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Quality-of-life and performance status results from the phase 3 RAINBOW study of ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated gastric or gastroesophageal junction adenocarcinoma

Al-Batran SE, Van Cutsem E, Cheul Oh S, Bodoky G, Shimada Y, Hironaka S, et al.

Ann Oncol. 2016 Jan 7 [Epub ahead of print]

Abstract
 

BACKGROUND:

The RAINBOW phase 3 trial demonstrated that addition of ramucirumab to paclitaxel improved overall survival, progression-free survival, and tumor response rate in fluoropyrimidine-platinum previously treated patients with advanced gastric/gastroesophageal junction adenocarcinoma. Here we present results from quality of life (QoL) and performance status (PS) analyses.

PATIENTS AND METHODS:

Patients with Eastern Cooperative Oncology Group PS of 0/1 were randomized to receive ramucirumab (8 mg/kg IV) or placebo on Days 1 and 15 of a 4-week cycle, with both arms receiving paclitaxel (80 mg/m2) on Days 1, 8, and 15. Patient-reported outcomes were assessed with the QoL/health status questionnaires EORTC QLQ-C30 and EQ-5D at baseline and six week intervals. PS was assessed at baseline and Day 1 of every cycle. 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. Hazard ratios (HRs) for treatment effect were estimated using stratified Cox proportional hazards models.

RESULTS:

Of 665 patients randomized, 650(98%) provided baseline QLQ-C30 and EQ-5D data, and 560(84%) also provided data from ≥1post-baseline time point. Baseline scores for both instruments were similar between arms. Of the 15 QLQ-C30 scales, 14 had HR<1, indicating similar or longer TtD in QoL for ramucirumab+paclitaxel. Treatment with ramucirumab+paclitaxel was also associated with a delay in TtD of PS to ≥2 (HR=0.798, p=0.0941). Alternate definitions of PS deterioration yielded similar results: PS ≥3 (HR=0.656, p=0.0508), deterioration by ≥1 PS level (HR=0.802, p=0.0444), and deterioration by ≥2 PS levels (HR=0.608, p=0.0063). EQ-5D scores were comparable between treatment arms, stable during treatment, and worsening at discontinuation.

CONCLUSION:

In patients with previously-treated advanced gastric/GEJ cancer, addition of ramucirumab to paclitaxel prolonged overall survival while maintaining patient QoL with delayed symptom worsening and functional status deterioration.


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