bluuebunny/crossref_metadata_2025_split huggingface dataset:
Targeted therapy for advanced salivary cancer with HER2 or hedgehog alterations: Interim data from MyPathway.
Authors: Kurzrock Razelle , Meric-Bernstam Funda , Hurwitz Herbert , Hainsworth John D. , Spigel David R. , Bose Ron , Swanton Charles , Burris Howard A. , Sweeney Christopher , Yoo Bongin , Beattie Mary Stanley , Patel Rajesh , Schulze Katja , Lam Elaine Tat 
Published: September 2018

6086 Background: Salivary gland cancers comprise <1% of cancers. Advanced cases have a 40% 5-year survival rate. Due to their rarity, no standard treatment guidelines exist. However, salivary duct carcinomas have morphological and gene expression profiles similar to breast cancers, and 20–40% of this subset have HER2 alterations. MyPathway (NCT02091141) is an ongoing, phase 2, multi-basket study evaluating the efficacy of targeted treatments in nonindicated tumor types with alterations in the HER2, BRAF, Hedgehog (Hh), or EGFR pathways. We present interim data for patients with salivary cancer. Methods: Patients had advanced salivary cancer with HER2 (amplification, overexpression, and/or mutation) or Hh (SMO or PTCH-1) alterations, locally assessed by gene sequencing, FISH, or IHC, as applicable. Patients received standard doses of pertuzumab + trastuzumab or vismodegib, respectively, until disease progression or unacceptable toxicity. The primary endpoint is investigator-assessed objective response rate (ORR) by RECIST v1.1. Results: As of Nov 30, 2016, 8 patients had been treated for salivary cancer, all carcinomas (7 had HER2 alterations; 1 had an Hh alteration). One HER2 patient without a post-baseline tumor assessment by data cut-off was not evaluable for efficacy. Characteristics and outcomes are shown (Table). Of 6 patients with a complete response (CR) or partial response (PR), 5 patients were still receiving study treatment by the data cut-off, with a median time on treatment of 4.6 months (range 1.4–12.5). There were no new safety signals. Conclusions: Six of 7 patients (86%) with advanced salivary carcinoma achieved CR or PR by targeting HER2 (n=5) or Hh (n=1) alterations. These promising results merit study of these treatments in additional patients. Accrual to MyPathway is ongoing. Clinical trial information: NCT02091141. [Table: see text]
Primary outcomes analysis of a multicenter randomized controlled trial of an interactive decision tool for patients with breast cancer.
Authors: Hawley Sarah T. , An Lawrence C. , Li Yun , Resnicow Ken , Morrow Monica , Jagsi Reshma , Katz Steven J. 
Published: September 2018

6500 Background: High quality treatment decisions require that patients are well informed about treatment and that their values are considered. Yet studies show that patient knowledge about breast cancer treatment trade-offs is low and appraisal of decision-making is not optimal. Methods: We conducted a randomized controlled trial (RCT) of a tailored, comprehensive (locoregional and systemic treatment) and interactive decision tool (iCanDecide), compared with static online information. 537 newly diagnosed, early stage breast cancer patients were enrolled at the first visit in 22 surgical practices. Participants were surveyed 5 weeks (N = 496; RR 92%) post enrollment after locoregional treatment decision-making. The primary outcome was a high quality decision, including two components: high knowledge about treatment options and a values concordant treatment decision. The main secondary outcome was preparation for decision making. We evaluated the distribution of participants in each arm, and conducted logistic regression modeling to assess the association between the intervention and the outcomes controlling for patient characteristics and strength of treatment preference at enrollment. Results: Significantly more intervention than control patients had high knowledge (60% vs. 42%, p < 0.001), although the majority of both groups reported values concordant treatment (~84%). Intervention patients also reported feeling prepared for decision making significantly more often than controls (45% vs. 32%, P < 0.01). Patients randomized to the interactive intervention had higher knowledge (OR: 2.2; 95% CI 1.2-4.0) and preparation for decision making (OR: 1.5; 95% CI 1.1-1.4), even after adjusting for age, education, race, stage and clinical site. Conclusions: In this large RCT, a tailored, interactive treatment decision tool for breast cancer improved knowledge and prepared patients for complicated decision making, more than access to static online information. Future work to further integrate such tools into the clinical workflow is needed. Clinical trial information: NCT01840163.
Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.
Authors: Shepshelovich Daniel , Goldvaser Hadar , Wang Lisa , Abdul Razak Albiruni Ryan , Bedard Philippe L. 
Published: September 2018

