Background: To investigate the efficacy of combined hyperfractionated radiation therapy (HFX RT) plus accelerated HFX RT and concomitant chemotherapy (CHT) in stage IIIA or IIIB non-small-cell lung cancer (NSCLC) compared with HFX RT alone.
Methods: From August 1998 to December 2001, 56 patients with NSCLC were randomized into the following groups: HFX RT alone group (group I, n=28), HFX RT with 1.2 Gy twice daily to a total dose of 45.6 Gy, followed by accelerated HFX RT with 1.6 Gy twice daily, the total planned radiation dose was 68.0 Gy in tumour; HFX RT/CHT concomitant group (group II, n=28), same RT with CHT consisting of 20 mg/m² of cisplatin (DDP) on days 1 to 3 and 50 mg/m² of etoposide (VP 16) on days 1 to 3, repeated every two weeks during the RT course.
Results: The overall response rate was 78.6% in group II, including 10 patients with complete response and 12 with partial response; 39.3% in group I, including 11 patients with partial response. Group II had a higher overall response rate compared to Group I (P=0.003). The median survival time was 16 months for group II, 13 months for group I. There was a significant difference in the median survival time between two groups (P= 0.000 3 ). Group II (57.1%) had a lower distant metastasis rate compared with group I (85.7%) (P= 0.018 ). Patients in group II showed a higher incidence of acute and/or late high-grade toxicity (hematologic toxicity, esophagitis, late lung toxicity) compared with group I patients, but no significant difference was observed between the two groups.
Conclusions: The HFX RT plus accelerated HFX RT and concomitant PDD/VP-16 CHT is tolerable and substantially increases the response rate and prolongs survival in IIIA/IIIB NSCLC patients.