Effect of pentoxifylline on radiation response of non-small cell lung cancer: a phase III randomized multicenter trial

Purposes: The objectives of this prospective clinical trial were to determine whether pentoxifylline improves the radiation response and survival in patients with non-small cell lung cancer. Materials and methods: From July 1993 through October 1994, 64 patients with histologically confirmed Stage I, II and III non-small cell lung cancer were randomly divided into pentoxifylline (Pento) + Radiotherapy (RT) group and RT alone group. Out of the 64 patients, only 47 patients who had measurable tumors on chest X-ray views were analyzed and divided into Pento + RT group (n = 27) and RT alone group (n = 20). Total tumor dose of 65-70 Gy was delivered as conventional fractionated radiation schedules. Pento was given to the patients 3 X 400 mg/day with a daily dose of 1200 mg during RT. Results: Complete response (CR), partial response (PR), and stable in Pento + RT group were three (11%), 13 (48%), and 11 (41%), respectively, as compared with corresponding values of three (15%), 13 (65%), and four (20%) in the RT alone group. The median time to relapse in the Pento + RT group was 11 months which was 2 months longer than for the RT alone group (P > 0.05), All the patients in both groups showed lower than or equal to grade 2 dysphagia, odynophagia, pulmonary fibrosis, and pneumonitis. The median survival was 18 months in the Pento + RT group and 7 months in the RT alone group. The I-year survival rate was 60% in the Pento + RT group and 35% in the RT alone group, the 2-year survival rate was 18% in the Pento + RT group and 12% in the RT alone group. But these differences were not statistically significant (P > 0.05). Conclusion: We concluded that Pento is a modestly effective radiation response modifier and provide benefit in the treatment of non-small eel lung cancer. (C) 2000 Elsevier Science Ireland Ltd. All rights reserved.