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Excessive Toxicity When Treating Central Tumors in a Phase II Study of Stereotactic Body Radiation Therapy for Medically Inoperable Early-Stage Lung Cancer

Robert Timmerman, Ronald McGarry, Constantin Yiannoutsos, Lech Papiez, Kathy Tudor, Jill DeLuca, Marvene Ewing, Ramzi Abdulrahman, Colleen DesRosiers, Mark Williams, James Fletcher

From the Department of Radiation Oncology, The University of Texas Southwestern Medical Center, Dallas, TX; and the Department of Radiation Oncology, Department of Medicine (Biostatistics), Division of Pulmonology, and Department of Radiology (Nuclear Medicine), Indiana University School of Medicine, Indianapolis, IN

Address reprint requests to Robert Timmerman, MD, Department of Radiation Oncology, The University of Texas Southwestern Medical Center, 5801 Forest Park Rd, Dallas, TX 75390-9183; email: robert.timmerman{at}utsouthwestern.edu

PURPOSE: Surgical resection is standard therapy in stage I non–small-cell lung cancer (NSCLC); however, many patients are inoperable due to comorbid diseases. Building on a previously reported phase I trial, we carried out a prospective phase II trial using stereotactic body radiation therapy (SBRT) in this population.

PATIENTS AND METHODS: Eligible patients included clinically staged T1 or T2 ( 7 cm), N0, M0, biopsy-confirmed NSCLC. All patients had comorbid medical problems that precluded lobectomy. SBRT treatment dose was 60 to 66 Gy total in three fractions during 1 to 2 weeks.

RESULTS: All 70 patients enrolled completed therapy as planned and median follow-up was 17.5 months. The 3-month major response rate was 60%. Kaplan-Meier local control at 2 years was 95%. Altogether, 28 patients have died as a result of cancer (n = 5), treatment (n = 6), or comorbid illnesses (n = 17). Median overall survival was 32.6 months and 2-year overall survival was 54.7%. Grade 3 to 5 toxicity occurred in a total of 14 patients. Among patients experiencing toxicity, the median time to observation was 10.5 months. Patients treated for tumors in the peripheral lung had 2-year freedom from severe toxicity of 83% compared with only 54% for patients with central tumors.

CONCLUSION: High rates of local control are achieved with this SBRT regimen in medically inoperable patients with stage I NSCLC. Both local recurrence and toxicity occur late after this treatment. This regimen should not be used for patients with tumors near the central airways due to excessive toxicity.

Supported by Grant No. 5R21CA097721-02 from the United States National Institutes of Health.

Presented in an oral format at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), Denver, CO, October 16-20, 2005.

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

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