Originally published as JCO Early Release 10.1200/JCO.2008.21.5681 on May 4 2009

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Outcome in a Prospective Phase II Trial of Medically Inoperable Stage I Non–Small-Cell Lung Cancer Patients Treated With Stereotactic Body Radiotherapy

From the Karolinska University Hospital and Karolinska Institutet, Stockholm; Sahlgrenska University Hospital, Gothenburg; Uppsala University Hospital, Uppsala; Malmö University Hospital, Malmö; Linköping University Hospital, Linköping, Sweden; Aarhus University Hospital, Aarhus, Denmark; and Trondheim University Hospital, Trondheim, Norway.

Corresponding author: Pia Baumann, MD, Department of Oncology and Radiotherapy, Radiumhemmet, Karolinska University Hospital Solna, 171 76 Stockholm, Sweden; e-mail: pia.baumann{at}karolinska.se.

Purpose The impact of stereotactic body radiotherapy (SBRT) on 3-year progression-free survival of medically inoperable patients with stage I non–small-cell lung cancer (NSCLC) was analyzed in a prospective phase II study.

Patients and Methods Fifty-seven patients with T1NOMO (70%) and T2N0M0 (30%) were included between August 2003 and September 2005 at seven different centers in Sweden, Norway, and Denmark and observed up to 36 months. SBRT was delivered with 15 Gy times three at the 67% isodose of the planning target volume.

Results Progression-free survival at 3 years was 52%. Overall- and cancer-specific survival at 1, 2, and 3 years was 86%, 65%, 60%, and 93%, 88%, 88%, respectively. There was no statistically significant difference in survival between patients with T1 or T2 tumors. At a median follow-up of 35 months (range, 4 to 47 months), 27 patients (47%) were deceased, seven as a result of lung cancer and 20 as a result of concurrent disease. Kaplan-Meier estimated local control at 3 years was 92%. Local relapse was observed in four patients (7%). Regional relapse was observed in three patients (5%). Nine patients (16%) developed distant metastases. The estimated risk of all failure (local, regional, or distant metastases) was increased in patients with T2 (41%) compared with those with T1 (18%) tumors (P = .027).

Conclusion With a 3-year local tumor control rate higher than 90% with limited toxicity, SBRT emerges as state-of-the-art treatment for medically inoperable stage I NSCLC and may even challenge surgery in operable instances.

Supported by grants from the Nordic Cancer Union, the Stockholm Cancer Society, and research funds of the Stockholm County Council and the Swedish Cancer Society.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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