We have carried out a randomized phase Ill study in 105 patients with advanced nonsmall cell lung cancer, comparing a fourdrug cisplatin-mitomycin-based combination chemotherapy regimen t o sequential single-agent therapy. The combination chemotherapy regimen consisted of mitomycin C (10 mg/m2), vinblastine (5 mglm'), methotrexate (40 mg/m2), and cisplatin (40 mg/m2) given every 28 days. Sequential single-agent chemotherapy consisted of mitomycin C (10 mg/m2) monthly until progression followed by vinblastine (5 mg/m2) every 2 weeks until progression followed by methotrexate (40 mg/m2) weekly until relapse. Patients failing either regimen were followed with supportive care. The objective response rate for the sequential single-agent therapy was 19% versus 25% for the combination chemotherapy group (P > .5). The median survival for the single-agent group was 166 days and 191 days for the combination chemotherapy group. Overall survival was not statistically different between the two groups ( P > .5).
Leucopenia, anemia, and prolonged anorexia with nausea and vomiting were more common in the combination chemotherapy group compared to the single-agent group. This study failed to demonstrate a sufficient therapeutic benefit in the face of the added toxicity for the combination chemotherapy regimen compared to sequential singleagent therapy.