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
Mené auprès de 665 patients atteints d'un adénocarcinome de l'estomac ou de la jonction gastro-œsophagienne de stade avancé, cet essai européen de phase III évalue les effets de l'ajout du ramucirumab au paclitaxel sur la qualité de vie
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.