KEY TAKEAWAYS
- Phase 3 of RAINBOW aimed to assess the effectiveness and safety of combining ramucirumab with paclitaxel for treating advanced GEJ adenocarcinoma.
- Progression-free survival was significantly longer in the ramucirumab plus paclitaxel group compared to the placebo plus paclitaxel group.
- The trial demonstrated the combination of ramucirumab with paclitaxel provided a significant improvement in PFS.
In the global phase 3 RAINBOW study, the administration of ramucirumab in combination with paclitaxel demonstrated a notable enhancement in overall survival when compared to the administration of placebo alongside paclitaxel in patients diagnosed with advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma.
RAINBOW-Asia study was a randomized, double-blind, placebo-controlled, phase 3 clinical trial conducted at 32 medical facilities in China, Malaysia, the Philippines, and Thailand. Adult patients (≥18 years) diagnosed with metastatic or locally advanced, unresectable gastric or GEJ adenocarcinoma, who have previously undergone treatment with fluoropyrimidine-platinum-based chemotherapy were enrolled in a randomized controlled trial.
The patients were assigned through a centralized interactive web response system in a 2:1 ratio to receive either intravenous administration of ramucirumab at a dose of 8 mg/kg or a placebo. The administration occurred on days 1 and 15 of each 28-day cycle. Additionally, the patients received intravenous paclitaxel at an 80 mg/m2 dose on days 1, 8, and 15 of the same cycle. Randomization was stratified based on Eastern Cooperative Oncology Group performance status and the presence of peritoneal metastases. The co-primary endpoints encompassed progression-free and overall survival, as per medical terminology. Efficacy analyses were conducted within the intention-to-treat population, while the safety analysis contained patients who received at least one dose of the study treatment. During the period from March 2, 2017, to June 30, 2020, a total of 440 individuals were subjected to random assignment for the administration of either ramucirumab in combination with paclitaxel (n=294) or placebo in combination with paclitaxel (n=146).
The median progression-free survival was 4·14 months (95% CI 3·71-4·30) in the group receiving ramucirumab plus paclitaxel, in comparison to 3·15 months (2·83-4·14) in the group receiving placebo plus paclitaxel (hazard ratio [HR] 0·765, 95% CI 0·613-0·955, P=0·0184). The median overall survival was 8.71 months (95% CI 7.98-9.49) in the group receiving ramucirumab plus paclitaxel and 7.92 months (6.31-9.10) in the group receiving placebo plus paclitaxel (HR 0.963, 95% CI 0.771-1.203, P=0.7426). The most prevalent grade 3 or worse treatment-related adverse events observed were a reduction in neutrophil count (159 [54%] out of 293 patients in the ramucirumab plus paclitaxel group compared to 56 [39%] out of 145 in the placebo plus paclitaxel group), a decrease in white blood cell count (127 [43%] vs. 42 [29%]), anemia (46 [16%] vs. 24 [17%]), hypertension (21 [7%] vs. nine [6%]), and febrile neutropenia (18 [6%] vs. one [<1%]).
Source: https://pubmed.ncbi.nlm.nih.gov/34626550/
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02898077
Xu RH, Zhang Y, Pan H, Feng J, Zhang T, Liu T, Qin Y, Qin S, Yin X, Liu B, Ba Y, Yang N, Voon PJ, Tanasanvimon S, Zhou C, Zhang WL, Shen L. 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 randomized, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021 Dec;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7. Epub 2021 Oct 7. PMID: 34626550.
