Health-related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetax
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RESEARCH ARTICLE
Open Access
Health‑related quality of life in the randomized phase 3 study of ramucirumab plus docetaxel versus placebo plus docetaxel in platinum‑refractory advanced urothelial carcinoma (RANGE) Andrea Necchi1*, Hiroyuki Nishiyama2, Nobuaki Matsubara3, Jae‑Lyun Lee4, Daniel P. Petrylak5, Ronald de Wit6, Alexandra Drakaki7, Astra M. Liepa8, Huzhang Mao8, Katherine Bell‑McGuinn8 and Thomas Powles9
Abstract Background: To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). Methods: RANGE—a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramu‑ cirumab (10 mg/kg) plus docetaxel (75 mg/m2) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organiza‑ tion for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL fivedimensions (EQ-5D-5L) were administered at baseline, start of each cycle, and 30-day follow-up visit. A ≥ 10-point change in QLQ-C30 scores was considered meaningful. Rates of improved/stable scores were compared between treatment arms using Fisher’s exact test. Time to deterioration (TtD) was estimated and compared using Kaplan–Meier estimation and log-rank test. Results: Of the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compli‑ ance was ≥ 88% for first 8 cycles. Mean baseline QLQ-C30 scores were similar between arms, with global quality of life (QoL), fatigue, pain, and insomnia having greatest impairment. Postbaseline rates of improved/stable QLQ-C30 scores were similar between treatment arms except for greater improvement in pain score with ramucirumab. TtD of QLQC30 scales favored ramucirumab arm. Baseline EQ-5D-5L index and visual analogue scale scores were similar between arms, followed by relatively stable on-treatment scores. EQ-5D-5L scores worsened at post-discontinuation follow-up visit. Conclusions: Ramucirumab plus docetaxel did not negatively impact QoL compared with docetaxel alone in platinum-refractory aUC. Improved TtD and tumor associated rates of pain favored ramucirumab treatment. Clinical trail registration: NCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125. Date of registration: April 24th 2015
*Correspondence: [email protected] 1 Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, 20133 Milan, Italy Full list of author information is available at the end of the article © The Author(s) 2020. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
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