bluuebunny/crossref_metadata_2025_split huggingface dataset:
Ribociclib-induced acute kidney injury: Uncover the MONALEESA’s dark face.
Authors: Hajir Maissoune , Abu-Hijlih Ramiz Ahmad , Abu Sheikha Areej , Alqasem Kholoud , Abdel-Razeq Hikmat 
Published: June 2022

1063 Background: The phase-3 MONALEESA-2,-3 and -7 randomized trials showed improved progression-free survival (PFS) and overall survival (OS) with the addition of cyclin D-cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib to endocrine therapy in women with advanced-stage breast cancer. However, ribociclib induced acute renal injury is not recognized in these studies. In this report, we explore ribociclib-induced acute kidney injury (AKI) in breast cancer patients receiving ribociclib. Methods: We performed a retrospective chart review of all breast cancer patients who received ribociclib at our institution between April 2019 and September 2021. Patients and disease characteristics were collected, details of creatinine kinetics in relation to administration of ribociclib and other nephrotoxic drugs were obtained. Acute kidney injury grades (AKI-KDIGO classification) were captured. Results: 145 females, median age 60.0 years, all with advanced-stage breast cancer treated with aromatase inhibitors (AI) or fulvestrant plus ribociclib were reviewed. A total of 26 (17.9%) patients developed AKI; 3 were grade-I, 21 grade-II and 2 were grade-III. Rate of AKI was significantly higher (n = 15, 48.4%) among 31 patients on other concomitant nephrotoxic drugs, compared to 11 (9.6%) of 114 other patients, p = 0.001. Nephrotoxic drugs include non-steroidal anti-inflammatory (38%), metformin (30%), angiotensin-II receptor blockers (26%), and angiotensin-converting enzyme inhibitors (11%). Median time to develop AKI was 54 (range, 21-168) days, while the median time for creatinine recovery was 5 (range, 4-7) days after holding the drugs. Average creatinine increment for affected patients was 2.28 times the baseline level. Time to AKI was shorter, but not statistically significant, among patients on nephrotoxic drugs and recovery was faster after stopping these drugs (Table). Conclusions: Ribociclib-induced AKI is not uncommon and not adequately addressed. Though reversable in majority of patients, some patients may develop grade-III AKI or require treatment interruption. Nephrotoxic medications seem to significantly enhance ribociclib-associated renal injury. Withhold these medications with periodical assessment by nephrologist is strongly recommended in these patients. Larger studies are warranted to validate our findings. [Table: see text]
Real-world outcomes of Black women versus non-Hispanic White women with advanced triple-negative breast cancer treated with immune checkpoint inhibitors at an urban cancer center.
Authors: Aldrich Jeffrey , Switchenko Jeffrey M. , Kalinsky Kevin , Bhave Manali A. 
Published: June 2022

1074 Background: Black women (BW) are disproportionately diagnosed with metastatic triple negative breast cancer (mTNBC) compared to Non-Hispanic White women (NHW). Median overall survival (OS) in mTNBC remains poor at 12-18 months. While immune checkpoint inhibitors (ICIs) are a promising treatment strategy, BW were significantly underrepresented in pivotal clinical trials that led to the approval of ICIs in mTNBC. Therefore, the efficacy, safety, and optimal biomarkers of ICI response in BW remain unknown. We sought to compare baseline characteristics and outcomes between BW and NHW with mTNBC treated with an ICI and chemotherapy at an urban tertiary care institution. Methods: BW and NHW with advanced unresectable or mTNBC treated with an ICI plus chemotherapy at Emory University between 2019 and 2021 were retrospectively evaluated. Baseline characteristics, including next generation sequencing (NGS), as well as clinical outcomes between BW and NHW were compared using Kruskal-Wallis tests and Fisher’s exact tests. Progression free survival (PFS) and OS were analyzed with the Kaplan-Meir method. Results: Forty-one women with PDL-1 positive mTNBC treated with an ICI and chemotherapy were identified [BW, n = 26 (63%) and NHW, n = 15 (37%)]. A majority of patients had relapsed disease (73%); however BW were more likely to have de novo metastatic disease compared to NHW (38% vs 7%, p = 0.03). Twenty-seven (66%) patients received atezolizumab and 14 (34%) were treated with pembrolizumab. Of the 23 (56%) patients with NGS testing, alterations in TP53, PIK3CA, and BRCA were seen in 23 (100%), 5 (31%), and 1 (6%) patient, respectively. Median tumor mutational burden was similar between BW and NHW (5 vs 7, p = 0.8). BW had numerically lower median PDL-1 (SP142) compared to NHW (1% vs 2%, p = 0.5). Rates of immune and dose-limiting chemotherapy-related adverse events were similar between BW and NHW (Table). There were no differences in ICI response between groups, though BW had fewer complete responses and a shorter median PFS compared to NHW. Median OS was 12 months in BW compared to 28 months in NHW (p = 0.1). Conclusions: Our experience with real-world use of this regimen showed that BW had fewer complete responses and a trend towards worse OS compared to NHW. BW had numerically lower median PDL-1 expression compared to NHW, suggesting further investigation of biomarkers, potentially by Race, are needed to better identify responders to ICI in mTNBC. [Table: see text]
Lurbinectedin in patients with pretreated BRCA1/2-associated metastatic breast cancer: Results from a phase II basket study.
