局部晚期三阴性乳腺癌新辅助化疗后的病理学完全缓解和无复发生存：卡铂＋紫杉醇优于表柔比星＋紫杉醇

　　2016年7月13日，美国《肿瘤标靶》在线发表中国医学科学院北京协和医学院附属肿瘤医院和福建省肿瘤医院张频、王翔、李青、袁芃、王佳玉、郑山、蔡锐刚、马飞、樊英、徐兵河等学者的随机Ⅱ期研究报告，发现局部晚期三阴性乳腺癌新辅助化疗后的病理学完全缓解和无复发生存：卡铂＋紫杉醇＞表柔比星＋紫杉醇。

　　三阴性乳腺癌的新辅助疗法尚无标准化疗方案。该研究比较了卡铂＋紫杉醇与三阴性乳腺癌新辅助化疗常用的表柔比星＋紫杉醇。

　　91例中位年龄47岁的II/III期三阴性乳腺癌患者（未绝经者占65%）被随机分入紫杉醇＋卡铂组（47例）和表柔比星＋紫杉醇组（44例），分别接受每3周紫杉醇（175mg/m²，第1天）＋卡铂（曲线下面积=5，第2天）或表柔比星（75mg/m²第1天）＋紫杉醇（175mg/m²，第1天）新辅助化疗4～6个周期。主要观察终点为病理学完全缓解率，次要观察终点包括无复发生存、总生存、安全性。

　　经过中位随访55.0个月，结果发现，紫杉醇＋卡铂组与表柔比星＋紫杉醇组相比，客观缓解率相似（89.4%比79.5%，P=0.195），病理学完全缓解率（38.6%比14.0%，P=0.014）和5年无复发生存率（77.6%和56.2%，P=0.043）显著提高，总生存未见显著差异（P=0.350），不良事件相似，除了较多血小板减少见于紫杉醇＋卡铂组（P=0.001）。

　　因此，该研究提示，作为三阴性乳腺癌的新辅助化疗方案，对于改善病理学完全缓解率和无复发生存而言，紫杉醇＋卡铂优于表柔比星＋紫杉醇。进一步Ⅲ期研究已经开始。

Oncotarget. 2016 Jul 14. [Epub ahead of print]

Better pathologic complete response and relapse-free survival after carboplatin plus paclitaxel compared with epirubicin plus paclitaxel as neoadjuvant chemotherapy for locally advanced triple-negative breast cancer: a randomized phase 2 trial.

Zhang P, Yin Y, Mo H, Zhang B, Wang X, Li Q, Yuan P, Wang J, Zheng S, Cai R, Ma F, Fan Y, Xu B.

Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Fujian Provincial Cancer Hospital, Fuzhou, China.

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.

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.

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).

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.

KEYWORDS: breast cancer; carboplatin; neoadjuvant chemotherapy; paclitaxel; triple negative

PMID: 27447966

DOI: 10.18632/oncotarget.10607