Combination versus sequential single‐agent chemotherapy in the treatment of patients with advanced non‐small cell lung cancer

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Abstract
We have carried out a randomized phase Ill study in 105 patients with advanced non‐small cell lung cancer, comparing a fourdrug cisplatin‐mitomycin‐based combination chemotherapy regimen to sequential single‐agent therapy. The combination chemotherapy regimen consisted of mitomycin C (10 mg/m2), vinblastine (5 mg/m2), 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.

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