By Timothy A. O'Leary
GENEVA -- April 29, 2008 -- The nonfatal toxicity that sometimes accompanies stereotactic body radiation therapy (SBRT) appears to be an acceptable adverse effect of the treatment in patients with early-stage non-small-cell lung cancer (NSCLC), researchers reported here at the 1st European Lung Cancer Conference (ELCC).
Robert D. Timmerman, MD, Radiation Oncologist, University of Texas Southwestern Medical Center, Dallas, Texas, and collaborators in the Radiation Therapy Oncology Group 0236 protocol studied a cohort of 59 patients between May 2004 and October 2006. Subjects in this phase 3 trial had inoperable NSCLC and had no other planned therapy.
The prescribed radiation dose for each patient was 20 Gy to be administered in 3 fractions for a total dose of 60 Gy. A subsequent analysis showed the actual dose to be 54 Gy total.
The median age of patients was 72 years. Most were female.
Compliance was "extremely good," Dr. Timmerman said in a presentation on April 24, adding that only 3 patients were declared ineligible because of failure to comply with the treatment regimen.
There were criteria for stopping the treatment in case of excess toxicity. None of these criteria were met in the study. No patient died as a result of treatment.
With median follow-up at 14.7 months, there was 1 case of grade 4 toxicity (2% of the total cohort) and 7 cases of grade 3 toxicity (13%).
Of the 8 patients with grades 3 or 4 toxicity, 3 reported decreased pulmonary function, 1 had cough/dyspnea, 1 had hypoxia, 1 had pneumonitis, 1 had cough/forced expiratory volume, and 1 had pneumothorax.
There were 2 cases of grade 3 dermatitis, 1 grade 3 syncope, 1 grade 3 rib fracture, and 1 grade 3 fatigue reported as related to protocol treatment.
"Using an ablative total dose of 54 Gy in 3 fractions appears to be associated with acceptable treatment-related morbidity in a population of frail patients with medically inoperable early stage non-small-cell lung cancer with peripheral lesions," Dr. Timmerman said.
[Presentation title: Interim Toxicity Analysis of RTOG 0236 Using Stereotactic Body Radiation Therapy to Treat Medically Inoperable Early Stage Lung Cancer Patients. Abstract 250O]
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