diagnoses included testicular cancer (34%) and Hodgkin Lymphoma (HL) (18%) among males and breast cancer (48%), HL (13%) and genitourinary cancers (13%) among females. Applications were received from individuals residing in 49 of the United States, as well as Washington DC and Puerto Rico. The applicants received care from a total of 1,245 cancer centers. For men, $438,711 was saved, averaging $375/patient. For women, $3,904,303 was saved in practitioner cost and $4,665,775 in medication costs averaging $6,497/patient. Conclusions: Financial assistance for FP at the time of a cancer diagnosis for AYAs is a persistent and growing need. Female cancer patients face significantly greater costs to preserve fertility. Further studies are needed to determine the true financial burden to patients and the degree to which lack of financial resources and insurance coverage prevent FP in this population. [Table: see text]
An intervention study to reduce black-white treatment disparities in early stage non-small cell lung cancer.
Authors: Walker Paul R. , Cykert Sam , Edwards Lloyd , Arya Rohan , Dilworth-Anderson Peggye
Published: September 2018

6560

Background: Racial disparities in the treatment of non-small lung cancer (NSCLC) continue to exist leading to poorer outcomes in African-Americans (AA) compared to Caucasians (C). Our previous multi-institutional prospective cohort study of 386 patients identified a surgical rate in early stage NSCLC of 66% C but only 55% AA (p = 0.05; OR 0.75; 95% CI 0.57-0.99). (Cykert et al JAMA 2010) A 3 year retrospective chart review of all patients with early stage NSCLC at the 3 academic institutions involved in this current intervention study identified 714 patients with early stage NSCLC. Baseline surgical rates 69% for C and 66% for AA. Combined stereotactic body radiation therapy (SBRT) with surgery C 80% and AA 76%. Controlling for co-morbidities, COPD, age and other demographic data, the OR for surgery AA compared to C 0.64 (95% CI 0.43-0.96) and for combined surgery or SBRT AA compared to C 0.61 (95% CI 0.43-0.96). Methods: Patients with a stage I or II NSCLC were identified and randomized to each institution’s standard of care approach or to an ‘intervention’ component utilizing a trained navigator to enhance patient communication and treatment understanding. Results: 244 patients were prospectively recruited into this intervention study. Mean age 65.7 years; 54% women; 89 (34%) AA. The intervention group showed an overall surgical rate of 74% (74.8% C, 71.4% AA; p = 0.6). Combined treatment of either surgery or SBRT increased an ablative treatment to 91.9% for C and 94.1% AA patients (p = 0.5). Logistic regression was performed comparing the intervention group to the baseline group. Results showed that overall treatment improved for both C and AA, the surgical and overall treatment disparity between C and AA was no longer present, while age, COPD, and clinical stage remained significant predictors of treatment. Conclusions: A multifaceted intervention designed to enhance patient communication and treatment understanding removed the surgical and overall early lung cancer treatment disparity between AA and C. Clinical trial information: NCT01687738.
Disparities in prognosis communication among parents of children with cancer: The impact of race and ethnicity.
Authors: Ilowite Maya , Cronin Angel M. , Kang Tammy I , Mack Jennifer W.
Published: September 2018

6562

Background: Most parents of children with cancer say they want detailed prognostic information about their child’s cancer. However, prior work has been conducted in populations of limited diversity. We sought to evaluate the impact of parental race/ethnicity on prognosis communication experiences amongst parents of children with cancer. Methods: We surveyed 357 parents of children with cancer, and the children’s physicians at Dana-Farber Cancer Institute/Boston Children’s Hospital and Children’s Hospital of Philadelphia. Our outcome measures were parental preferences for prognostic information, physician beliefs about parental preferences, prognosis communication processes and communication outcomes. Except where noted, associations were assessed by logistic regression with generalized estimating equations to correct for physician clustering. Results: 87% of parents wanted as much detail as possible about their child’s prognosis, with no significant differences by race/ethnicity (P = .50). Physician beliefs about parental preferences for prognosis communication varied based on parent race/ethnicity. 60% of physicians for White parents reported they believed parents wanted as much detail as possible about their child’s prognosis, versus 36%, 38%, and 64% of physicians, respectively, for Black, Hispanic, and Asian/Other parents (P = .04). Parent race/ethnicity was not associated with actual prognostic disclosure as reported by parents (P = .79) or by physicians (P = .61). Accurate understanding of prognosis was higher amongst White (51%) versus non-White parents (range 22%-29%), although this difference was not statistically significant (P = .13, unadjusted). Conclusions: The majority of parents, regardless of racial and ethnic background, want detailed prognostic information about their child’s cancer. However, physicians rarely recognize the information needs of Black and Hispanic parents. Despite this discrepancy, prognosis communication outcomes were largely equivalent. Our findings suggest that in order to meet parents’ information needs, physicians should ask about the information preferences of parents of children with cancer prior to prognosis discussions.
Miami NICE trial: Nutritional support for patients incurring chemotherapy side effects.
Authors: Hansra Damien Mikael , Diaz Catherine , Camp Skip , Randolph Caroline , Norman-Tiner Christine , Antunez de Mayolo Jorge
Published: September 2018

