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Investigational New Drugs

, Volume 30, Issue 1, pp 357–363 | Cite as

A pilot study of S-1 plus cisplatin versus 5-fluorouracil plus cisplatin for postoperative chemotherapy in histological stage IIIB-IV (M0) gastric cancer

  • Sung Sook Lee
  • Hei-Cheul Jeung
  • Hyun Cheol Chung
  • Sung Hoon Noh
  • Woo Jin Hyung
  • Ji Yeong Ahn
  • Sun Young RhaEmail author
PHASE II STUDIES

Summary

Background Although its efficacy is unproven, 5-fluorouracil plus cisplatin (FP) is used to prevent postoperative relapse in gastric cancer. We investigated the safety and feasibility of S-1 plus cisplatin (SP) vs. FP for stage IIIB-IV (M0) gastric cancer. Methods Following curative resection, 41 stage IIIB-IV (M0) gastric cancer patients were assigned to SP (eight 14-day cycles of S-1 [40 mg/m2 twice daily] plus cisplatin [60 mg/m2 day 1] administered every 3 weeks) or FP (six 3-day cycles of FU [1 g/m2 per day] plus cisplatin [80 mg/m2 day 1] every 4 weeks). Doses were reduced based on predefined criteria. Results Patient characteristics were balanced between the two arms. In total, 124 cycles of SP (N = 20, median = 7, range 1–8) and 113 cycles of FP (N = 21, median 6, range 1–6) were administered. The median relative dose intensity per patient was 75% (49.99–100%) for S-1, 100% (75–100%) for cisplatin in SP, and 100% (64–100%) for 5-FU, 100% (60–100%) for cisplatin in FP. The relative dose intensity of FP was stable, while that of SP decreased during treatment. After median follow-up of 7.9 months (3.8–14.55), the median RFS was not reached. Relapse occurred in two (10%) patients on SP and five (23.8%) in the FP arm (P = 0.24). The incidence of grade 3–4 granulocytopenia was 36.8% with SP and 14.3% with FP. Grade 3–4 non-hematologic toxicities included fatigue (5.2% with SP vs. 4.8% with FP), vomiting (10.5% with SP vs. 0% with FP), and infection (5.2% with SP vs. 0% FP). Conclusion S-1 plus cisplatin was feasible and tolerable as adjuvant treatment for stage IIIB-IV (M0) gastric cancer. However, because of decreased relative dose intensity during treatment, further study is warranted to determine optimal dosage and combination.

Keywords

S-1 Stage IIIB-IV (M0) Gastric cancer 

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Copyright information

© Springer Science+Business Media, LLC 2010

Authors and Affiliations

  • Sung Sook Lee
    • 1
  • Hei-Cheul Jeung
    • 1
  • Hyun Cheol Chung
    • 1
  • Sung Hoon Noh
    • 2
  • Woo Jin Hyung
    • 2
  • Ji Yeong Ahn
    • 2
  • Sun Young Rha
    • 2
    • 3
    Email author
  1. 1.Division of Oncology, Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea
  2. 2.Division of Oncology, Department of SurgeryYonsei University College of MedicineSeoulSouth Korea
  3. 3.Division of Oncology, Department of Internal MedicineYonsei University College of MedicineSeoulSouth Korea

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