Safety and Efficacy of the Combination Lurbinectedin plus Doxorubicin from a Phase 1b Trial in Patients with Advanced/Metastatic Soft-Tissue Sarcoma.

Purpose: While cytotoxic chemotherapy is the standard first-line treatment for patients with metastatic soft-tissue sarcoma (STS), clinical outcomes remain suboptimal. Our prior study showed lurbinectedin plus doxorubicin is well tolerated with promising clinical activity in STS. We designed this phase 1b trial to optimize dosing as the basis for a randomized trial in leiomyosarcoma and to further explore the safety profile and efficacy signal.

Image-guided percutaneous ablation of hepatic epithelioid hemangioendothelioma.

Purpose: Disease control and survival following percutaneous ablation of hepatic epithelioid hemangioendothelioma (EHE) was studied retrospectively.

Methods: Six patients underwent 16 image-guided ablation procedures to treat 35 liver tumors from 2015 to 2022 (17 microwave ablation, 9 irreversible electroporation, 8 cryoablation, and 1 radiofrequency ablation). Technical success, local progression, intrahepatic progression, distant progression, overall survival, and adverse events were assessed.

Phase II Study of Eribulin plus Pembrolizumab in Metastatic Soft-tissue Sarcomas: Clinical Outcomes and Biological Correlates.

Purpose: Eribulin modulates the tumor-immune microenvironment via cGAS-STING signaling in preclinical models. This non-randomized phase II trial evaluated the combination of eribulin and pembrolizumab in patients with soft-tissue sarcomas (STS).

Patients And Methods: Patients enrolled in one of three cohorts: leiomyosarcoma (LMS), liposarcomas (LPS), or other STS that may benefit from PD-1 inhibitors, including undifferentiated pleomorphic sarcoma (UPS).

SAR-096: Phase II Clinical Trial of Ribociclib in Combination with Everolimus in Advanced Dedifferentiated Liposarcoma (DDL) and Leiomyosarcoma (LMS).

Purpose: Dedifferentiated liposarcoma (DDL) and leiomyosarcoma (LMS) are two common subtypes of soft-tissue sarcoma, a rare group of diseases for which new treatments are needed. Chemotherapy remains the standard option for advanced disease. Targeting cyclin-dependent kinase 4 and 6 (CDK4/6) in DDL and mTOR in LMS is of biologic interest.

Atezolizumab for Advanced Alveolar Soft Part Sarcoma.

Background: Alveolar soft part sarcoma (ASPS) is a rare soft-tissue sarcoma with a poor prognosis and no established therapy. Recently, encouraging responses to immune checkpoint inhibitors have been reported.

Methods: We conducted an investigator-initiated, multicenter, single-group, phase 2 study of the anti-programmed death ligand 1 (PD-L1) agent atezolizumab in adult and pediatric patients with advanced ASPS.

Phase 2 trial of palbociclib and ganitumab in patients with relapsed Ewing sarcoma.

Background: Ewing sarcoma (EWS) is an aggressive sarcoma with few treatment options for patients with relapsed disease. Cyclin-dependent kinase 4 (CDK4) is a genomic vulnerability in EWS that is synergistic with IGF-1R inhibition in preclinical studies. We present the results of a phase 2 study combining palbociclib (CDK4/6 inhibitor) with ganitumab (IGF-1R monoclonal antibody) for patients with relapsed EWS.

Epithelioid hemangioendothelioma, an ultra-rare cancer: a consensus paper from the community of experts.

Epithelioid hemangioendothelioma (EHE) is an ultra-rare, translocated, vascular sarcoma. EHE clinical behavior is variable, ranging from that of a low-grade malignancy to that of a high-grade sarcoma and it is marked by a high propensity for systemic involvement. No active systemic agents are currently approved specifically for EHE, which is typically refractory to the antitumor drugs used in sarcomas.

Real-world outcomes of patients with locally advanced or metastatic epithelioid sarcoma.

Background: Limited data are available on the real-world effectiveness and safety of systemic therapies for advanced (surgically unresectable and/or metastatic) epithelioid sarcoma (ES).

Methods: A retrospective medical records review was conducted in patients with advanced ES who were initiating first-line or ≥2 lines of systemic therapy (2000-2017) at 5 US cancer centers. The real-world overall response rate (rwORR), the duration of response (rwDOR), the disease control rate (rwDCR) (defined as stable disease for ≥32 weeks or any duration of response), and progression-free survival (rwPFS) were assessed by radiology reports.

The Angiosarcoma Project: enabling genomic and clinical discoveries in a rare cancer through patient-partnered research.

Despite rare cancers accounting for 25% of adult tumors, they are difficult to study due to the low disease incidence and geographically dispersed patient populations, which has resulted in significant unmet clinical needs for patients with rare cancers. We assessed whether a patient-partnered research approach using online engagement can overcome these challenges, focusing on angiosarcoma, a sarcoma with an annual incidence of 300 cases in the United States. Here we describe the development of the Angiosarcoma Project (ASCproject), an initiative enabling US and Canadian patients to remotely share their clinical information and biospecimens for research.

A phase II multi-strata study of lurbinectedin as a single agent or in combination with conventional chemotherapy in metastatic and/or unresectable sarcomas.

Chemotherapy objective response rates (ORRs) in metastatic soft tissue sarcoma (STS) are typically 20-40% with median progression-free survival (PFS) less than 6 months. Lurbinectedin is a new anticancer agent under investigation. The primary objective of this three-arm, phase II study was to determine the disease control rate (DCR = ORR + stable disease [SD]) at 24 weeks of lurbinectedin alone or with chemotherapy in STS.

