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Purpose <p>The REGARD trial resulted in insurance approval for ramucirumab monotherapy; however, it did not include Japanese patients. Subsequent phase II trials and retrospective studies have examined Japanese cohorts, but reports identifying prognostic factors remain limited.</p> Methods <p>A total of 27 patients across six institutions received ramucirumab monotherapy as a second-line treatment for gastric cancer between September 2017 and December 2019.</p> Results <p>The median age of 27 patients was 74 years (range: 36–90). Eighteen patients were male, and ten had intestinal-type gastric cancer. Metastases were observed in 6 patients in the liver, 3 in the lung, 18 in lymph nodes, and 14 in the peritoneum. Third-line chemotherapy was administered to 6 patients. The response rate was 3.7%, and the disease control rate was 18.5%. The median progression-free survival was 2.1 months, and the median overall survival was 3.0 months. Of the 27 patients, 6 received third-line treatment and 4 received nivolumab alone. Overall survival did not differ significantly between patients who received third-line treatment and those who did not. The median progression-free survival showed no significant differences based on tumor markers (carcinoembryonic antigen and CA19-9), age, histology, or metastases in the lung, lymph nodes, or peritoneum. In contrast, liver metastases were associated with poorer progression-free survival (HR:4.735 (95% CI: 1.508–14.86) and overall survival HR:2.906 (95% CI: 1.031–8.189).</p> Conclusions <p>Ramucirumab monotherapy is selected for patients with poor general condition, but it is suggested to have a poor prognosis, particularly in cases with liver metastases.</p>

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Outcomes of Ramucirumab Monotherapy for Advanced Gastric Cancer in a Multi-institutional Cohort Study in Japan

  • 期刊论文

  • 发表日期：

    2026年1月13日

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  • Yoshinori Kikuchi,
  • Sakae Nagaoka,
  • Nobue Futawatari,
  • Muneharu Fujisaki,
  • Hidejiro Urakami,
  • Mao Tsuru,
  • Satoshi Yajima,
  • Yoko Oshima,
  • Hideaki Shimada

摘要

Purpose

The REGARD trial resulted in insurance approval for ramucirumab monotherapy; however, it did not include Japanese patients. Subsequent phase II trials and retrospective studies have examined Japanese cohorts, but reports identifying prognostic factors remain limited.

Methods

A total of 27 patients across six institutions received ramucirumab monotherapy as a second-line treatment for gastric cancer between September 2017 and December 2019.

Results

The median age of 27 patients was 74 years (range: 36–90). Eighteen patients were male, and ten had intestinal-type gastric cancer. Metastases were observed in 6 patients in the liver, 3 in the lung, 18 in lymph nodes, and 14 in the peritoneum. Third-line chemotherapy was administered to 6 patients. The response rate was 3.7%, and the disease control rate was 18.5%. The median progression-free survival was 2.1 months, and the median overall survival was 3.0 months. Of the 27 patients, 6 received third-line treatment and 4 received nivolumab alone. Overall survival did not differ significantly between patients who received third-line treatment and those who did not. The median progression-free survival showed no significant differences based on tumor markers (carcinoembryonic antigen and CA19-9), age, histology, or metastases in the lung, lymph nodes, or peritoneum. In contrast, liver metastases were associated with poorer progression-free survival (HR:4.735 (95% CI: 1.508–14.86) and overall survival HR:2.906 (95% CI: 1.031–8.189).

Conclusions

Ramucirumab monotherapy is selected for patients with poor general condition, but it is suggested to have a poor prognosis, particularly in cases with liver metastases.