A retrospective analysis of ramucirumab monotherapy in previously treated Japanese patients with advanced or metastatic gastric adenocarcinoma.

Abstract

BACKGROUND:

The REGARD trial demonstrated that ramucirumab monotherapy improved both overall survival (OS) and progression-free survival (PFS) compared with best supportive care plus placebo as second-line treatment for patients with advanced gastric cancer. However, the efficacy and safety of ramucirumab monotherapy for previously treated Japanese patients with advanced gastric cancer remains unknown.

METHODS:

Previously treated Japanese patients with advanced gastric cancer who received ramucirumab monotherapy between June 2015 and March 2016 at the Cancer Institute Hospital were enrolled in the study. OS, PFS, best overall response, and safety profiles were retrospectively evaluated.

RESULTS:

Nineteen patients were enrolled in this study. Ramucirumab monotherapy was generally administered as third-line therapy. After a median follow-up period of 7.4 months, the median PFS was 2.1 months (95% CI 1.0-3.5), and median OS was 12.9 months (95% CI 2.3, not reached). In 13 patients who had measurable lesions on radiologic examination, partial response was observed in one patient (7.7%) and stable disease was observed in five patients (38.5%). A total of 12 patients (63.2%) had adverse events (AEs). Common AEs included hypertension (8 patients, 42.1%), fatigue (6 patients, 31.6%), and bleeding (5 patients, 26.3%). Grade 3 AEs included gastrointestinal bleeding and aspiration pneumonia (1 patient each, 5.3%).

CONCLUSIONS:

Our data suggest that ramucirumab monotherapy in Japanese patients with previously treated advanced gastric cancer has comparable efficacy and safety profiles as reported in the REGARD trial.

• Authors: Satoshi Murahashi, Daisuke Takahari, Takeru Wakatsuki, Naoki Fukuda, Takashi Ichimura, Mariko Ogura, Masato Ozaka, Eiji Shinozaki, Izuma Nakayama, Tomohiro Matsushima, Hiroki Osumi, Keisho Chin, Kensei Yamaguchi
• Journal: International journal of clinical oncology (Int J Clin Oncol) Vol. 23 Issue 1 Pg. 92-97 (Feb 2018) ISSN: 1437-7772 [Electronic] Japan
• PMID: 28913565 (Publication Type: Clinical Trial, Journal Article)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• ramucirumab

Topics

• Adenocarcinoma (drug therapy, mortality, pathology)
• Adult
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents (adverse effects, therapeutic use)
• Asian People
• Disease-Free Survival
• Female
• Humans
• Male
• Middle Aged
• Retrospective Studies
• Stomach Neoplasms (drug therapy, mortality, pathology)
• Treatment Outcome