Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China, 200032.
Sci Rep. 2019 Mar 5;9(1):3563. doi: 10.1038/s41598-019-39314-y.
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 125 mg/m nab-paclitaxel on days 1, 8 and 15 followed by 75 mg/m cisplatin on day 1 of a 28-day cycle. In NCT01550848, eighty-four MBC patients received 125 mg/m nab-paclitaxel and 800 mg/m 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.
我们的研究旨在比较nab-紫杉醇联合顺铂（AP）与nab-紫杉醇联合吉西他滨（AG）在转移性乳腺癌（MBC）患者中的疗效和安全性。我们从两项单臂、II 期 MBC 研究中收集数据。在 NCT01149798 中，73 例 MBC 患者接受 125mg/m2nab-紫杉醇，第 1、8 和 15 天给药，随后在 28 天周期的第 1 天给予 75mg/m2顺铂。在 NCT01550848 中，84 例 MBC 患者接受 125mg/m2nab-紫杉醇和 800mg/m2吉西他滨，第 1、8 和 15 天给药，每 28 天为一个周期。终点是这些方案的总体缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）和安全性特征。在纳入的 157 例患者中，AP 和 AG 组的 ORR 分别为 67.1%和 52.4%（优势比[OR] = 0.246；风险比[HR] = 1.485；95%置信区间[CI]，0.762-2.985）。AP 和 AG 组的中位随访时间分别为 26.3 和 23.3 个月后，中位 PFS 分别为 9.8 个月（95%CI，8.1-11.6）和 8.1 个月（95%CI，6.8-9.4），中位 OS 分别为 26.9 个月（95%CI，22.4-31.4）和 25.5 个月（95%CI，19.3-31.4）。在调整转移灶数量、肝转移发生情况和化疗线数后，两组之间的 PFS 和 OS 均无显著差异（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）。然而，AP 组转移性三阴性乳腺癌（mTNBC）患者的 PFS 明显优于 AG 组（HR = 0.308；95%CI，0.129-0.732；p = 0.008）。AP 组的不良反应比 AG 组更常见，但除外水肿和肌痛。两种方案在 MBC 患者中均显示出显著的疗效且耐受性良好。接受 AP 治疗的 mTNBC 患者 PFS 更长。然而，AP 组的不良反应更为常见。因此，AP 可能值得推荐给 mTNBC 患者，而 AG 可能是其他亚型 MBC 患者的更好选择。
