Purpose: A Phase II study to evaluate the response rate and toxicity of daily protracted cisplatin and etoposide with concurrent chest irradiation in patients with locally advanced, unresectable nonsmall cell lung cancer (NSCLC).
Methods and materials: Twenty-one patients with histologically confirmed locally advanced inoperable NSCLC (Stage IIIA or IIIB) were entered on study. Radiotherapy consisted of 50.4 Gy in 1.8 Gy fractions followed by a 10 Gy boost in 2 Gy fractions. Chemotherapy included the following: Cisplatin was given at 5 mg/m2 i.v. Monday-Friday before RT weeks 1-6. Etoposide was given at 25 mg/m2 i.v. M-F weeks 1, 2, 5, and 6, with 50 mg/m2 p.o. daily on the same weekends. Because of severe myelosuppression in the first two patients, etoposide only was subsequently changed to 20 mg/m2 i.v. M-F weeks 1, 2, 5, and 6.
Results: Twenty patients were eligible and evaluable. The overall response rate was 65% (95% confidence interval 41-85%). The median progression-free survival was 43 weeks. The median overall survival was 50.2 weeks with a 1-year survival rate of 45%. Five patients (25%) developed severe radiation pneumonitis, leading to early closure of the study.
Conclusions: Combining daily protracted cisplatin and etoposide with concurrent thoracic irradiation in patients with locally advanced unresectable NSCLC yields a high overall response rate and a median survival that is at least comparable to other combined modality trials. However, future studies using protracted radiosensitizing chemotherapy should be approached cautiously in light of the high incidence of severe radiation pneumonitis encountered in this trial.