6568

Background: Few studies have been performed addressing nutritional interventions & mitigation strategies to address side effects such as weight gain, anorexia, dysgeusia, in patients (pts) undergoing chemotherapy. We aim to study the effect of nutritional counseling on body mass index (BMI) and other side effects in pts undergoing systemic chemotherapy. Methods: Prospective randomized study of 50 pts into two groups (A & B). Group A was randomized to standard of care: oncologist visits once per month x 3 months, routine physician counseling & dietary recommendations. Group B: standard of care + nutritionist intervention which included 3 visits x 30 mins each. Nutritionists performed an initial assessment of pts at the first session (template provided in poster) then tailored dietary counseling monthly x3 months which includes dietary strategies to mitigate side effects, pt & caregiver education, recipes, & handouts (provided in poster). Inclusions: medically insured male & female adults with active malignancies (hematologic &boncologic) on chemotherapy (neoajuvant, adjuvant, palliative). Exclusions: pts with head & neck, stomach, esophagus, pancreatic tumors & pts with pre-existing cachexia. Data collected: pt gender, age, race, ethnicity, cancer subtype, TNM staging, chemotherapy regimen. Primary objective: compare change in BMI at visit 1, 2, &3. Secondary endpoints: anorexia, nausea, vomiting, depression, etc. reported in poster. Mean change in BMI, secondary endpoints compared using students T-test with ANOVA using SAS software version 8.0 & minitab version 17. Results: Group A initial BMI = 28.85 vs group B initial BMI = 27.34 (p = 0.05). Change in BMI group A vs B at visit 1 (0.4 vs 0.09, p = 0.002), visit 2 (4.6 vs -0.52, p = 0.001), visit 3 (6.5 vs 0.46, p = 0.003). Demographics & secondary endpoints reported in poster. Conclusions: We found dietary counseling in addition to standard of care was associated with significant mitigation of weight gain in patients on systemic chemotherapy. Dietary counseling is a relatively simple, inexpensive, individualized, & reproducible method to mitigate chemotherapy related weight gain.
Prospective assessment of psychosocial outcomes of contralateral prophylactic mastectomy.
Authors: Brewster Abenaa M. , Peterson Susan K. , Bedrosian Isabelle , Thompson Alastair Mark , Black Dalliah MaShon , Nelson Jonathan , Cook Robert , DeSnyder Sarah Marie , Hunt Kelly , Cantor Scott B. , Volk Robert Joseph , Dong Wenli , Parker Patricia A.
Published: September 2018

