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

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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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Acknowledgments

We wish to thank Professor Suzuki and Dr. Nishiyama for statistical analyses advice.

Author information

Authors and Affiliations

  1. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, 467-8601, Japan

    Hiromi Kataoka, Yoshinori Mori, Takaya Shimura, Hirotada Nishie, Makoto Natsume & Takashi Joh

  2. Department of Gastroenterology, Kasugai Municipal Hospital, 1-1-1 Takaki-cho, Kasugai, Aichi, 486-8510, Japan

    Hisato Mochizuki, Yoshikazu Hirata & Satoshi Sobue

  3. Gifu Prefectural Tajimi Hospital, 5-161, Maehata-cho, Tajimi, Gifu, 507-8522, Japan

    Takashi Mizushima & Hitoshi Sano

  4. Toyokawa City Hospital, 23 Noji, Yahata-cho, Toyokawa, Aichi, 442-8561, Japan

    Yusuke Mizuno & Makoto Nakamura

  5. Nagoya City West Medical Center, 1-1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, 462-8508, Japan

    Atsuyuki Hirano, Kenji Tsuchida, Kazunori Adachi & Kyoji Seno

  6. Nagoya City East Medical Center, 1-2-23 Wakamizu, Chikusa-ku, Nagoya, Aichi, 464-8547, Japan

    Mika Kitagawa & Takashi Kawai

Authors
  1. Hiromi Kataoka
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  2. Yoshinori Mori
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  3. Takaya Shimura
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  4. Hirotada Nishie
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  5. Makoto Natsume
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  6. Hisato Mochizuki
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  7. Yoshikazu Hirata
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  8. Satoshi Sobue
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  9. Takashi Mizushima
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  10. Hitoshi Sano
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  11. Yusuke Mizuno
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  12. Makoto Nakamura
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  13. Atsuyuki Hirano
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  14. Kenji Tsuchida
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  15. Kazunori Adachi
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  16. Kyoji Seno
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  17. Mika Kitagawa
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  18. Takashi Kawai
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  19. Takashi Joh
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Corresponding author

Correspondence to Yoshinori Mori.

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Kataoka, H., Mori, Y., Shimura, T. et al. A phase II prospective study of the trastuzumab combined with 5-weekly S-1 and CDDP therapy for HER2-positive advanced gastric cancer. Cancer Chemother Pharmacol 77, 957–962 (2016). https://doi.org/10.1007/s00280-016-3013-y

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  • DOI: https://doi.org/10.1007/s00280-016-3013-y

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