Ramucirumab plus paclitaxel as a second-line treatment in HER2-positive gastric cancer: subgroup analysis of a nationwide, real-world study in Korea (KCSG-ST19-16)

Bum Jun Kim, Hee Jung Jee, Sun Young Rha, Hye Sook Han, Min Hee Ryu, Se Hoon Park, Jong Gwang Kim, Woo Kyun Bae, Keun Wook Lee, Do Youn Oh, Ji Hye Byun, Dong Sook Kim, Young Ju Suh, Hyonggin An, Dae Young Zang

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Background: A subgroup analysis of data from a nationwide study (KCSG-ST19-16) was performed to evaluate the efficacy and safety of second-line ramucirumab plus paclitaxel treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric or gastro-esophageal junction (GEJ) adenocarcinoma. Methods: The KCSG-ST19-16 study enrolled a total of 1063 patients from 56 hospitals in South Korea with advanced gastric or GEJ adenocarcinoma, who had received second-line treatment with ramucirumab plus paclitaxel. HER2 status was known for 994 (93.5%) of these patients, who were thus included in the subgroup analysis. Results: In total, 163 of 994 patients (16.4%), had HER2-positive gastric or GEJ adenocarcinoma. The objective response rate to ramucirumab plus paclitaxel treatment was significantly higher in patients with HER2-positive disease compared to those with HER2-negative disease (23.0% [95% confidence interval (CI), 15.9–30.1] vs. 15.1% [95% CI, 12.3–17.9], p = 0.025). The median progression-free survival was longer in patients with HER2-positive versus HER2-negative disease, but the difference was not statistically significant (4.3 months [95% CI, 3.7–5.3] vs 3.7 months [95% CI, 3.4–4.0], p = 0.054). There was no statistically significant difference in median overall survival (OS) between the groups (9.8 months [95% CI, 8.9–12.3] vs 10.1 months [95% CI, 9.2–10.9], p = 0.564). Conclusions: In patients with HER2-positive gastric or GEJ adenocarcinoma, the objective response rate to second-line treatment with ramucirumab plus paclitaxel was significantly higher compared to patients with HER2-negative disease. However, an increased response to treatment was not associated with an improvement in OS.

Original languageEnglish
Pages (from-to)609-618
Number of pages10
JournalGastric Cancer
Issue number3
Publication statusPublished - 2022 May

Bibliographical note

Funding Information:
This work was supported by the Health Insurance Review & Assessment Service (HIRA) and Korean Cancer Study Group (KCSG). We would like to thank all of the investigators and support staff who generously participated in this study.

Publisher Copyright:
© 2022, The Author(s) under exclusive licence to The International Gastric Cancer Association and The Japanese Gastric Cancer Association.

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research


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