Chen Shin-Cheh, Chang Hsien-Kun, Lin Yung-Chang, Cheung Yun-Chung, Tsai Chien-Sheng, Leung Wai-Man, Hsueh Swei, Chen Miin-Fu
Department of Surgery, Chang Gung Memorial Hospital, Chang Gung University, College of Medicine, Taoyuan, Taiwan.
Onkologie. 2005 Jun;28(6-7):339-44. doi: 10.1159/000085414. Epub 2005 Jun 2.
Primary systemic therapy (PST) with a combination of epirubicin and paclitaxel achieves high response rates in locally advanced breast cancer (LABC), but considerable toxicity occurs and the patient's compliance is poor. In this open-label phase II trial toxicity of a weekly administration schedule was evaluated.
On days 1 and 8 of each 3-week cycle, 45 patients with non-inflammatory breast cancer received epirubicin (35 mg/m(2), intravenous bolus) followed by paclitaxel (80 mg/m(2) in 500 ml of normal saline infused over 3 h) for 3 cycles. Surgery was done 2 weeks after primary chemotherapy, followed by another 6 cycles of adjuvant CEF (cyclophosphamide 500 mg/m(2), epirubicin 70 mg/m(2), 5-fluorouracil 500 mg/m(2)) chemotherapy.
The median tumor size before and after PST was 6.0 and 2.0 cm, respectively. The clinical response rate was 96%, including 24% complete remission; 5 patients (11%) achieved pathologically complete response (pCR) including 3 patients with carcinoma in situ. Only 5 (11%) patients underwent breast conserving surgery although there were 15 patients suitable. Axillary nodes were negative in 16 (36%) of the 45 patients. Febrile neutropenia was found in 1 patient. There was no severe cardiac toxicity or serious adverse events.
PST with weekly epirubicin and paclitaxel was an effective and well-tolerated combination for LABC, although only few patients underwent breast conserving surgery.
表柔比星与紫杉醇联合进行的初始全身治疗（PST）在局部晚期乳腺癌（LABC）中可实现较高的缓解率，但会出现相当大的毒性，且患者的依从性较差。在这项开放标签的II期试验中，对每周给药方案的毒性进行了评估。
在每3周周期的第1天和第8天，45例非炎性乳腺癌患者接受表柔比星（35mg/m²，静脉推注），随后接受紫杉醇（80mg/m²加入500ml生理盐水中，在3小时内输注），共3个周期。在原发性化疗后2周进行手术，随后进行另外6个周期的辅助性CEF（环磷酰胺500mg/m²、表柔比星70mg/m²、5-氟尿嘧啶500mg/m²）化疗。
PST前后肿瘤大小的中位数分别为6.0cm和2.0cm。临床缓解率为96%，包括24%的完全缓解；5例患者（11%）达到病理完全缓解（pCR），其中包括3例原位癌患者。尽管有15例患者适合保乳手术，但只有5例（11%）患者接受了保乳手术。45例患者中有16例（36%）腋窝淋巴结为阴性。1例患者出现发热性中性粒细胞减少。未发现严重心脏毒性或严重不良事件。
对于LABC，每周使用表柔比星和紫杉醇进行PST是一种有效且耐受性良好的联合治疗方案，尽管只有少数患者接受了保乳手术。
