Mitomycin C continuous infusion as salvage chemotherapy in pretreated patients with advanced gastric cancer

Our purpose was to evaluate the safety and therapeutic activity of continuo usly infused mitomycin C in patients with recurring or progressive metastat ic gastric cancer following first-line chemotherapy. Patients were treated with mitomycin C 20 mg/m(2) i.v. over a time period of 120 h followed by a 3-week rest period, All patients received prednisone 50 mg p.o. prophylacti cally for 5 days to prevent hemolytic uremic syndrome and pulmonary side ef fects. Twenty-two consecutively enrolled patients were assessable for toxic ity and 20 for response evaluation completing at least one full course of c hemotherapy (two patients evaluable but not measurable). Patient characteri stics: median age: 63 years (39-76); Sex (M/F): 13/9; median Karnofsky stat us: 70% (50-100%); resection of primary tumor n = 12 (55%); sites of metast ases: liver n = 17 (77%), locally advanced n = 10 (45%), peritoneum n = 13 (59%), lungs n = 5 (23%), bone n = 3 (14%) and lymph nodes n = 14 (64%), Pr evious chemotherapy regimens: bolus 5-FU/folinic acid n = 6 (27%), ELF n = 4 (18%), EAP n = 3 (14%) and continuous 5-FU/folinic acid/cisplatin/paclita xel n = 9 (41%). In 20 evaluable patients one complete and five partial rem issions were observed; overall response rate 30.0% [95% confidence interval (CI): 9.1-50.9%] with a median response duration of 2.1 months (range: 2-6 ). The median survival was 3.6 months (95% CI: 2.1-6.0) resulting in a 6-mo nth survival rate of 30% since start of mitomycin C. WHO grade III/IV mucos itis, diarrhea and fever/infection occurred in 9% of patients each. Cumulat ive thrombo- and leukocytopenia (WHO grade III/IV) were observed in four an d two patients, respectively, Treatment had to be stopped early in two pati ents, No severe renal dysfunction, pulmonary toxicity or evidence of hemoly tic uremic syndrome was observed, Fatigue during the 120 h infusion of mito mycin C was common (11 of 22 patients). We conclude that continuous infusio n of mitomycin C is feasible on an outpatient basis, revealing an acceptabl e toxicity, Mitomycin C demonstrates single-agent activity in pretreated ga stric cancer, but has only limited efficacy following cisplatin/paclitaxel- based first-line chemotherapy. [(C) 1999 Lippincott Williams & Wilkins].