6569

Background: Increasing numbers of women are choosing contralateral prophylactic mastectomy (CPM) despite the lack of knowledge about its effect on long-term psychosocial adjustment. The objective of the study was to examine patient-centered psychosocial outcomes of women with breast cancer who have CPM versus those who do not in order to enhance shared surgical decision making. Methods: We enrolled 308 women with newly diagnosed, non-hereditary breast cancer prior to surgery (CPM or no CPM) at MD Anderson Cancer Center and Kelsey-Seybold Clinic between 2012 and 2015. Women completed validated questionnaires assessing psychosocial factors including quality of life (QOL), body image concerns, cancer distress, trust in physician and decision satisfaction pre-surgery and at 1, 6 and 12-months post-surgery. Repeated measures models were fitted to assess the association between psychosocial outcomes measured at each time point and CPM status adjusting for time effect. Results: Among 252 women (mean age 56) who completed pre and post-surgery questionnaires, 60% were non-Hispanic white, 16% non-Hispanic black, 16% Hispanic, 8% mixed race and 17% had CPM. Women who had CPM had higher scores for cancer distress and body image concerns and lower scores for QOL than women who did not have CPM at pre-surgery (p = 0.04, p < 0.01, p = 0.20, respectively), and at 1 month (p = 0.42, p < 0.001, p < 0.01, respectively), 6 months (p = 0.03, p < 0.001, p = 0.05, respectively) and 12 months (p = 0.01, p < 0.001, p = 0.01, respectively) post-surgery. After adjusting for time effect, women who had CPM had higher post-surgery scores for cancer distress (p = 0.03), body image concerns (p < 0.0001), QOL (p < 0.01) and lower trust in physician (p = 0.03) than women who did not have CPM. There was no statistically significant difference by CPM status for cancer knowledge or decision satisfaction. Conclusions: This is the first study to demonstrate that psychosocial factors such as cancer distress, QOL and body image concerns are not improved by having CPM. The results highlight the importance of evaluating psychosocial factors pre- and post- surgery and the need to incorporate psychosocial assessment and counseling in the CPM decision making process.
Understanding the non-curative potential of palliative chemotherapy: Do patients hear what they want to hear?
Authors: Enzinger Andrea Catherine , Wind Jen , Frank Elizabeth , McCleary Nadine Jackson , Cronin Christine , Sanoff Hanna Kelly , Van Loon Katherine , Matin Khalid , Bullock Andrea J. , Meropol Neal J. , Uno Hajime , Schrag Deborah
Published: September 2018

6575

Background: Misconceptions about the curative potential of PC are common, and may arise from gaps in informed consent. Another contributing factor could be patients’ desire, or lack of desire, for information about prognosis and PC outcomes. Methods: We surveyed 137 patients with advanced colorectal (N = 102) or pancreatic cancer (N = 35) within 2 weeks of consultation about 1st or 2ndline PC, as part of randomized trial of a PC education intervention at 6 US sites. Patients rated how much information they wanted about PC risks/benefits, including impact on prognosis. Responses ranged from no information to as much as possible on a 5-point Likert scale. They reported decision-making preferences; whether a doctor discussed curability, and how likely they thought PC was to cure their cancer. Chi square and Wilcoxon tests examined whether information and decision-making preferences, or curability discussions were associated with expectations of cure. Multivariable logistic regressions evaluated whether associations were modified by age, race, gender, marital status, or cancer type. Results: Only 44.5% of patients accurately reported that their cancer was not at all likely to be cured by PC. Most patients wanted a lot, or as much information as possible about PC risks/benefits, including likelihood of cure (81.7%), cancer control (84.7%), and impact on length of life (80.3%). Most patients preferred shared (70.8%) versus active or passive decision-making. Neither decision-making nor prognostic information preferences were associated with expectations of cure. Patients (13.9%) who did not recall curability discussions were less likely to have accurate expectations (21% v 48%; OR, 0.29; 95% CI, 0.07-.97). Patient characteristics did not significantly confound this association. Conclusions: Most patients value shared decision-making and want maximal information about PC risks/benefits, including impact on prognosis. Despite wanting prognostic information and reporting curability discussions, many patients report inaccurate expectations about cure from PC. Future studies should examine whether these assertions reflect misunderstandings, differences in belief, or expressions of hope.
Prophylactic anticoagulation to benefit younger patients under 65 years of age with metastatic lung cancer: An analysis of the 2013 Healthcare Cost and Utilization Project (HCUP) data.
Authors: Bagchi Arindam , Iyer Veena , Hamouda Danae , Nai Qiang , Khuder Sadik , Verghese Cherian
Published: September 2018

