Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer

Purpose: A phase III study was performed to determine whether concurrent or sequential treatment with radiotherapy (87) and chemotherapy (CT) improves survival in unresectable stage III non-small-cell lung cancer (NSCLC). Patients and Methods: Patients were assigned to the two treatment arms. In the concurrent arm, chemotherapy consisted of cisplatin (80 mg/m(2) on days 1 and 29), vindesine (3 mg/m(2) on days 1, 8, 29, and 36), and mitomycin ( 8 mg/m2 on days 1 and 29). RT began on day 2 at a dose of 28 Gy (2 Gy per f raction and 5 fractions per week for a total of 14 fractions) followed by a rest period of 10 days, and then repeated, In the sequential arm, the same CT was given, but PT was initiated after completing CT and consisted of 56 Gy (2 Gy per fraction and 5 fractions per week for a total of 28 fractions ). Results: Three hundred twenty patients were entered onto the study. Pretrea tment characteristics were well balanced between the treatment arms. The re sponse rate for the concurrent arm was significantly higher (84.0%) than th at of the sequential arm (66%) (P = .0002), The median survival duration wa s significantly superior in patients receiving concurrent therapy (16.5 mon ths), as compared with those receiving sequential therapy(13.3 months) (P = .03998). Two-, 3-, 4-, and 5-year survival rates in the concurrent group ( 34.6% 22.3%, 16.9%, and 15.8%, respectively) were better than those in the sequential group (27.4%, 1 4.7%, 10.1%, and 8.9% respectively). Myelosuppre ssion was significantly greater among patients on the concurrent arm than o n the sequential arm (P = .0001). Conclusion: In selected patients with unresectable stage III NSCLC, the con current approach yields a significantly increased response rate and enhance d median survival duration when compared with the sequential approach.