[A randomized controlled trial comparing short-term MF chemotherapy with MF and long-term carmofur chemotherapy as an adjuvant to curative resection of stomach cancer].
In order to clarify the clinical response to long-term adjuvant chemotherapy with carmofur (HCFU), a comparative multicenter trial has been performed by a randomized controlled method. Curatively resected patients suffering from stomach cancer were randomly allocated into two arms. Arm A consisted of those receiving short-term MF chemotherapy (mitomycin C, 0.04 mg/kg + 5-fluorouracil, 5.0 mg/kg X 6, IVr) and arm B consisted of arm A plus long-term carmofur chemotherapy (Mifurol, 6-12 mg/kg/day over 12 weeks, PO). The difference of overall survival probability between the two study arms was significant in fabior of arm B (P less than 0.05) up to three years after surgery. The difference of survival curves was more distinct (P less than 0.01) in the case of the advanced stage of the cancer such as serosal inversion [ps (+)] and lymph node metastasis [n (+)]. The side effects of carmofur, mostly subjective symptoms such as gastrointestinal toxicities, pollakisuria, and sensation of hotness, were reversible. From the results, it is suggested that carmofur maintenance therapy is effective for the prevention of postsurgical recurrence of stomach cancer by means of the prolongation of patient survival.
Nakazato
H
H
Koike
A
A
Ichihashi
H
H
D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives*; D006801:Humans; D016685:Mitomycin; D008937:Mitomycins / Q000008:administration & dosage; D011184:Postoperative Period; D011379:Prognosis; D011897:Random Allocation; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality
D000970:Antineoplastic Agents; D008937:Mitomycins; D016685:Mitomycin; C017367:carmofur; D005472:Fluorouracil