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
| Autor: | Han-Kwang Yang, KH Jung, Ku Lee, Tae Yong Kim, Noe Kyeong Kim, Yung-Jue Bang, HM Chang, KJ Choe, D. S. Heo, WS Kim |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Male
medicine.medical_specialty medicine.medical_treatment Mitomycin Adenocarcinoma Gastroenterology Sensitivity and Specificity Disease-Free Survival Drug Administration Schedule Statistics Nonparametric Gastrectomy Reference Values Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Doxorubicin Infusions Intravenous Survival rate Neoplasm Staging Probability Proportional Hazards Models Chemotherapy Analysis of Variance Korea Dose-Response Relationship Drug business.industry Stomach Mitomycin C Biopsy Needle Cancer Hematology medicine.disease Combined Modality Therapy Surgery Survival Rate medicine.anatomical_structure Treatment Outcome Oncology Fluorouracil Chemotherapy Adjuvant Female business medicine.drug Follow-Up Studies |
| Zdroj: | Annals of oncology : official journal of the European Society for Medical Oncology. 13(11) |
| ISSN: | 0923-7534 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|