6581

Background: Cancer patients have increased risk of venous thromboses. Venous thromboembolism (VTE) is reported to be a leading cause of death in cancer patients. It has been hypothesized that prophylactic anticoagulation for VTE might improve prognosis and quality of life. Based on our analysis of the 2013 HCUP data, we propose that prophylactic anticoagulation should be considered for patients younger than 65 years with metastatic lung cancer. Methods: Patients were selected using ICD-9 diagnoses codes for metastatic lung cancer and VTE. Diagnoses were stratified by site including upper extremity, lower extremity, pulmonary, abdominal and nonpulmonary thoracic VTE. Patients were stratified by age, sex, race and ethnicity. Differences in incidence of VTE among groups were calculated by the Chi-Square method using the SAS software. Results: There were a total of 16,577 VTE events amongst 182,863 cases of metastatic lung cancer. Subgroup analyses showed that patients younger than 65 years of age had 356.82 more PE events per 100,000 individuals compared to those at or older than 65 years (p < 0.0001). The same age group also showed 374.83 more UE, 286.94 more nonpulmonary thoracic and 263.97 more abdominal (Abd) VTE events per 100,000 individuals (p-values, p < 0.0001). There was no statistically significant difference in the incidence of LE VTE’s between the subgroups. Conclusions: Prophylactic anticoagulation should be considered in patients < 65 years of age with metastatic lung cancer. Increased incidence of VTE in these patients may contribute towards greater morbidity and mortality associated with metastatic lung cancer in this subgroup. [Table: see text]
Patterns in provider types and cost of surveillance testing in early-stage breast cancer patients: A regional study.
Authors: Lyman Gary H. , Fedorenko Catherine R. , Walker Julia Rose , Panattoni Laura Elizabeth , Greenlee Stuart , Kreizenbeck Karma L. , Greenwood-Hickman Mikael Anne , Barger Sarah , Blau Sibel , McGee Richard A. , Conklin Ted , Smith Bruce , Ramsey Scott David
Published: September 2018

6582

Background: Although ASCO Choosing Wisely guidelines recommend against routine surveillance testing or imaging for asymptomatic individuals with early-stage breast cancer (ESBC) treated with curative intent, they are frequently performed. Physician specialty and costs associated with surveillance testing and imaging were examined in ESBC patients. Methods: Cancer registry patient records in Western Washington from 2007 to 2015 were linked with claims from two regional commercial insurers. Selected patients had been diagnosed with stage I/II breast cancer and treated with mastectomy or lumpectomy + radiation. Surveillance was considered from the first 4 month gap in treatment (surgery, chemo, radiation) through 13 months or restart of treatment. Evaluation and Management (E&M) and procedure codes for tumor marker (CEA, CA 15-3, CA 27.29) and advanced imaging (PET, CT, bone scan) were identified. Specialty codes were used to determine provider type. Physician visits were matched to tests using E&M codes in the +/- 7 days around each test. Cost included total reimbursed amount from insurers during the surveillance period. Results: During surveillance, 2,193 patients averaged 13.3 physician visits [median: 11, IQR: 8-17]. Oncologists (91%) and PCPs (83%) were the most common specialties with an average of 3.7 visits each. Overall, 37% of patients received tumor marker tests (avg = 2.8 tests/patient) and 17% received advanced imaging (avg = 1.5 images/patient). The mean total cost during the surveillance period was $18,403 (SD $26,640). Costs were higher for those patients who received tumor marker testing or advanced imaging. Conclusions: Patients frequently see oncologists and PCPs during early surveillance. Targeting oncologists to improve appropriate tumor marker testing could have the largest impact on aligning practice with Choosing Wisely recommendations and potentially reducing the financial burden on patients. [Table: see text]
Transparency around disapproval reasons of early-phase trial proposals submitted to the National Cancer Institute (NCI).
Authors: Massett Holly A. , Gravell Amy , Waters Brittany , Mishkin Grace , Denicoff Andrea , Ivy S. Percy , Moscow Jeffrey , Zwiebel James A. , Montello Michael , Abrams Jeffrey S.
Published: September 2018

