bluuebunny/crossref_metadata_2025_split huggingface dataset:
Final result for SAFIA trial for neoadjuvant palbociclib in patients with operable luminal breast cancer responding to fulvestrant.
Authors: Al-Saleh Khalid A. , El Zawahry Heba Mohamed , Bounedjar Adda , Oukkal Mohammed , Saadeddin Ahmed , Mahfouf Hassen , Kamel Bouzid , Bensalem Assia , Abdel-Razeq Hikmat , Kandil Alaa , Abulkhair Omalkhair A. M. , Al-Foheidi Meteb Owaish , Ghosn Marwan , Boussen Hamouda , Haddaoui Abderrazak , Ayari Jihene Braham , Alghamdi Mohammed , Abdulaziz Nashwa A. , Kullab Sharif Ahmed , Nabholtz Jean-Marc A. 
Published: June 2022

596 Background: Luminal, human epidermal growth factor receptor 2 (HER2)-negative breast cancer (BC) encompasses the most common subtype of breast malignancies. Neoadjuvant strategies of operable BC are primarily based upon chemotherapy (CT), while neoadjuvant hormone therapy (NAHT) has not been well studied in the Middle East and North Africa (MENA) region. However, these tumors might respond poorly to neoadjuvant CT with significant side effects, emphasizing the need to identify patients who could be candidates for NAHT. Methods: The SAFIA trial is a prospective multicentre, international, double-blind, neoadjuvant phase-III trial using upfront 21-gene Oncotype DX Breast Recurrence Score assay (RS) <31) to select operable Luminal HER2-negative patients for induction hormonal therapy with Fulvestrant 500 mg +/– Goserelin (F/G) before randomizing responding patients to F/G + Palbociclib (Cyclin-Dependent Kinase 4/6 inhibitor / CDK 4/6) versus F/G + Placebo. The primary endpoint of this study was the complete pathologic response (pCR) rate. Results: A total of 354 patients were enrolled, leading to 277 patients treated with induction F/G. Of these, 253 responding patients were randomized to F/G fulvestrant with palbociclib or Placebo. Two hundred and thirty patients were evaluable for pathologic response. No statistically significant differences were identified in terms of pCR rates between F/G with palbociclib or placebo: 2% versus 7%, respectively. According to the radiologic responses post- induction F/G, the hormone sensitivity rate was 89.8%, while the clinical benefit of 8–9 months of neoadjuvant F/G was 96%. Safety in the MENA population was acceptable with a grade 3-4 neutropenia rate of 25% in the F/G plus palbociclib arm. The feasibility of performing the 21-gene breast recurrence score assay on core biopsy specimens was optimal in 96.4% of cases. Conclusions: The addition of palbociclib to neoadjuvant F/G did not show any additional benefit in terms of pathologic response, including pCR in neoadjuvant therapy of Luminal HER2-negative BC responding to induction F/G. The use of an upfront 21-gene assay appeared feasible on biopsy specimens, and the identification of tumors with RS<31 allowed to select endocrine sensitive patients, leading ultimately to a 96% clinical benefit with 8–9 months of F/G neoadjuvant therapy. Clinical trial information: NCT03447132. [Table: see text]
Changes in opioid prescription, potential misuse, and substance use disorder in pediatric cancer survivors following the 2016 CDC opioid prescribing guideline.
