concurrent chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). We performed a prospective trial examining dose-painted intensity-modulated radiotherapy (IMRT) as a strategy to improve the efficacy and safety of chemoradiotherapy for NSCLC. Materials/Methods: Patients with inoperable stage IIB-III NSCLC and ECOG performance status 0-2 who underwent staging PET were eligible for this single-arm study. All patients were treated with a 25-fraction course of dose-painted IMRT. Tumors or lymph nodes with MTV exceeding 25 cc were deemed "high risk" and received 65 Gy. Lesions smaller than 25 cc were considered "low risk" and treated with 57 Gy until November 2014, when the study was amended to reduce the prescription dose for such lesions to 52.5 Gy. All patients received concurrent weekly carboplatin (AUC 2) and paclitaxel (45 mg/m 2) during radiotherapy, and consolidation chemotherapy with the same agents was optional. Patients underwent post-treatment PET 12-16 weeks after completion of IMRT. The primary study endpoint was the absence of high residual metabolic activity (maximum SUV > 6) in the lungs and regional lymph nodes on post-treatment PET. Results: Thirty-five enrolled subjects with 116 hypermetabolic tumors and lymph nodes were eligible for analysis. The primary endpoint was met for 24/30 patients (80%) who underwent post-treatment PET, satisfying our pre-specified efficacy objective. Median follow-up duration for living patients is 17.0 months. Median survival time has not been reached. One and two-year actuarial rates of overall survival are 71% and 51%, respectively. Twenty-three patients (66%) have developed disease progression. Progression in a tumor or lymph node targeted with radiotherapy was observed in five patients at the time of first disease progression. Treating progression in other sites and death without progression as competing risks, the two-year cumulative incidence rate of local disease progression in 25 high-risk lesions is 9%. The two-year cumulative incidence rate of local disease progression in the 91 low-risk lesions that were treated with a low radiotherapy dose is 3%. Conclusion: Dose-painted IMRT based on pre-treatment PET metrics with concurrent chemotherapy for locally advanced NSCLC yields high rates of metabolic response, local disease control, and overall survival. This strategy should be pursued to maximize the therapeutic ratio of radiotherapy in this setting.
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