Authors: Boni Valentina , Pistilli Barbara , Brana Irene , Shapiro Geoffrey , Trigo Perez Jose Manuel Manuel , Moreno Victor , Castellano Daniel E. , Fernandez Cristian Marcelo , Kahatt Carmen Maria , Alfaro Vicente , Siguero Mariano , Zeaiter Ali Hassan , Longo Federico , Zaman Khalil , Antón Torres Antonio , Paredes Lario Alfredo , Huidobro Vence Gerardo , Subbiah Vivek 
Published: June 2022

1092 Background: Lurbinectedin (L) is a selective inhibitor of oncogenic transcription that leads to cell apoptosis and shows antitumor activity against homologous recombination repair-deficient cell lines. A previous phase II study (Cruz et al. JCO 2018;36:3134-3143) demonstrated antitumor activity in patients (pts) with pretreated metastatic breast cancer (median of 1 prior advanced chemotherapy line) and BRCA1/2-mutated tumors with L 3.5 mg/m2 or 7.0 mg flat dose (equivalent to 4.0 mg/m2) every three weeks [q3wk]). This report focuses on the outcomes in the BRCA1/2-associated breast cancer cohort of a phase II Basket multitumor trial. Methods: This phase II study evaluated L 3.2 mg/m2 1-hour intravenous (i.v.) infusion q3wk in a cohort of 21 female pts with pretreated BRCA1/2-associated breast cancer. The primary efficacy endpoint was ORR according to RECIST v1.1. Secondary endpoints included duration of response (DoR), progression-free survival (PFS), OS and safety. Results: Median age was 45 years (range, 29-73 years). Hormone receptor (HR)+ disease was observed in 76.2% of pts, triple negative disease in 19.0% and HER2+ in 9.5%. BRCA1 and BRCA2 were reported in 47.6% and 52.4% of pts, respectively. Median number of prior lines of chemotherapy for advanced disease was 2 (range, 0-3 lines). Prior poly(ADP-ribose) polymerase inhibitors and platinum compounds had been administered to 23.8% and 47.6% of pts, respectively. Confirmed partial response (PR) was observed in six pts (ORR = 28.6%; 95% CI, 11.3-52.2%). Lurbinectedin was active in both BRCA mutations: four PRs in 11 pts (36.4%) in BRCA2 and two PRs in 10 pts (20.0%) in BRCA1. Median DoR was 8.6 months, median PFS was 4.1 months and median OS was 16.1 months. Stable disease (SD) was observed in ten pts (47.6%), including three pts with unconfirmed response in a subsequent tumor assessment (ORR unconfirmed = 42.9% [95%CI, 21.8-66.0]). Clinical benefit rate (PR + SD≥4 months) was 76.2% (95% CI, 52.8-91.8%). The most common grade 3/4 toxicity was neutropenia (42.9%; grade 4, 23.8%; with no febrile neutropenia). Conclusions: This phase II study met its primary endpoint and confirmed the activity of L in pretreated BRCA1/2-associated breast cancer pts. L 3.2 mg/m2 1-hour i.v. infusion q3wk showed an acceptable, predictable and manageable safety profile. Considering the exploratory aim of this trial as well as previous results in other phase II study, further development of L in this indication is warranted. Clinical trial information: NCT02454972.
