Abstract
BackgroundIn this phase II study, we evaluated the efficacy, toxicity, and patterns of failure of elective lymph node irradiation (ENI) late course accelerated hyper-fractionated radiotherapy (LCAHRT) concurrently with cisplatin-based chemotherapy (CHT) for esophageal squamous cell carcinoma (ESCC).MethodsPatients with clinical stage II-IVa (T1-4N0-1M0 or M1a) ESCC were enrolled between 2004 and 2011. Radiation therapy (RT) comprised two courses: The first course of radiation covered the primary and metastatic regional tumors and high risk lymph nodal regions, given at 2 Gy per fraction for a dose of 40 Gy. In the second course, LCAHRT was delivered to the boost volume twice a day for an additional 19.6 Gy in 7 treatment days, using 1.4 Gy per fraction. Two cycles of CHT were given at the beginning of RT.ResultsThe median age and Karnofsky performance status were 63 years and 80, respectively. The American Joint Committee on Cancer stage was II in 14 (20.6%) patients, III in 32 (47.1%), and IVa in 22 (32.3%). With a median follow-up of 18.5 months, the overall survival at 1-, 3-, 5-year were 75.5%, 46.5%, 22.7% for whole group patients, versus 78.6%, 49.4%, 39.9% for patients with stage II–III. The patterns of first failure from local recurrence, regional failure, and distant metastasis were seen in 20.6%, 17.6%, and 19.1%, respectively. The most frequent acute high-grade (≥ 3) toxicities were esophagitis and leucopenia, occurred in 26.4% and 32.4%.ConclusionsENI LCAHRT concurrently with CHT was appeared to be an effective regimen for ESCC patient with a favorable and tolerated profile. Further observation with longer time and randomized phase III trial is currently underway.Trial registrationChiCTR-TRC-09000568
Highlights
In this phase II study, we evaluated the efficacy, toxicity, and patterns of failure of elective lymph node irradiation (ENI) late course accelerated hyper-fractionated radiotherapy (LCAHRT) concurrently with cisplatin-based chemotherapy (CHT) for esophageal squamous cell carcinoma (ESCC)
Based on the results of the Radiation Therapy Oncology Group (RTOG) phase III intergroup trial 85–01 and 95–04, the standard therapy for patients with localized esophagus carcinoma selected for nonsurgical treatment is radiation therapy (RT) plus concurrent chemotherapy [1,2]
It is postulated theoretically that a shortened irradiation course, still keeping the total radiation dose, or increased dose of radiation delivered in the late course of the treatment would improve local control for esophageal carcinoma by overcoming the deleterious effects of accelerated repopulation
Summary
In this phase II study, we evaluated the efficacy, toxicity, and patterns of failure of elective lymph node irradiation (ENI) late course accelerated hyper-fractionated radiotherapy (LCAHRT) concurrently with cisplatin-based chemotherapy (CHT) for esophageal squamous cell carcinoma (ESCC). In an attempt to improve these results, RTOG 95–04 increased radiation dose from 50.0 Gy to 64.8 Gy, intensification of the radiation dose did not improve local/regional control or survival [2]. It is postulated theoretically that a shortened irradiation course, still keeping the total radiation dose, or increased dose of radiation delivered in the late course of the treatment would improve local control for esophageal carcinoma by overcoming the deleterious effects of accelerated repopulation. Clinical data from China [5] has shown late course accelerated hyperfractionated radiotherapy (LCAHRT) improved the 5-year OS (odds ratio [OR] = 2.93, 95% CI: 2.15–4.00, p < 0.00001) and 5-year local control (OR = 3.96, 95% CI: 2.91–5.38, p < 0.00001) than standard fractionated RT in the localized esophageal carcinoma. Clinical investigation in nasopharyngeal [6,7] and lung carcinoma [8] displayed promising treatment outcome
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