%0 Clinical Trial, Phase II
%T Trastuzumab With S-1 Plus Cisplatin in HER2-positive Advanced Gastric Cancer Without Measurable Lesions: OGSG 1202.
%A Endo S
%A Kurokawa Y
%A Gamoh M
%A Kimura Y
%A Matsuyama J
%A Taniguchi H
%A Takeno A
%A Kawabata R
%A Kawada J
%A Masuzawa T
%A Yamamoto K
%A Kobayashi K
%A Sakai D
%A Shimokawa T
%A Satoh T
%J Anticancer Res
%V 39
%N 2
%D Feb 2019
%M 30711995
%F 2.435
%R 10.21873/anticanres.13213
%X <B>OBJECTIVE: </B>Trastuzumab with S-1 plus cisplatin was proved to be effective for human epidermal growth factor receptor type 2 (HER2)-positive advanced gastric cancer with measurable lesions. However, the efficacy and safety of this regimen in the absence of measurable lesions are unknown.<BR><B>METHODS: </B>Patients with HER2-positive gastric cancer without measurable lesions received cisplatin plus trastuzumab intravenously on day 1 and oral S-1 on days 1-14 of a 21-day cycle. The primary end-point was overall survival, and 40 patients were planned to be enrolled.<BR><B>RESULTS: </B>Fifteen patients were enrolled. The median overall survival was 14.4 months. The 1- and 3-year overall survival rates were 66.7 % and 26.7 %, respectively. Major grade 3-4 adverse events included neutropenia (47%), anemia (40%), diarrhea (20%), nausea (20%), and anorexia (20%).<BR><B>CONCLUSIONS: </B>Trastuzumab with S-1 plus cisplatin might be effective and tolerable for HER2-positive advanced gastric cancer without measurable lesions.