Open-Label, Phase II Trial of Extracellular Regulated Kinase Inhibition Alone and in Combination With Autophagy Inhibition in Patients With Metastatic Pancreatic Cancer.

Purpose: Oncogenic mutations in Kirsten rat sarcoma virus are present in over 90% of pancreatic ductal adenocarcinomas (PDACs). Preclinical data suggest that PDAC cells treated with inhibitors of the mitogen-activated protein kinase pathway demonstrate elevated autophagic flux. In this study, we evaluate the clinical efficacy of combining LY3214996 (extracellular regulated kinase inhibitor) with hydroxychloroquine (HCQ; autophagy inhibitor) in patients with metastatic PDAC.

A Summary of the HCC-CARE Symposium: Collaborative Approaches to Reaching Equity in Hepatocellular Carcinoma in Boston by 2030.

Hepatocellular carcinoma (HCC) is a leading cause of cancer mortality in the United States. Disparities in HCC incidence and mortality are amplified in Boston, Massachusetts, which has 42% higher HCC mortality than the nation. HCC-CARE was a one-day symposium that aimed to identify goals and strategies necessary to eliminate HCC disparities in the Greater Boston area by 2030.

Clinical and Social Predictors of Surgical Treatment for Anterior Cruciate Ligament Injuries.

Background: While anterior cruciate ligament (ACL) injury is often managed surgically in the young, active population, nonoperative management may be considered in older adults. Surgical decision-making in adults is usually based on patient preference, level of functional disability, and the presence of comorbidities. Understanding the role of clinical predictors in surgical decision-making can help identify disparities in treatment outcomes.

Usability, Acceptability, and Barriers to Implementation of a Collaborative Agenda-Setting Intervention (CASI) to Promote Person-Centered Ovarian Cancer Care: Development Study.

Background: People with advanced ovarian cancer and their caregivers report unmet supportive care needs. We developed a Collaborative Agenda-Setting Intervention (CASI) to elicit patients' and caregivers' needs through the patient portal before a clinic visit and to communicate these needs to clinicians using the electronic health record.

Objective: We aimed to assess the usability and acceptability of the CASI and identify barriers to and facilitators of its implementation.

Health-related social needs mitigate ethnoracial inequities in patient-reported mental health.

Purpose: To characterize the relationship between ethnoracial identity, health-related social needs (HRSNs), and mental health (MH), and to examine the mediating role of HRSNs on the relationship between MH and ethnoracial identity.

Methods: Data from 30,437 adults who were seeking care within Mass General Brigham integrated health system in United States and had completed PROMIS Global Health within three years of their most recent HRSNs screening between March 1, 2018 and January 31, 2023 were included. The presence and magnitude of PROMIS Global MH score differences for six ethnoracial groups (White non-Hispanic, White Hispanic, Black (Hispanic and non-Hispanic), Asian non-Hispanic, Other non-Hispanic and Other Hispanic (includes Asian Hispanic) was assessed.

A phase II study of ramucirumab and somatostatin analog therapy in patients with advanced neuroendocrine tumors.

Objectives: Well-differentiated neuroendocrine tumors (NET) are highly vascular tumors characterized by their expression of vascular endothelial growth factor (VEGF). This trial investigated the activity of ramucirumab, a monoclonal antibody that targets VEGF receptor-2 (VEGFR-2) and inhibits activity of VEGF, in combination with somatostatin analog therapy in patients (pts) with advanced extra-pancreatic NET.

Methods: We conducted a single-arm phase II trial enrolling pts with advanced, progressive extra-pancreatic NET.

Insomnia Prevalence and Correlates in Cancer Patients Undergoing Treatment.

Background: Insomnia is the most common sleep disturbance among cancer patients undergoing active treatment. If untreated, it is associated with significant physical and psychological health consequences. Prior efforts to determine insomnia prevalence and correlates have primarily assessed patients in clinical trials, in limited disease groups, and excluding important patient subgroups.

Clinical outcomes and ctDNA correlates for CAPOX BETR: a phase II trial of capecitabine, oxaliplatin, bevacizumab, trastuzumab in previously untreated advanced HER2+ gastroesophageal adenocarcinoma.

Preclinical studies suggest that simultaneous HER2/VEGF blockade may have cooperative effects in gastroesophageal adenocarcinomas. In a single-arm investigator initiated clinical trial for patients with untreated advanced HER2+ gastroesophageal adenocarcinoma, bevacizumab was added to standard of care capecitabine, oxaliplatin, and trastuzumab in 36 patients (NCT01191697). Primary endpoint was objective response rate and secondary endpoints included safety, duration of response, progression free survival, and overall survival.

Experience and Needs of Patients With Young-Onset Colorectal Cancer and Their Caregivers: A Qualitative Study.

Purpose: The incidence of young-onset colorectal cancer (YOCRC; defined as patients who are diagnosed with CRC before age 50 years) is rising rapidly, and CRC is predicted to be the leading cause of cancer death in this age group by 2030. Yet, there has been limited research into the experiences and needs of patients with YOCRC and their caregivers. The goal of this study was to better understand the experiences and needs of patients with YOCRC and their caregivers.

Strategies for Implementing an Electronic Patient-Reported Outcomes-Based Symptom Management Program Across Six Cancer Centers.

Background: Electronic patient-reported outcome (ePRO)-based symptom management improves cancer patients' outcomes. However, implementation of ePROs is challenging, requiring technical resources for integration into clinical systems, substantial buy-in from clinicians and patients, novel workflows to support between-visit symptom management, and institutional investment.

