Cancer Chemotherapy and Pharmacology

, Volume 77, Issue 5, pp 957–962 | Cite as

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

  • 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
Original Article

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.

Keywords

Human epidermal growth factor receptor type 2 (HER2) Trastuzumab Advanced gastric cancer (AGC) 

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Copyright information

© Springer-Verlag Berlin Heidelberg 2016

Authors and Affiliations

  • Hiromi Kataoka
    • 1
  • Yoshinori Mori
    • 1
  • Takaya Shimura
    • 1
  • Hirotada Nishie
    • 1
  • Makoto Natsume
    • 1
  • Hisato Mochizuki
    • 2
  • Yoshikazu Hirata
    • 2
  • Satoshi Sobue
    • 2
  • Takashi Mizushima
    • 3
  • Hitoshi Sano
    • 3
  • Yusuke Mizuno
    • 4
  • Makoto Nakamura
    • 4
  • Atsuyuki Hirano
    • 5
  • Kenji Tsuchida
    • 5
  • Kazunori Adachi
    • 5
  • Kyoji Seno
    • 5
  • Mika Kitagawa
    • 6
  • Takashi Kawai
    • 6
  • Takashi Joh
    • 1
  1. 1.Department of Gastroenterology and MetabolismNagoya City University Graduate School of Medical SciencesNagoyaJapan
  2. 2.Department of GastroenterologyKasugai Municipal HospitalKasugaiJapan
  3. 3.Gifu Prefectural Tajimi HospitalTajimiJapan
  4. 4.Toyokawa City HospitalToyokawaJapan
  5. 5.Nagoya City West Medical CenterNagoyaJapan
  6. 6.Nagoya City East Medical CenterNagoyaJapan

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