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01-05-2016 | Original Article

A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer

Authors: Hiromi Kataoka, Yoshinori Mori, Takaya Shimura, Hirotada Nishie, Makoto Natsume, Hisato Mochizuki, Yoshikazu Hirata, Satoshi Sobue, Takashi Mizushima, Hitoshi Sano, Yusuke Mizuno, Makoto Nakamura, Atsuyuki Hirano, Kenji Tsuchida, Kazunori Adachi, Kyoji Seno, Mika Kitagawa, Takashi Kawai, Takashi Joh

Published in: Cancer Chemotherapy and Pharmacology | Issue 5/2016

Abstract

Background

We evaluated the efficacy and safety of 5-weekly S-1 and cisplatin combined with trastuzumab, a monoclonal antibody against human epidermal growth factor receptor type 2 (HER2) for HER2-positive advanced gastric cancer (AGC).

Methods

This phase II study treatment consisted of S-1 (80–120 mg per day) orally on day 1–21, cisplatin (60 mg/m²) intravenously on day 8, and trastuzumab (8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) intravenously. The primary end point was 1-year survival rate. The secondary end points included overall survival, progression-free survival (PFS), response rate (RR), and safety.

Results

A total 22 patients from seven centers were enrolled. In the 20 patients evaluable for analysis, the 1-year survival rate was 70 % (95 % confidence interval (CI) 49.9–90.1 %), and median survival time, PFS, and RR were 15.3, 7.5 months and 41.2 %, respectively. Major grade 3/4 adverse events were neutropenia (30 %), anorexia (30 %), leukopenia (25 %), fatigue (20 %), and anemia (15 %).

Conclusions

Five-weekly S-1 and cisplatin combined with trastuzumab showed effective with favorable safety profile in patients with HER2-positive AGC.

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Title: A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer
Authors: Hiromi Kataoka
Yoshinori Mori
Takaya Shimura
Hirotada Nishie
Makoto Natsume
Hisato Mochizuki
Yoshikazu Hirata
Satoshi Sobue
Takashi Mizushima
Hitoshi Sano
Yusuke Mizuno
Makoto Nakamura
Atsuyuki Hirano
Kenji Tsuchida
Kazunori Adachi
Kyoji Seno
Mika Kitagawa
Takashi Kawai
Takashi Joh
Publication date: 01-05-2016
Publisher: Springer Berlin Heidelberg
Published in: Cancer Chemotherapy and Pharmacology / Issue 5/2016
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-016-3013-y

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Abstract

Background

Methods

Results

Conclusions

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