6585

Background: NCI’s ETCTN accepts Letters of Intent (LOI) for a new clinical trial either from a response to a solicitation for studies, or via unsolicited LOIs, where investigators independently propose novel studies. While the LOI approval rate for the first two years of the ETCTN was 100% for solicited LOI’s, it was only 36% for unsolicited LOIs. Therefore, we analyzed all ETCTN LOI disapproval letters (DL) for unsolicited LOIs to identify the major reasons for disapproval. Methods: A content analysis was conducted on DLs issued between March 2014 and March 2016 (N = 50). Two coders independently scored disapproval reasons per letter using a code sheet with 22 categories identified from a sample of DLs (Intercoder Reliability = 97%). Results: All DLs were issued for unsolicited LOIs (44% = Ph 1; 26% = Ph 1/2; 30% = Ph 2); 271 reasons were identified across the 50 DLs (mean = 5.4/DL). High-level categories included concerns with study design, scientific rationale, feasibility, modality and administrative reasons. The top disapproval reasons were: Insufficient preclinical animal model data (54% of DLs); weak rationale/background (52%); inadequate information for biomarker correlative studies (46%); dose/scheduling plan absent or weak (36%); clinical data not adequately advanced (34%); and, patient population not described/inconsistent with treatment (34%). Top reasons for Phase 1 and 1/2 LOIs resembled the total but Phase 2 LOIs deviated slightly, with ‘weak objective/endpoint’ and ‘biomarker correlative studies’ as top DL reasons. Other common reasons were problems with combination study agents, company/drug collaboration, and competing trials. Conclusions: The reasons for LOI disapproval can be categorized and quantified. To increase transparency in the NCI ETCTN LOI review process, disapproval reasons for each DL are now collected on a standardized coding sheet, and will be reported quarterly to ETCTN PIs. NCI will also meet with all Grant PIs in Spring, 2017 to jointly discuss concerns and explore quality improvement solutions regarding the LOI submission process. The outcome of this meeting will be reported at ASCO as part of our findings.
Physician volume and discontinuation of rituximab during lymphoma treatment.
Authors: Huntington Scott F. , Long Jessica B. , Hoag Jessica R. , Wang Rong , Zeidan Amer M , Giri Smith , Gore Steven , Ma Xiaomei , Gross Cary Philip , Davidoff Amy J.
Published: September 2018

6593

Background: Despite the high complexity of cancer therapies, studies evaluating provider-level volume and outcomes of systemic treatments are lacking. As rituximab was the first approved monoclonal immunotherapy, and has the potential for severe infusion reactions, we hypothesize that low provider volume is associated with early rituximab discontinuation. Methods: We conducted a retrospective cohort study using Surveillance, Epidemiology, and End Results -Medicare data.Individuals 66+ years old with B cell non-Hodgkin lymphoma (NHL) diagnosed during 2004-2011 and 1+ rituximab claims were included. A provider was assigned to each patient-rituximab initiation using Medicare claims. We used a 12-month lookback from each initiation to categorize provider volume (0, 1-2, or 3+ rituximab initiations) in the prior year. Our primary outcome was early discontinuation, defined as receipt of 1-2 rituximab cycles within 180 days of initiation. We used a modified Poisson regression to account for provider level correlation and estimated the relative risk of early discontinuation in patients with 6+ months of follow up after rituximab initiation. A Cox proportional hazards model was used to measure the impact of discontinuation on overall survival. Results: A total of15,110 patients (median age: 75 years) initiated rituximab with 2,684 providers. The majority (70.4%) initiated rituximab in conjunction with chemotherapy and 1,146 (7.6%) experienced early rituximab discontinuation. Provider experience with rituximab during the previous 12 months was associated with early discontinuation in a dose-dependent manner (adjusted relative risk [aRR]: 1.57, [95% confidence interval [CI]:1.35-1.83], p < .001 for 0 vs 3+ initiations; aRR: 1.19 [95% CI:1.03-1.37], p = .02 for 1-2 vs. 3+ initiations). In addition, rituximab discontinuation was associated with a higher risk of death (adjusted hazard ratio: 1.39 [95% CI:1.28-1.52], p < .001). Conclusions: Lower physician volume is associated with increased risk of early discontinuation in older adults initiating rituximab for NHL. Due to the association between early discontinuation and mortality, physician volume may be an important factor in providing high quality NHL care.
Patient safety: A progressive deprescribing model in patients with advanced solid tumors assisted at Instituto Oncológico Henry Moore (IOHM).
Authors: Gil Deza Ernesto , Morgenfeld Eduardo L. , Rivarola Edgardo G. J. , Muino Marcelo , Garcia Gerardi Carlos Fernando , Tognelli Flavio , Abal Mariana , Ares Sandra L. , Montiel Monica , Gercovich Felipe G.
Published: September 2018

