BilT03: Phase 1b/2 multicenter trial of nivolumab with 5-fluorouracil and liposomal irinotecan for previously treated advanced biliary tract cancer.

Background: Second-line chemotherapy with 5-fluorouracil/leucovorin (5FULV) and liposomal irinotecan improves survival in advanced biliary tract cancer (BTC). In this phase 1b/2 trial, we investigated the combination of 5FULV and liposomal irinotecan with nivolumab following progression on first-line chemotherapy for advanced BTC.

Methods: Patients received 2,400 mg/m 5-fluorouracil, leucovorin (dose level: 0:400 or -1:200 mg/m), 70 mg/m liposomal irinotecan, and 240 mg nivolumab every 2 weeks (ClinicalTrials.

Burnout Among Mid-Career Academic Medical Faculty.

Importance: Studies reveal that most physicians report symptoms of burnout. Less is known about burnout in mid-career medical faculty specifically.

Objective: To characterize burnout and its risk factors, particularly differences by gender, among mid-career medical faculty.

National science foundation grant awardees' perspectives on Article X and sexual harassment in science.

Federal scientific agencies seek to make an impact on the continued prevalence of sexual harassment in the scientific academic community beyond institutional self-regulation. The National Science Foundation's Article X, released in 2018, is one of the most significant and ambitious federal policy initiatives to address sexual harassment. The present article presents the results of the first study to examine scientists' knowledge and attitudes about this important recent policy.

The Disproportionate Effects of the COVID-19 Pandemic on the Time Allocation of Recipients of NIH Career Development Awards Who Are Women or Caregivers of Dependents.

Purpose: To understand time allocation of a national medical faculty cohort 1.5-2 years after the COVID-19 pandemic began compared with before.

Method: From August 2021-April 2022, the authors conducted a retrospective survey of 1,430 clinician-researchers who received National Institutes of Health career-development awards between 2006-2009 asking about domestic and professional time allocation prepandemic and at the time of surveys (TOS).

Are We Missing Acute Toxicities Associated With Hypofractionated Breast Irradiation? A Report From a Large Multicenter Cohort Study.

Purpose: The efficacy and long-term safety of hypofractionated whole breast irradiation (HF-WBI) have been established through multiple randomized trials, yet data about acute toxicities remain more limited. Since 2013, our group has prospectively collected acute toxicity data from weekly treatment evaluations and additional assessment after completion. In 2016, we intentionally shifted the posttreatment assessment follow-up visit from 1 month to 2 weeks to evaluate for missed acute toxicity occurring in that immediate posttreatment window.

Omission of Radiotherapy After Breast-Conserving Surgery for Women With Breast Cancer With Low Clinical and Genomic Risk: 5-Year Outcomes of IDEA.

Purpose: Multiple studies have shown a low risk of ipsilateral breast events (IBEs) or other recurrences for selected patients age 65-70 years or older with stage I breast cancers treated with breast-conserving surgery (BCS) and endocrine therapy (ET) without adjuvant radiotherapy. We sought to evaluate whether younger postmenopausal patients could also be successfully treated without radiation therapy, adding a genomic assay to classic selection factors.

Methods: Postmenopausal patients age 50-69 years with pT1N0 unifocal invasive breast cancer with margins ≥2 mm after BCS whose tumors were estrogen receptor-positive, progesterone receptor-positive, and human epidermal growth factor receptor 2-negative with Oncotype DX 21-gene recurrence score ≤18 were prospectively enrolled in a single-arm trial of radiotherapy omission if they consented to take at least 5 years of ET.

Factors Associated With Cardiac Radiation Dose Reduction After Hypofractionated Radiation Therapy for Localized, Left-Sided Breast Cancer in a Large Statewide Quality Consortium.

Purpose: Limiting cardiac radiation dose is important for minimizing long-term cardiac toxicity in patients with left-sided early-stage breast cancer.

Methods And Materials: Prospectively collected dosimetric data were analyzed for patients undergoing moderately hypofractionated radiation therapy to the left breast within the Michigan Radiation Oncology Quality Consortium from 2016 to 2022. The mean heart dose (MHD) goal was progressively tightened from ≤2 Gy in 2016 to MHD ≤ 1.

Health Data Sharing Perspectives of Patients Receiving Care in CancerLinQ-Participating Oncology Practices.

Purpose: CancerLinQ seeks to use data sharing technology to improve quality of care, improve health outcomes, and advance evidence-based research. Understanding the experiences and concerns of patients is vital to ensure its trustworthiness and success.

Methods: In a survey of 1,200 patients receiving care in four CancerLinQ-participating practices, we evaluated awareness and attitudes regarding participation in data sharing.

Devimistat in Combination with Gemcitabine and Cisplatin in Biliary Tract Cancer: Preclinical Evaluation and Phase Ib Multicenter Clinical Trial (BilT-04).

Purpose: Devimistat (CPI-613) is a novel inhibitor of tumoral mitochondrial metabolism. We investigated the effect of devimistat in vitro and in a phase Ib clinical trial in patients with advanced biliary tract cancer (BTC).

