Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

Kei Muro; Takatsugu Ogata; Yukiya Narita; Zev A. Wainberg; Eric Van Cutsem; Kensei Yamaguchi; Yongzhe Piao; Yumin Zhao; Patrick M. Peterson; Sameera R. Wijayawardana; Paolo Abada; Anindya Chatterjee

doi:10.5230/jgc.2023.23.e15

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자료유형: 학술저널

저자정보: Kei Muro (Aichi Cancer Center Hospital) Takatsugu Ogata (Aichi Cancer Center Hospital Nagoya Japan) Yukiya Narita (Aichi Cancer Center Hospital Nagoya Japan) Zev A. Wainberg (University of California Los Angeles Los Angeles CA United States) Eric Van Cutsem (University Hospitals Gasthuisberg/Leuven & Katholieke Universiteit (KU) Leuven Leuven Belgium) Kensei Yamaguchi (Cancer Institute Hospital of Japanese Foundation for Cancer Research Tokyo Japan) Yongzhe Piao (Eli Lilly Japan K.K. Kobe Japan) Yumin Zhao (Eli Lilly and Company Indianapolis IN United States) Patrick M. Peterson (Eli Lilly and Company Indianapolis IN United States) Sameera R. Wijayawardana (Eli Lilly and Company Indianapolis IN United States) Paolo Abada (Eli Lilly and Company Indianapolis IN United States) Anindya Chatterjee (Eli Lilly and Company Indianapolis IN United States)

저널정보: 대한위암학회 Journal of Gastric Cancer Journal of Gastric Cancer 제23권 제2호

발행연도: 2023.4

수록면: 289 - 302 (14page)

DOI: 10.5230/jgc.2023.23.e15

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Purpose: Liver metastasis (LM) is reported in approximately 40% of patients with advanced/metastatic gastric/gastroesophageal junction adenocarcinoma (metastatic esophagogastric adenocarcinoma; mGEA) and is associated with a worse prognosis. This post-hoc analysis from the RAINBOW trial reported the efficacy, safety, and biomarker outcomes of ramucirumab and paclitaxel combination treatment (RAM+PAC) in patients with (LM+) and without (LM−) LM at baseline. Materials and Methods: Patients (n=665) were randomly assigned on a 1:1 basis to receive either RAM+PAC (LM+: 150, LM−: 180) or placebo and paclitaxel (PL+PAC) (LM+: 138, LM−: 197). The overall survival (OS) and progression-free survival (PFS) were evaluated using stratified Kaplan–Meier and Cox regression models. The correlation of dichotomized biomarkers (VEGF-C, D; VEGFR-1,2) with efficacy in the LM+ versus LM− subgroups was analyzed using the Cox regression model with reported interaction P-values. Results: The presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM− (OS HR, 0.71 [LM+] vs. 0.88 [LM−]; PFS HR, 0.47 [LM+] vs. 0.76 [LM−]). Treatment-emergent adverse events were similar between patients with and without LM. No predictive relationship was observed between biomarker levels (VEGF-C, D; VEGFR-1,2) and efficacy outcome (OS, PFS) (all interaction P-values >0.05). Conclusions: RAM provided a significant benefit, irrespective of LM status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.

#Ramucirumab #Stomach neoplasms #Vascular endothelial growth factors

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