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

• Published in: Annals of oncology Vol. 13; no. 11; pp. 1779 - 1785
• Main Authors: Chang, H. M., Jung, K. H., Kim, T.-Y., Kim, W. S., Yang, H.-K., Lee, K. U., Choe, K. J., Heo, D. S., Bang, Y.-J., Kim, N. K.
• Format: Journal Article
• Language: English
• Published: Oxford Oxford University Press 01.11.2002
• Subjects: 5-fluorouracil; Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adenocarcinoma - pathology; Adenocarcinoma - surgery; Analysis of Variance; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Biological and medical sciences; Biopsy, Needle; Chemotherapy; Chemotherapy, Adjuvant; Combined Modality Therapy; Disease-Free Survival; Dose-Response Relationship, Drug; doxorubicin; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Drug Administration Schedule; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Follow-Up Studies; Gastrectomy - methods; gastric cancer; Humans; Infusions, Intravenous; Key words: adjuvant chemotherapy; Korea; Male; Medical sciences; Mitomycin - administration & dosage; Mitomycin - adverse effects; mitomycin C; Neoplasm Staging; Pharmacology. Drug treatments; phase III trial; Probability; Proportional Hazards Models; Reference Values; Sensitivity and Specificity; Statistics, Nonparametric; Stomach Neoplasms - drug therapy; Stomach Neoplasms - mortality; Stomach Neoplasms - pathology; Stomach Neoplasms - surgery; Survival Rate; Treatment Outcome; Korea; Adenocarcinoma; Antineoplastic agent; Phase III trial; Human; Postoperative; Stomach; Drug combination; Mitomycin; Fluoropyrimidine derivatives; Adjuvant treatment; Malignant tumor; Doxorubicin; Chemotherapy; Surgery; Digestive diseases; Pyrimidine derivatives; Anthracyclins; Gastric disease; Fluorouracil
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdf302

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.