Authors: Ji Xu , Hu Xin , Brock Katharine Elizabeth , Effinger Karen Elizabeth , Zhang Bo , Lipscomb Joseph 
Published: June 2022

6506 Background: The 2016 Centers for Disease Control and Prevention (CDC) guideline for prescribing opioids, despite not being intended for cancer-related pain, has been shown to be associated with declines in opioid prescriptions among adults with cancer. We examine the changes in opioid prescription, potential misuse, and substance use disorder (SUD) following the guideline release among pediatric cancer survivors, a population at high risk for chronic pain. Methods: Using nationwide private insurance claims data, we identified survivors (aged ≤21 years at cancer diagnosis) who completed treatment for leukemia, lymphoma, central nervous system, bone, or gonadal cancers in 2009-2018 (N=8,969). We also identified enrollees without cancer who were matched based on age, gender, and region as a control group (N=44,845). Outcomes included (1) any opioid prescription and (2) any indicator for potential misuse or SUD within 1-year post-therapy. We conducted interrupted time series analysis, where time period was assessed by quarters based on the quarter-year of patients’ therapy completion. Segmented linear regression was conducted to estimate the immediate change (“level” change) and the change in the time trend (“slope” change) in each outcome after the guideline release in March 2016, accounting for autocorrelation. Results: Before the guideline release, opioid prescription rate (21.1% vs. 7.2%) and rate of potential misuse or SUD (5.6% vs. 1.9%) were higher among survivors than controls ( p<0.05). Post guideline release, we found a declining trend in opioid prescription rate among survivors (slope change = -1.0 percentage point [ppt]; p<0.001). Survivors also experienced an immediate level decrease (-2.0 ppt; p=0.040) and a decreasing trend (slope change = -0.4 ppt; p=0.004) in the rate of potential misuse or SUD. Among controls, there were decreasing trends in opioid prescription rate (slope change = -0.3 ppt; p<0.001) and rate of potential misuse or SUD (slope change = -0.1 ppt; p=0.042). By three years post guideline release, relative reductions in opioid prescription rate and rate of potential misuse or SUD were 51.8% and 76.0%, respectively, among survivors ( p<0.05), with controls experiencing smaller relative reductions (29.4% and 36.5%; p<0.05). Conclusions: Following the release of the CDC opioid prescribing guideline in March 2016, there were reductions in opioid prescription rate and rate of potential opioid misuse or SUD among both pediatric cancer survivors and controls, with survivors experiencing greater reductions.
Representation of women in clinical trials supporting the FDA-approval of contemporary anticancer therapies.
Authors: Babcook Melissa A. , Nidhi Neha , Carter Rebecca R , Bonsu Janice , Yildiz Vedat , Wei Lai , Ruz Patrick , Paskett Electra D. , Addison Daniel 
Published: June 2022

6521 Background: Contemporary anticancer drugs frequently have different efficacy and side effects in men and women. Yet, whether women are well-represented in pivotal trials supporting contemporary anticancer drugs is unknown. The objective of this study was to characterize the representation of women in trials supporting the use of contemporary anticancer drugs. Methods: We retrospectively evaluated all pivotal (phase II and III) trials supporting FDA-approval of anticancer drugs from 1998 to 2018, derived from Drugs@FDA, clinicaltrials.gov, MEDLINE, and publicly available FDA-drug reviews. Expected population rates were derived from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) program, and US Census databases. The primary outcome was the report of any gender-specific analysis of efficacy and/or safety, irrespective of treatment-arm. The secondary outcome was the proportional representation of women across trials, evaluated by a participation-to-prevalence ratio (PPR) of 0.85, according to cancer-type. Female representation was also assessed as change across time. Differences in pooled binary endpoint hazard ratios, by the presence or absence of adequate female representation, were also assessed. Results: In total, there were 97,566 participants, enrolled in 189 clinical trials, evaluating 123 anticancer therapies. Gender was reported in 182 (96.3%) clinical trials, of which 43.4% (42,299) were women, compared to 55.6% (55,267) men ( P < 0.01). Overall, women were under-represented in clinical trials of anticancer therapies by a mean of 16.5% compared to the proportional incidence of all cancers in women. Women were the most under-represented in gastric (PPR = 0.821) and liver (PPR = 0.619) cancer trials. Sex-based drug efficacy analysis was only published in 36.8% of trials. Over time, the trend of percentage women recruited into clinical trials increased, but not at a rate comparable to prevalence (-5.0 to -5.5% of prevalence), and the gap in under-representation of women in anticancer therapy clinical trials is widening. Conclusions: Among pivotal clinical trials supporting contemporary FDA-approved cancer drugs, women were frequently under-represented. Additional studies are needed to understand the impact of under-representation on contemporary anticancer therapy outcomes.
Impact of equal access by race and ethnicity on patients in the Veterans Health Administration (VHA) treated for diffuse large B-cell lymphoma (DLBCL).
