Intermittent fasting and its impact on toxicities, symptoms and quality of life in patients on active cancer treatment.

Intermittent fasting is a dietary intervention that is increasingly being tested for positive outcomes in patients receiving cancer treatment. In this review, we examine the impact of intermittent fasting on symptoms, toxicities, and quality of life in patients undergoing cancer therapy and highlight unmet investigative areas to prompt future research. While current evidence is preliminary and conclusions mixed, some promising clinical studies suggest that intermittent fasting interventions may improve fatigue and reduce gastrointestinal toxicities in certain patients with cancer.

Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial.

Patients with rare solid tumors treated on early phase trials experience toxicities from their tumors and treatments. However, limited data exist to describe the detailed symptom burden suffered by these patients, particularly those with rare solid tumors treated with immunotherapy. We performed a prospective longitudinal study to capture patient-reported symptom burden.

Dietary influences on symptomatic and non-symptomatic toxicities during cancer treatment: A narrative review.

The general nutritional status of cancer patients could be a central determinant of cancer treatment-related toxicity and an indicator of cancer symptoms such as cancer-related cachexia and weight loss. This narrative scientific review covers the impact of dietary patterns (for example, Mediterranean diet, short-term fasting, ketogenic diet), dietary components (for example, fruits and vegetables, fish oils, turmeric/curcumin, dietary fiber, phytochemicals, vitamin/mineral dietary supplements), and the gut microbiota on symptoms, toxicities, and adverse events associated with cancer treatment. Although several studies have produced controversial or inconclusive results, some promising preclinical studies and initial clinical trials suggest that dietary interventions may alleviate certain cancer treatment-related symptoms and toxicities.

Adoptive cell therapy in gynecologic cancers: A systematic review and meta-analysis.

Adoptive cell therapy (ACT) has shown promise in hematologic and solid tumors. While data supports immunogenicity of gynecologic cancers, the benefit of ACT is not yet clear. To address this question, we performed a comprehensive systematic review and meta-analysis.

Patient-Reported Out-of-Pocket Costs and Financial Toxicity During Early-Phase Oncology Clinical Trials.

Background: Clinical trials are an important therapeutic option for patients with cancer. Although financial burden in cancer treatment is well documented, the financial burden associated with clinical trials is not well understood.

Patients And Methods: We conducted a survey regarding economic burden and financial toxicity in patients with cancer enrolled in phase I clinical trials for >1 month.

Diet-related interventions for cancer-associated cachexia.

Purpose: Cancer-associated cachexia is a common condition in patients with advanced cancer, and is associated with extreme and involuntary weight loss and irreversible muscle wasting. Despite its high morbidity and mortality, there is no known treatment to reverse its effects. Thus, there is increasing interest in whether diet and exercise can assist in the minimization of cancer-associated cachexia.

Evaluating the psychometric properties of the Immunotherapy module of the MD Anderson Symptom Inventory.

Introduction: Immunotherapies have revolutionized the treatment of various cancers, but little is known about their symptomatic toxicity. Assessing these symptoms is best accomplished by asking the patients themselves. However, such reports are subjective and may face challenges as bonafide scientific data.

Pre-clinical animal models are poor predictors of human toxicities in phase 1 oncology clinical trials.

Background: Our objective was to determine the correlation between preclinical toxicity found in animal models (mouse, rat, dog and monkey) and clinical toxicity reported in patients participating in Phase 1 oncology clinical trials.

Methods: We obtained from two major early-Phase clinical trial centres, preclinical toxicities from investigational brochures and clinical toxicities from published Phase 1 trials for 108 drugs, including small molecules, biologics and conjugates. Toxicities were categorised according to Common Terminology Criteria for Adverse Events version 4.

Factors affecting symptom presentation in an early-phase clinical trials clinic patient population.

Increasing numbers of oncology therapies are being approved based on early-phase single-arm studies. Yet, little is known regarding the use of patient-reported outcomes in single-arm oncology trials testing novel therapies. We examined patient-reported symptom severity and symptom interference with activity- (WAW: work, general activity, walking) and mood-(REM: relations with others, enjoyment of life, mood) related functioning, and their association with factors known to influence symptom severity reporting, in early-phase clinical trials clinic patients.

Improving attribution of adverse events in oncology clinical trials.

Attribution of adverse events (AEs) is critical to oncology drug development and the regulatory process. However, processes for determining the causality of AEs are often sub-optimal, unreliable, and inefficient. Thus, we conducted a toxicity-attribution workshop in Silver Springs MD to develop guidance for improving attribution of AEs in oncology clinical trials.

Cancer-Related Internet Use and Its Association With Patient Decision Making and Trust in Physicians Among Patients in an Early Drug Development Clinic: A Questionnaire-Based Cross-Sectional Observational Study.

Background: The role of cancer-related internet use on the patient-physician relationship has not been adequately explored among patients who are cancer-related internet users (CIUs) in early-phase clinical trial clinics.

Objective: We examined the association between cancer-related internet use and the patient-physician relationship and decision making among CIUs in an early drug development clinic.

Methods: Of 291 Phase I clinic patients who completed a questionnaire on internet use, 179 were CIUs.

Erratum: Ocular toxicities associated with targeted anticancer agents: an analysis of clinical data with management suggestions.

[This corrects the article DOI: 10.18632/oncotarget.17634.

Cancer-Related Internet Use and Online Social Networking Among Patients in an Early-Phase Clinical Trials Clinic at a Comprehensive Cancer Center.

Purpose: We examined patterns, correlates, and the impact of cancer-related Internet use among patients with advanced cancer in a phase I clinical trials clinic for molecularly targeted oncologic agents.