Patients And Methods: Cell viability assays of devimistat ± gemcitabine and cisplatin (GC) were performed and the effect of devimistat on mitochondrial respiration via oxygen consumption rate (OCR) was evaluated.

Gender Composition in Biomedical Research Grant Submissions and Grant Review Panels Before Versus During the COVID-19 Pandemic.

This study examined the gender composition of career development award applicants and grant review panels during the pandemic compared with that beforehand. Data were collected from 14 Health Research Alliance (HRA) organizations, which fund biomedical research and training. HRA members provided the gender of grant applicants and grant reviewers during the pandemic (April 1, 2020, to February 28, 2021) and prepandemic (April 1, 2019, to February 29, 2020).

Frequency, barriers, outcomes, and consequences of reporting sexual harassment in clinical oncology.

Sexual harassment is increasingly recognized as widely prevalent in medicine. Broad efforts at the organizational and society level are working to address this inequity, but many of these efforts rely on reporting to eradicate problematic behaviors and shift culture. We examined, among oncologists experiencing sexual harassment, the frequency of reporting, as well as barriers, outcomes, and consequences of reporting.

Gender Differences of Endowed Professorship in Obstetrics and Gynecology Departments at Top Academic Institutions.

Gender equity is a critical issue in academic medicine. Whether there is equitable access to the prestige and resources of endowed professorships merits evaluation. We investigated this question in obstetrics and gynecology, a field that focuses on the health of women and in which women are much better represented than other specialties of medicine.

Retrospective Cohort Analysis of Aspirin Use and Venous Thromboembolism in Patients with Pancreatic Cancer and an Indwelling Central Venous Catheter.

 Patients with pancreatic cancer are at high risk of developing venous thromboembolism (VTE). It is unknown if aspirin reduces the risk of VTE in this setting.  We sought to determine whether there is an association between aspirin use and VTE risk in patients with pancreatic cancer receiving chemotherapy with a central venous catheter (CVC).

Gender differences in endowed chairs in Departments of Psychiatry and Behavioral Sciences from the top-10 NIH-funded medical schools in the US.

The current study examined gender differences in endowed chairs within Departments of Psychiatry and Behavioral Sciences across the top 10 NIH-funded Schools of Medicine. The names of full professors with and without endowed chairs were collected and a multivariable logistic regression model was constructed to predict having an endowed chair considering gender, primary degree, NIH funding, and citation number. Secondary analyses repeated the models separately for individuals holding an MD or MD/PhD versus those with a non-MD doctoral degree (i.

Mediators of Racial Disparities in Heart Dose Among Whole Breast Radiotherapy Patients.

Background: Racial disparities in survival of patients with cancer motivate research to quantify treatment disparities and evaluate multilevel determinants. Previous research has not evaluated cardiac radiation dose in large cohorts of breast cancer patients by race nor examined potential causes or implications of dose disparities.

Methods: We used a statewide consortium database to consecutively sample 8750 women who received whole breast radiotherapy between 2012 and 2018.

Factors Associated With Endowed Chair Allocation in Medical Oncology in the United States.

To explore persisting gender disparities across leadership roles in medicine, we examined factors associated with holding endowed chairs in US oncology divisions. In 2019, we identified 95 academic oncology divisions, using the Oncology Division Chiefs and Department Chairs listing in the American Society of Clinical Oncology myConnection forum. We collected public information on gender, degree, total National Institutes of Health funding as principal investigator, H-indices, publication and citation numbers, and graduation year and constructed a multivariable logistic regression model.

Identifying Patients Whose Symptoms Are Underrecognized During Treatment With Breast Radiotherapy.

Importance: Understanding whether physicians accurately detect symptoms in patients with breast cancer is important because recognition of symptoms facilitates supportive care, and clinical trials often rely on physician assessments using Common Toxicity Criteria for Adverse Events (CTCAE).

Objective: To compare the patient-reported outcomes (PROs) of patients with breast cancer who received radiotherapy from January 1, 2012, to March 31, 2020, with physicians' CTCAE assessments to assess underrecognition of symptoms.

Design, Setting, And Participants: This cohort study included a total of 29 practices enrolled in the Michigan Radiation Oncology Quality Consortium quality initiative.

The Impact of Chemotherapy on Toxic Effects and Cosmetic Outcome in Patients Receiving Whole Breast Irradiation: An Analysis Within a Statewide Quality Consortium.

Purpose: We investigated whether the use of chemotherapy before whole breast irradiation (WBI) using either conventional fractionation (CWBI) or hypofractionation (HWBI) is associated with increased toxic effects or worse cosmetic outcome compared with WBI alone.

Methods And Materials: We identified 6754 patients who received WBI alone (without a third field covering the superior axillary and supraclavicular nodal regions) with data prospectively collected in a statewide consortium. We reported rates of 4 toxic effects: physician-reported acute moist desquamation, patient-reported acute moderate/severe breast pain, a composite acute toxic effect measure (including moist desquamation and either patient- or physician-reported moderate/significant breast pain), and physician-reported impaired cosmetic outcome at 1 year after WBI.