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- Title
Multicenter phase II study of trastuzumab plus S-1 alone in elderly patients with HER2-positive advanced gastric cancer (JACCRO GC-06).
- Authors
Kimura, Yutaka; Fujii, Masashi; Masuishi, Toshiki; Nishikawa, Kazuhiro; Kunisaki, Chikara; Matsusaka, Satoshi; Segawa, Yoshihiko; Nakamura, Masato; Sasaki, Kinro; Nagao, Narutoshi; Hatachi, Yukimasa; Yuasa, Yasuhiro; Asami, Shinya; Takeuchi, Masahiro; Furukawa, Hiroshi; Nakajima, Toshifusa; on behalf of the JACCRO GC-06 Study Group
- Abstract
Background: S-1 plus cisplatin is a standard regimen for advanced gastric cancer (AGC) in Asia. The ToGA trial established a fluoropyrimidine plus cisplatin and trastuzumab as a standard treatment for human epidermal growth factor receptor 2 (HER2)-positive AGC. In the HERBIS-1 trial, trastuzumab combined with S-1 plus cisplatin showed promising antitumor activity in patients with HER2-positive AGC. However, cisplatin has several important drawbacks, including vomiting and renal toxicity. These disadvantages of cisplatin are prominent in elderly patients. Therefore, we conducted a prospective phase II study of trastuzumab plus S-1 without cisplatin in elderly patients with HER2-positive AGC.Methods: Patients 65 years or older who had HER2-positive AGC received S-1 orally on days 1-28 of a 42-day cycle and trastuzumab intravenously on day 1 of a 21-day cycle.Results: A total of 51 patients were enrolled. Two patients were ineligible. The full analysis set thus comprised 49 patients. The median age was 71 years (range 65-85). The confirmed response rate was 40.8% (95% CI 27.1-54.6%), and the null hypothesis was rejected. The median follow-up period was 10.6 months. Median overall survival was 15.8 months. Median progression-free survival was 5.1 months, and time to treatment failure was 4.0 months. Major grade 3 or 4 adverse events included neutropenia (12.0%), anemia (24.0%), diarrhea (10.0%), and anorexia (12.0%). There was one treatment-related death.Conclusions: Trastuzumab in combination with S-1 alone demonstrated promising antitumor activity and manageable toxic effects as well as promising survival results in elderly patients with HER2-positive AGC.Clinical trials registration: UMIN000007368.
- Subjects
TRASTUZUMAB; ANTINEOPLASTIC agents; DRUGS; GASTRIC diseases; PATIENTS
- Publication
Gastric Cancer, 2018, Vol 21, Issue 3, p421
- ISSN
1436-3291
- Publication type
Article
- DOI
10.1007/s10120-017-0766-x