Subgroup analysis of patients with no prior chemotherapy in EMERALD: A phase 3 trial evaluating elacestrant, an oral selective estrogen receptor degrader (SERD), versus investigator’s choice of endocrine monotherapy for ER+/HER2-advanced/metastatic breast cancer (mBC).
Authors: Kaklamani Virginia G. , Bardia Aditya , Aftimos Philippe Georges , Cortes Javier , Lu Janice M. , Neven Patrick , Streich Guillermo , Montero Alberto J. , Forget Frederic , Mouret-Reynier Marie-Ange , Sohn Joohyuk , Taylor Donatienne , Harnden Kathleen Kiernan , Khong Hung T. , Kocsis Judit , Dalenc Florence , Dillon Patrick Michael , Tonini Giulia , Grzegorzewski Kris , Bidard François-Clement 
Published: June 2022

1100 Background: EMERALD demonstrated significantly prolonged progression-free survival (PFS) and a manageable toxicity profile for elacestrant vs standard of care endocrine therapy (SOC) in patients with ER+/HER2- mBC following progression on prior endocrine and CDK4/6 inhibitor therapy. Benefit was observed in the overall study population and in patients with ESR1 mutations (mESR1). Here, we report a subgroup analysis from EMERALD in patients with no prior chemotherapy. Methods: EMERALD (NCT03778931) is a randomized, open-label, phase 3 trial that enrolled patients with ER+/HER2− mBC who had 1–2 lines of endocrine therapy, mandatory pretreatment with a CDK4/6 inhibitor, and ≤1 chemotherapy. Patients were randomized 1:1 to elacestrant (400 mg orally daily) or SOC (investigator’s choice of fulvestrant or aromatase inhibitor). Primary endpoints were PFS in all patients and patients with mESR1. In this analysis, we compared PFS between elacestrant and SOC in patients without prior chemotherapy. Results: Among the 477 patients enrolled in the trial, 77.8% (n = 371) had not received prior chemotherapy for mBC (median age = 64). Among patients without prior chemotherapy, treatment with elacestrant was associated with significantly prolonged PFS compared to SOC in both the overall population (hazard ratio [HR] = 0.68 [95% CI, 0.52-0.89] P = 0.004; median PFS 3.7 vs 2.0; 6-mo PFS 38% vs 23%; 12-mo PFS 27% vs 12%), and patients with mESR1 (HR = 0.54 [95% CI, 0.36-0.80] P = 0.002; median PFS 5.3 vs 1.9; 6-mo PFS 44% vs 24%; 12-mo PFS 31% vs 12%). Key treatment-related adverse events (AEs) in the no prior chemotherapy elacestrant group were nausea (25.9%), fatigue (12.7%), and hot flush (11.1%). There were no treatment-related deaths in either group. Conclusions: Among patients with ER+/HER2− mBC without prior chemotherapy, elacestrant significantly prolonged PFS compared to SOC endocrine therapy and showed favorable outcomes in this subgroup. Clinical trial information: NCT03778931.
Development and assessment of the effectiveness of an LGBT cultural sensitivity training for oncologists: The COLORS training.
Authors: Schabath Matthew B. , Perez-Morales Jaileene , Hernandez Eryk N. , Miller Jarred D. , Seay Julia , Quinn Gwendolyn P. 
Published: June 2022

11000 Background: Published studies report oncologists have limited knowledge about LGBT health and cancer needs but also report high interest in receiving education regarding the unique health needs of LGBT patients with cancer. As such, our group developed the Curriculum for Oncologists on LGBT populations to Optimize Relevance and Skills (COLORS), an interactive web-based LGBT cultural sensitivity training for oncologists that focused on focused on improving knowledge and communication skill-building. We report here on the results from two single-arm feasibility/acceptability trials and one randomized pragmatic trial (RPT) demonstrating effectiveness of the COLORS training. Methods: The first single-arm trial included 44 oncologists from three cancer centers in Florida and the second single-arm trial included 50 oncology fellows recruited through ASCO. The RPT included 225 oncologists randomly selected for equal distribution across the U.S., and participants were randomly assigned to either the COLORS training or a publicly available, web-based LGBT comparison training. Each of these studies included pre- and post-training assessments of LGBT-related knowledge, attitudes, and affirming practices. The RCT included a 3-month follow-up assessment to gauge retention of LGBT-affirming knowledge, attitudes, and practices over time. Results: Both single arm trials demonstrated that the COLORS training was feasible, acceptable, and results from the pre- and post-training assessments suggested the training improved knowledge, attitudes, and affirming practice behaviors. In the RPT, those randomized to COLORS demonstrated significant improvements in LGBT-related attitudes pre- to post-training (p < 0.01), and no significant changes in attitudes were observed among those randomized to the comparison training (p = 0.98). Both trainings yielded significant (p < 0.01) increases from pre- to post-training in LGBT-affirming practice behaviors. Likewise, both trainings yielded significant (p < 0.01) improvements in knowledge from pre- to post-training. Similar significant findings were observed when we analyzed the 3-month follow-up assessment. Conclusions: Results from the prior single-arm trials and the current RCT demonstrate that the COLORS training is effective in improving oncologist knowledge, attitudes, and affirming clinical practices related to the care of LGBT patients with cancer. Part of this work was funded by the Bristol Myers Squibb (BMS) Foundation and BMS Company.
