Journal of Gastric Cancer

  • 제23권2호
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  • Pages.289-302
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  • 2023
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  • 2093-582X(pISSN)
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  • 2093-5641(eISSN)
대한위암학회 (The Korean Gastric Cancer Association)
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Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

  • Takatsugu Ogata (Aichi Cancer Center Hospital) ;
  • Yukiya Narita (Aichi Cancer Center Hospital) ;
  • Zev A. Wainberg (University of California Los Angeles) ;
  • Eric Van Cutsem (University Hospitals Gasthuisberg/Leuven & Katholieke Universiteit (KU) Leuven) ;
  • Kensei Yamaguchi (Cancer Institute Hospital of Japanese Foundation for Cancer Research) ;
  • Yongzhe Piao (Eli Lilly Japan K.K.) ;
  • Yumin Zhao (Eli Lilly and Company) ;
  • Patrick M. Peterson (Eli Lilly and Company) ;
  • Sameera R. Wijayawardana (Eli Lilly and Company) ;
  • Paolo Abada (Eli Lilly and Company) ;
  • Anindya Chatterjee (Eli Lilly and Company) ;
  • Kei Muro (Aichi Cancer Center Hospital)
  • 투고 : 2022.06.27
  • 심사 : 2022.12.25
  • 발행 : 2023.04.30
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초록

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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과제정보

The authors gratefully acknowledge Louise McGrath and Elaine Jennings employees of Eli Lilly and Company for providing editorial and process support, and Dana Schamberger of Syneos Health for providing editorial support.

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