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Phase II trial of three-dimensional conformal radiation therapy for stage I non-small cell lung cancer (NSCLC) in elderly patients.

7230 Background: Conventional aggressive treatments for lung cancer are intolerable for the elderly patients, even in case of early stage disease, because many elderly patients have higher mortality and morbidity rates due to coexisting medical complications such as cardiovascular disease and chronic pulmonary disease. Recently, three-dimensional conformal radiation therapy (3D-CRT) has been performed to treat stage I non-small cell lung cancers (NSCLC), providing high dose of radiation to the tumors without increasing the dose to the surrounding normal lung tissue, which might improve curability without severe toxicities in elderly patients. Thus, we designed a phase II trial to evaluate the effectiveness of 3D-CRT for stage I NSCLC in elderly patients.


METHODS
Eligibility criteria was as follows: stage I pathologically proven NSCLC, age ≥ 70 years, a performance status (PS) of 0-3(ECOG), no limitations of respiratory status, V20 ≤ 20 %. Radiation therapy was planned with 6 MV X-ray, non-coplanar static 3D-CRT method. All patients were given 60 Gy or more in 3-4 Gy/ fraction.


RESULTS
Eighteen patients were registered in this trial between September 1999 and December 2002. Median age was 80.5 years (range, 70-87). As for T-stage, T1 was 13 and T2 was 5. As for PS, 0 was 1, 1 was 11, 2 was 4 and 3 was 2. Median follow-up time was 16 months (range, 4-41), median total dose was 66 Gy (range, 60-75), and median overall treatment time was 30 days (range, 25-38). One- and three-year local control rates were 92.9 % and 92.9 %, respectively. One- and three-year overall survival rates were 100 % and 69.2 %, respectively. Stratified by PS, 3-year local control rate of PS0-1 was 100 %, and that of PS2-3 was 75 %. Three-year overall survival rate of PS0-1 was 88.9 %, and that of PS2-3 was 50 %. As for toxicity, only two patients experienced grade 2 radiation toxicity of the lungs and all of the other events categorized into grade 0 or 1 (assessed by NCI-CTC criteria).


CONCLUSIONS
This phase II trial demonstrates that 3D-CRT for stage I NSCLC in elderly patients was considered to be one of the most promising treatment methods, especially in case of good performance status. No significant financial relationships to disclose.