2ND LINE CHEMOTHERAPY FOR METASTATIC COLORECTAL-CARCINOMA - A PHASE-II STUDY WITH MITOMYCIN-C, ADRIAMYCIN AND LONIDAMINE

25 patients with metastatic colorectal carcinoma previously treated wi th 5-fluorouracil and folinic acid for advanced disease, were treated with mitomycin C 8 mg/m(2) i.v. bolus on day 1, adriamycin 40 mg/m(2) i.v. bolus on day 1, and lonidamine 150 mg per os t.i.d. starting one day before chemotherapy and stopping 2 days after the end of chemother apy. Treatment was repeated every 4 weeks. All patients had previous s urgery and systemic chemotherapy with 5-fluorouracil and folinic acid given as first line chemotherapy for metastatic tumor. Sites of diseas e included liver, lung, nodes, abdomen, and bone. All enrolled patient s were evaluable for objective response. Only one patient, affected by rectal carcinoma, showed a partial response (4%) which lasted 5.8+ mo nths. No complete response was seen. Stable disease was recorded in 4 cases (16%) with a mean duration of 4.6+ months. All remaining patient s had progressive disease. Median overall survival was 8.7+ months. To xicity was significant. Grade 3 thrombocytopenia was seen in 8 cases ( 32%), and grade 3 leukopenia in 5 cases (20%). Grade 3 vomiting was ob served in 9 patients (36%). The combination of mitomycin C, adriamycin and lonidamine is not effective in the treatment of metastatic colore ctal adenocarcinoma resistant to 5-fluorouracil-based chemotherapy. Th ese data suggest that lonidamine is not able to potentiate antineoplas tic activity of chemotherapeutic drugs in humans and its use in colore ctal cancer should be avoided since it has no or little impact on resp onse rate and survival.