Gastric Cancer

, Volume 20, Issue 6, pp 970–977 | Cite as

Phase I/II study of a combination of capecitabine, cisplatin, and intraperitoneal docetaxel (XP ID) in advanced gastric cancer patients with peritoneal metastasis

  • Hyungwoo Cho
  • Min-Hee Ryu
  • Kyu-pyo Kim
  • Baek-Yeol Ryoo
  • Sook Ryun Park
  • Bum Soo Kim
  • In-Seob Lee
  • Hee-Sung Kim
  • Moon-Won Yoo
  • Jeong Hwan Yook
  • Seong Tae Oh
  • Byung Sik Kim
  • Yoon-Koo Kang
Original Article
  • 376 Downloads

Abstract

Background

This study was conducted to determine the recommended dose (RD) of intraperitoneal docetaxel (ID) in combination with systemic capecitabine and cisplatin (XP) and to evaluate its efficacy and safety at the RD in advanced gastric cancer (AGC) patients with peritoneal metastasis.

Methods

AGC patients with peritoneal metastasis received XP ID, which consists of 937.5 mg/m2 of capecitabine twice daily on days 1–14, 60 mg/m2 of intravenous cisplatin on day 1, and intraperitoneal docetaxel at 3 different dose levels (60, 80, or 100 mg/m2) on day 1, every 3 weeks. In the phase I study, the standard 3 + 3 method was used to determine the RD of XP ID. In the phase II study, patients received RD of XP ID.

Results

In the phase I study, ID 100 mg/m2 was chosen as the RD, with one dose-limiting toxicity (ileus) out of six patients. The 39 AGC patients enrolled in the phase II study received the RD of XP ID. The median progression-free survival was 11.0 months (95% CI 6.9–15.1), and median overall survival was 15.1 months (95% CI 9.1–21.1). The most frequent grade 3/4 adverse events were neutropenia (38.6%) and abdominal pain (30.8%). The incidence of abdominal pain cumulatively increased in the later treatment cycles.

Conclusions

Our study indicated that XP ID was effective, with manageable toxicities, in AGC patients with peritoneal metastasis. As the cumulative incidence of abdominal pain was probably related to bowel irritation by ID, it might be necessary to modify the dose.

Keywords

Gastric cancer Chemotherapy Peritoneal metastasis 

Notes

Acknowledgements

A part of the study medication (Docetaxel) was provided by Sanofi-Aventis Korea Ltd.

Compliance with ethical standards

Ethical standards

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent was obtained from all patients for being included in the study.

Conflict of interest

Yoon-Koo Kang is a consultant for Roche, Novartis, Sanofi, Ono, Daehwa, Bristol-Myers Squibb, AstraZeneca, and Blueprint. Sook Ryun Park has received a speaker honorarium from Roche. The authors have no other conflicts of interest to declare.

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Copyright information

© The International Gastric Cancer Association and The Japanese Gastric Cancer Association 2017

Authors and Affiliations

  • Hyungwoo Cho
    • 1
  • Min-Hee Ryu
    • 2
  • Kyu-pyo Kim
    • 2
  • Baek-Yeol Ryoo
    • 2
  • Sook Ryun Park
    • 2
  • Bum Soo Kim
    • 3
  • In-Seob Lee
    • 3
  • Hee-Sung Kim
    • 3
  • Moon-Won Yoo
    • 3
  • Jeong Hwan Yook
    • 3
  • Seong Tae Oh
    • 3
  • Byung Sik Kim
    • 3
  • Yoon-Koo Kang
    • 2
  1. 1.Department of Internal Medicine, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulKorea
  2. 2.Department of Oncology, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulKorea
  3. 3.Department of Surgery, Asan Medical CenterUniversity of Ulsan College of MedicineSeoulKorea

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