Dhanraj K M, Dubashi B, Gollapalli S, Kayal S, Cyriac Sunu Lazar
Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.
Department of Radiodiagnosis, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India.
Med Oncol. 2015 Dec;32(12):261. doi: 10.1007/s12032-015-0697-5. Epub 2015 Oct 31.
The aim of the study was to assess and compare the clinical and pathological response and the toxicity profile between neoadjuvant chemotherapy FEC followed by docetaxel versus AC followed by docetaxel in locally advanced breast cancer patients. Between June 2013 and June 2014, 148 patients diagnosed with LABC were randomized into two groups with 74 in each group. Group 1 received AC (adriamycin 60 mg/m(2), cyclophosphamide 600 mg/m(2)) followed by docetaxel 100 mg/m(2) with primary GCSF prophylaxis and group 2 received FEC (5-fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), cyclophosphamide 500 mg/m(2)) followed by docetaxel 75 mg/m(2). MRM/BCS was performed for all patients after NACT and assessed for pathological response. Toxicity profile was assessed according to CTCAE version 4. All baseline parameters were equally matched between the two regimens. 90 % of patients completed NACT and underwent surgery. pCR rates were 31 % in group 1 and 34 % in group 2 without any difference. Any grade of hand-foot syndrome was significantly high in group 1 as compared to group 2. Grade 3 and grade 4 neutropenia and febrile neutropenia were significantly high in group 1 as compared to group 2. Median follow-up was 13.7 months (range, 2.9-25 months). There was no difference in the 2-year PFS between group 1 and group 2 (70.9 vs. 73.8 %, respectively) and OS (87.8 vs. 91.8 %, respectively) in our study population. Chemotherapy with FEC followed by docetaxel can be considered as an optimal neoadjuvant regimen in LABC as compared to AC followed by docetaxel.
本研究的目的是评估和比较局部晚期乳腺癌患者中，新辅助化疗采用氟尿嘧啶-表柔比星-环磷酰胺（FEC）序贯多西他赛与多柔比星-环磷酰胺（AC）序贯多西他赛的临床和病理反应以及毒性特征。2013年6月至2014年6月期间，148例诊断为局部晚期乳腺癌（LABC）的患者被随机分为两组，每组74例。第1组接受AC方案（多柔比星60mg/m²、环磷酰胺600mg/m²），随后接受多西他赛100mg/m²并进行一级粒细胞集落刺激因子（GCSF）预防；第2组接受FEC方案（5-氟尿嘧啶500mg/m²、表柔比星100mg/m²、环磷酰胺500mg/m²），随后接受多西他赛75mg/m²。所有患者在新辅助化疗（NACT）后均接受改良根治性乳房切除术（MRM）/保乳手术（BCS），并评估病理反应。根据美国国立癌症研究所不良事件通用术语标准（CTCAE）第4版评估毒性特征。两种方案之间所有基线参数均匹配。90%的患者完成了新辅助化疗并接受了手术。第1组的病理完全缓解（pCR）率为31%，第2组为34%，无差异。与第2组相比，第1组任何级别的手足综合征发生率显著更高。与第2组相比，第1组3级和4级中性粒细胞减少症以及发热性中性粒细胞减少症的发生率显著更高。中位随访时间为13.7个月（范围2.9 - 25个月）。在我们的研究人群中，第1组和第2组的2年无进展生存期（PFS）（分别为70.9%和73.8%）和总生存期（OS）（分别为87.8%和91.8%）无差异。与AC序贯多西他赛相比，FEC序贯多西他赛化疗可被视为局部晚期乳腺癌的一种最佳新辅助方案。
