JNJ-64041757 (JNJ-757), a Live, Attenuated, Double-Deleted -Based Immunotherapy in Patients With NSCLC: Results From Two Phase 1 Studies.

Introduction: JNJ-64041757 (JNJ-757) is a live, attenuated, double-deleted -based immunotherapy expressing human mesothelin. JNJ-757 was evaluated in patients with advanced NSCLC as monotherapy (phase 1) and in combination with nivolumab (phase 1b/2).

Methods: Patients with stage IIIB/IV NSCLC who had received previous therapy were treated with JNJ-757 (1 × 10 or 1 × 10 colony-forming units [CFUs]) alone (NCT02592967) or JNJ-757 (1 × 10 CFU) plus intravenous nivolumab 240 mg (NCT03371381).

Predicting two-year longitudinal MD Anderson Dysphagia Inventory outcomes after intensity modulated radiotherapy for locoregionally advanced oropharyngeal carcinoma.

Objectives/hypothesis: To determine the factors associated with longitudinal patient-reported dysphagia as measured by the MD Anderson Dysphagia Inventory (MDADI) in locoregionally advanced oropharyngeal carcinoma (OPC) survivors treated with split-field intensity modulated radiotherapy (IMRT).

Study Design: Retrospective patient analysis.

Methods: A retrospective analysis combined data from three single-institution clinical trials for stage III/IV head and neck carcinoma.

Progress in chemoprevention drug development: the promise of molecular biomarkers for prevention of intraepithelial neoplasia and cancer--a plan to move forward.

This article reviews progress in chemopreventive drug development, especially data and concepts that are new since the 2002 AACR report on treatment and prevention of intraepithelial neoplasia. Molecular biomarker expressions involved in mechanisms of carcinogenesis and genetic progression models of intraepithelial neoplasia are discussed and analyzed for how they can inform mechanism-based, molecularly targeted drug development as well as risk stratification, cohort selection, and end-point selection for clinical trials. We outline the concept of augmenting the risk, mechanistic, and disease data from histopathologic intraepithelial neoplasia assessments with molecular biomarker data.

Chemoprevention of head and neck cancer.

Squamous cell carcinoma of the head and neck is the most common epithelial neoplasm of the upper aerodigestive tract and represents a major health concern in the United States and worldwide. Invasive squamous cell carcinoma is the end result of a multiyear, multistep process of accumulation of genetic and phenotypic damage. Chemoprevention is defined as the use of pharmacologic or natural agents that inhibit the development of invasive cancer whether by blocking the DNA damage that initiates carcinogenesis or by arresting or reversing the progression of premalignant cells in which such damage has already occurred.

Chemoprevention of head and neck cancer: an update.

Squamous cell carcinoma of the head and neck is an important public health problem worldwide that is clearly associated with the widely accepted risk factors of tobacco smoking and alcohol use and is the end result of a multiyear, multipath disease process of progressive genetic and associated tissue damage. Chemoprevention, the use of drugs or other agents to inhibit, delay, or reverse this process, is recognized as a very promising and important area in head and neck cancer research. Chemoprevention research is based on the increasing body of knowledge of the biology underlying head and neck tumorigenesis and is expected to ultimately result in a decrease in the incidence of head and neck cancer.