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

International Journal of Clinical Oncology volume 23, pages 92–97 (2018)Cite this article

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.

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Acknowledgement

This work was funded by the research foundation of the JFCR.

Author information

Affiliations

  1. Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    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

Authors
  1. Satoshi Murahashi
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  2. Daisuke Takahari
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  3. Takeru Wakatsuki
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  4. Naoki Fukuda
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  5. Takashi Ichimura
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  6. Mariko Ogura
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  7. Masato Ozaka
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  8. Eiji Shinozaki
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  9. Izuma Nakayama
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  10. Tomohiro Matsushima
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  11. Hiroki Osumi
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  12. Keisho Chin
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  13. Kensei Yamaguchi
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Corresponding author

Correspondence to Daisuke Takahari.

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The authors declare no conflicts of interest.

Research involving human participants and/or animals

No.

Informed consent

Informed consent was obtained from all patients for inclusion in this study.

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Cite this article

Murahashi, S., Takahari, D., Wakatsuki, T. et al. A retrospective analysis of ramucirumab monotherapy in previously treated Japanese patients with advanced or metastatic gastric adenocarcinoma. Int J Clin Oncol 23, 92–97 (2018). https://doi.org/10.1007/s10147-017-1192-0

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  • DOI: https://doi.org/10.1007/s10147-017-1192-0

Keywords

  • Ramucirumab
  • Monotherapy
  • Gastric Cancer
  • Japanese