nab-Paclitaxel Plus Durvalumab in Patients With Previously Treated Advanced Stage Non-small Cell Lung Cancer (ABOUND.2L+).
nab-Paclitaxel Plus Durvalumab in Patients With Previously Treated Advanced Stage Non-small Cell Lung Cancer (ABOUND.2L+).
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DOI：
10.3389/fonc.2020.569715
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发表时间：
2020
影响因子：
4.7
通讯作者：
Ong TJ
中科院分区：
文献类型：
--
作者：
Morgensztern D;Dols MC;Ponce Aix S;Postmus PE;Bennouna J;Fischer JR;Juan-Vidal O;Stewart DJ;Ardizzoni A;Bhore R;Wolfsteiner M;Reck M;Talbot D;Govindan R;Ong TJ
背景：无可操作基因改变的晚期非小细胞肺癌（NSCLC）的标准治疗是铂基化疗双药和免疫检查点阻断剂（ICB），可同时或顺序使用，肿瘤进展时再使用多西他赛。然而，需要更有效的治疗方法。我们评估了nab-紫杉醇和durvalumab联合治疗先前治疗过的晚期NSCLC患者。方法：先前接受单线铂基双药治疗的晚期NSCLC患者，有或没有ICB，没有激活EGFR突变或ALK易位，每21天接受nab-紫杉醇100mg /m2（第1天和第8天）加durvalumab 1125mg（第15天）。主要终点为无进展生存期（PFS）。主要次要终点包括总生存期（OS）和安全性。结果：2016年2月至2016年12月，79例患者入组。中位年龄为63岁。大多数患者为男性（68.4%），非鳞状组织学（69.6%），既往未接受过ICB治疗（88.6%）。中位PFS为4.5个月；中位OS为10.1个月。先前接受过ICB治疗的生存期事后分析显示，初次接受ICB治疗的患者的中位PFS和OS分别为4.4和9.9个月，而先前接受过ICB治疗的患者的中位PFS和OS分别为6.9个月，且无法估计。最常见的治疗不良事件是虚弱（46.2%）和腹泻（34.6%）；发生4例治疗相关死亡（5.1%）。结论：nab-紫杉醇联合杜伐单抗是可行的，且具有抗肿瘤活性，无新的安全信号。在先前治疗过的NSCLC患者中使用紫杉烷和ICB的其他研究是有必要的。临床试验注册：ClinicalTrials.gov注册（NCT02250326）。稿号：2014-001105-41
Background: The standard therapy for advanced stage non-small cell lung cancer (NSCLC) with no actionable gene alterations is a platinum-based chemotherapy doublet and immune checkpoint blocker (ICB), either concurrently or sequentially, followed by docetaxel at the time of tumor progression. However, more effective treatments are needed. We evaluated the nab-paclitaxel and durvalumab combination in patients with previously treated advanced stage NSCLC. Methods: Patients with advanced stage NSCLC previously treated with one line of platinum-based doublet with or without an ICB and no activating EGFR mutations or ALK translocations received nab-paclitaxel 100 mg/m2 (days 1 and 8) plus durvalumab 1,125 mg (day 15) every 21 days. The primary endpoint was progression-free survival (PFS). Key secondary endpoints included overall survival (OS) and safety. Results: Between February 2016 and December 2016, 79 patients were enrolled. The median age was 63 years. Most patients were males (68.4%), had non-squamous histology (69.6%), and had no prior ICB treatment (88.6%). The median PFS was 4.5 months; median OS was 10.1 months. A post hoc analysis of survival by prior ICB treatment revealed a median PFS and OS of 4.4 and 9.9 months, respectively, in ICB-naive patients and 6.9 months and not estimable, respectively, in patients previously treated with ICB. The most common treatment-emergent adverse events were asthenia (46.2%) and diarrhea (34.6%); four treatment-related deaths (5.1%) occurred. Conclusions: The nab-paclitaxel and durvalumab combination is feasible and demonstrated antitumor activity without new safety signals. Additional studies using taxanes and ICB in patients with previously treated NSCLC are warranted. Clinical Trial Registration: ClinicalTrials.gov registration (NCT02250326). EudraCT number: 2014-001105-41
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影响因子：
10.9
作者：
Brahmer JR;Govindan R;Anders RA;Antonia SJ;Sagorsky S;Davies MJ;Dubinett SM;Ferris A;Gandhi L;Garon EB;Hellmann MD;Hirsch FR;Malik S;Neal JW;Papadimitrakopoulou VA;Rimm DL;Schwartz LH;Sepesi B;Yeap BY;Rizvi NA;Herbst RS
通讯作者：
Herbst RS
DOI：
10.1016/s0140-6736(16)32517-x
发表时间：
2017-01-21
期刊：
Lancet (London, England)
影响因子：
--
作者：
Rittmeyer A;Barlesi F;Waterkamp D;Park K;Ciardiello F;von Pawel J;Gadgeel SM;Hida T;Kowalski DM;Dols MC;Cortinovis DL;Leach J;Polikoff J;Barrios C;Kabbinavar F;Frontera OA;De Marinis F;Turna H;Lee JS;Ballinger M;Kowanetz M;He P;Chen DS;Sandler A;Gandara DR;OAK Study Group
通讯作者：
OAK Study Group
影响因子：
45.3
作者：
Shepherd, FA;Dancey, J;Berille, J
通讯作者：
Berille, J
影响因子：
168.9
作者：
Garon, Edward B.;Ciuleanu, Tudor-Eliade;Perol, Maurice
通讯作者：
Perol, Maurice
影响因子：
15.9
作者：
Ramakrishnan, Rupal;Assudani, Deepak;Gabrilovich, Dmitry I.
通讯作者：
Gabrilovich, Dmitry I.