6594

Background: "Deprescribing is the process of withdrawal of an inappropriate medication, supervised by a health care professional with the goal of managing polypharmacy and improving outcomes" ( Br J Clin Pharmacol 80:6, 1254. 2015). The aim of this paper is to present a model for deprescribing used at IOHM. Methods: Between 09/26/2012 and 09/26/2016, 10,053 pt filled out a Past Medical History Form, listing all the medications they were taking regularly. We selected all the pt. with advanced solid tumors (AST). In each pt the expected survival was established in order to evaluate the usefulness of the Tx. The drugs were classified in three groups: A) Green: Adequate (must be maintained); B) Yellow: Questionable (could be maintained or removed) or C) Red: Avoidable (must be removed). Results: We registered 2,103 pt who met the inclusion criteria. Sex F/M: 905 /1198. Median age 63 y (r = 19-99). A total of 1,629 pt. (77%) were taking medications on a regular basis. The total amount of medications was 5,679 . Median medications per patient: 3 (range: 1-14). Eighty percent of the pt (1,298 pt) were receiving questionable of avoidable medications. The following table shows the distribution of medications per group. Conclusions: A) In this cohort of 2,103 pt with AST, half of them had an average life expectancy of less than one year. B) 1,298 out of 1,629 pt (80%) were receiving a questionable medication C) 596/5,769 (10%) of the registered drugs, had to be suspended immediately and at least a thousand more could be eliminated. d) Obstacles to deprescribing were essentially medical ignorance, fear and inexperience. [Table: see text]
Measuring cancer care experiences: Introducing SEER-CAHPS.
Authors: Rincon Maria Andrea , Kent Erin , Lines Lisa M , Gaillot Sarah , Schussler Nicola C. , Halpern Michael T. , Mollica Michelle , Smith Ashley Wilder
Published: September 2018

6595

Background: Care experience ratings are recognized as measures of healthcare quality. Here we introduce a new, public data resource, SEER-CAHPS, which links cancer registry data from the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) program with Medicare claims and the Medicare Consumer Assessment of Healthcare Providers and Systems (MCAHPS) survey. Methods: The SEER-CAHPS resource includes cancer registry data from 1973-2011 (diagnosis, incidence, mortality, and sociodemographic data), Medicare CAHPS survey data from 1998-2013 (sociodemographic, health status, and care experience ratings), and Medicare fee-for-service (FFS) claims data from 2002-2013. The survey includes global ratings of overall care, personal doctor, specialist, health plan, and prescription drug plans, and composite ratings of doctor communication, care coordination, getting needed care, and getting care quickly. Data also contain survey weights to account for the Medicare CAHPS sampling design. Cross-sectional and longitudinal analyses are possible. Results: Currently, SEER-CAHPS includes 205,339 individuals with a history of cancer documented in SEER (FFS: 26,802 with a survey before cancer diagnosis, and 55,231 with a survey after cancer diagnosis; Medicare Advantage [MA]: 57,227 with a survey before cancer diagnosis and 71,436 with a survey after cancer diagnosis). The data resource also includes 724,965 MCAHPS respondents without cancer in SEER regions (FFS: 282,592; MA: 447,358). The data provide insights on topics including experiences of cancer patients in their last year of life; experiences of cancer survivors; and the associations of guideline-concordant follow-up care with patient experiences among cancer survivors. We will demonstrate project sample-size estimation and present instructions for submitting data access applications. Conclusions: SEER-CAHPS, a new, publicly available resource, provides population-based, cancer-specific data on patient experiences, health outcomes and healthcare utilization.
Trends in aggressive care at the end-of-life for stage IV lung cancer patients.
Authors: Mrad Chebli , Abougergi Marwan S , Daly Robert Michael
Published: September 2018

