Koen Hendrickx

CPT-11 and mitomycin-C in heavily pre-treated patients with metastatic colorectal cancer: a belgian multicentre phase II study

3716 Background: Data on third-line chemotherapy for metastatic colorectal cancer are lacking and the treatment is questionable. The aim of this prospective study is to evaluate the safety and efficacy of CPT-11 combined with mitomycin-C in heavily pre-treated patients with metastatic colorectal cancer. This association might have synergistic activity. METHODS Fourty nine patients (median age: 61; range: 42-79); WHO PS 0/1/2: n = 16/29/4) were included. All patients had metastatic disease with progression after two lines of chemotherapy (Folfiri 1st line followed by Folfox 2d line, n = 33, Folfox 1st line followed by Folfiri 2d line, n = 13, other regimen, n = 3). The investigational regimen consisted of CPT-11 150 mg/m2 as a 90 min infusion D1 and mitomycin-C 5 mg/m2 as bolus D1, q 2 weeks. RESULTS All patients received at least one cycle of chemotherapy (median: 5.5; range: 1-15); dose reduction or delay occured in respectively 8 (16%) and 14 (28%) patients. Fourty six patients were evaluable for response: PR = 3/46 (6.5%); SD = 18/46 (39%); PD = 25/46 (54%). Median survival is not yet reached. Grade 3/4 toxicities occured in 18/49 patients (37%), hematological toxicities in 11/49 (22%), non hematological toxicities in 9/49 (18%). Febrile neutropenia occured in 2 patients with one toxic death. CONCLUSIONS CPT-11 and mitomycin-C seems to effectively stabilize disease progression in heavily pre-treated patients with metastatic colorectal cancer with a manageable safety profile. No significant financial relationships to disclose.