Comparative trial of combination chemotherapy in extensive squamous carcinoma of the lung: a Southwest Oncology Group Study.

The Southwest Oncology Group carried out a comparative study of two combination chemotherapy regimens in 231 patients with extensive squamous carcinoma of the lung. One regimen consisted of bleomycin, adriamycin, CCNU, vincristine, and mechlorethamine (BACON). The other involved mechlorethamine, adriamycin, and CCNU (NAC) in the same dose and schedule but with the deletion of vincristine and bleomycin. The response rate was 21% for BACON and 16% for NAC. The median survival time (MST) was 16 weeks for all patients receiving each regimen. Pretreatment performance statues (PS) was significantly related to the response rates: these were 28% for BACON and 23% for NAC among fully ambulatory patients (PS, 8-10) versus 15% for BACON and 10% for NAC among those with a lesser PS (P less than 0.05). Survival was also influenced by PS; the MST was 28 weeks for PSs 8-10 with either regimen compared to an overall MST of 11.5 weeks for patients with PSs 5-7 and 2.8 weeks for PSs 1-4. The toxicity of the two regimens was comparable with a 4% incidence of treatment-related deaths. An additional 10% of the patients were hospitalized because of life-threatening but reversible toxic effects. The only patients for whom there may be an improvement in MST over that expected from supportive care alone are those with PSs 8-10. Patients who demonstrated response or improvement, regardless of PS, had a significantly longer MST: 39.5 versus 11.2 weeks for those who did not respond (P = 0.001).

RCT Entities:   Population Interventions Outcomes