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KMID : 1141820230230020289
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Journal of Gastric Cancer
2023 Volume.23 No. 2 p.289 ~ p.302
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Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study
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Takatsugu Ogata
Yukiya Narita
Zev A. Wainberg
Eugene Kim
Kensei Yamaguchi
Yongzhe Piao
Yumin Zhao
Patrick M. Peterson
Sameera R. Wijayawardana
Paolo Abada
Anindya Chatterjee
Anindya Chatterjee
Kei Muro
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Abstract
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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.
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KEYWORD
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Ramucirumab, Stomach neoplasms, Vascular endothelial growth factors
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