Authors: Ananth Snegha , Al-Abayechi Alaq , Blaize Jean-Pierre , Boyle Lauren , Djoufack Djoumessi Raissa Lakene , Espinoza Gutarra Manuel Ricardo , Franklin Kathleen , Lu Lindsey , Lucero Kana , Mader Michael , Nazarewicz Phillip , Nooruddin Zohra , Pandya Abhishek , Roman Souza Gabriel , Song Michael Meansup , Warnecke Brian , Whitehead Jennifer , Williams Madison H. , Williams Ryan A. 
Published: June 2022

6526 Background: Racial and ethnic disparities in access to care and outcomes are well-established and are critical issues across several malignancies, including DLBCL. Previous studies from national registry datasets have shown racial disparities in DLBCL disease characteristics, treatment and outcomes. The VHA is an equal access system providing a unique environment to investigate cancer disparities across the disease continuum. Methods: This is a retrospective chart review of 4033 randomly selected patients with an ICD code for lymphoma treated within the VHA between 01/01/2011 and 12/31/2017. Data abstractors collected baseline patient and disease characteristics and treatment responses for those with an initial diagnosis of DLBCL in that time frame. Survival time was determined via electronic health record query on 11/30/2021. Chi-square tests were used to analyze relationship between race and variables of interest. Cox proportional hazards model was used to estimate hazard ratios (HR) for race and controlling factors. Results: 2141 DLBCL patients met our inclusion criteria. 97% were male. Majority were Non-Hispanic Whites (NHW 75%) followed by Non-Hispanic Blacks (NHB 12.5%), Hispanics (H 5.7%) and others (O 6.8%). NHB were diagnosed at younger median age (63 years) when compared to the NHW, H and O (68 years). There was no statistically significant difference in stage at diagnosis, IPI score, cell of origin (COO) and hit status amongst racial subgroups. Outcomes analysis (Table) revealed similar treatment and response rates, median OS, 1- and 2- year survival across all racial subgroups. However, after adjusting for age, IPI, COO, and exposure to agent orange, and including up to 10-years of survival data, H had 36% lower risk of death (HR=0.64, 95% CI 0.44-0.93) than NHW, while NHB and O had similar outcomes to NHW. Conclusions: This large retrospective study is a continuation of our group’s work (Williams et al, 2020) that doubles the cohort size and confirms that when standard of care therapy is given with equal access to care, short-term treatment and survival outcomes are same for all races. Further studies are needed to analyze risk factors associated with differences in long term outcomes.[Table: see text]
Concrete resource needs and frailty among older adults with cancer: The Cancer and Aging Resilience Evaluation (CARE) Registry.
Authors: Williams Grant Richard , Giri Smith , Dai Chen , Al-Obaidi Mustafa , Harmon Christian , Bona Kira , Landier Wendy , Bhatia Smita , Wolfson Julie Anna 
Published: June 2022

6546 Background: Concrete resource needs (CRN: insecurity of food, utilities, and/or housing) are important and modifiable indicators of poverty. Prior work among adults with chronic cardiometabolic diseases demonstrates that CRN-targeted interventions improve health outcomes. Poverty is associated with inferior health outcomes among patients with cancer. Frailty is a recognized state of increased vulnerability and is associated with increased toxicities from cancer therapies and reduced survival. The prevalence of CRN among older adults with cancer and its role in modifying the risk of frailty remains unknown. We aimed to (1) describe the prevalence of CRN and (2) examine the association between CRN and frailty among older adults with cancer. Methods: The CARE registry prospectively enrolls older adults (≥60y) with cancer seen at UAB as new patients. Single-item screening measures captured food, housing and utility insecurity in addition to the baseline CARE geriatric assessment beginning 8/2020. The 44-item CARE Frailty Index (based on the principles of deficit accumulation) was used to define frailty. Multivariable analysis examined association of CRN with frailty, adjusting for age, race, sex, education, employment, marital status, and cancer type and stage. Results: The cohort included 485 participants with a mean age at enrollment of 69y; 63.7% were male; 20.4% were non-Hispanic Black. The most prevalent cancer types included colorectal (33.0%), pancreatic (16.3%) and hepatobiliary (12.2%) cancers. Median time from cancer diagnosis to study enrollment was 35 days. The overall prevalence of CRN was 6.6% (insecurity of housing [2.9%], food [4.3%], and utilities [4.1%]). Participants with CRN were less educated ( < HS: 21.9% vs. 9.9%, p= 0.01), more often widowed/divorced (53.1% vs. 35.1%, p= 0.003) and more likely to be disabled (43.8% vs. 12.4%, p< 0.001). Overall, 33.8% of patients were frail. In multivariable analysis, patients with CRN had a 6.24 higher odds of frailty (95% CI 1.72-22.7, p= 0.005) compared to those without CRN after adjustment for above-mentioned covariates. Conclusions: CRN represents a novel exposure that is independently associated with frailty. In order to inform a CRN-targeted intervention for the growing number of older adults with cancer, future work is warranted to examine the CRN construct in this population, including examination of more detailed screening measures and CRN-associated cancer outcomes.