6514 Background: The 2007 Food and Drug Administration (FDA) Amendments Act mandated reporting of results of clinical trials in ClinicalTrials.gov, a large public registry, within 12 months of completion. We compared results reported for phase I trials in ClinicalTrials.gov and matched primary publications. Methods: The ClinicalTrials.Gov database was searched for completed adult phase I cancer trials with reported results. Only trials with dose escalation of systemically administered medications were included. PubMed was searched for matching primary publications, defined as identical intervention, number of arms and enrolled subjects, published prior to November 1, 2016. Results reported in the primary publication were compared with the ClinicalTrials.gov database using a 28-point score (2 = complete agreement; 1 = partial agreement; 0 = no mention) for 14-items related to study design (4 items), outcome measures (4 items) and safety profile (6 items). The ClinicalTrials.gov database was used as the reference for results reporting. Linear regression was used to identify factors associated with incomplete reporting. Results: After a review of 583 trials in ClinicalTrials.gov, 163 matching primary publications were identified, comprising 95 (58%) phase I and 68 (42%) phase I/II trials. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were omitted or downgraded in publications in 39% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Items that were incompletely reported in publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Phase I (p < 0.001) and multicenter trials (p = 0.002) were associated with higher reporting scores than phase I/II and single center trials. Conclusions: Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicaTrials.gov may provide a more comprehensive overview of safety data from new cancer drug trials.
Factors influencing prostate cancer treatment decisions for African American (AA) and Caucasian (CA) men.
Authors: Gordon Brittaney-Belle Elizabeth , Basak Ramsankar , Usinger Deborah S , Godley Paul Alphonso , Chen Ronald C. 
Published: September 2018

6517 Background: Prostate cancer causes a disproportionate burden to AA men, and AA men are less likely than CA men to receive aggressive treatment. This is the first study to examine factors influencing treatment decision-making of AA vs. CA men in a population-based cohort. Methods: 1171 men were enrolled soon after diagnosis and before treatment through Rapid Case Ascertainment of the North Carolina state cancer registry. Researchers asked patients regarding their priorities in treatment decision-making and information sources. Differences in AA and CA men were compared using the chi-square test. Results: The most important factor for both AA and CA men was curing cancer, and preserving QOL was second most important. However, AA men were more concerned about additional factors including impact on daily activities (74% very important AA vs 58% CA for intermediate/high risk disease), recovery time (81% vs 50%), cost (66% vs 32%) and treatment time (76% vs 39%) (p < .001 for each item). The most important source of information impacting treatment decisions for CA men were physician recommendations (61%), personal research (32%) and family/friend opinion (7%); for AA men, the corresponding numbers were 50%, 32% and 19%. Conclusions: AA and CA men with prostate cancer are both concerned about curing cancer, but AA men are more likely to consider multiple other social and personal factors as important in their decision-making process. Improved understanding of these differences may provide opportunities to address racial disparities in prostate cancer. [Table: see text]
Assessment of actionability of cancer genomic testing panels based on a structured clinical trial knowledge base.
Authors: Levy Mia Alyce , Micheel Christine , Jain Neha , Mittendorf Kathleen F 
Published: September 2018

6533 Background: Today’s oncologist is responsible for choosing appropriate cancer genomics tests to inform patient treatment from multiple available platforms, weighing cost, availability, sensitivity and specificity, and clinical actionability. Knowledge-driven clinical decision support tools can assist clinicians in choosing the panel that is most informative in a given clinical space. Methods: Using a queryable knowledgebase of >1800 active clinical trials containing structured eligibility criteria curations for diagnosis and genomic alterations, we compared two CLIA-regulated genomic panels for clinical actionability over the landscape of solid, breast, and lung cancer clinical trials. Results: The larger panel (73 genes) was more actionable than the smaller panel (62 genes) in the breast cancer (10x more trials returned) and solid tumor (2.7x more trials returned) clinical trial space, while the smaller panel returned 1.2x more trials in the lung cancer space (see table). Conclusions: This analysis demonstrates that patient diagnosis has a significant effect on the potential clinical actionability of a given genomic panel. Further, this analysis demonstrates the clinical utility of knowledge-driven clinical decision support tools for test selection, especially given the often-limited tumor sample available, cost of genomic panel testing, and continuously shifting trial landscape. [Table: see text]
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]