Hyperfractionated accelerated radiotherapy (HART) for inoperable, nonmetastatic non-small cell lung carcinoma of the lung (NSCLC): results of a phase II study for patients ineligible for combination radiochemotherapy.

PURPOSE: To evaluate a hyperfractionated and accelerated radiotherapy (HART) protocol in patients with inoperable non-small cell lung carcinoma (NSCLC) who were ineligible for combination radiochemotherapy studies. METHODS AND MATERIALS: From February 1989 through August 1994, 23 patients ineligible for available combined modality protocols in our institution were enrolled and treated with HART, consisting of 63 Gy given in 42 fractions of 1.5 Gy each, twice daily, with a minimum time interval of 6 h between fractions, 5 days a week, over an elapsed time of 4.2 weeks, or 29 days. There was no planned interruption. RESULTS: The 1-, 2-, and 3-year survival rates were 61%, 39%, and 19%, respectively, with a median survival of 16.8 months. At the time of analysis, 4 patients are alive and 19 have died, 16 from NSCLC and 3 from cardiac disease. Overall response rate was 48%, with 22% of patients achieving a complete response and 26% a partial response. Correlation between acute response rate and survival was poor. First site of relapse was local-regional in 8 patients (35%), distant in 6 patients (26%), and local-regional and distant in 4 (17%) patients. One patient had Grade IV and 2 had Grade III esophagitis. One patient presented with chronic Grade III lung toxicity. There were no treatment-related deaths. CONCLUSION: In this group of 23 patients ineligible for radiochemotherapy, this HART regime was quite feasible and was followed by little toxicity. Results in this particularly poor prognosis NSCLC patient category should be compared to series with a similar patient profile; however, median survival is at least similar to that obtained in recent series of combination radiochemotherapy.