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 Necchi, Hiroyuki Nishiyama, Nobuaki Matsubara, Jae-Lyun Lee, Daniel P. Petrylak, Ronald de Wit, Alexandra Drakaki, Astra M. Liepa, Huzhang Mao, Katherine Bell-McGuinn, Thomas Powles

Research output: Contribution to journalArticlepeer-review

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. Ramucirumab (10 mg/kg) plus docetaxel (75 mg/m(2)) or placebo plus docetaxel were administered every 21 days until disease progression or unacceptable toxicity. Patients received maximum 10 cycles of docetaxel. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) and EuroQoL five-dimensions (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, textasciitilde 97C30 data. On-treatment compliance was ≥ 88 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 QLQ-C30 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.
Original languageEnglish
Pages (from-to)181
Number of pages1
JournalBMC Urology
Volume20
Issue number1
DOIs
Publication statusPublished - Nov 1 2020

Keywords

  • Quality of life
  • Patient-reported outcomes
  • Bladder cancer
  • Urothelial carcinoma
  • Antiangiogenesis
  • Neoplasm metastatsis
  • Ramucirumab
  • Urinary bladder neoplasm

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