Ramucirumab Plus Paclitaxel in Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
In the double-blind, randomized phase 3 RAINBOW trial, overall survival and progression-free survival were improved for patients with previously treated gastric/gastroesophageal junction (GEJ) adenocarcinoma in the ramucirumab (RAM) + paclitaxel (PAC) arm compared to placebo (PBO) + PAC1. The objective tumor response rates were also significantly improved: 28% for RAM + PAC vs 16% for PBO + PAC (P =.0001). In the current presentation, Bodoky and colleagues described the timing and duration of responses and quality of life (QoL) in RAINBOW.2
In RAINBOW, patients were randomized 1:1 to RAM 8 mg/kg or PBO on days 1 and 15 + PAC 80 mg/m2 on days 1, 8, and 15 (28-day cycle). Radiographic assessment of disease per RECIST v1.1 and assessment of QoL with the EORTC QLQ-C30 were performed at baseline and at 6-week intervals following the first dose of study therapy. Time to response (TTR) was defined as the time from randomization to first tumor response (complete or partial). Duration of response (DoR) was defined as the time from first tumor response to disease progression.
Median TTR was 6.7 weeks (range 4.3-33.3) for RAM + PAC pts and 6.6 weeks (5.1-37.1) for PBO + PAC pts. A detailed swimmer plot confirmed that a majority of RAM + PAC pts (58% [53/92]) and PBO + PAC pts (61% [33/54]) responded by the first 6-week assessment. Of these responders, 11% (6/53) and 6% (2/33) were still responding at 12 months. Median DoR was 4.4 months (95% CI 4.1, 5.5) in the RAM + PAC arm and 2.8 months (95% CI 2.1, 4.2) in the PBO + PAC arm (HR = 0.66, 95% CI 0.45, 0.97; P =.0332). At 6 weeks, rates of improved or stable QoL scores among responders were similar between treatment arms and higher among the responders (73% RAM + PAC vs 74% PBO + PAC) than in the intent-to-treat population (53% vs 50%). The authors concluded that patients with advanced gastric/GEJ cancer not only showed an improved tumor response rate with RAM + PAC, but responses were also more durable. For the majority of patients, response occurred within the first 6 weeks of therapy and was associated with a QoL benefit. Regardless of treatment arm, patients who experienced a tumor response were more likely to report improved or stable QoL, including in dimensions related to disease symptoms.
- Wilke H, et al. Lancet Oncol. 2014;15:1224-1235.
- Bodoky G, et al. ASCO 2016 Gastrointestinal Cancers Symposium. Abstract 45.