Patient-reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial

• Type of Material: Article
• Authors: Laurie E. Steffen McLouth, University of Kentucky; Fengmin Zhao, Dana Farber Cancer Institute; Taofeek Owonikoko, Emory University; Josephine L. Feliciano, Johns Hopkins University; Nisha A. Mohindra, Northwestern University; Suzanne E. Dahlberg, Dana Farber Cancer Institute; James L. Wade, III, Heartland NCORP; Gordan Srkalovic, Sparrow Herbert Herman Cancer Center; Bradley W. Lash, Guthrie Clinic; Joseph W. Leach, Metro Minnesota NCORP; Ticiana Leal, Emory University; Charu Aggarwal, University of Pennsylvania; David Cella, Northwestern University; Suresh Ramalingam, Emory University; Lynne I. Wagner, Wake Forest University
• Language: English
• Date: 2020-08-28
• Publisher: WILEY
• Publication Version: Final Published Version
• Copyright Statement: © 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1002/cam4.3416
• Title of Journal or Parent Work: CANCER MEDICINE
• Volume: 9
• Issue: 20
• Start Page: 7511
• End Page: 7523
• Grant/Funding Information: This study was coordinated by the ECOG‐ACRIN Cancer Research Group (Peter J. O'Dwyer, MD and Mitchell D. Schnall, MD, PhD, Group Co‐Chairs) and supported by the National Cancer Institute of the National Institutes of Health under the following award numbers: CA180820, CA180794, CA189828, CA180864, CA180802, CA189830, CA189971, CA180790, CA189863, CA180799. Dr McLouth was supported by R25 CA122061; PI: Avis.
• Keywords: tolerability; Oncology; Science & Technology; INDUCED PERIPHERAL NEUROPATHY; SYMPTOMS; chemotherapy-induced peripheral neuropathy; RISK; patient-reported outcomes; QUESTIONNAIRE; small cell; PACLITAXEL; ASSOCIATION; HEARING-LOSS; veliparib; Life Sciences & Biomedicine
• Research Categories: Biology, Cell; Health Sciences, Oncology

Abstract

Objectives: The ECOG-ACRIN Cancer Research Group trial E2511 recently demonstrated a potential benefit for the addition of veliparib to cisplatin-etoposide (CE) in patients with extensive stage small cell lung cancer (ES-SCLC) in a phase II randomized controlled trial. Secondary trial endpoints included comparison of the incidence and severity of neurotoxicity, hypothesized to be lower in the veliparib arm, and tolerability of the addition of veliparib to CE. Physician-rated and patient-reported neurotoxicity was also compared. Materials and Methods: Patients randomized to veliparib plus CE (n = 64) or placebo plus CE (n = 64) completed the 11-item Functional Assessment of Cancer Therapy Gynecologic Oncology Group Neurotoxicity (questionnaire pre-treatment, end of cycle 4 [ie 3 months after randomization] and 3 months post-treatment [ie 6-months]). Adherence analysis was based on treatment forms. Results and Conclusion: No significant differences in mean or magnitude of change in neurotoxicity scores were observed between treatment arms at any time point. However, patients in the placebo arm reported worsening neurotoxicity from baseline to 3-months (M difference = −1.5, P =.045), compared to stable neurotoxicity in the veliparib arm (M difference = −0.2, P =.778). Weakness was the most common treatment-emergent (>50%) and moderate to severe (>16%) symptom reported, but did not differ between treatment arms. The proportion of adherence to oral therapy in the overall sample was 75%. Three percent of patients reported clinically significant neurotoxicity that was not captured by physician assessment. Neurotoxicity scores were not different between treatment arms. The addition of veliparib to CE appeared tolerable, though weakness should be monitored. ClinicalTrials.gov Identifier: NCT01642251.