Methods: The SIMPRO Research Consortium developed eSyM, an electronic health record-integrated, ePRO-based symptom management program for medical oncology and surgery patients and deployed it at six cancer centers between August 2019 and April 2022 in a type II hybrid effectiveness-implementation cluster randomized stepped-wedge study.

Social Determinants of Health Needs and Health-related Quality of Life Among Surgical Patients: A Retrospective Analysis of 8512 Patients.

Objective: To assess associations between social determinants of health (SDOH) needs and health-related quality of life (HRQOL) among surgical patients.

Background: Despite the profound impact of SDOH on health outcomes, studies examining the effect of SDOH needs on HRQOL among surgical patients are limited.

Methods: A retrospective study was conducted using responses from the SDOH needs assessment and the Patient-Reported Outcomes Measurement Information Systems Global Health instrument of adults seen in surgical clinics at a single institution.

Feasibility of Weekly Electronic Health Record-Embedded Patient-Reported Outcomes for Patients Starting Oral Cancer-Directed Therapy.

Purpose: To examine the feasibility of integrating a symptom management platform into the electronic health record (EHR) using electronic patient-reported outcomes (ePROs) during oral cancer-directed therapy (OCDT) and explore the impact of prompting oncology nurse navigators (ONNs) to respond to severe symptomatic adverse events (SAEs).

Materials And Methods: Adults prescribed OCDT at Dana-Farber Cancer Institute were consecutively invited to participate. Participants received weekly messages to complete ePROs.

G-CSF rescue of FOLFIRINOX-induced neutropenia leads to systemic immune suppression in mice and humans.

Background: Recombinant granulocyte colony-stimulating factor (G-CSF) is routinely administered for prophylaxis or treatment of chemotherapy-induced neutropenia. Chronic myelopoiesis and granulopoiesis in patients with cancer has been shown to induce immature monocytes and neutrophils that contribute to both systemic and local immunosuppression in the tumor microenvironment. The effect of recombinant G-CSF (pegfilgrastim or filgrastim) on the production of myeloid-derived suppressive cells is unknown.

Combined PD-1, BRAF and MEK inhibition in BRAF colorectal cancer: a phase 2 trial.

While BRAF inhibitor combinations with EGFR and/or MEK inhibitors have improved clinical efficacy in BRAF colorectal cancer (CRC), response rates remain low and lack durability. Preclinical data suggest that BRAF/MAPK pathway inhibition may augment the tumor immune response. We performed a proof-of-concept single-arm phase 2 clinical trial of combined PD-1, BRAF and MEK inhibition with sparatlizumab (PDR001), dabrafenib and trametinib in 37 patients with BRAF CRC.

Programmatic Precision Oncology Decision Support for Patients With Gastrointestinal Cancer.

Purpose: With the growing number of available targeted therapeutics and molecular biomarkers, the optimal care of patients with cancer now depends on a comprehensive understanding of the rapidly evolving landscape of precision oncology, which can be challenging for oncologists to navigate alone.

Methods: We developed and implemented a precision oncology decision support system, GI TARGET, (Gastrointestinal Treatment Assistance Regarding Genomic Evaluation of Tumors) within the Gastrointestinal Cancer Center at the Dana-Farber Cancer Institute. With a multidisciplinary team, we systematically reviewed tumor molecular profiling for GI tumors and provided molecularly informed clinical recommendations, which included identifying appropriate clinical trials aided by the computational matching platform MatchMiner, suggesting targeted therapy options on or off the US Food and Drug Administration-approved label, and consideration of additional or orthogonal molecular testing.

Infrastructure to Support Accrual of Older Adults to National Cancer Institute Clinical Trials.

As part of ongoing efforts to meaningfully improve recruitment, enrollment, and accrual of older adults into cancer clinical trials, the National Cancer Institute (NCI) sponsored a workshop with experts across the country entitled Engaging Older Adults in the NCI Clinical Trials Network: Challenges and Opportunities. Three working groups, including Study Design, Infrastructure, and Stakeholders, were formed, who worked together to offer synergistic improvements in the system. Here, we summarize the workshop discussions of the Infrastructure Working Group, whose goal was to address infrastructural challenges, identify underlying resources, and offer solutions to facilitate accrual of older adults into cancer clinical trials.

Framework for integrating electronic patient-reported data in routine cancer care: an Oncology Intake Questionnaire.

Objective: As part of ongoing implementation of electronic patient-reported outcome tools at the Dana-Farber Cancer Institute, here we describe the development of the electronic New Patient Intake Questionnaire.

Materials And Methods: The original New Patient Intake Questionnaire includes a review of symptoms, oncology history, family history, health behaviors, health and social status, health literacy and numeracy, which was modified for integration into the EHR using content determination, build and configuration, implementation, analytics, and interventions. The engagement of key stakeholders, including patients, clinical staff, and providers, throughout the development and deployment of the electronic Questionnaire was crucial to producing a successful tool.

Barriers to Electronic Patient-Reported Outcome Measurement Among Patients with Cancer and Limited English Proficiency.

Importance: Often electronic tools are built with English proficient (EP) patients in mind. Cancer patients with limited English proficiency (LEP) experience gaps in care and are at risk for excess toxic effects if they are unable to effectively communicate with their care team.

Objective: To evaluate whether electronic patient-reported outcome tools (ePROs) built to improve health outcomes for EP patients might also be acceptable for LEP patients in the context of oral cancer-directed therapies (OCDT).