Abstract
BackgroundThe purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5 Gy in 10 fractions in postmastectomy patients.MethodsFrom March 2014 to December 2015, 85 patients with locally advanced breast cancer were eligible to participate in this study with a schedule of 36.5 Gy in 10 fractions. Intensity-modulated radiation therapy (IMRT) was delivered to the chest wall with or without the supraclavicular region. The primary endpoint was radiation-related toxicities. The secondary endpoints were locoregional failure-free survival (LRFFS), disease-free survival (DFS) and overall survival (OS). And the outcomes were compared with our retrospective study of 72 patients with 42.5 Gy in 16 fractions.ResultsThe median follow-up was 69.0 (range 66.5-71.5) months in the 36.5 Gy group and 93.0 (range 91.9-94.1) months in the 42.5 Gy group, respectively. Radiation-related toxicities were mainly grade 1, although a few patients had grade 2 plexopathy (1.2%) and acute skin toxicity (1.2%) in the 36.5 Gy group, and grade 2 acute skin toxicity (5.6%) and lymphedema (4.2%) in the 42.5 Gy group. There were no significant differences between the groups in acute and late toxicities. For all the patients, the 5-year LRFFS, DFS and OS were 97.7 and 100.0%, 93.1 and 90.3%, 98.8 and 97.2%, respectively, without significant differences between the groups.ConclusionPostmastectomy HFRT with a schedule of 36.5 Gy in 10 fractions was feasible, with mild toxicities and excellent 5-year clinical outcome.Trial registrationTrial registration number: ChiCTR-ONRC-14004391.Date of registration: 9/3/2014.
Highlights
The purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5 Gy in 10 fractions in postmastectomy patients
There was no significant difference between the groups in the incidence of late toxicities
Clinical outcomes At the time of last follow-up, one patient in the 36.5Gy group developed regional recurrence, while no locoregional recurrence was detected in the 42.5Gy group
Summary
The purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5 Gy in 10 fractions in postmastectomy patients. Conventionally fractionated radiotherapy (CFRT) typically delivers 50Gy in 25 fractions of 2Gy over 5 weeks. Postmastectomy HFRT delivery has been limited because of the lack of high-level evidence, data from a few published studies indicate that moderate HFRT seems feasible to deliver with an efficacy comparable to that of CFRT, for example, 43.5Gy in 15 fractions [8], 36.63Gy in 11 fractions [9], 23Gy in 4 fractions [10], and 40Gy in 15 fractions, 26 or 27Gy in 5 fractions [11]. We retrospectively analysed the data of our previous study on HFRT with 42.5Gy in 16 fractions as the historical control to confirm the feasibility of the hypofractionation regimen with 10 fractions
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