A multilevel intervention increased accrual of Native Hawaiians and other Pacific Islanders to a national breast cancer screening trial.
Authors: Wakuk Srue , Berenberg Jeffrey L. , Capps Erin , Morris Paul , Cheng Shirley , Bryant-Greenwood Kate , Cassel Kevin 
Published: June 2022

6547 Background: The University of Hawaii Cancer Center (UHCC) Minority/Underserved NCI Community Oncology Research Program (Hawaii MU NCORP) provides access to NCI-sponsored clinical trials in Hawaii. The Hawaii MU NCORP is dedicated to increasing minority and underserved accruals to clinical trials. Native Hawaiian women have the highest breast cancer incidence and mortality; only 26% of Micronesian women in Hawaii over the age of 40 have ever had a mammogram. In 2018, the Hawaii MU NCORP became a recruitment site for the ECOG-ACRIN Tomosynthesis Mammographic Imaging Screening Trial (TMIST). A pilot study was launched in 2019, to support our NCORP recruitment of underrepresented Native Hawaiian and other Pacific Islander (NHPI) women to the TMIST study. Subsequently, specific funding was provided by the NCI’s Center to Reduce Cancer Health Disparities that enabled the UHCC’s Office of Community Outreach and Engagement (COE) to develop an effective multilevel recruitment strategy together with the Hawaii MIU NCORP. Methods: To foster community awareness of the TMIST study among NHPI women, the UHCC COE hired a Community Health Educator (CHE). The CHE, a Pacific Islander woman, utilized small group educational sessions to provide culturally and linguistically appropriate cancer prevention information and promote the TMIST study to NHPI women in Hawaii. The CHE worked in partnership with Hawaii MU NCORP clinical research associates (CRAs) in these efforts. In 2020, statewide COVID-19 health and safety protocols were enacted, limiting public group interactions in Hawaii. Despite this challenge, the CHE successfully adapted the in-person educational sessions on clinical trials and TMIST to conduct sessions using Zoom and Facebook Messenger. Results: Before the hire of the CHE in 2019, only one Pacific Islander (Micronesian) woman was recruited to the TMIST in Hawaii. The CHE conducted 21 community health events with 426 attendees from 2019 to 2021. The Hawaii MU NCORP NHPI TMIST enrollment went from the 9.9% in 2018 to 2019, to 20.1% in 2019 to 2020 and to 33% in 2020 to 2021. To date, 18 Micronesian, 52 Native Hawaiian and 6 Other Pacific Islander women out of 353 participants ware enrolled. Conclusions: The multilevel intervention of our CHE, in collaboration with NCORP staff providing clinical trial awareness training and community outreach, resulted in increasing the enrollment of NHPI women to the TMIST Trial. CHE-led community health education sessions on cancer prevention can be delivered using emergent technologies and social media. The use of culturally and gender concordant CHEs working with CRAs have the potential to increase awareness and accruals to cancer clinical trials.
Variation of use of targeted therapies and molecular diagnostic testing by practice type for non-small cell lung cancer and colorectal cancer.
