Clinical Study

BJC Open article

British Journal of Cancer (2013) 108, 1245–1251. doi:10.1038/bjc.2013.86 www.bjcancer.com
Published online 28 February 2013

Adjuvant chemotherapy for gastric cancer: a randomised phase 3 trial of mitomycin-C plus either short-term doxifluridine or long-term doxifluridine plus cisplatin after curative D2 gastrectomy (AMC0201)

Y-K Kang1, H-M Chang1, J H Yook2, M-H Ryu1, I Park1, Y J Min3, D Y Zang4, G Y Kim5, D H Yang6, S J Jang7, Y S Park7, J-L Lee1, T W Kim1, S T Oh2, B K Park8, H-Y Jung9 and B S Kim2

  1. 1Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul 138-736, Korea
  2. 2Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, Korea
  3. 3Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan 682-060, Korea
  4. 4Department of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang 431-070, Korea
  5. 5Department of Surgery, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan 682-060, Korea
  6. 6Department of Surgery, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang 431-070, Korea
  7. 7Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, Korea
  8. 8LSK Global Pharma Services, Seoul, Korea
  9. 9Departments of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul 138-736, Korea

Correspondence: Dr Y-K Kang, E-mail: ykkang@amc.seoul.kr

Received 21 November 2012; Revised 24 January 2013; Accepted 1 February 2013
Advance online publication 28 February 2013

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Abstract

Background:

  

This phase 3 study evaluated the efficacy of new adjuvant chemotherapy (MFP), which intensified the mitomycin-C (MMC) plus short-term doxifluridine (Mf) for gastric cancer.

Patients and methods:

  

A total of 855 patients (424 in Mf, 431 in MFP) with pathological stage II–IV (M0) gastric cancer after D2 gastrectomy were randomly assigned to receive either Mf (MMC 20mgm−2, followed by oral doxifluridine 460–600mgm−2 per day for 3 months) or MFP (MMC 20mgm−2, followed by oral doxifluridine 460–600mgm−2 per day for 12 months with 6 monthly infusions of 60mgm−2 of cisplatin) chemotherapy.

Results:

  

With a median follow-up of 6.6 years, there was no difference between the two groups in recurrence-free survival (RFS) (5-year RFS 61.1% in Mf and 57.9% in MFP; hazard ratio 1.10 (95% CI 0.89–1.35); P=0.39) and overall survival (OS) (5-year OS 66.5% in Mf and 65.0% in MFP; hazard ratio 1.11 (95% CI 0.89–1.39); P=0.33).

Conclusion:

  

Intensification of Mf adjuvant chemotherapy by prolonging the duration of oral fluoropyrimidine and adding cisplatin was safe but not effective to improve the survivals in curatively resected gastric cancer patients.

Keywords:

mitomycin-C; doxifluridine; cisplatin; adjuvant chemotherapy; gastric cancer; D2 gastrectomy