Feasibility of virtual stress management and resiliency training (SMART) for oncology fellows during the COVID-19 pandemic.
Authors: Williams Colt , Chesak Sherry , Pachman Deirdre R. , Rhee Laura , Dierkhising Ross , Leventakos Konstantinos 
Published: June 2022

11016 Background: Stress Management and Resiliency Training (SMART) is a validated resilience training program designed to reduce stress, improve emotional resilience, and decrease burnout. The prevalence of burnout among practicing oncologists is as high as 40%, but unknown among oncology trainees. We implemented a virtual format of the SMART program to the Hematology/Oncology fellowship at Mayo Clinic to assess the feasibility of such a delivery, measure baseline rates of burnout in this group, and to investigate if a virtual method of delivery is as effective as in-person delivery as described in the literature. Methods: The SMART project was a mixed-methods, prospective, single arm clinical trial. Hematology/Oncology Fellows at Mayo Clinic were invited to participate. Four one-hour training sessions were conducted virtually. Fellows were given access to SMART online video modules and a book which supported the content covered during virtual training, a companion resilience mobile app, and a paperback mindfulness journal. Stress, burnout, and emotional resilience were measured at baseline and three months post-intervention using the Perceived Stress Scale (PSS), Maslach Burnout Inventory (MBI), and Connor-Davidson Resilience Scale (CD-RISC2). Changes in mean scores on the PSS, MBI, and CD-RISC2 were assessed using the Wilcoxon signed-rank test. Program feedback and feasibility data were obtained during a virtual focus group. Audio transcripts from the focus group were codified for thematic analysis and verified by intercoder triangulation. A 6-month assessment will be due in March 2022. Results: 26 of 50 fellows invited participated in our study. At baseline, 24% of participants had measurable burnout and 92% had moderate to high stress. At 3-months, the number of participants with moderate to high stress decreased to 71%, while rates of burnout remained unchanged. The PSS demonstrated a decrease in mean stress (-10.9%, p = 0.005), while the MBI demonstrated decreased emotional exhaustion (MBI-EE -6.01%, p = 0.04), an improved sense of personal achievement (MBI-PA 28.1%, p < 0.001), but slightly worse feelings of depersonalization (MBI-DP 16.46%, p = 0.05). The CD-RISC2 suggested no change in global emotional resilience (-0.71%, p = 0.82). Thematic analysis of the focus group data revealed that participants overwhelmingly found the program beneficial (83% of all responses), 20% indicated improved stress, and 15% indicated improved work performance. Conclusions: Oncology fellows in this study had lower rates of burnout compared to practicing oncologists. Virtual implementation of the SMART program is feasible and resulted in improvements in stress and prevented worsened burnout. Outcomes were comparable to previously published studies conducted in-person. Focus group participants found the training beneficial, reported lower stress, and improved work performance.
A systemic look at professional burnout and well-being within an urban cancer center as a roadmap to recovery.
