Abstract
BackgroundTo evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC).MethodsRANGE—a randomized, double-blinded, phase 3 trial in patients with platinum-refractory aUC. Ramucirumab (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 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.ResultsOf the 530 patients, ~ 97% patients in each arm provided baseline QLQ-C30 data. On-treatment compliance 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 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.ConclusionsRamucirumab 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 registrationNCT02426125. https://clinicaltrials.gov/ct2/show/NCT02426125. Date of registration: April 24th 2015
Highlights
To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma
There can be concerns when a second agent is added to chemotherapy if gains in efficacy are accompanied by increased toxicity [19], such as in the RANGE study where there were numerically higher rates of any-grade diarrhea, decreased appetite, nausea, and stomatitis in the ramucirumab plus docetaxel arm compared with the placebo plus docetaxel arm [3]
The longer progression-free survival (PFS) was consistent with trend for longer Time to deterioration (TtD) in global quality of life (QoL) in the ramucirumab plus docetaxel arm
Summary
To evaluate patient-reported outcomes with ramucirumab plus docetaxel, a regimen which improved progression-free survival in platinum-refractory advanced urothelial carcinoma (aUC). Median survival is approximately 12–14 months with standard first-line platinum-based chemotherapy for advanced/ metastatic disease [1]. Despite approvals of various targeted therapies for platinum-refractory advanced UC, most patients have limited treatment options as they experience disease progression. Ramucirumab plus docetaxel has shown higher response rate and improved progression-free survival (PFS) compared to placebo plus docetaxel in the platinum-refractory population [2, 3]. Quality of life (QoL) is an important factor in the treatment decision-making process for patients with cancer where symptom palliation is the primary goal of therapy [4, 5]. Monitoring of QoL via patient-reported symptoms is associated with better outcomes than observed with usual care [6]
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