• Achilles J Fakiris, Ronald C McGarry, Constantin T Yiannoutsos, Lech Papiez, Mark Williams, Mark A Henderson, and Robert Timmerman.
• Department of Radiation Oncology, Indiana University School of Medicine, 535 Barnhill Drive, Indianapolis, IN 46202, USA. afakiris@iupui.edu
• Int. J. Radiat. Oncol. Biol. Phys. 2009 Nov 1; 75 (3): 677-82.

PurposeThe 50-month results of a prospective Phase II trial of stereotactic body radiation therapy (SBRT) in medically inoperable patients are reported.Methods And MaterialsA total of 70 medically inoperable patients had clinically staged T1 (34 patients) or T2 (36 patients) (< or =7 cm), N0, M0, biopsy-confirmed non-small-cell lung carcinoma (NSCLC) and received SBRT as per our previously published reports. The SBRT treatment dose of 60-66 Gy was prescribed to the 80% isodose volume in three fractions.ResultsMedian follow-up was 50.2 months (range, 1.4-64.8 months). Kaplan-Meier local control at 3 years was 88.1%. Regional (nodal) and distant recurrence occurred in 6 (8.6%) and 9 (12.9%) patients, respectively. Median survival (MS) was 32.4 months and 3-year overall survival (OS) was 42.7% (95% confidence interval [95% CI], 31.1-54.3%). Cancer-specific survival at 3 years was 81.7% (95% CI, 70.0-93.4%). For patients with T1 tumors, MS was 38.7 months (95% CI, 25.3-50.2) and for T2 tumors MS was 24.5 months (95% CI, 18.5-37.4) (p = 0.194). Tumor volume (< or =5 cc, 5-10 cc, 10-20 cc, >20 cc) did not significantly impact survival: MS was 36.9 months (95% CI, 18.1-42.9), 34.0 (95% CI, 16.9-57.1), 32.8 (95% CI, 21.3-57.8), and 21.4 months (95% CI, 17.8-41.6), respectively (p = 0.712). There was no significant survival difference between patients with peripheral vs. central tumors (MS 33.2 vs. 24.4 months, p = 0.697). Grade 3 to 5 toxicity occurred in 5 of 48 patients with peripheral lung tumors (10.4%) and in 6 of 22 patients (27.3%) with central tumors (Fisher's exact test, p = 0.088).ConclusionBased on our study results, use of SBRT results in high rates of local control in medically inoperable patients with Stage I NSCLC.

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