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Annals of Oncology 13:1779-1785, 2002
© 2002 European Society for Medical Oncology

Original Paper

A phase III randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C versus 5-fluorouracil and mitomycin C versus 5-fluorouracil alone in curatively resected gastric cancer

H. M. Chang1, K. H. Jung1, T.-Y. Kim1,3, W. S. Kim1, H.-K. Yang2, K. U. Lee2, K. J. Choe2, D. S. Heo1,3,+, Y.-J. Bang1,3 and N. K. Kim1,3

1 Department of Internal Medicine, 2 Department of Surgery and 3 Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea

Received 26 November 2001; revised 13 May 2002; accepted 29 May 2002

Background:

A phase III single-center randomized trial was performed in order to determine whether the addition of mitomycin C (MMC) and/or doxorubicin to 5-fluorouracil (5-FU) as adjuvant chemotherapy could influence survival in patients with curatively resected gastric cancer.

Patients and methods:

A total of 416 patients who had undergone curative resection for stage IB–IIIB gastric adenocarcinoma were stratified according to the stage and type of surgery, and then randomized to receive one of the three chemotherapy regimens, 5-FU alone (F) or 5-FU and MMC (FM) or 5-FU, doxorubicin and MMC (FAM) within 5 weeks after surgery.

Results:

Of 416 patients registered, 395 (133 in F, 131 in FM and 131 in FAM) were assessable. Median follow-up duration was 91 months. Five-year overall survival rates were 67.2% for F, 67.0% for FM and 66.7% for FAM (P = 0.97). Five-year disease-free survival rates were 62.1% for F, 63.3% for FM and 62.5% for FAM (P = 0.83). Hematological toxicities were more frequent in the FM and FAM groups, whereas stomatitis was more common in the F group.

Conclusions:

Compared with adjuvant 5-FU alone, the addition of MMC and/or doxorubicin to 5-FU did not influence survival in patients with resected gastric cancer.

Key words: adjuvant chemotherapy, doxorubicin, 5-fluorouracil, gastric cancer, mitomycin C, phase III trial


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