Stereotactic body radiation therapy (SBRT) of centrally located medically inoperable early-stage non-small cell lung cancer (T1-T3N0M0) - A subgroup analysis of the expanded HILUS study.

INTRODUCTION: Centrally located early-stage non-small cell lung cancer (ES NSCLC) with tumors close to the bronchi is potentially curable with stereotactic body radiation therapy (SBRT). To evaluate the clinical benefit of the treatment, both the risk of high-grade toxicity as well as the treatment efficacy need to be assessed.

MATERIAL AND METHODS: From the expanded HILUS cohorts, 72 patients with T1-T3N0M0 NSCLC were included in the current analysis. All patients had been treated with SBRT in 8 fractions to 56 Gy for a tumor located within 2 cm from the tracheobronchial tree. Primary endpoint was progression free survival (PFS) and secondary endpoints included pattern of failure, local control (LC), lung cancer-specific survival (LCSS), overall survival (OS) and toxicity. The Kaplan-Meier method and Cox regression analysis were used.

RESULTS: The median age of the cohort was 73 years and all patients suffered from comorbidities prior to SBRT. T2-T3 tumors were seen in 65 % of the patients. Seventeen patients relapsed after SBRT and distant recurrence was the most common form of relapse. Three-year PFS was 31 % (95 % CI 22-44) and largely explained by the short overall survival (38 % (95 % CI 22-44) at 3 years). Three-year rates of LC and LCSS were 97 % (95 % CI 92-100) and 76 % (95 % CI 65-89), respectively. Twelve patients (17 %) suffered from grade 5 toxicity, of which 9 were bronchopulmonary bleedings.

CONCLUSION: The severe toxic profile limits the clinical benefit using SBRT with the investigated approach for patients with centrally located ES NSCLC.