Stereotactic Body Radiation Therapy for Inoperable Early Stage Lung Cancer
- Robert Timmerman, MD;
- Rebecca Paulus, BS;
- James Galvin, PhD;
- Jeffrey Michalski, MD;
- William Straube, PhD;
- Jeffrey Bradley, MD;
- Achilles Fakiris, MD;
- Andrea Bezjak, MD;
- Gregory Videtic, MD;
- David Johnstone, MD;
- Jack Fowler, PhD;
- Elizabeth Gore, MD;
- Hak Choy, MD
- Author Affiliations: Department of Radiation Oncology, University of Texas Southwestern Medical Center, Dallas (Drs Timmerman and Choy); Radiation Therapy Oncology Group, Philadelphia, Pennsylvania (Ms Paulus); Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, Pennsylvania (Dr Galvin); Department of Radiation Oncology, Washington University, St Louis, Missouri (Drs Michalski, Straube, and Bradley); Department of Radiation Oncology, Indiana University, Indianapolis (Dr Fakiris); Department of Radiation Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada (Dr Bezjak); Department of Radiation Oncology, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Videtic); Division of Thoracic Surgery, Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire (Dr Johnstone); Department of Radiation Oncology, School of Medicine and Public Health, University of Wisconsin, Madison (Dr Fowler); and Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee (Dr Gore).
Abstract
Context Patients with early stage but medically inoperable lung cancer have a poor rate of primary tumor control (30%-40%) and a high rate of mortality (3-year survival, 20%-35%) with current management.
Objective To evaluate the toxicity and efficacy of stereotactic body radiation therapy in a high-risk population of patients with early stage but medically inoperable lung cancer.
Design, Setting, and Patients Phase 2 North American multicenter study of patients aged 18 years or older with biopsy-proven peripheral T1-T2N0M0 non–small cell tumors (measuring <5 cm in diameter) and medical conditions precluding surgical treatment. The prescription dose was 18 Gy per fraction × 3 fractions (54 Gy total) with entire treatment lasting between 1½ and 2 weeks. The study opened May 26, 2004, and closed October 13, 2006; data were analyzed through August 31, 2009.
Main Outcome Measures The primary end point was 2-year actuarial primary tumor control; secondary end points were disease-free survival (ie, primary tumor, involved lobe, regional, and disseminated recurrence), treatment-related toxicity, and overall survival.
Results A total of 59 patients accrued, of which 55 were evaluable (44 patients with T1 tumors and 11 patients with T2 tumors) with a median follow-up of 34.4 months (range, 4.8-49.9 months). Only 1 patient had a primary tumor failure; the estimated 3-year primary tumor control rate was 97.6% (95% confidence interval [CI], 84.3%-99.7%). Three patients had recurrence within the involved lobe; the 3-year primary tumor and involved lobe (local) control rate was 90.6% (95% CI, 76.0%-96.5%). Two patients experienced regional failure; the local-regional control rate was 87.2% (95% CI, 71.0%-94.7%). Eleven patients experienced disseminated recurrence; the 3-year rate of disseminated failure was 22.1% (95% CI, 12.3%-37.8%). The rates for disease-free survival and overall survival at 3 years were 48.3% (95% CI, 34.4%-60.8%) and 55.8% (95% CI, 41.6%-67.9%), respectively. The median overall survival was 48.1 months (95% CI, 29.6 months to not reached). Protocol-specified treatment-related grade 3 adverse events were reported in 7 patients (12.7%; 95% CI, 9.6%-15.8%); grade 4 adverse events were reported in 2 patients (3.6%; 95% CI, 2.7%-4.5%). No grade 5 adverse events were reported.
Conclusion Patients with inoperable non–small cell lung cancer who received stereotactic body radiation therapy had a survival rate of 55.8% at 3 years, high rates of local tumor control, and moderate treatment-related morbidity.
