三阴性乳腺癌：顺铂优于吉西他滨

　　2019年3月5日，英国《自然》旗下《科学报告》在线发表复旦大学附属肿瘤医院的两项研究合并分析报告，比较了白蛋白紫杉醇＋顺铂与白蛋白紫杉醇＋吉西他滨治疗转移性乳腺癌患者的有效性和安全性。

　　分析数据来自两项单中心单组非随机小样本II期研究：

• NCT01149798（BR2010-02）2010年6月～2011年5月入组转移性乳腺癌患者73例（其中肝转移27例、多处转移58例、既往至少二线化疗37例、三阴性乳腺癌16例）每28天的第1、8、15天接受白蛋白紫杉醇125mg/m²、第1天接受顺铂75mg/m²

• NCT01550848（BR2011-07）2012年1月～2014年7月入组转移性乳腺癌患者84例（其中肝转移48例、多处转移78例、既往至少二线化疗25例、三阴性乳腺癌12例）每28天的第1、8、15天接受白蛋白紫杉醇125mg/m²＋吉西他滨800mg/m²

　　研究终点为这些方案的总缓解率、无进展生存、总生存、安全性。

　　结果，白蛋白紫杉醇＋顺铂与白蛋白紫杉醇＋吉西他滨相比：

• 总缓解率：67.1%比52.4%（比值比：1.485，95%置信区间：0.762～2.985）

• 中位随访时间：26.3比23.3个月

• 中位无进展生存：9.8比8.1个月（95%置信区间：8.1～11.6、6.8～9.4，未分层风险比：0.769，95%置信区间：0.541～1.092，P=0.142）

• 中位总生存：26.9比25.5个月（95%置信区间：22.4～31.4、19.3～31.4，未分层风险比：0.686，95%置信区间：0.426～1.104，P=0.120）

　　不过，对于三阴性乳腺癌患者，白蛋白紫杉醇＋顺铂（16例）与白蛋白紫杉醇＋吉西他滨（12例）相比，复发或死亡风险显著减少69.2%（无进展生存风险比：0.308，95%置信区间：0.129～0.732，P=0.008）。

　　白蛋白紫杉醇＋顺铂与白蛋白紫杉醇＋吉西他滨相比，不良事件发生率较高，除了水肿和肌肉疼痛。

　　因此，根据该两项研究合并分析结果，对于转移性乳腺癌患者，两种方案均有显著效果，并且耐受性良好。不过，对于三阴性乳腺癌患者，白蛋白紫杉醇＋顺铂与白蛋白紫杉醇＋吉西他滨相比，无进展生存时间较长、不良事件较多。白蛋白紫杉醇＋顺铂可能值得被推荐用于转移性三阴性乳腺癌，而白蛋白紫杉醇＋吉西他滨可能是其他亚型转移性乳腺癌患者的较好选择，故有必要开展多中心大样本随机双盲对照研究进行验证。

Sci Rep. 2019 Mar 5. [Epub ahead of print]

Cisplatin shows greater efficacy than gemcitabine when combined with nab-paclitaxel in metastatic triple-negative breast cancer.

Yi Li, Yannan Zhao, Chengcheng Gong, Yizhao Xie, Xichun Hu, Jian Zhang, Leiping Wang, Sheng Zhang, Jun Cao, Zhonghua Tao, Biyun Wang.

Fudan University Shanghai Cancer Center, Shanghai Medical College, Fudan University, Shanghai, China.

Our study aimed to compare the efficacy and safety of nab-paclitaxel plus cisplatin (AP) with nab-paclitaxel plus gemcitabine (AG) in patients with metastatic breast cancer (MBC). We collected data from two single-arm, phase II MBC studies. In NCT01149798, seventy-three MBC patients received 125mg/m² nab-paclitaxel on days 1, 8 and 15 followed by 75mg/m² cisplatin on day 1 of a 28-day cycle. In NCT01550848, eighty-four MBC patients received 125mg/m² nab-paclitaxel and 800mg/m² gemcitabine on days 1, 8, and 15 of a 28-day cycle. The endpoints were the overall response rate (ORR), progression-free survival (PFS), overall survival (OS) and safety profiles of these regimens. Among the 157 patients included, the ORR were 67.1% and 52.4% for the AP and AG arms, respectively (odds ratio [OR]=0.246; hazard ratio [HR]=1.485; 95% confidence interval [CI], 0.762-2.985). After median follow-up periods of 26.3 and 23.3 months in the AP and AG arms, the median PFS were 9.8 months (95%CI, 8.1-11.6) and 8.1 months (95%CI, 6.8-9.4), respectively, while the median OS were 26.9 months (95%CI, 22.4-31.4) and 25.5 months (95%CI, 19.3-31.4), respectively. Neither PFS nor OS adjusted for the number of metastases, occurrence of liver metastasis and chemotherapeutic lines differed significantly between the two arms (PFS:HR=0.769; 95%CI, 0.541-1.092; p=0.142; OS:HR=0.686; 95%CI, 0.426-1.104; p=0.120). However, PFS was significantly better with AP than with AG in metastatic triple-negative breast cancer (mTNBC) patients (HR=0.308; 95%CI, 0.129-0.732; p=0.008). Adverse events were more common with AP than with AG, except for edema and myalgia. Both regimens showed substantial efficacy and were tolerated well in MBC patients. mTNBC who received AP rather than AG showed longer PFS. However, adverse events were more common with AP. Thus, AP may be worth recommending to mTNBC, while AG may be a better alternative for MBC patients with other subtypes.

DOI: 10.1038/s41598-019-39314-y

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