O-0016 - RAINBOW: global, phase 3, randomized, double-blind study of ramucirumab plus paclitaxel vs placebo plus paclitaxel patients with previously treated...

Date 27 June 2014
Event World GI 2014
Session Presentation of selected abstracts
Topics Anti-Cancer Agents & Biologic Therapy
Gastric Cancer
Presenter Salah-Eddin Al-Batran
Citation Annals of Oncology (2014) 25 (suppl_2): ii105-ii117. 10.1093/annonc/mdu193
Authors C. Oh Sang1, T.Y. Kim2, A. Ohtsu3
  • 1Korean University, Seoul/KR
  • 2Seoul National University Cancer Hospital, Seoul/KR
  • 3National Cancer Center Hospital East, Kashiwa/JP

Abstract

Introduction

Addition of ramucirumab (RAM) to paclitaxel (PTX) resulted in statistically significantly improved overall survival, progression-free survival, and tumor response rate for previously treated patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma (Wilke et al, GI Cancer Symposium 2014). Here we present results for quality of life (QoL), health status, and performance status (PS).

Methods

Patients who had previously received fluoropyrimidine- and platinum-based therapy and with ECOG PS of 0/1 were randomized to receive RAM 8 mg/kg IV or placebo (PL) on Days 1 and 15 every 4 weeks; both arms received PTX 80 mg/m2 on Days 1, 8 and 15. Patients completed the EORTC QLQ-C30 (v3) and EQ-5D at baseline, every 6 weeks from start of therapy, and at discontinuation. Investigator-rated ECOG PS was assessed at baseline, prior to every cycle, at discontinuation, and at 30-day follow-up. Time to deterioration (TtD) in each QLQ-C30 scale was defined as randomization to first worsening of ≥10 points (on 100-point scale) and TtD in PS was defined as first worsening to ≥2. Additional analyses were performed varying the definition of PS deterioration. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models. In addition, QLQ-C30 scores were classified as improved or worsened if changed by ≥10 points relative to baseline, otherwise classified as stable. EQ-5D results were summarized descriptively.

Results

Of 665 patients randomized, 322/330 (98%) of RAM + PTX and 328/335 (98%) of PL + PTX patients provided baseline QLQ-C30 data and 87% and 82%, respectively, provided both BL and post-BL data; similar rates were reported for the EQ-5D. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 parameters, 14 had HRs <1, indicating similar or longer TtD in QoL for RAM + PTX. For all QLQ-C30 parameters and at all on-therapy assessment times, the proportion of patients reporting improved or stable scores was greater in the RAM + PTX arm; in general, more patients were classified as stable than improved. Select results are presented in the table below. While on therapy, EQ-5D scores were relatively unchanged in both arms, but worsened at discontinuation with mean change from baseline of -0.16 for RAM + PTX and -0.19 for PL + PTX. The HR for TtD in PS was 0.80; alternate definitions for PS deterioration also yielded HRs < 1.

Conclusion

For patients with advanced gastric cancer, addition of RAM to PTX did not impair QoL or health status. Compared with PL + PTX, QoL and PS were maintained for a longer time and more patients reported stable or improved QoL scores.