Results of a phase I/IIa trial of SV-BR-1-GM inoculation with low-dose cyclophosphamide and interferon alpha (Bria-IMT) in metastatic breast cancer.

This Phase I/IIa open-label, single-arm clinical trial addressing advanced, refractory, metastatic breast cancer was conducted at six medical centers in the United States. We repeated inoculations with irradiated SV-BR-1-GM, a breast cancer cell line with antigen-presenting activity engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), with pre-dose low-dose cyclophosphamide and post-dose local interferon alpha. Twenty-six patients were enrolled; 23 (88.

Palbociclib in Patients With Soft Tissue Sarcoma With Amplifications: Results From the Targeted Agent and Profiling Utilization Registry Study.

Purpose: Targeted Agent and Profiling Utilization Registry (TAPUR) is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results of a cohort of patients with soft tissue sarcoma with cyclin-dependent kinase 4 () amplification treated with palbociclib are reported.

Methods: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0 to 2, adequate organ function, and no standard treatment options.

Avanzando Caminos (Leading Pathways): design and procedures of the Hispanic/Latino Cancer Survivorship Study.

Avanzando Caminos (Leading Pathways): The Hispanic/Latino Cancer Survivorship Cohort Study aims to examine the influence of sociocultural, medical, stress-related, psychosocial, lifestyle, behavioral, and biological factors on symptom burden, health-related quality of life, and clinical outcomes among Hispanics/Latinos who have been previously treated for cancer. Avanzando Caminos is a prospective, cohort-based study of 3000 Hispanics/Latinos who completed primary cancer treatment within the past 5 years that is representative of the general Hispanic/Latino population in the United States. Participants will complete self-report measures at baseline (time [T] 1), 6 months (T2), 1 year (T3), 2 years (T4), 3 years (T5), 4 years (T6), and 5 years (T7).

Cerebrospinal Fluid Testing in Leptomeningeal Progression of HER2-Negative Breast Cancer Reveals HER2 Positivity, Leading to HER2-Targeted Therapy: A Case Report.

The treatment of breast cancer is largely determined by protein expression assays of estrogen receptor, progesterone receptor, and Her2/neu (HER2) status. These prognostic markers may vary due to tumor heterogeneityor the evolution of prognostic markers throughout the course of treatment. This report presents a case of a patient who initially presented with HER2-negative breast cancer and had rapidly progressed on numerous lines of treatment.

Triple Primary Cancers: An Analysis of Genetic and Environmental Factors.

Unlabelled: The occurrence of multiple primary cancers (MPC) is thought to reflect increased cancer susceptibility in patients due to a combination of genetic and environmental factors. Here we conducted a retrospective review of 2,894 consecutive patients evaluated at a single institution and identified 31 (1.14%) individuals with a history of three or more primary cancers, then analyzed the genetic and environmental influences associated with their propensity for developing malignancies.

Sunitinib in Patients With Breast Cancer With or Amplifications or Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Purpose: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. Results from cohorts of patients with metastatic breast cancer (BC) with and alterations treated with sunitinib are reported.

Methods: Eligible patients had measurable disease, Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, and no standard treatment options.

The Effect of Disability and Social Determinants of Health on Breast and Cervical Cancer Screenings During the COVID-19 Pandemic.

Introduction: The objective of this study was to examine the effect of disability status and social determinants of health (SDOH) on adherence to breast and cervical cancer screening recommendations during the COVID-19 pandemic.

Methods: We conducted a secondary analysis of the 2018 and 2020 Behavioral Risk Factor Surveillance System (BRFSS) data sets. We defined adherence to screenings according to the US Preventive Services Task Force guidelines for breast and cervical cancer screening.

Cobimetinib Plus Vemurafenib in Patients With Solid Tumors With Mutations: Results From the Targeted Agent and Profiling Utilization Registry Study.

Purpose: The Targeted Agent and Profiling Utilization Registry Study is a phase II basket study evaluating antitumor activity of commercially available targeted agents in patients with advanced cancers with genomic alterations known to be drug targets. The results in a cohort of patients with solid tumors with mutations treated with cobimetinib plus vemurafenib are reported.

Methods: Eligible patients had measurable disease (RECIST v.

Factors Associated With Unmet Supportive Care Needs and Emergency Department Visits and Hospitalizations in Ambulatory Oncology.

Importance: Patients with cancer experience multiple supportive care needs (eg, coping and financial counseling) that, if not addressed, may result in poor clinical outcomes. Limited work has assessed the factors associated with unmet needs in large and diverse samples of ambulatory oncology patients.

Objective: To characterize the factors associated with unmet supportive care needs among ambulatory oncology patients and to assess whether such needs were associated with emergency department (ED) visits and hospitalizations.

Cobimetinib Plus Vemurafenib in Patients With Colorectal Cancer With Mutations: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Purpose: TAPUR is a phase II basket trial evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancer and genomic alterations known to be drug targets. The results of a cohort of patients with colorectal cancer (CRC) with mutations treated with cobimetinib (C) plus vemurafenib (V) are reported.

