Platinum-based combination chemotherapy in advanced non-small cell lung cancer: a randomized phase II trial of the Cancer and Leukemia Group B.

The Cancer and Leukemia Group B (CALGB) utilized a randomized phase II trial design to evaluate two cisplatin-based combinations, cisplatin-cytarabine (ara-C) and cisplatin-vinblastine, in 151 patients with advanced non-small cell lung cancer. Patients entered on study had not received prior chemotherapy. Platinum doses were equivalent in the two treatment programs. The total response rate (complete response, partial response, regression of evaluable disease) for the cisplatin-vinblastine group was 22% (16/73). Failure-free survival at six months for this group was 41%, survival at six months was 63%. The cisplatin-ara-C group had a total response rate of 9% (7/78) with a failure-free survival at six months of 14% and a six-month survival of 47%. Severe or life-threatening toxicity was seen in 73% of cisplatin-vinblastine cases and 59% of cisplatin-ara-C patients. Neither regimen is active enough to warrant designation as "standard therapy" for patients with M1 disease.

RCT Entities:   Population Interventions Outcomes