6614

Background: Prior studies have demonstrated that high-intensity end-of-life care improves neither survival nor quality of life for cancer patients. The National Quality Forum endorses dying from cancer in an acute care setting, ICU admission in the last 30 days of life, and chemotherapy in the last 14 days of life as markers of poor quality care. Methods: Discharge data from the National Inpatient Sample database was analyzed for 3,030,866 acute care hospitalizations of metastatic lung cancer patients between 1998 and 2014. Longitudinal analysis was conducted to determine trends in aggressive care at the end-of-life and multivariate logistic regression was performed to determine associations with age, race, region, hospital characteristics, and aggressive care. Results: In-hospital mortality for metastatic lung cancer patients decreased from 17% to 11%. Among terminal hospitalizations, utilization of radiation therapy and chemotherapy decreased from 4.6% to 3.0% and from 4.8% to 3.0%, respectively. However, the proportion admitted to the ICU increased from 13.3% to 27.9% and invasive procedures increased from 1.2% to 2.0%. Reflecting this aggressive end-of-life care, mean total charges for a terminal hospitalization rose from $29,386 to $72,469, adjusted for inflation. Among patients who died in the inpatient setting, the ICU stay translated into higher total costs (+$16,962, CI: $15,859 to $18,064) compared to patients who avoided the ICU. Promisingly, palliative care encounters for terminal hospitalizations increased during this period from 8.7% to 53.0% and was correlated with a decrease in inpatient chemotherapy (OR = 0.56, CI: 0.47 to 0.68), radiotherapy (OR = 0.77, CI: 0.65 to 0.92), and ICU admissions (OR = 0.48, CI: 0.45 to 0.53) but had only a modest impact on terminal hospitalization cost (-$2,992, CI: -$3,710 to -$2,275). Multivariable analysis showed variation by patient and hospital characteristics in aggressive care utilization. Conclusions: Among patients with metastatic lung cancer there has been a substantial increase in ICU use during terminal hospitalizations, resulting in high cost for the health care system. Inpatient palliative care has the potential to reduce aggressive end-of-life interventions.
Bias in valuation of health care benefits in metastatic prostate cancer: A contingent valuation of willingness to pay.
Authors: Sousa Nuno , Costa Telma , Monteiro-Soares Matilde , Rocha Gonçalves Francisco , Azevedo Luis Filipe
Published: September 2018

6616

Background: Willingness to pay (WTP) studies assess societal valuation of healthcare interventions. Prostate cancer (PC) is the most common cancer diagnosis in men. We explore factors that may bias valuation of health care benefits through contingent valuation of WTP for therapeutic innovation in metastatic castration-resistant PC. Methods: Cross-sectional study of Portuguese Society (SOC) and Healthcare Providers (HCP). Monthly WTP assessed through biding and open-ended questions by standardized survey with 2 baseline scenarios: ScA 12-month median survival, ScB 30-month median survival. Respondents considered own financial resources and expenses and for each therapeutic scenario reported WTP, out-of-pocket, and expected National Healthcare System (NHCS) WTP. Impact of demographic, personal medical history and household income assessed by tweedie generalized linear model. Results: 1000 subjects on societal cohort and 100 physicians provided valid responses. Subjects reported higher WTP values when NHCS was to provide treatment compared to out-of-pocket cost. For NHCS perspective median WTP for ScA was 2,133€ for HCP vs 5,510€ for SOC and ScB 1 963€ for HCP vs 5,479€ for SOC. Overall, societal cohort’s NHCS mean WTP was 2.6 (ScA) and 2.8 (ScB) times higher (p < .001) than healthcare providers, but with no difference for out-of-pocket WTP. This difference remained significant when adjusted for all other factors. Additionally, subjects with prior personal or familial history of cancer and subjects with higher household income provided higher WTP estimates. In HCP cohort, urologists reported higher WTP compared to Medical Oncologists. Conclusions: This study provides critical insight into differing valuation of cancer treatments between physicians and society and potential biases in individual valuation of healthcare benefits. Improvement of societal’s perception and understanding of cost-benefit assessments is critical to designing an equitable healthcare system.
Determinants of spending for metastatic breast, lung, and colorectal cancer in SEER-Medicare.
Authors: Hassett Michael J. , Banegas Matthew P. , Uno Hajime , Weng Shicheng , Cronin Angel M. , O'Keeffe-Rosetti Maureen Cecelia , Carroll Nikki , Hornbrook Mark C , Ritzwoller Debra P.
Published: September 2018

