Randomized controlled trial of late-course concurrent versus sequential chemoradiotherapy after mastectomy and axillary surgery in locally advanced breast cancer

Abstract

Background:Concurrent chemoradiotherapy could increase the local control rate in patients with high recurrence risk after breast-conserving surgery, but the effect of concurrent chemoradiotherapy after mastectomy and axillary dissection is not clear. The aim of the study was to compare the effects of late-course concurrent chemoradiotherapy (CCRT) versus sequential therapy (SCRT) after mastectomy and axillary surgery in locally advanced breast cancer.Methods:This was a randomized controlled trial of 155 patients with stage pT3–4p N1–3c M0 or pAnyT pN2–3c M0 breast cancer undergoing 5-fluorouracil+epirubicin+cyclophosphamide followed by docetaxel (FEC-D) chemotherapy after mastectomy and axillary dissection. Patients were randomized to the CCRT group (intensity-modulated radiation therapy was performed concurrently with docetaxel) or to the SCRT group (radiotherapy after chemotherapy). Recurrences, adverse reactions, and short-term effects were observed.Results:All the patients completed the planned therapy. The median follow-up was 39 (range, 16–62) months. Compared with SCRT, the 3-year local-regional recurrence-free survival (LRFS) in the CCRT group was improved (81.8% vs 92.3%, P = .046). There was no significant difference in 3-year disease-free survival (DFS) and overall survival (OS). In the pT3–4 pN1–3 cM0 subgroup, the 3-year local recurrence-free survival and DFS were significantly improved in the CCRT group (69.4% vs 88.2%, P = .036; and 41.7% vs 72.6%, P = .049, respectively). No significant difference was observed adverse reactions between the 2 groups.Conclusion:LRFS of patients with locally advanced invasive breast cancer after mastectomy and axillary surgery was better with CCRT than with SCRT and with similar profiles of adverse reactions. The DFS of patients staged pT3–4 pN1–3 cM0 was also improved.

Efficacy and Safety of Concurrent Chemoradiotherapy with Docetaxel for Locally Advanced Breast Carcinoma after Modified Radical Mastectomy

“…Examination of TNM stage in consecutive group therapy showed that 30 patient in the third stage and 22 patient in the simultaneous group therapy are in this stage and considering that most patients are in these stages, which is consistent with the results of other studies in which most patients are in these stages (15). This lack of difference in TNM stage is also consistent with the study of Lu, Y et al (2017) who were not significantly different in TNM stage (16).…”

CONcurrent ChEmotherapy and RadioTherapy in adjuvant treatment of breast cancer (CONCERT): a phase 2 study

“…The occurrence of grade 1-2 radiation skin reactions was similar in the weekly and 3-weekly paclitaxel groups (89.7% and 88.3%, p = 0.803). It also showed cardio-pulmonary safety [18,19]. Cardiac troponin T is a well-established biomarker of cardiac damage in myocardial infarction due to ischaemic heart disease.…”

“…There was no difference in OS in node positive and negative cohorts. In a recent small randomised trial by Lu et al [ 19 ] the 3-year DFS and OS were reported to be 76.9% and 64.9% for node positive, and 87.2% and 81.8% for node negative cohorts respectively, but without significant difference. They treated all patients with IMRT and reported no grade 3–4 radiation toxicity.…”

“…The occurrence of grade 1–2 radiation skin reactions was similar in the weekly and 3-weekly paclitaxel groups (89.7% and 88.3%, p = 0.803). It also showed cardio-pulmonary safety [ 18 , 19 ].…”