Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer.
Weekly Paclitaxel given concurrently with Durvalumab has a favorable safety profile in triple-negative metastatic breast cancer.
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DOI：
10.1038/s41598-021-98113-6
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发表时间：
2021-09-27
影响因子：
4.6
通讯作者：
Al-Tweigeri T
中科院分区：
文献类型：
--
作者：
Ghebeh H;Al-Sayed A;Eiada R;Cabangon L;Ajarim D;Suleman K;Tulbah A;Al-Tweigeri T
治疗性抗pd - l1抗体作为单一疗法是安全的，尽管对三阴性乳腺癌（TNBC）的疗效很小。该试验旨在测试Durvalumab和紫杉醇治疗转移性TNBC的安全性和有效性。在这项开放标签单臂试验中，每周静脉注射5个周期紫杉醇（IV），同时每2周静脉注射Durvalumab。在联合治疗之前，单独使用紫杉醇一个周期，用于免疫启动，然后单独使用Durvalumab，直到疾病进展或不可接受的毒性。在2017年至2019年期间，14名患者接受了至少一个周期的联合治疗。除1例皮肤病变外，该疗法是安全的，无剂量限制毒性。71%的患者报告了不良事件（ae），并且没有因联合治疗而死亡。无论级别如何，最常见的ae是头痛和周围神经病变，分别发生在4名患者（29%）中，其次是3名患者（21%）的疲劳和皮疹。3/4级不良事件发生3例（21%），最常见的是头痛和贫血，2例（14%）发生。5例患者的客观缓解率（ORR）得到证实，中位持续时间为10.0个月。中位无进展生存期（PFS）和总生存期（OS）分别为5个月和20.7个月。Durvalumab和紫杉醇联合使用是安全的，为其他药物留下了空间。这是首个Durvalumab联合紫杉醇治疗TNBC的报道（NCT02628132）。
Therapeutic anti-PD-L1 antibodies are safe as a monotherapy, albeit with minimal efficacy in triple-negative breast cancer (TNBC). This trial aimed to test the safety and efficacy of Durvalumab and Paclitaxel in metastatic TNBC. In this open-label, one-arm trial, five cycles of weekly paclitaxel were delivered intravenously (IV) concurrent with Durvalumab that was given IV every 2 weeks. The combination was preceded by one cycle of paclitaxel alone, for immunological priming, followed by Durvalumab solo until disease progression or unacceptable toxicity. Between 2017 and 2019, 14 patients received at least one cycle of the combination therapy. The therapy was safe with no-dose limiting toxicity, except one case of skin lesions. Adverse events (AEs) were reported in 71% of patients, and there was no death due to the combination therapy. Regardless of grade, the most common AEs were headache and peripheral neuropathy, as each happened in four patients (29%), followed by fatigue and skin rash in three patients (21%) each. Grade 3/4 AEs were experienced by three patients (21%), with the most common being headache and anemia, which happened in two patients (14%). The confirmed objective response rate (ORR) was observed in five patients with a median duration of 10.0 months. Median Progression-free survival (PFS) and overall survival (OS) were 5 and 20.7 months, respectively. The combination of Durvalumab and Paclitaxel is safe, leaving room for additional agents. This is the first report on the combination of Durvalumab and Paclitaxel in the treatment of TNBC (NCT02628132).
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影响因子：
3.8
作者：
Elkum N;Dermime S;Ajarim D;Al-Zahrani A;Alsayed A;Tulbah A;Al Malik O;Alshabanah M;Ezzat A;Al-Tweigeri T
通讯作者：
Al-Tweigeri T
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
11.5
作者：
Gajewski, Thomas F.
通讯作者：
Gajewski, Thomas F.
影响因子：
1.8
作者：
Gong, Wenrong;Song, Qibin;Yi, Xianjin
通讯作者：
Yi, Xianjin
DOI：
10.3747/co.2007.96
发表时间：
2007-02-01
期刊：
Current oncology (Toronto, Ont.)
影响因子：
--
作者：
Maroun, J A;Anthony, L B;Wong, R
通讯作者：
Wong, R