6621

Background: A substantial proportion of cancer spending is directed towards patients with metastatic disease. Past efforts to characterize spending for metastatic cancer have been limited, because they have not included patients with recurrent disease or analyzed spending across the entire episode of care. Spending for stage IV and recurrent metastatic cancer patients may differ. Methods: Using SEER-Medicare data from 2008-13, we identified breast (BC), colorectal (CRC), and lung (LC) cancer patients who were continuously enrolled in parts A, B and D, and had either stage IV or recurrent disease (i.e., return of cancer after resection of stage I-III disease). Mean total Medicare spending/patient per month and per year (2012$US) were estimated from 12 months prior to 12 months after diagnosis, and described for relevant patient sub-groups. Results: In a cohort of 27,847 patients, total spending for stage IV vs. recurrent cancer was 61-73% lower in the year before diagnosis ($11,339 vs. $28,796 for BC; $13,359 and $49,804 for CRC; $15,118 and $49,555 for LC), and 28-88% higher in the year after diagnosis ($68,787 and $42,091 for BC; $111,304 and $58,657 for CRC; $92,181 and $72,354 for LC). When considering the 2 year-period spanning the diagnosis, spending was similar (≤14%) between groups. The primary drivers of spending differences between patients with stage IV and recurrent disease were cancer type and time from diagnosis (Table). Younger age, higher comorbidity, and SEER region were also drivers of higher spending, especially after diagnosis. Conclusions: Spending patterns differ for patients with stage IV vs. recurrent cancer, suggesting different patterns of care that warrant further investigation. Spending differences after diagnosis were driven largely by part B spending, which was due in part to differential chemotherapy use. [Table: see text]
Allogeneic hematopoietic cell transplant (alloHCT) for hematologic malignancies in human immunodeficiency virus infected (HIV) patients (pts): Blood and Marrow Transplant Clinical Trials Network (BMT CTN 0903)/AIDS Malignancy Consortium (AMC-080) trial.
Authors: Ambinder Richard F. , Wu Juan , Logan Brent , Durand Christine , Shields Ryan , Popat Uday R. , Little Richard F. , Mcmahon Deborah , Mellors John Watson , Ayala Ernesto , Kaplan Lawrence D. , Noy Ariela , Howard Alan , Forman Stephen J. , Mendizabal Adam M , Horowitz Mary M. , Navarro Willis H. , Alvarnas Joseph C.
Published: September 2018

7006

Background: AlloHCT has been regarded as risky in HIV pts, with concern about fatal infection. We set out to assess feasibility and safety of alloHCT in this first prospective multicenter trial. Methods: The primary endpoint was 100-day non-relapse mortality (NRM). Pts had drug-susceptible HIV; age ≥ 15 yr; adequate organ function; acute myeloid leukemia (AML) or acute lymphocytic leukemia (ALL), high risk myelodysplastic syndrome (MDS), or Hodgkin (HL) or non-Hodgkin lymphoma (NHL) beyond first CR; an 8/8 HLA-matched related or at least a 7/8 unrelated donor. Pts received myeloablative (MA) or reduced intensity (RI) regimens. HIV outgrowth assays (VOA) were performed with resting CD4+T-cells in pts who had clinically undetectable HIV plasma RNA at 1 yr. Results: Between 5/2012 and 12/2015, 17 pts underwent alloHCT. Pts were: male (17); white (11), African American (3), Other/Unknown (3); median age 47 yrs (25-64). Associated malignancies were AML (9), ALL (2), MDS (2), HL (1), NHL (3). Median CD4 was 224 (55-833). Conditioning was MA (8) and RI (9). At 100 days there was no NRM, 13 pts were in CR, 4 pts had relapsed/progressive disease; and 8 pts achieved complete chimerism. The cumulative incidence of Grades (Gr) II-IV acute Graft vs Host Disease (GvHD) was 41 % (95%CI: 18 %, 64%). At 6 mo, OS was 82 % (95% confidence interval [CI]: 55%, 94%); 9 pts achieved complete chimerism. At 1 year, OS was 57 % (CI: 31%, 77 %); 8 deaths were from relapsed/progressive disease (5), acute GvHD (1), adult respiratory distress syndrome (1) and liver failure (1). Infections were reported in 11 pts (3 Gr 2, 8 Gr 3). Infectious HIV was detected by VOA in 2 of 3 pts who were mixed chimeras but 0 of 2 who were 100% donor. Median follow up of survivors is 24 mo (7 to 27 ). Conclusions: HIV pts with heme malignancies underwent MA or RI alloHCT without any100-day NRM and there were no infectious deaths at 1 year. AlloHCT should be considered the standard of care for HIV pts who meet usual eligibility criteria. Clinical trial information: NCT01410344.