A multicenter, double-blind, randomized phase III trial of ramucirumab plus docetaxel versus placebo plus docetaxel for treatment of Stage IV non-small cell lung cancer after disease progression on or after platinum-based therapy (REVEL): An Indian patient subgroup analysis

Abstract

Background: Ramucirumab plus docetaxel has been shown to improve survival as a second-line treatment for patients with Stage IV non-small-cell lung cancer (NSCLC) in the multicenter, double-blind, randomized, Phase III trial, REVEL.Objective: In this exploratory analysis, we aimed to assess the safety and efficacy of ramucirumab plus docetaxel in the Indian patient subgroup of the REVEL study.Materials and Methods: Adult patients with histologically or cytologically confirmed NSCLC of either squamous or non-squamous histology, who progressed during or after first-line platinum-based chemotherapy were randomized to receive either ramucirumab plus docetaxel or placebo plus docetaxel. We performed a descriptive analysis of the baseline characteristics, safety, and efficacy of the Indian subgroup of the overall REVEL study (NCT01168973). The analyses presented here are not intended for comparison purposes either between treatment arms or to the overall REVEL study.Results: Fifty-five Indian patients were included in the REVEL study. Baseline characteristics and prior therapies of these patients were well-balanced between the treatment arms. Almost 80% patients had non-squamous histology, and 78.2% were men. All patients had received prior standard platinum-based therapy: 25.5% of patients received maintenance, while 18.2% received taxane (paclitaxel only) as part of their first-line therapy. The incidence of treatment-emergent adverse events regardless of grade was similar between the two arms in the Indian safety subgroup. Patients treated with ramucirumab plus docetaxel experienced a median overall survival (OS) of 13.5 months (95% confidence interval [CI], 5.7–17.6) and progression-free survival (PFS) of 5.6 months (95% CI, 2.8–7.0) relative to a median OS of 5.3 months (95% CI: 3.6–9.9) and PFS of 1.5 months (95% CI: 1.3–5.2), for those treated with placebo plus docetaxel.Conclusion: In this exploratory analysis, Indian patients enrolled in the REVEL study demonstrated prolonged OS and PFS when treated with ramucirumab plus docetaxel, consistent with the overall results of the REVEL study. Ramucirumab plus docetaxel appears to be well tolerated by Indian patients, as the rates for most adverse events were similar with and without ramucirumab.