Methods: Eligible patients had advanced CRC, no standard treatment options, measurable disease (RECIST), Eastern Cooperative Oncology Group performance status 0-2, adequate organ function, tumors with V600E/D/K/R mutations, and no , , or mutations.

Implementation and Feasibility of an Electronic Health Record-Integrated Patient-Reported Outcomes Symptom and Needs Monitoring Pilot in Ambulatory Oncology.

Purpose: Describe the feasibility and implementation of an electronic health record (EHR)-integrated symptom and needs screening and referral system in a diverse racial/ethnic patient population in ambulatory oncology.

Methods: Data were collected from an ambulatory oncology clinic at the University of Miami Health System from October 2019 to January 2021. Guided by a Patient Advisory Board and the Exploration, Preparation, Implementation, and Sustainment model, was developed to assess physical and psychologic symptoms and needs of ambulatory oncology patients before appointments to triage them to supportive services when elevated symptoms (eg, depression), barriers to care (eg, transportation and childcare), and nutritional needs were identified.

Pembrolizumab in Patients With Metastatic Breast Cancer With High Tumor Mutational Burden: Results From the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Purpose: The TAPUR Study is a phase II basket trial that aims to identify signals of antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Results in a cohort of patients with metastatic breast cancer (mBC) with high tumor mutational burden (HTMB) treated with pembrolizumab are reported.

Methods: Patients with advanced mBC received standard doses of either 2 mg/kg or 200 mg infusions of pembrolizumab every 3 weeks.

Pathologic and molecular responses to neoadjuvant trastuzumab and/or lapatinib from a phase II randomized trial in HER2-positive breast cancer (TRIO-US B07).

In this multicenter, open-label, randomized phase II investigator-sponsored neoadjuvant trial with funding provided by Sanofi and GlaxoSmithKline (TRIO-US B07, Clinical Trials NCT00769470), participants with early-stage HER2-positive breast cancer (N = 128) were recruited from 13 United States oncology centers throughout the Translational Research in Oncology network. Participants were randomized to receive trastuzumab (T; N = 34), lapatinib (L; N = 36), or both (TL; N = 58) as HER2-targeted therapy, with each participant given one cycle of this designated anti-HER2 therapy alone followed by six cycles of standard combination chemotherapy with the same anti-HER2 therapy. The primary objective was to estimate the rate of pathologic complete response (pCR) at the time of surgery in each of the three arms.

Cetuximab in Patients with Breast Cancer, Non-Small Cell Lung Cancer, and Ovarian Cancer Without KRAS, NRAS, or BRAF Mutations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study.

Background: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study, a phase II basket study, evaluates anti-tumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known as drug targets.

Objective: With no known genomic targets predictive of sensitivity to cetuximab, cetuximab was evaluated in patients with breast cancer (BC), non-small cell lung cancer (NSCLC), and ovarian cancer (OC), without KRAS, NRAS, or BRAF mutations.

Patients And Methods: Eligible patients with advanced BC, NSCLC, and OC received a cetuximab loading dose, then weekly infusions (250 mg/m over 60 min).

Development of a multigenerational digital lifestyle intervention for women cancer survivors and their families.

Objectives: This paper presents the results of a study developed to inform the design of a multigenerational digital lifestyle intervention for overweight/obese women cancer survivors and their families. We followed the first six phases of the Integrate, Design, Assess, and Share (IDEAS) framework.

Methods: Grandmothers with breast, endometrial, or ovarian cancers (n = 46; 66.

Generation of HER2-specific antibody immunity during trastuzumab adjuvant therapy associates with reduced relapse in resected HER2 breast cancer.

Background: Resected HER2 breast cancer patients treated with adjuvant trastuzumab and chemotherapy have superior survival compared to patients treated with chemotherapy alone. We previously showed that trastuzumab and chemotherapy induce HER2-specific antibodies which correlate with improved survival in HER2 metastatic breast cancer patients. It remains unclear whether the generation of immunity required trastuzumab and whether endogenous antibody immunity is associated with improved disease-free survival in the adjuvant setting.

Delivery of NKG2D ligand using an anti-HER2 antibody-NKG2D ligand fusion protein results in an enhanced innate and adaptive antitumor response.

NKG2D ligands link the innate and adapative immune response by activating the receptors expressed on effector cells of both the innate (NK) and adaptive immune systems (CD8(+) T cells). In this study, we explored the potential therapeutic utility of this intersection by fusing the murine NKG2D ligand Rae-1β to the 3' end of an anti-HER2 IgG3 antibody containing an intact Fc domain (anti-HER2 IgG3-Rae-1β), thereby targeting an NK cell activation signal to HER2+ breast tumor cells. The antitumor efficacy of this anti-HER2-Rae-1β fusion protein was examined in a mouse mammary tumor model engineered to express HER2 (EMT6-HER2 cells).

Ocular involvement as the initial manifestation of T-cell chronic lymphocytic leukemia.

Purpose: To present a case of T-cell chronic lymphocytic leukemia (T-CLL) manifesting as an intraocular lymphoma.

Design: Interventional case report.

Methods: We performed a vitreous biopsy in a 67-year-old woman who presented with blurred vision and vitreous cellular infiltration.