Authors: Moadel Alyson B. , Papalezova Katia , Milner Gabrielle , Gipson-Fine Amber , Kalnicki Shalom 
Published: June 2022

11017 Background: As the U.S. health care system’s vulnerabilities have been laid bare by an unremitting pandemic, it behooves us to build in resiliency as we look towards recovery. The “burnout epidemic” facing oncology clinicians has been well documented prior to the pandemic. From a systemic perspective, however, data across the cancer service line is scant. In an effort to identify the stress points and strengths of an oncology service line, we present cross-sectional data from 2018 examining burnout, physical and emotional well-being, and self-care needs across all primary cancer center roles within a major urban cancer center in NYC. Methods: An anonymous online survey was completed by 310 of 646 (48%) cancer service providers comprised of physicians, nurses, clinical support staff, managers, and clerical staff. The abbreviated Maslach Burnout Inventory (MBI-9), the Mental Health Inventory (MHI), and the brief COPE were included. Results: Respondents ranged from nurses (15%) to clinical support staff (29%), with 79% identifying as female. In a snapshot view, 25% of the sample endorsed feeling burned out from work. Rates of emotional exhaustion were highest among nurses (41%) and lowest among physicians (14%), p < 0.06. Depersonalization rates ranged from 1% for physicians to 11% for nurses and clerical staff (p < 0.003). A breakdown of those who would not choose the same career over again: clerical (36%), management (28%), nurses/clinical support staff (23%) and physicians (11%), p < 0.053). Clinical levels of distress ranged from 20% (clerical staff) to 30% (nurses). Self-reported health (1-5) was lower among clerical staff and nurses (3.1) compared to physicians (3.9), p < 0.001. The majority of staff utilized adaptive coping strategies including positive reframing and planning, with religion and humor often endorsed. Interest in counseling and communication skills training ranged from 56%/57% among physicians to 84%/88% among clerical staff, respectively. Conclusions: This panoramic view of one cancer service line just prior to the pandemic points to particular systemic stresses in areas of emotional exhaustion, career choice questioning, and psychological and physical health. While levels of burnout fall within and below rates reported in the literature, it also points to fault lines affecting key service line positions, particularly nurses and clerical staff. At the same time, it highlights an underlying resiliency in coping and receptivity to self-care and development. In response to this internal needs assessment, our cancer center is working towards building a stronger foundation in which staff will not only survive the expected and unexpected stresses of working in health care but find meaning and joy in work. While we cannot predict the future, we can learn from the past. In this vein, a Well-Being Committee that includes representatives across the cancer service line was launched in 2022.
Characterization of industry relationships in oncology.
Authors: Harrison Rebecca A. , Majd Nazanin , Johnson Margaret O. , Urbauer Diana L. , Puduvalli Vinay K. , Khasraw Mustafa 
Published: June 2022

11025 Background: Collaborative relationships between academic oncology and the pharmaceutical industry are essential for therapeutic development in oncology. Despite this, formal training and mentorship in developing productive industry collaborations are not routinely included in oncology training. Since little research has been done to characterize and optimize the efficiency of these relationships, we sought to better understand the nature of such collaborations in order to identify areas for optimization. Methods: An electronic survey was administered to 1000 randomly selected ASCO members. The survey included 23 questions eliciting demographic and practice information, and 26 questions eliciting respondents’ views around oncology-industry collaborations. Survey results were analyzed using descriptive statistics. Results: There were 225 survey respondents. Most were from the United States (70%), worked at an academic institution (60.1%), worked in medical oncology (81.2%), and had an active relationship with industry (85.8%). 26.7 % of respondents reported difficulty establishing a relationship with industry collaborators. Many relied on federal (39.5%) or departmental (30.2%) funding to supplement their research ventures. Partnerships were initiated by the respondents themselves (34.6%) or industry partners (31.9%) with similar frequency, whereas institutional affiliations (15.7%) and collaborative groups (5.8%) were reported as less common means for establishing collaborations. The majority (85.3%) of respondents stated these collaborations were of importance to their career. Inclusion in industry sponsored trials (71.1%) and commitment to research funding (66.3%) were considered early signs of a productive relationship, whereas lack of effective communication (86.1%) or little engagement by senior industry leadership (63.1%) were early red flags. Most respondents (75%) did not report having had mentorship in developing these relationships. Scientific integrity was generally thought to be preserved (92%) and there was little concern over the quality of the collaborative product (95%). Many shared concern over potential conflict of interest if a compensated relationship promoted an industry product for clinical care/research (60%), yet also stated these relationships did not shape their interactions with patients (67%). Conclusions: This study provides novel data characterizing the nature of collaborative industry-academia relationships in oncology. While respondents considered these collaborations an important part of clinical and academic oncology, formal education or mentorship around these relationships is rare. Further study exploring the structure of effective industry collaborations, optimizing methods to provide education in this area at all career stages, navigating conflict of interest issues in these relationships, and understanding industry perspectives is warranted.