Phase II Study: The Outcome of Hypofractionated Involved-Field Radiation Therapy With Concurrent Chemotherapy for the Treatment of Locally Advanced Non-small Cell Lung Cancer.

Abstract

This phase II study aimed to evaluate the efficacy and safety of hypofractionated involved-field radiation therapy (HypoFx-IFRT) in 2.5 Gy fractions and concurrent chemotherapy for locally advanced stage IIIA and B nonsmall cell lung cancer (LA-NSCLC) without prolonging treatment delivery time beyond 6 weeks. We analyzed the overall survival (OS), progression-free survival, and safety of the treatment. This prospective, single center, single-arm trial was initiated in 2010. All LA-NSCLC patients were treated with HypoFx-IFRT using 3-dimensional conformal radiation therapy. The median total dose of HypoFx-IFRT was 67.5 Gy (range, 60-70). From December 2010 to October 2016, 36 patients were ultimately enrolled and evaluated. The trial closed early owing to slow accrual. The median follow-up duration was 50 months in all patients and 65 months in surviving patients. The 1-, 3-, and 5-year OS rates were 88.9% (95% confidence interval [CI], 78.6%-99.2%), 61.1% (95% CI, 45.2%-77.0%), and 54.1% (95% CI, 37.3%-70.9%), respectively. The median time for OS was not reached. The median time for progression-free survival was 10.7 months. The incidence rates of grade 3 radiation pneumonitis, esophagitis and esophageal stenosis were 8.3%, 2.8%, and 2.8%, respectively, and no acute or late toxicities of grade 4 or 5 were observed. This study indicated that HypoFx-IFRT with concurrent chemotherapy yielded an acceptable safety profile and might be beneficial in the survival outcomes of patients with LA-NSCLC.