ASCO 中国之声：袁芃教授：三阴乳腺癌辅助化疗的可能替代方案

Abstract:

Background: Todetermine optimal adjuvant chemotherapy for early triple negative breast cancerdepends on efficacy and toxicity. We sought to examine if six cycles TP isnon-inferior to standard four cylces EC followed by four cycles T but withshorter treatment duration and reduced toxicity. Methods: Ptswith operable triple negative breast cancer were enrolled and randomized (1:1)to receive either six cycles TP (docetaxel:75 mg/m2; carboplatin:AUC = 5, day 1) or four cycles EC(epirubicin: 90 mg/m2;cyclophosphamide :600mg/m2 , day 1) followed by four cycles T(docetaxel : 100mg/m2 , day 1). Both regimens were repeatedevery three weeks. Randomization was stratified by lymph node status. Theprimary end point was median DFS. A sample size of 500 patients were requiredto detect the difference (a = 0.05, β = 80%). Results: FromJune 2010 to Jan 2015, 298 pts were enrolled in the study including 152 pts inEC-T arm and 146 pts in ET arm. Patients’ characteristics were well balancedbetween two arms. In total, 60.5% and 69.9% of patients were node-negative inEC-T arm and TP arm, respectively. In addition, the proportion of patientsdiagnosed as TNM Stage I, II and III was 33.6%, 55.3% and 11.2% in EC-T arm,whereas it accounted for 39.0%, 54.1% and 6.2% in TP arm. After median 39.5months followed-up, 32 events were observed (16 in EC-T, 16 in TP). The 5y DFSwas 83.8% in EC-T arm and 80.0% in TP arm (log-rank p = 0.961, HR 0.983, 95%CI= 0.490—1.970). Both regimens were well tolerated. The most frequent hematologicaltoxicity was neutropenia (Grade 3/4: 67.8% in EC-T vs. 39.0% in EP). The mostfrequent non- hematological toxicity were anorexia (All Grades: 80.3% in EC-Tvs. 62.3% in EP), liver dysfunction (All Grades: 32.2% in EC-T vs. 24.0% inEP), and neurosensory difficulties (All Grades: 26.3% in EC-T vs. 15.8% inTP). Conclusions: Benefit from six cycles TPwas similar as from four cycles EC followed by four cycles T, with lowertoxicity observed in patients with operable triple negative breast cancer.Clinical trial information: NCT01150513