CONCURRENT CHEMORADIATION THERAPY WITH ORAL ETOPOSIDE AND CISPLATIN FOR LOCALLY ADVANCED INOPERABLE NON-SMALL-CELL LUNG-CANCER - RADIATION-THERAPY ONCOLOGY GROUP PROTOCOL-91-06

Purpose: Patients with locally advanced inoperable non-small-cell lung cancer (NSCLC) have a poor clinical outcome. We conducted a prospecti ve study to evaluate the merit of chemotherapy administered concurrent ly with hyperfractionated thoracic radiation therapy. Patients and Met hods: Seventy-nine patients with inoperable NSCLC were enrolled onto a multicenter phase II trial of concurrent chemoradiation therapy. Trea tment consisted of two cycles of oral etoposide 100 mg/d (50 mg twice daily) on days 1 to 14 of a 28-day cycle (75 mg/d if body-surface area [BSA] < 1.70 m(2)), intravenous cisplatin 50 mg/m(2) on days 1 and 8, and hyperfractionated radiation therapy 5 days per week (1.2 Gy twice daily > 6 hours apart; total, 69.6 Gy). Results: Seventy-six assessab le patients with a Karnofsky performance status greater than or equal to 60 and adequate organ function who had received no prior therapy we re evaluated for clinical outcome and toxic effects. After a minimum f ollow-up duration of 21 months, the 1- and 2-year survival rates and m edian survival duration were 67%, 35%, and 18.9 months overall; they w ere 70%, 42%, and 21.1 months for patients with weight loss of less th an or equal to 5%. Toxicity was significant; 57% developed grade 4 hem atologic toxicity, 53% grade 3 or 4 esophagitis, and 25% grade 3 or 4 lung toxicity. However, only 6.6% of patients had grade 4 or lethal no nhematologic toxicity, which included three treatment-related deaths ( two of pneumonitis and one of renal failure). Conclusion: Concurrent c hemoradiation therapy with oral etoposide and cisplatin plus hyperfrac tionated radiation therapy is feasible. The survival outcome from this regimen compares favorably with that of other chemoradiation trials a nd even of multimodality trials that have included surgery. (C) 1996 b y American Society of Clinical Oncology.