Authors: Roberts Thomas , Kehl Kenneth L. , Brooks Gabriel A. , Sholl Lynette M. , Wright Alexi A. , Bai Barbara , Landrum Mary Beth , Keating Nancy Lynn 
Published: June 2022

6551 Background: Targeted therapies are important first-line treatments for many patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). All patients with newly-diagnosed metastatic NSCLC and CRC should undergo molecular diagnostic testing to guide treatment selection. Methods: We used 100% Medicare fee-for-service data from 2015 through 2019 to identify beneficiaries with incident metastatic NSCLC or CRC receiving systemic therapy and to assign beneficiaries to oncology practices. We then assessed for use of molecular diagnostic testing and targeted therapies in these cohorts. We used linear mixed effects models to assess patient and practice characteristics associated with molecular diagnostic testing and targeted therapy use. Results: Rates of molecular diagnostic testing increased between 2015 and 2019 for NSCLC and CRC. In 2019, rates of molecular diagnostic testing were 85% and 65% for NSCLC and CRC, respectively. Rates of targeted therapy use did not increase over time for NSCLC or CRC, and were 8% and 5%, respectively, in 2019. Compared to National Cancer Institute (NCI)-designated cancer centers, rates of molecular diagnostic testing for CRC were 3.7 percentage points lower at practices associated with non-academic hospitals and 10.6 percentage points lower at small independent practices. Rates of targeted therapy use for NSCLC were 4.8, 5.9 and 5.5 percentage points lower at academic medical centers, large independent practices and small independent practices, respectively, compared to NCI centers. Conclusions: Rates of molecular diagnostic testing for NSCLC and CRC increased in recent years, but testing rates remain below recommended levels, and targeted therapy use remains low. Substantial variation in testing and targeted therapy use by practice type suggest that the practice where a patient is treated may impact access to recommended testing and efficacious treatments. [Table: see text]
Reducing oncology readmissions through a multidisciplinary discharge approach.
Authors: DiBenedetto Samantha , Pierce Eric , Wells Leah , Keng Michael Kenneth 
Published: June 2022

6561 Background: Hospital readmissions are associated with increased health care utilization and unfavorable patient outcomes. Oncology patients have an increased risk of hospital readmission compared to the general patient population. The 30-day readmission rate for cancer patients at our institution is 27.7% which is higher than the reported national average of 20.2%. We sought to reduce 30-day hospital readmission rates by 25% for solid tumor oncology patients through a prospective integrated multidisciplinary discharge approach. Methods: Hospital readmissions for adult patients with a known solid tumor cancer diagnosis admitted to the oncology service at UVA from Jan 2019 – Apr 2019 were identified. Baseline information on tumor type, reason for readmission, interventions, length of stay (LOS), and inpatient morbidity and mortality (including ICU admission and transition to hospice) were collected via retrospective review. Qualitative and quantitative tools including process maps, cause-and-effect diagrams, Pareto charts, and priority matrix were used to identify potential areas for intervention. Two PDSA cycles were implemented: daily multidisciplinary discharge rounds with physicians, nursing, social work, case management, and PT/OT (PDSA1), and a templated discharge email to patients’ primary oncology team including attending oncologist, mid-level providers, nurse coordinator, pharmacist, and urgent care team (PDSA2). An SPC chart with 3-σ limits and t-test of unequal variance with 2-sided p-value was used to evaluate impact on readmission rates from baseline to PDSA2. Results: Following PDSA1 (May 2019 – Oct 2019), the 30-day readmission was 25.7%; PDSA2 was postponed due to COVID-19, however the 30-day readmission rate remained stable during the pandemic. Following PDSA2 (Sept 2021 – Dec 2021), the 30-day readmission rate was 18.2% corresponding to an absolute decrease of 34.3% which was statistically significant (p≤0.05). This was associated with a trend towards increased LOS, rate of ICU admission, and case-mix severity index although not statistically significant. There was no significant difference in inpatient mortality or transition to hospice (Table). Conclusions: Implementation of multidisciplinary discharge rounds and templated discharge communication resulted in a significant decrease in rate of 30-day readmissions for solid tumor oncology patients. There was a trend towards increased LOS and ICU admissions without increased inpatient mortality. Improvement in discharge email compliance and implementation of an urgent symptom clinic may further reduce the 30-day readmission rate. [Table: see text]