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7‐year follow‐up after stereotactic ablative radiotherapy for patients with stage I non–small cell lung cancer: Results of a phase 2 clinical trial
Author(s) -
Sun Bing,
Brooks Eric D.,
Komaki Ritsuko U.,
Liao Zhongxing,
Jeter Melenda D.,
McAleer Mary F.,
Allen Pamela K.,
Balter Peter A.,
Welsh James D.,
O'Reilly Michael S,
Gomez Daniel,
Hahn Stephen M.,
Roth Jack A.,
Mehran Reza J.,
Heymach John V.,
Chang Joe Y.
Publication year - 2017
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.30693
Subject(s) - medicine , sabr volatility model , lung cancer , stage (stratigraphy) , radiation therapy , clinical endpoint , surgery , clinical trial , cancer , radiology , nuclear medicine , randomized controlled trial , volatility (finance) , paleontology , stochastic volatility , financial economics , economics , biology
BACKGROUND The authors evaluated the efficacy, patterns of failure, and toxicity of stereotactic ablative radiotherapy (SABR) for patients with medically inoperable, clinical stage I non–small cell lung cancer (NSCLC) in a prospective clinical trial with 7 years of follow‐up. Clinical staging was performed according to the seventh edition of the American Joint Committee on Cancer TNM staging system. METHODS Eligible patients with histologically confirmed NSCLC of clinical stage I as determined using positron emission tomography staging were treated with SABR (50 grays in 4 fractions). The primary endpoint was progression‐free survival. Patients were followed with computed tomography and/or positron emission tomography/computed tomography every 3 months for the first 2 years, every 6 months for the next 3 years, and then annually thereafter. RESULTS A total of 65 patients were eligible for analysis. The median age of the patients was 71 years, and the median follow‐up was 7.2 years. A total of 18 patients (27.7%) developed disease recurrence at a median of 14.5 months (range, 4.3‐71.5 months) after SABR. Estimated incidences of local, regional, and distant disease recurrence using competing risk analysis were 8.1%, 10.9%, and 11.0%, respectively, at 5 years and 8.1%, 13.6%, and 13.8%, respectively, at 7 years. A second primary lung carcinoma developed in 12 patients (18.5%) at a median of 35 months (range, 5‐67 months) after SABR. Estimated 5‐year and 7‐year progression‐free survival rates were 49.5% and 38.2%, respectively; the corresponding overall survival rates were 55.7% and 47.5%, respectively. Three patients (4.6%) experienced grade 3 treatment‐related adverse events. No patients developed grade 4 or 5 adverse events (toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0]). CONCLUSIONS With long‐term follow‐up, the results of the current prospective study demonstrated outstanding local control and low toxicity after SABR in patients with clinical stage I NSCLC. Regional disease recurrence and distant metastases were the dominant manifestations of failure. Surveillance for second primary lung carcinoma is recommended. Cancer 2017;123:3031–39. © 2017 American Cancer Society .