52 P - Mitomycin C. vlnorelbine. carboplatin and Gm-CSF for treatment of advanced non small cell lung carcinoma (NSCLC)

Twenty-one patients (13 males, 8 females; median age 56 years, range 20 to 75; median WHO performance status 1, range 0-2) with non resectable NSCLC (stage III B: 6, stage IV: 15) were treated with an intravenous combination chemotherapy regimen consisting of mitomycin C 8 mg/m2 on day 1, vinorelbine 40 mg/m2 on days 1 + 21, carboplatin 250 mg/m2 on days 1 + 21, and GmCSF 5 mcg/kg administered subcutaneously from days 2 to 8 and 22 to 28. Treatment cycles were repeated every 6 weeks. Until today, 17 patients are evaluable in terms of toxicity and response assessment, and 4 cases are too early. A total of 60 courses was administered. Overall objective response was noted in 7 patients (41 %), including 2 complete and 5 partial responses. There was no change in 6 patients, and 4 had progressive disease. Median duration of response, time to progression, and survival have not been reached yet. Myelosuppression was the most frequently encountered adverse reaction, though WHO grade 4 leukopenia/granulocytopenia and/or grade 3 thrombocytopenia necessitating a 25 % dose attenuation occurred in only 4 patients. Non hematologic side effects were generally mild and reversible, and included nausea/emesis in 47%, alopecia in 35%, peripheral neuropathy and constipation both in 17%, and infections in 23%. Preliminary results suggest an encouraging therapeutic index for this combination regimen in advanced NCSLC and encourage the recruitment of a larger number of patients.