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Hypofractionated radiotherapy in ten fractions for postmastectomy patients: A phase II study compared with another hypofractionation schedule with sixteen fractions

The purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5Gy in 10 fractions in postmastectomy patients. From March 2014 to December 2015, 85 patients with locally advanced breast cancer were eligible to participate in this study with a schedule of 36.5Gy in 10 fractions. | Jiang et al. BMC Cancer 2021 21 1284 https doi.org 10.1186 s12885-021-09032-8 RESEARCH Open Access Hypofractionated radiotherapy in ten fractions for postmastectomy patients a phase II study compared with another hypofractionation schedule with sixteen fractions Huayong Jiang1 2 Lingling Meng2 Huijuan Zhang2 Xiangkun Dai2 Qian Zhang2 Zhongjian Ju2 Wei Yu2 and Lin Ma1 2 Abstract Background 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. Methods From 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. Results The 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. Conclusion Postmastectomy HFRT with a schedule of 36.5 Gy in 10 fractions was feasible with mild toxicities and excellent 5-year clinical outcome. Trial registration Trial registration number ChiCTR- ONRC- 14004 391. Date of .