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一项 II 期研究的最终结果,该研究评估了nab-紫杉醇、贝伐珠单抗和吉西他滨作为 HER2 阴性转移性乳腺癌一线治疗的疗效。

Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer.

机构信息

Florida Cancer Specialists and Research Institute, Gainesville, FL, USA.

出版信息

Breast Cancer Res Treat. 2010 Sep;123(2):427-35. doi: 10.1007/s10549-010-1002-0. Epub 2010 Jun 29.

Abstract

In order to examine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-P) in combination with bevacizumab (B) and gemcitabine (G) for the first-line treatment of patients with HER2-negative metastatic breast cancer (MBC). In this single-center, open-label phase II trial, patients with HER2-negative MBC received gemcitabine 1500 mg/m(2), nab-paclitaxel 150 mg/m(2), and bevacizumab 10 mg/kg (each administered intravenously) on days 1 and 15 of a 28-day cycle. The primary end point was progression free survival (PFS); secondary end points were overall response rate (ORR), complete (CR) and partial (PR) response rates, clinical benefit (ORR + stable disease), overall survival (OS), and safety. Thirty patients were enrolled. One patient was ineligible and was not included in analysis. Median PFS was 10.4 months (95% CI: 5.6-15.2 months). ORR was 75.9%, comprising eight (27.6%) CRs and 14 (48.3%) PRs; five patients had stable disease (SD) and two patients (6.9%) had progressive disease (PD) as their best response. The clinical benefit rate was 93.1% (27/29) in the overall group and 84.6% in the triple-negative cohort (11/13). The 18-month survival rate was 77.2% (95% CI: 51.1-90.5%). Eight (27.6%) patients experienced grade 3 or 4 toxicity: grade 4 neutropenic fever (n = 1) and grade 3 infection (n = 6), leukopenia, thrombocytopenia, peripheral neuropathy, seizure, shortness of breath, hematuria, and cardiac tamponade (one each). First-line therapy with nab-P, B, and G demonstrated a median PFS of 10.4 months and a 75.9% ORR with acceptable toxicity; this novel combination warrants investigation in a randomized study.

摘要

为了评估纳米白蛋白结合紫杉醇(nab-P)联合贝伐珠单抗(B)和吉西他滨(G)一线治疗人表皮生长因子受体 2(HER2)阴性转移性乳腺癌(MBC)患者的疗效和安全性。在这项单中心、开放标签的 II 期临床试验中,HER2 阴性 MBC 患者接受吉西他滨 1500mg/m2,nab-P 150mg/m2,贝伐珠单抗 10mg/kg(均静脉输注),每 28 天为一个周期,第 1 和第 15 天给药。主要终点是无进展生存期(PFS);次要终点是总缓解率(ORR)、完全缓解(CR)和部分缓解(PR)率、临床获益(ORR+疾病稳定)、总生存期(OS)和安全性。共纳入 30 例患者。1 例患者因不符合条件而未纳入分析。中位 PFS 为 10.4 个月(95%CI:5.6-15.2 个月)。ORR 为 75.9%,包括 8 例(27.6%)CR 和 14 例(48.3%)PR;5 例患者疾病稳定(SD),2 例(6.9%)患者疾病进展(PD)为最佳缓解。总体人群和三阴性队列(13 例)的临床获益率分别为 93.1%(27/29)和 84.6%。18 个月生存率为 77.2%(95%CI:51.1-90.5%)。8 例(27.6%)患者发生 3 或 4 级毒性:4 级中性粒细胞减少性发热(1 例)和 3 级感染(6 例),白细胞减少、血小板减少、周围神经病变、癫痫发作、呼吸困难、血尿和心脏压塞(各 1 例)。nab-P、B 和 G 的一线治疗中位 PFS 为 10.4 个月,ORR 为 75.9%,毒性可接受;这种新的联合方案值得在随机研究中进一步探讨。

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