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RAINBOW-Asia: ramucirumab plus paclitaxel explored as second-line option for Chinese patients

With no second-line therapy currently approved in China, the authors report findings consistent with the global RAINBOW study and suggest this combination might be a treatment option in this setting.

  • Rui-Hua Xu, MD; Yanqiao Zhang, MD; Hongming Pan, MD; Jifeng Feng, MD; Tao Zhang, MD; Tianshu Liu, MD; et al.

  • October 6, 2021

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Evidence before this study

Before the study began, we searched PubMed and presentations at major oncology congresses for articles or abstracts published in English between Oct 12, 2011, and Dec 17, 2015, that reported primary results of clinical trials assessing second-line systemic treatment in patients with advanced gastric cancer. Publications describing multimodality treatment with surgery or radiotherapy were excluded. We used the search terms “stomach neoplasms” AND (“advanced” OR “recurrent” OR “metastatic”) AND (“drug therapy” OR “chemotherapy”) AND (“phase III” OR “phase 3” OR “randomised”), and we filtered the search by “clinical trial”. Several new targeted therapeutic agents have been tested as second-line treatments for advanced gastric cancer, but these have mostly failed to produce the desired efficacy and safety results in large clinical trials. A notable exception is ramucirumab, as a single agent or in combination with paclitaxel, which is the only approved second-line regimen for advanced gastric cancer in the USA and European Union, based on findings of the REGARD and RAINBOW studies. The REGARD and RAINBOW studies did not enrol patients from mainland China, and various studies have shown that geographic and ethnic differences between Asian and non-Asian populations, and also within Asian populations, potentially affect the presentation and outcome of gastric cancer. Therefore, this bridging study (RAINBOW-Asia) was designed to evaluate the efficacy and safety of ramucirumab in combination with paclitaxel in Asian, predominantly Chinese, patients with advanced gastric or gastro-oesophageal (GEJ) adenocarcinoma who had progressed on standard therapy with platinum and fluoropyrimidines.

Added value of this study

To date, no second-line therapy has been approved for advanced gastric or GEJ adenocarcinoma in China; the only options are taxane or irinotecan monotherapy or paclitaxel/fluoropyrimidine-based chemotherapy regimens, which have poor outcomes. The development of novel therapeutic options for Chinese patients with advanced gastric cancer is therefore urgently needed. The efficacy data and safety profile of ramucirumab in combination with paclitaxel in the RAINBOW-Asia study, which included a predominantly Chinese population, demonstrate a favourable risk–benefit profile, consistent with the global RAINBOW study. Therefore, this combination might be an effective treatment option for Chinese patients with advanced gastric or GEJ adenocarcinoma in the second-line setting.

Implications of all the available evidence

RAINBOW-Asia provides evidence that ramucirumab plus paclitaxel might be a treatment option for Chinese patients with advanced gastric or GEJ adenocarcinoma in the second-line setting.

Source: The Lancet Gastroenterology & Hepatology

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