International Journal of Clinical Oncology

, Volume 23, Issue 1, pp 92–97 | Cite as

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

  • 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
Original 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.

Keywords

Ramucirumab Monotherapy Gastric Cancer Japanese 

Notes

Acknowledgement

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

Compliance with ethical standards

Conflict of interest

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.

References

  1. 1.
    GLOBOCAN (2012) Cancer Incident and mortality worldwide: IARC cancer base no. 11 (Internet). http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
  2. 2.
    Center for Cancer Control and Information Services, National Cancer Center Japan (2016) Projected cancer statistics. http://ganjoho.jp/en/public/statistics/short_pred.html
  3. 3.
    de Aretxabala X, Konishi K, Yonemura Y et al (1987) Node dissection in gastric cancer. Br J Surg 74:770–773CrossRefPubMedGoogle Scholar
  4. 4.
    Nonaka S, Oda I, Nakaya T et al (2011) Clinical impact of a strategy involving endoscopic submucosal dissection for early gastric cancer: determining the optimal pathway. Gastric Cancer 14:56–62CrossRefPubMedGoogle Scholar
  5. 5.
    Sakuramoto M, Sasako T, Yamaguchi T et al (2007) Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 357:1810–1820CrossRefPubMedGoogle Scholar
  6. 6.
    Boku N, Yamamoto S, Fukuda H et al (2009) Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study. Lancet Oncol 10:1063–1069CrossRefPubMedGoogle Scholar
  7. 7.
    Cunningham D, Starling N, Rao S et al (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358:36–46CrossRefPubMedGoogle Scholar
  8. 8.
    Koizumi W, Narahara H, Hara T et al (2008) S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol 9:215–221CrossRefPubMedGoogle Scholar
  9. 9.
    Narahara H, Iishi H, Imamura H et al (2011) Randomized phase III study comparing the efficacy and safety of irinotecan plus S-1 with S-1 alone as first-line treatment for advanced gastric cancer (study GC0301/TOP-002). Gastric Cancer 14:72–80CrossRefPubMedPubMedCentralGoogle Scholar
  10. 10.
    Hironaka S, Zenda S, Boku N et al (2006) Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer. Gastric Cancer 9:14–18CrossRefPubMedGoogle Scholar
  11. 11.
    Kang JH, Lee SI, Lim DH et al (2012) Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone. J Clin Oncol 30:1513–1518CrossRefPubMedGoogle Scholar
  12. 12.
    Hironaka S, Ueda S, Yasui H et al (2013) Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial. J Clin Oncol 31:4438–4444CrossRefPubMedGoogle Scholar
  13. 13.
    Ohtsu A, Shah MA, Van Cutsem E et al (2011) Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a randomized, double-blind, placebo-controlled phase III study. J Clin Oncol 29:3968–3976CrossRefPubMedGoogle Scholar
  14. 14.
    Fuchs CS, Tomasek J, Yong CJ et al (2014) Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet 383:31–39CrossRefPubMedGoogle Scholar
  15. 15.
    Wilke H, Muro K, Van Cutsem E et al (2014) Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial. Lancet Oncol 15:1224–1235CrossRefPubMedGoogle Scholar
  16. 16.
    Shitara K, Muro K, Shimada Y et al (2016) Subgroup analyses of the safety and efficacy of ramucirumab in Japanese and Western patients in RAINBOW: a randomized clinical trial in second-line treatment of gastric cancer. Gastric Cancer 19:927–938CrossRefPubMedGoogle Scholar
  17. 17.
    Japanese Gastric Cancer Association (2017) Japanese gastric cancer treatment guideline 2014 (ver. 4). Gastric cancer. 2017; 20(1): 1−19Google Scholar
  18. 18.
    Wakatsuki T, Zhang W, Yang D et al. (2012) Ethnic gene profile of genes involved in angiogenesis to predict regional bevacizumab efficacy difference in gastric cancer. J Clin Oncol. 30; 15s: suppl abstr. 4026Google Scholar
  19. 19.
    Van Cutsem E, de Haas S, Kang YK et al (2012) Bevacizumab in combination with chemotherapy as first-line therapy in advanced gastric cancer: a biomarker evaluation from the AVAGAST randomized phase III trial. J Clin Oncol 30:2119–2127CrossRefPubMedGoogle Scholar
  20. 20.
    Yamada Y, Higuchi K, Nishikawa K et al (2015) Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naive patients with advanced gastric cancer. Ann Oncol 26:141–148CrossRefPubMedGoogle Scholar
  21. 21.
    Ueda S, Satoh T, Gotoh M et al (2015) A phase Ib study of safety and pharmacokinetics of ramucirumab in combination with paclitaxel in patients with advanced gastric adenocarcinomas. Oncologist 20:493–494CrossRefPubMedPubMedCentralGoogle Scholar

Copyright information

© Japan Society of Clinical Oncology 2017

Authors and Affiliations

  • Satoshi Murahashi
    • 1
  • Daisuke Takahari
    • 1
  • Takeru Wakatsuki
    • 1
  • Naoki Fukuda
    • 1
  • Takashi Ichimura
    • 1
  • Mariko Ogura
    • 1
  • Masato Ozaka
    • 1
  • Eiji Shinozaki
    • 1
  • Izuma Nakayama
    • 1
  • Tomohiro Matsushima
    • 1
  • Hiroki Osumi
    • 1
  • Keisho Chin
    • 1
  • Kensei Yamaguchi
    • 1
  1. 1.Department of GastroenterologyThe Cancer Institute Hospital of Japanese Foundation for Cancer ResearchTokyoJapan

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