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阿替利珠单抗(联合 Nab-紫杉醇):晚期三阴性乳腺癌的治疗评价。

Atezolizumab (in Combination with Nab-Paclitaxel): A Review in Advanced Triple-Negative Breast Cancer.

机构信息

Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand.

出版信息

Drugs. 2020 Apr;80(6):601-607. doi: 10.1007/s40265-020-01295-y.

Abstract

Atezolizumab (Tecentriq), an immune checkpoint inhibitor against programmed death ligand 1 (PD-L1), is the first immunotherapy agent to be approved (for use in combination with nab-paclitaxel) in the USA, the EU (as first-line) and Japan for the treatment of advanced triple-negative breast cancer (TNBC). Approval was based on the results of the phase III IMpassion130 trial in patients with unresectable locally advanced or metastatic TNBC, in which atezolizumab plus nab-paclitaxel significantly prolonged progression-free survival (PFS) when compared to placebo plus nab-paclitaxel in the intent-to-treat (ITT) population and the PD-L1+ subgroup. Statistically significant overall survival (OS) benefits were not seen in two interim analyses and final OS data are awaited. The tolerability and safety profile of atezolizumab plus nab-paclitaxel was consistent with those of each individual drug. The most common treatment-related adverse events included neutropenia, peripheral neuropathy and reduced neutrophil count. Adverse events of special interest occurred with higher frequency in patients who received atezolizumab plus nab-paclitaxel than placebo plus nab-paclitaxel, and were mostly immune-related (e.g. immune-related rash, hypothyroidism and hepatitis). Health-related quality of life was not significantly impacted by the addition of atezolizumab to nab-paclitaxel therapy. Thus, atezolizumab plus nab-paclitaxel is a useful immunochemotherapy option for patients with unresectable locally advanced or metastatic TNBC, including those whose tumours have PD-L1 expression ≥ 1%.

摘要

阿替利珠单抗(Tecentriq)是一种针对程序性死亡配体 1(PD-L1)的免疫检查点抑制剂,是第一个被批准在美国、欧盟(一线治疗)和日本联合 nab-紫杉醇用于治疗晚期三阴性乳腺癌(TNBC)的免疫治疗药物。该批准基于 III 期 IMpassion130 试验在不可切除的局部晚期或转移性 TNBC 患者中的结果,与安慰剂联合 nab-紫杉醇相比,阿替利珠单抗联合 nab-紫杉醇在意向治疗(ITT)人群和 PD-L1+亚组中显著延长了无进展生存期(PFS)。两次中期分析未观察到统计学意义上的总生存期(OS)获益,最终 OS 数据仍在等待中。阿替利珠单抗联合 nab-紫杉醇的耐受性和安全性与各单药一致。最常见的治疗相关不良事件包括中性粒细胞减少、周围神经病变和中性粒细胞计数减少。与安慰剂联合 nab-紫杉醇相比,接受阿替利珠单抗联合 nab-紫杉醇治疗的患者发生了更多的特殊关注的不良事件,这些不良事件大多与免疫相关(如免疫相关性皮疹、甲状腺功能减退和肝炎)。阿替利珠单抗联合 nab-紫杉醇治疗并未显著影响健康相关生活质量。因此,阿替利珠单抗联合 nab-紫杉醇是不可切除的局部晚期或转移性 TNBC 患者的一种有用的免疫化疗选择,包括那些肿瘤 PD-L1 表达≥1%的患者。

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