Race-, Age-, and Gender-Based Characteristics and Toxicities of Targeted Therapies on Phase I Trials

• Type of Material: Article
• Authors: Taofeek Owonikoko, Emory University; Adeniyi K. Busari, Emory University; Sungjin Kim, Emory University; Zhengjia Chen, Emory University; Adebowale Akintayo, Emory University; Colleen Lewis, Emory University; Bradley Carthon, Emory University; Olatunji Alese, Emory University; Bassel El-Rayes, Emory University; Suresh Ramalingam, Emory University; R Donald Harvey, Emory University
• Language: English
• Date: 2018-01-01
• Publisher: Karger Publishers
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2018 S. Karger AG, Basel. Copyright: All rights reserved.
• Final Published Version (URL): http://dx.doi.org/10.1159/000488763
• Title of Journal or Parent Work: Oncology
• ISSN: 0030-2414
• Volume: 95
• Issue: 3
• Start Page: 138
• End Page: 146
• Grant/Funding Information: This work was supported in part by the National Cancer Institute at the National Institutes of Health Career Development Award grants (NIH/NCI 5K23CA164015 to TK Owonikoko) and Cancer Center Support Grant (NIH/NCI P30CA138292 to WJ Curran, Jr.) in support of the Biostatistics and Bioinformatics Shared resource of Winship Cancer Institute of Emory University.
• Keywords: SURVIVAL; Life Sciences & Biomedicine; CHEMOTHERAPY; Tolerability; SOCIOECONOMIC-STATUS; END-OF-LIFE; ONCOLOGY TRIALS; Science & Technology; Race; CARE; CELL LUNG-CANCER; Phase I study; Oncology; Targeted therapy; CLINICAL-TRIALS; Toxicity; Gender; CHRONIC MYELOID-LEUKEMIA; PERSONALIZED MEDICINE
• Research Categories: Sociology, Ethnic and Racial Studies; Health Sciences, Toxicology; Health Sciences, Oncology

Abstract

Background: The impact of age-, gender-, and race-based differences on safety and efficacy in phase I clinical trials has not been well studied. Methods: We analyzed data from phase I clinical trials evaluating targeted biologic agents in patients with advanced solid malignancies. Race and gender distribution of enrolled patients was compared to the referral population demographics at the city, metro, and state levels. The association between age, gender, and race with type, frequency, and severity of treatment-emergent toxicities and clinical benefit was assessed using univariate and multivariable models. Results: Data from 117 eligible patients - Blacks/Caucasians/Others (27/85/5); male/female (66/51) - were obtained. Blacks were younger than Caucasian patients (median age of 56 vs. 62 years, p = 0.004). Nausea/vomiting was more frequent in female patients (43 vs. 24%, p = 0.03), while hematologic toxicity was more likely in Whites. While median time on treatment was comparable (113 vs. 91; p = 0.840), the median overall survival was significantly shorter for Blacks versus Caucasians (7.4 vs. 11.4 months; p = 0.0227). Black race (HR 2.11; 95% CI 1.24-3.60; p = 0.006) and older age (HR 1.03; 95% CI 1.00-1.06; p = 0.029) were associated with an increased risk of death. Conclusions: Age-, gender-, and race-based disparities were observed with specific toxicity and survival outcomes on phase I clinical trials of anticancer agents.