Adding ramucirumab to paclitaxel as second-line therapy improved progression-free survival (PFS) in Asian patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma, according to research published in The Lancet Gastroenterology & Hepatology.1
In the prior RAINBOW study (ClinicalTrials.gov Identifier: NCT01170663), ramucirumab plus paclitaxel improved PFS and overall survival (OS), when compared with placebo plus paclitaxel, in patients with advanced gastric or GEJ adenocarcinoma.2
The current study, RAINBOW-Asia (ClinicalTrials.gov Identifier: NCT02898077), was designed to compare ramucirumab-paclitaxel with placebo-paclitaxel in Asian, predominantly Chinese, patients with advanced gastric or GEJ adenocarcinoma.
The phase 3 trial included 440 patients who had received first-line chemotherapy with platinum plus fluoropyrimidine. The patients’ median age was 57.5 years (range, 18-84 years), 68% were men, 89% were Chinese, 35% had peritoneal metastasis, and 78% had a performance status of 1.
The patients were randomly assigned to receive ramucirumab-paclitaxel (294 patients) or placebo-paclitaxel (146 patients). The objective response rate was 26.5% in the ramucirumab arm and 21.9% in the placebo arm.
The median PFS was significantly longer in the ramucirumab arm than in the placebo arm — 4.14 months and 3.15 months, respectively (hazard ratio [HR], 0.765; 95% CI, 0.613-0.955, P =.0184). Improvements in PFS with ramucirumab were observed across most subgroups.
The median OS was not significantly longer in the ramucirumab arm than in the placebo arm — 8.71 months and 7.92 months, respectively (HR, 0.963; 95% CI, 0.771-1.203, P =.7426).
The incidence of treatment-emergent adverse events (AEs) was 99% in both arms. Serious AEs occurred in 34% of patients in the ramucirumab arm and 26% of patients in the placebo arm.
Grade 3-4 AEs occurred in 76% of patients in the ramucirumab arm and 66% of those in the placebo arm. The most common grade 3 or higher AEs were decreased neutrophil count, decreased white blood cell count, and anemia.
In the ramucirumab arm, there were 4 fatal AEs related to treatment — multiple organ dysfunction syndrome, respiratory failure, anemia, and cerebral infarction. In the placebo arm, there were 2 fatal AEs related to treatment — respiratory failure and sudden death.
“The efficacy data and safety profile of ramucirumab in combination with paclitaxel in the RAINBOW-Asia study, which included a predominantly Chinese population, demonstrate a favorable risk-benefit profile, consistent with the global RAINBOW study,” the researchers wrote. “Therefore, this combination might be an effective treatment option for Chinese patients with advanced gastric or GEJ adenocarcinoma in the second-line setting.”
Disclosures: This research was supported by Eli Lilly and Company. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
- Xu R-H, Zhang Y, Pan H, et al. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): A randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. Published online October 6, 2021. doi:10.1016/S2468-1253(21)00313-7
- Wilke H, Muro K, Van Cutsem E, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): A double-blind, randomised phase 3 trial. Lancet Oncol. 2014;15(11):1224-35. doi:10.1016/S1470-2045(14)70420-6