Phase 2 study of high-dose proton therapy with concurrent chemotherapy for unresectable XXXX .

@entity1 @entity137 @entity66 @entity55 @entity5 @entity3003 @entity2910 @entity1149 @entity1311 @entity3 @entity1909
BACKGROUND: The authors sought to improve the @entity137 of conventional concurrent chemoradiation therapy for @entity5 ( @entity1149 ) by using proton-beam therapy to escalate the radiation dose to the @entity5 . They report early results of a phase 2 study of high-dose proton therapy and concurrent chemotherapy in terms of @entity137 , failure patterns, and survival. METHODS: Forty-four @entity1 with @entity5 were treated with 74 grays (radiobiologic equivalent) proton therapy with weekly @entity3003 (area under the curve, 2 U) and @entity1311 (50 mg/m(2)). Disease was staged with positron emission tomography/computed tomography (CT), and treatments were simulated with 4-dimensional (4D) CT to account for @entity5 motion. Protons were delivered as passively scattered beams, and treatment simulation was repeated during the treatment process to determine the need for adaptive replanning. RESULTS: Median follow-up time was 19.7 months (range, 6.1-44.4 months), and median overall survival time was 29.4 months. No @entity1 experienced grade 4 or 5 proton-related adverse events. The most common nonhematologic grade 3 @entity137 were @entity1909 (n = 5), @entity2910 (n = 5), and @entity55 (n = 1). Nine (20.5%) @entity1 experienced @entity66 recurrence, but only 4 (9.1%) had isolated local failure. Four (9.1%) @entity1 had regional lymph node recurrence, but only 1 (2.3%) had isolated regional recurrence. Nineteen (43.2%) @entity1 developed distant @entity3 . The overall survival and progression-free survival rates were 86% and 63% at 1 year. CONCLUSIONS: Concurrent high-dose proton therapy and chemotherapy are well tolerated, and the median survival time of 29.4 months is encouraging for unresectable @entity5 .
