Randomized phase II study of weekly paclitaxel with and without carboplatin followed by cyclophosphamide/epirubicin/5-fluorouracil as neoadjuvant chemotherapy for stage II/IIIA breast cancer without HER2 overexpression
Randomized phase II study of weekly paclitaxel with and without carboplatin followed by cyclophosphamide/epirubicin/5-fluorouracil as neoadjuvant chemotherapy for stage II/IIIA breast cancer without HER2 overexpression
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DOI：
10.1007/s10549-014-2947-1
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发表时间：
2014-06-01
影响因子：
3.8
通讯作者：
Fujiwara, Yasuhiro
中科院分区：
文献类型：
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作者：
Ando, Masashi;Yamauchi, Hideko;Fujiwara, Yasuhiro
在HER 2阴性乳腺癌的新辅助化疗中添加卡铂可能会提高病理完全缓解（pCR）率。我们评估了卡铂和每周紫杉醇（wPTX），随后环磷酰胺，表阿霉素和5-氟尿嘧啶（CEF）作为HER 2阴性乳腺癌新辅助化疗的疗效和安全性。II/IIIA期HER 2阴性乳腺癌患者被随机分配至术前接受CP-CEF（4个3周周期的卡铂[曲线下面积5 mg/mL/min，第1天]和wPTX [80 mg/m2（2），第1，8，15]，然后是4个3周周期的CEF [500/100/500 mg/m2]或P-CEF（4个周期的wPTX，然后是4个周期的CEF）。主要目的是pCR率。在181例合格患者中，89例随机分配至CP-CEF，92例分配至P-CEF。每组各有2例患者拒绝接受新辅助化疗。总体而言，CP-CEF中的88例患者和P-CEF中的91例患者可评估疗效和安全性。CP-CEF的pCR率显著高于P-CEF（31.8% vs. 17.6%，单侧P = 0.01）。在三阴性乳腺癌患者中，CP-CEF的pCR率显著高于P-CEF [61.2（23/37）vs. 26.3%（10/38），P = 0.003]。在CP-CEF中观察到的3-4级中性粒细胞减少症的发生率高于P-CEF（65.9% vs. 38.5%）。对于HER 2阴性乳腺癌，在新辅助wPTX中添加卡铂，然后进行CEF，可提高pCR率并加重血液毒性。
Addition of carboplatin to neoadjuvant chemotherapy in HER2-negative breast cancer may improve pathological complete response (pCR) rates. We evaluated the efficacy and safety of carboplatin and weekly paclitaxel (wPTX) followed by cyclophosphamide, epirubicin, and 5-fluorouracil (CEF) as neoadjuvant chemotherapy for HER2-negative breast cancer. Patients with stage II/IIIA HER2-negative breast cancer were randomly assigned to preoperatively receive CP-CEF (four 3-week cycles of carboplatin [area under the curve 5 mg/mL/min, day 1] and wPTX [80 mg/m(2), day 1, 8, 15] followed by four 3-week cycles of CEF [500/100/500 mg/m(2)] or P-CEF (four cycles of wPTX followed by four cycles of CEF). The primary objective was pCR rate. Of 181 eligible patients, 89 were randomly assigned to the CP-CEF and 92 to the P-CEF. Two patients in each arm refused to receive neoadjuvant chemotherapy. Overall 88 patients in the CP-CEF and 91 patients in the P-CEF were assessable for efficacy and safety. The pCR rate in the CP-CEF was significantly higher than that in the P-CEF (31.8 vs. 17.6 %, one-sided P = 0.01). Among patients with triple-negative breast cancer, the pCR rate in the CP-CEF was significantly higher than that in the P-CEF [61.2 (23/37) vs. 26.3 % (10/38), P = 0.003]. Grade 3-4 neutropenia was observed in the CP-CEF more frequently than in the P-CEF (65.9 vs. 38.5 %). Adding carboplatin to neoadjuvant wPTX followed by CEF for HER2-negative breast cancer improved the pCR rate and exacerbated hematotoxicity.