Methods: An anonymous questionnaire on Internet use for cancer-related purposes that incorporated input from phase I clinical trial oncologists and patients was self-administered by patients age ≥ 18 years in a phase I clinic. Multivariable modeling was used.

Ocular toxicities associated with targeted anticancer agents: an analysis of clinical data with management suggestions.

Ocular toxicities are among the most common adverse events resulting from targeted anticancer agents and are becoming increasingly relevant in the management of patients on these agents. The purpose of this study is to provide a framework for management of these challenging toxicities based on objective data from FDA labels and from analysis of the literature. All oncologic drugs approved by the FDA up to March 14, 2015, were screened for inclusion.

Insurance Clearance for Early-Phase Oncology Clinical Trials Following the Affordable Care Act.

The Affordable Care Act (ACA) required that private insurance plans allow clinical trial participation and cover standard-of-care costs, but the impact of this provision has not been well-characterized. We assessed rates of insurance clearance for trial participation within our large early-phase clinical trials program, before and after implementation of the requirement. We analyzed the departmental database for the Clinical Center for Targeted Therapy (CCTT) at MD Anderson Cancer Center (Houston, TX).

Relative Validity and Reliability of a 1-Week, Semiquantitative Food Frequency Questionnaire for Women Participating in the Supplemental Nutrition Assistance Program.

Background: The Supplemental Nutrition Assistance Program (SNAP) plays a critical role in reducing food insecurity by distribution of benefits at a monthly interval to participants. Households that receive assistance from SNAP spend at least three-quarters of benefits within the first 2 weeks of receipt. Because this expenditure pattern may be associated with lower food intake toward the end of the month, it is important to develop a tool that can assess the weekly diets of SNAP participants.

Sleep quality and its association with fatigue, symptom burden, and mood in patients with advanced cancer in a clinic for early-phase oncology clinical trials.

Background: Limited data exist about sleep quality for patients with advanced cancer in phase 1 clinical trials. Poor sleep quality is often not captured as an adverse event, and its association with fatigue, one of the most frequently reported adverse events, is not documented routinely. This article describes sleep quality and its relation with fatigue, symptom burden, and mood in patients recruited from an early-phase clinic for targeted therapy.

The isolation and characterization of CTC subsets related to breast cancer dormancy.

Uncovering CTCs phenotypes offer the promise to dissect their heterogeneity related to metastatic competence. CTC survival rates are highly variable and this can lead to many questions as yet unexplored properties of CTCs responsible for invasion and metastasis vs dormancy. We isolated CTC subsets from peripheral blood of patients diagnosed with or without breast cancer brain metastasis.

Phase 1b study of lenvatinib (E7080) in combination with temozolomide for treatment of advanced melanoma.

Objective And Methods: In this phase 1b study, patients with stage 4 or unresectable stage 3 melanoma were treated with escalating doses of lenvatinib (once daily) and temozolomide (TMZ) (days 1-5) in 28-day cycles, to determine the maximum tolerated dose (MTD) of the combination. Dose Level (DL)1: lenvatinib 20 mg, TMZ 100 mg/m2; DL2: lenvatinib 24 mg, TMZ 100 mg/m2; DL3: lenvatinib 24 mg, TMZ 150 mg/m2. Adverse events (AEs) were recorded and tumor response assessed per RECIST 1.

Phase I Dose-Escalation Study of the Multikinase Inhibitor Lenvatinib in Patients with Advanced Solid Tumors and in an Expanded Cohort of Patients with Melanoma.

Purpose: This "3+3" phase I study evaluated the safety, biologic, and clinical activity of lenvatinib, an oral multikinase inhibitor, in patients with solid tumors.

Experimental Design: Ascending doses of lenvatinib were administered per os twice daily in 28-day cycles. Safety and response were assessed for all patients.

Dual inhibition of the vascular endothelial growth factor pathway: a phase 1 trial evaluating bevacizumab and AZD2171 (cediranib) in patients with advanced solid tumors.

Background: The current study was conducted to evaluate the safety and biological activity of dual inhibition of the vascular endothelial growth factor (VEGF) pathway with combined bevacizumab and cediranib (a VEGF receptor tyrosine kinase inhibitor).

Methods: This was a 3 + 3 dose escalation study in patients with advanced solid tumors. Cediranib was given orally daily for 21 days and bevacizumab intravenously every 2 weeks.

Factors related to biopsy willingness in patients with advanced cancer in a phase 1 clinic for molecularly targeted therapy.

Purpose: Tumor biopsies are critical for delineating pharmacodynamic effects of drugs and for optimal patient selection during oncology clinical trials of molecular targeted therapies. The purpose of this study was to identify factors related to patients' willingness to provide study-related tumor biopsies in phase 1 clinical trials of molecularly targeted therapy.

Methods: An investigator-designed survey, that assessed biopsy willingness, demographic and clinical factors, was completed anonymously by patients with advanced cancer in a phase 1 clinic for targeted therapy.

Targeting the molecular chaperone heat shock protein 90 (HSP90): lessons learned and future directions.

Due to the critical role of heat shock protein 90 (HSP90) in regulating the stability, activity and intracellular sorting of its client proteins involved in multiple oncogenic processes, HSP90 inhibitors are promising therapeutic agents for cancer treatment. In cancer cells, HSP90 client proteins play a major role in oncogenic signal transduction (i.e.

A phase 1 study of gemcitabine combined with dasatinib in patients with advanced solid tumors.

Purpose: Dasatinib has been shown preclinically to overcome resistance to gemcitabine. We evaluated the safety and biological activity of the combination of dasatinib and gemcitabine in patients with advanced solid tumors.

Experimental Design: In a phase 1 study (3 + 3 design), patients received daily dasatinib with weekly gemcitabine on days 1, 8 and 15 of a 28-day cycle (except cycle 1 which was 8 weeks).