PMID- 28913565 OWN - NLM STAT- MEDLINE DCOM- 20180416 LR - 20231213 IS - 1437-7772 (Electronic) IS - 1341-9625 (Linking) VI - 23 IP - 1 DP - 2018 Feb TI - A retrospective analysis of ramucirumab monotherapy in previously treated Japanese patients with advanced or metastatic gastric adenocarcinoma. PG - 92-97 LID - 10.1007/s10147-017-1192-0 [doi] AB - 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. FAU - Murahashi, Satoshi AU - Murahashi S AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Takahari, Daisuke AU - Takahari D AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. daisuke.takahari@jfcr.or.jp. FAU - Wakatsuki, Takeru AU - Wakatsuki T AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Fukuda, Naoki AU - Fukuda N AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Ichimura, Takashi AU - Ichimura T AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Ogura, Mariko AU - Ogura M AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Ozaka, Masato AU - Ozaka M AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Shinozaki, Eiji AU - Shinozaki E AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Nakayama, Izuma AU - Nakayama I AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Matsushima, Tomohiro AU - Matsushima T AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Osumi, Hiroki AU - Osumi H AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Chin, Keisho AU - Chin K AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. FAU - Yamaguchi, Kensei AU - Yamaguchi K AD - Department of Gastroenterology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan. LA - eng PT - Clinical Trial PT - Journal Article DEP - 20170914 PL - Japan TA - Int J Clin Oncol JT - International journal of clinical oncology JID - 9616295 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antineoplastic Agents) SB - IM MH - Adenocarcinoma/*drug therapy/mortality/pathology MH - Adult MH - Aged MH - Antibodies, Monoclonal/adverse effects/*therapeutic use MH - Antibodies, Monoclonal, Humanized MH - Antineoplastic Agents/adverse effects/*therapeutic use MH - Asian People MH - Disease-Free Survival MH - Female MH - Humans MH - Male MH - Middle Aged MH - Retrospective Studies MH - Stomach Neoplasms/*drug therapy/mortality/pathology MH - Treatment Outcome MH - Ramucirumab OTO - NOTNLM OT - Gastric Cancer OT - Japanese OT - Monotherapy OT - Ramucirumab EDAT- 2017/09/16 06:00 MHDA- 2018/04/17 06:00 CRDT- 2017/09/16 06:00 PHST- 2017/05/17 00:00 [received] PHST- 2017/08/31 00:00 [accepted] PHST- 2017/09/16 06:00 [pubmed] PHST- 2018/04/17 06:00 [medline] PHST- 2017/09/16 06:00 [entrez] AID - 10.1007/s10147-017-1192-0 [pii] AID - 10.1007/s10147-017-1192-0 [doi] PST - ppublish SO - Int J Clin Oncol. 2018 Feb;23(1):92-97. doi: 10.1007/s10147-017-1192-0. Epub 2017 Sep 14.