Patients were accrued over a 3-year period from 22 US and Canadian institutions. Patients with LSCLC and good performance status were given thoracic radiation to 61.2 Gy over 5 weeks (daily 1.8-Gy fractions on days 1-22, then twice-daily 1.8-Gy fractions on days 23-33). Cisplatin (60 mg/m2 IV) was given on day 1 and etoposide (120 mg/m2 IV) on days 1-3 and days 22-24, followed by 2 cycles of cisplatin plus etoposide alone. Patients who achieved complete response were offered prophylactic cranial irradiation. Endpoints included overall and progression-free survival; severe esophagitis (Common Toxicity Criteria v 2.0) and treatment-related fatalities; response (Response Evaluation Criteria in Solid Tumors); and local control.
Seventy-two patients were accrued from June 2003 through May 2006; 71 were evaluable (median age 63 years; 52 % female; 58 % Zubrod 0). Median survival time was 19 months; at 2 years, the overall survival rate was 36.6 % (95 % confidence interval [CI] 25.6 % -47.7 % ), and progression-free survival 19.7 % (95 % CI 11.4 % -29.6 % ). Thirteen patients (18 % ) experienced severe acute esophagitis, and 2 (3 % ) died of treatment-related causes; 41 % achieved complete response, 39 % partial response, 10 % stable disease, and 6 % progressive disease. The local control rate was 73 % . Forty-three patients (61 % ) received prophylactic cranial irradiation.
The overall survival rate did not reach the projected goal; however, rates of esophagitis were lower, and local control higher, than projected. This treatment strategy is now one of three arms of a prospective trial of chemoradiation for LSCLC (Radiation Therapy Oncology Group 0538/Cancer and Leukemia Group B 30610).