Zhang Pin, Yin Yi, Mo Hongnan, Zhang Bailin, Wang Xiang, Li Qing, Yuan Peng, Wang Jiayu, Zheng Shan, Cai Ruigang, Ma Fei, Fan Yin, Xu Binghe
Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China.
Oncotarget. 2016 Sep 13;7(37):60647-60656. doi: 10.18632/oncotarget.10607.
BACKGROUND: No standard chemotherapy is used as neoadjuvant therapy in triple negative breast cancer (TNBC). This study has compared carboplatin plus paclitaxel with commonly used epirubicin plus paclitaxel as neoadjuvant chemotherapy (NAC) in TNBC. RESULTS: 91 patients with a median age of 47 years (PC 47 patients, EP 44 patients) were enrolled. 65% of the patients were premenopausal. While the objective response rate was similar in the PC and EP arm (89.4% vs. 79.5%, P = 0.195), the pCR rate in the PC arm was significantly higher (38.6% vs. 14.0%, P = 0.014). The median follow-up time was 55.0 months. 5-year RFS were 77.6% and 56.2%, significantly higher in the PC arm, P = 0.043. No significant difference in OS was observed between the two arms (P = 0.350). Adverse events were similar, except for more thrombocytopenia in the PC arm (P = 0.001). METHODS: Patients with stage II/III TNBC were randomized to receive either paclitaxel (175 mg/m2, day1) plus carboplatin (Area Under the Curve = 5, day2) (PC) or epirubicin (75mg/m2, day1) plus paclitaxel (175 mg/m2, day2) (EP) as NAC every three weeks for 4-6 cycles. The primary endpoint was rate of pathologic complete response (pCR).The secondary endpoints included relapse-free survival (RFS), overall survival (OS) and safety. CONCLUSIONS: This study suggested that the addition of carboplatin to paclitaxel was superior to the regimen of epirubicin plus paclitaxel as NAC for TNBC in terms of improving pCR rate and RFS. Further phase 3 study has already started.
背景:三阴性乳腺癌(TNBC)中尚无标准的化疗方案用于新辅助治疗。本研究比较了卡铂联合紫杉醇与常用的表柔比星联合紫杉醇作为TNBC新辅助化疗(NAC)的疗效。 结果:共纳入91例患者,中位年龄47岁(PC组47例,EP组44例)。65%的患者为绝经前女性。虽然PC组和EP组的客观缓解率相似(89.4%对79.5%,P = 0.195),但PC组的病理完全缓解(pCR)率显著更高(38.6%对14.0%,P = 0.014)。中位随访时间为55.0个月。5年无复发生存率(RFS)分别为77.6%和56.2%,PC组显著更高,P = 0.043。两组总生存期(OS)无显著差异(P = 0.350)。不良事件相似,只是PC组血小板减少更多见(P = 0.001)。 方法:II/III期TNBC患者被随机分为两组,分别接受紫杉醇(175 mg/m²,第1天)联合卡铂(曲线下面积=5,第2天)(PC组)或表柔比星(75mg/m²,第1天)联合紫杉醇(175 mg/m²,第2天)(EP组)作为NAC,每三周一次,共4 - 6个周期。主要终点为病理完全缓解(pCR)率。次要终点包括无复发生存期(RFS)、总生存期(OS)和安全性。 结论:本研究表明,在TNBC新辅助化疗中,紫杉醇联合卡铂在提高pCR率和RFS方面优于表柔比星联合紫杉醇方案。进一步的3期研究已经启动。
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