Ramucirumab Plus Docetaxel May Improve QoL in Urothelial Carcinoma
The impact of this treatment on quality of life was not previously reported.
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Ramucirumab plus docetaxel does not negatively affect quality of life (QoL) among patients with urothelial carcinoma (UC) compared with placebo and docetaxel, according to research being presented at the 2018 Genitourinary Cancers Symposium in San Francisco, California.1
For the phase 3 RANGE study (ClinicalTrials.gov Identifier: NCT02426125), investigators randomly assigned 530 patients with advanced or metastatic UC who had progressed on platinum-based therapy to receive ramucirumab 10 mg/kg plus docetaxel 75 mg/m2 (experimental) or placebo plus docetaxel (control) for up to 10 cycles. Ramucirumab plus docetaxel improved progression-free survival and the overall response rate, but the impact of treatment on QoL was not previously reported.
Patients were asked to complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) at baseline, prior to each cycle, and at the 30-day follow-up. Mean baseline scores were comparable between the study arms.
QoL remained consistent for both study arms over the course of treatment; the only improvement observed from baseline was for pain. Patients in the experimental arm had significantly improved QoL pain scores at cycles 4 and 7 (P < .05), and patients in both study arms experienced improvements for pain (ramucirumab, 14%-25%; placebo; 8%-24%) relative to other QoL scales during cycles 1 to 4.
A post hoc analysis suggested that patients who were responsive to treatment may experience greater relief from pain when treated with ramucirumab and docetaxel compared with placebo plus docetaxel: patients in the experimental arm reported an improvement of 31% to 32% in pain score compared with 14% to 26% among controls.
The authors concluded that “trends in improved [time to sustained deterioration] and improved rates of pain associated with tumor response favored [ramucirumab plus docetaxel].”
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- Necchi A, Nishiyama H, Matsubara N, et al. Quality-of-life (QoL) in RANGE: a phase 3 study of ramucirumab (RAM) plus docetaxel (DOC) versus placebo (P) plus DOC in platinum-refractory locally advanced or metastatic urothelial carcinoma (UC). Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.