Impact of training primary care physicians in behavioral counseling to reduce cardiovascular disease risk factors in Ecuador.

Objective: To assess the feasibility of implementing a physician-based, patient-centered counseling intervention model in Ecuador to improve the ability of primary care physicians (PCPs) to reduce cardiovascular disease (CVD) risk factors among patients.

Methods: This was a randomized clinical trial conducted in primary care clinics in Quito in 2014 - 2016. Participants included 15 PCPs and their adult patients at high risk of developing type-2 diabetes.

Immunotherapy with single agent nivolumab for advanced leiomyosarcoma of the uterus: Results of a phase 2 study.

Background: Immunotherapy has changed the therapeutic landscape in oncology. Advanced uterine leiomyosarcoma (ULMS) remains an incurable disease in most cases, and despite new drug approvals, improvements in overall survival have been modest at best. The goal of this study was to evaluate programmed-death 1 (PD-1) inhibition with nivolumab in this patient population.

Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial.

Background: Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components.

Objective: To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines.

Design: Randomized, controlled trial from June 2009 to January 2014.

The relation between cigarette smoking and risk of acute myeloid leukemia: an updated meta-analysis of epidemiological studies.

Smoking has been postulated as an environmental risk factor for acute myeloid leukemia (AML). The primary objective of this meta-analysis of observational studies was to evaluate the epidemiologic relationship between smoking and the risk of development of AML. Twenty-three studies published between January 1993 and December 2013 were included in our analysis, and accounted for 7,746 cases of AML.

Severity of depressive symptoms and accuracy of dietary reporting among obese women with major depressive disorder seeking weight loss treatment.

An elevation in symptoms of depression has previously been associated with greater accuracy of reported dietary intake, however this association has not been investigated among individuals with a diagnosis of major depressive disorder. The purpose of this study was to investigate reporting accuracy of dietary intake among a group of women with major depressive disorder in order to determine if reporting accuracy is similarly associated with depressive symptoms among depressed women. Reporting accuracy of dietary intake was calculated based on three 24-hour phone-delivered dietary recalls from the baseline phase of a randomized trial of weight loss treatment for 161 obese women with major depressive disorder.

Challenges in sodium intake reduction and meal consumption patterns among participants with metabolic syndrome in a dietary trial.

Background: Dietary guidelines suggest limiting daily sodium intake to <2,300 mg for the general population, and <1,500 mg/d for those with certain cardiovascular risk factors. Despite these recommendations, few Americans are able to achieve this goal. Identifying challenges in meeting these guidelines is integral for successful compliance.

Dietary magnesium intake improves insulin resistance among non-diabetic individuals with metabolic syndrome participating in a dietary trial.

Many cross-sectional studies show an inverse association between dietary magnesium and insulin resistance, but few longitudinal studies examine the ability to meet the Recommended Dietary Allowance (RDA) for magnesium intake through food and its effect on insulin resistance among participants with metabolic syndrome (MetS). The dietary intervention study examined this question in 234 individuals with MetS. Magnesium intake was assessed using 24-h dietary recalls at baseline, 6, and 12 months.

All-cause, cardiovascular, and cancer mortality rates in postmenopausal white, black, Hispanic, and Asian women with and without diabetes in the United States: the Women's Health Initiative, 1993-2009.

Using data from the Women's Health Initiative (1993-2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.

Unusual blasts with basophilic granules in 2 cases of de novo acute myeloid leukemia with inv3(q21q26.2) and monosomy 7 and coexpression of CD2 and CD31.

Acute myeloid leukemia with inv3(q21q26.2)/t(3,3)(q21;q26.2) is a subtype of acute myeloid leukemia associated with significant dysmyelopoiesis and a poor prognosis.

Randomized controlled trial of behavioral treatment for comorbid obesity and depression in women: the Be Active Trial.

Objective: Depression is associated with increased risk for obesity and worse weight loss treatment outcomes. The purpose of the present study was to test the hypothesis that delivering evidence-based behavior therapy for depression before a lifestyle weight loss intervention improves both weight loss and depression.

Design: In a randomized controlled trial, obese women with major depressive disorder (N=161, mean age=45.

Cetuximab, paclitaxel, carboplatin, and radiation for head and neck cancer: a survival analysis of a Brown University Oncology Group phase II study.

Objectives: To assess the effect on progression-free and overall survival from the addition of cetuximab to paclitaxel-based chemoradiation for patients with squamous cell head and neck cancer from Brown University Oncology Group studies.

Methods: BrUOG HN-204 patients with stage III or IV locally advanced squamous cell cancer of the head and neck without distant organ metastases received 4 weeks of induction cetuximab followed by weekly cetuximab, paclitaxel, carboplatin, and concurrent radiation. Recurrence and survival data were compared with previous Brown University studies utilizing the same paclitaxel-based chemoradiation with and without induction chemotherapy.

Statin therapy and the risk for diabetes among adult women: do the benefits outweigh the risk?

Purpose Of Review: The purpose of this review was to examine statin therapy and the risk for diabetes among adult women using a selective review.

Recent Findings: The literature contains reports of new-onset diabetes associated with statin use. While many studies do not report sex-specific results, there is evidence indicating the risk to benefit ratio may vary by gender.

Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

Objective: Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental.