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Abstract
Importance:
Stereotactic body radiation therapy (SBRT) has become a standard treatment for patients with medically inoperable early-stage lung cancer. However, its effectiveness in patients medically suitable for surgery is unclear.

Objective:
To evaluate whether noninvasive SBRT delivered on an outpatient basis can safely eradicate lung cancer and cure selected patients with operable lung cancer, obviating the need for surgical resection.

Design, Setting, and Participants:
Single-arm phase 2 NRG Oncology Radiation Therapy Oncology Group 0618 study enrolled patients from December 2007 to May 2010 with median follow-up of 48.1 months (range, 15.4-73.7 months). The setting was a multicenter North American academic and community practice cancer center consortium. Patients had operable biopsy-proven peripheral T1 to T2, N0, M0 non-small cell tumors no more than 5 cm in diameter, forced expiratory volume in 1 second (FEV1) and diffusing capacity greater than 35% predicted, arterial oxygen tension greater than 60 mm Hg, arterial carbon dioxide tension less than 50 mm Hg, and no severe medical problems. The data analysis was performed in October 2014.

Interventions:
The SBRT prescription dose was 54 Gy delivered in 3 18-Gy fractions over 1.5 to 2.0 weeks.

Main Outcomes and Measures:
Primary end point was primary tumor control, with survival, adverse events, and the incidence and outcome of surgical salvage as secondary end points.

Results:
Of 33 patients accrued, 26 were evaluable (23 T1 and 3 T2 tumors; 15 [58%] male; median age, 72.5 [range, 54-88] years). Median FEV1 and diffusing capacity of the lung for carbon monoxide at enrollment were 72.5% (range, 38%-136%) and 68% (range, 22%-96%) of predicted, respectively. Only 1 patient had a primary tumor recurrence. Involved lobe failure, the other component defining local failure, did not occur in any patient, so the estimated 4-year primary tumor control and local control rate were both 96% (95% CI, 83%-100%). As per protocol guidelines, the single patient with local recurrence underwent salvage lobectomy 1.2 years after SBRT, complicated by a grade 4 cardiac arrhythmia. The 4-year estimates of disease-free and overall survival were 57% (95% CI, 36%-74%) and 56% (95% CI, 35%-73%), respectively. Median overall survival was 55.2 months (95% CI, 37.7 months to not reached). Protocol-specified treatment-related grade 3, 4, and 5 adverse events were reported in 2 (8%; 95% CI, 0.1%-25%), 0, and 0 patients, respectively.

Conclusions and Relevance:
As given, SBRT appears to be associated with a high rate of primary tumor control, low treatment-related morbidity, and infrequent need for surgical salvage in patients with operable early-stage lung cancer.

Trial Registration:
ClinicalTrials.gov Identifier: NCT00551369.

Author information

Timmerman RD1,2, Paulus R3, Pass HI4, Gore EM5, Edelman MJ6,7, Galvin J8, Straube WL9, Nedzi LA1, McGarry RC10, Robinson CG11, Schiff PB12, Chang G13, Loo BW Jr14, Bradley JD11, Choy H1.
1
Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas.
2
Department of Neurological Surgery, University of Texas Southwestern Medical Center, Dallas.
3
NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania.
4
Department of Cardiothoracic Surgery, New York University School of Medicine, New York.
5
Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee.
6
Department of Hematology/Oncology, University of Maryland, Marlene and Stewart Greenebaum Cancer Center, Baltimore.
7
now with Department of Hematology/Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania.
8
Imaging and Radiation Oncology Core (IROC), Philadelphia, Pennsylvania.
9
Washington University in St Louis, St Louis, Missouri.
10
Department of Radiation Oncology, University of Kentucky, Lexington.
11
Department of Radiation Oncology, Washington University in St Louis, St Louis, Missouri.
12
Department of Radiation Oncology, New York University School of Medicine, New York.
13
Sutter General Hospital accrual under Mercy San Juan Radiation Oncology Center, Carmichael, California.
14
Department of Radiation Oncology, Stanford University School of Medicine, Stanford, California.