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.
Similar content being viewed by others
References
GLOBOCAN (2012) Cancer Incident and mortality worldwide: IARC cancer base no. 11 (Internet). http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
Center for Cancer Control and Information Services, National Cancer Center Japan (2016) Projected cancer statistics. http://ganjoho.jp/en/public/statistics/short_pred.html
de Aretxabala X, Konishi K, Yonemura Y et al (1987) Node dissection in gastric cancer. Br J Surg 74:770–773
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 14:56–62
Sakuramoto M, Sasako T, Yamaguchi T et al (2007) Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 357:1810–1820
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 10:1063–1069
Cunningham D, Starling N, Rao S et al (2008) Capecitabine and oxaliplatin for advanced esophagogastric cancer. N Engl J Med 358:36–46
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 9:215–221
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 14:72–80
Hironaka S, Zenda S, Boku N et al (2006) Weekly paclitaxel as second-line chemotherapy for advanced or recurrent gastric cancer. Gastric Cancer 9:14–18
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 30:1513–1518
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 31:4438–4444
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 29:3968–3976
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 383:31–39
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 15:1224–1235
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 19:927–938
Japanese Gastric Cancer Association (2017) Japanese gastric cancer treatment guideline 2014 (ver. 4). Gastric cancer. 2017; 20(1): 1−19
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. 4026
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 30:2119–2127
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 26:141–148
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 20:493–494
Acknowledgement
This work was funded by the research foundation of the JFCR.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
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.
About this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10147-017-1192-0