A phase II trial of 5-fluorouracil, leucovorin  and mitomycin C in patients with advanced gastric cancer.
OBJECTIVE
Low-dose leucovorin is a well known potentiator of 5-fluorouracil activity in colorectal cancer but not in gastric cancer. To assess their efficacy on response rate and survival, 5-fluorouracil and low-dose leucovorin were combined with mitomycin C.


METHODS
Fifty patients with gastric cancer and metastatic disease, unresectable or relapsed disease were treated with the following regimen every 28 days: mitomycin C, 7 mg/m2 IV bolus on day 1, and leucovorin, 20 mg/m2 IV, followed immediately by 5-fluorouracil, 375 mg/m2 on days 1-5. All had measurable disease and were assessable for toxicity. Prognostic factors were analyzed to examine any association with response rate or overall survival.


RESULTS
Nineteen of the 48 assessable patients (39.6%; 95% confidence interval [CI], 25.8-53.4) responded, including 4 complete responses (8.3%). The median progression-free survival was 108 days (range, 18+ - 146), and the median duration of survival was 338 days (11.3 months; range, 18+ - 903 days). Response rate and overall survival were not significantly associated with CEA level, performance status, age, or primary and metastatic tumor sites. Toxicity associated with the chemotherapy was tolerable, and all patients were treated at the outpatient clinic. Leukopenia and thrombocytopenia WHO grade ≥3 occurred in 5% and 1% of the patients, respectively. Nausea and vomiting were the most frequent adverse effects (29%), all grade 1 or 2.


CONCLUSIONS
Combination chemotherapy of 5-fluorouracil plus leucovorin with mitomycin C is effective for the treatment of advanced gastric cancer and is well tolerated.
Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea. srkjoy@paik.ac.kr
Sung Rok
SR
Kim
Young Jin
YJ
Yuh
Byeong Seok
BS
Sohn
Sung Hyun
SH
Yang
D000230:Adenocarcinoma / Q000175:diagnosis / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D009325:Nausea / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D011379:Prognosis; D012008:Recurrence; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
D016685:Mitomycin; D002955:Leucovorin; D005472:Fluorouracil