RANDOMIZED TRIAL COMPARING WEEKLY VERSUS 3-WEEK CHEMOTHERAPY IN SMALL-CELL LUNG-CANCER - A CANCER-RESEARCH CAMPAIGN TRIAL

Purpose: A randomized trial of chemotherapy, given on either a 1-week or a 9 week schedule, was performed in small-cell long cancer (SCLC) patients. The aim was to determine if weekly scheduling produced survival superior to conventional treatment. Patients and Methods: four hundred thirty-eight patients with SCLC with either limited disease (LD; 276 patients) or good-prognosis extensive disease (ED; 162 patients) were randomized. Weekly chemotherapy was 12 alternating cycles of ifosfamide/doxorubicin and cisplatin/etoposide (PE), while 3-week treatment was six alternating cycles of cyclophosphamide/doxorubicin/vincristine (CAV) and PE. Thoracic irradiation was administered 3 weeks after completion of chemotherapy to LD patients who attained a complete response (CR) or partial response (PR). Patients were well marched for clinical characteristics and prognostic factors. Results: Overall response was the same in both arms: 82.3% (39.4% CR) with weekly and 81.1% (36.9% CR) with 3-week treatment. The median survival (MS) durations were 10.8 and 10.6 months for weekly and 3-week chemotherapy, respectively. The 2-year survival rates were 11.8% and 11.7% in the weekly and 3-week arms, respectively. Received dose-intensity (DI) was 73.9% of projected for weekly treatment and 92.7% for 3-week treatment. Hematologic toxicity wets the major dose-limiting toxicity for the weekly treatment. Conclusion: This trial excludes at 90% power a benefit of greater then 10% for 2-year survival for weekly treatment. The received DI was reduced to a greater extent with weekly treatment, mainly due to hematologic toxicity. (C) 1994 by American Society of Clinical Oncology.