Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study
Source : https://jgc-online.org/DOIx.php?id=10.5230/jgc.2023.23.e15
Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study 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, 1 1 2 3 4 5 6 6 6 6 6 and Kei Muro 1 Email: Correspondence to Kei Muro.
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.
• Source: Journal of Gastric Cancer
• Conclusions: “RAM [ramucirumab] provided a significant benefit, irrespective of LM [liver metastasis] status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC [ramucirumab and paclitaxel combination treatment[ is a clinically meaningful therapeutic option for patients with mGEA [metastatic esophagogastric adenocarcinoma] and LM.”
• In the current post-hoc analysis of the RAINBOW trial, Japanese investigators explored the efficacy, safety, and biomarker outcomes of RAM+PAC treatment in patients with or without LM.
• RAM+PAC is the 2L standard of care worldwide, although the 2L transition rate for patients with mGEA is very low in most countries—except for Japan.
• In total, half of patients who progressed after 1L therapy are eligible for further treatment. Although RAM+PAC is not appropriate 2L for all patients, it can help patients with LM, according to the results of the current study.
• Conversion surgery, which is the resection in initially unresectable patients after response to chemotherapy, is utilized to treat eligible late-stage patients with mGEA in Japan. The data in this study demonstrated a higher ORR in the LM+ group (38%) vs. the LM− group (19%).
• “The active use of RAM+PAC may provide new opportunities for improved treatment outcomes in patients with LM, as they are potential candidates for conversion surgery,” the authors wrote.
• One limitation of the current post-hoc analysis is that it was not sufficiently powered for LM subgroup analysis.
• Similar mOS and mPFS were noted regardless of LM status, although the biomarker data were limited; there was not enough data to support a a predictive relationship between any marker and treatment effect (all P-values > ), per the authors..
• Regardless of the presence of LM, RAM offered a significant benefit, with more potent effects in patients with LM. Furthermore, there were no new safety signals. “RAM+PAC is a viable therapeutic option for patients with mGEA and LM as well as for those without LM,” the authors concluded.