Clinical factors associated with early progression and grade 3-4 toxicity in patients with advanced non-small-cell lung cancers treated with nivolumab.
Clinical factors associated with early progression and grade 3-4 toxicity in patients with advanced non-small-cell lung cancers treated with nivolumab.
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DOI：
10.1371/journal.pone.0195945
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发表时间：
2018
期刊：
影响因子：
3.7
通讯作者：
Giroux Leprieur E
中科院分区：
文献类型：
--
作者：
Dumenil C;Massiani MA;Dumoulin J;Giraud V;Labrune S;Chinet T;Giroux Leprieur E
晚期非小细胞肺癌（NSCLC）的预后已通过开发免疫检查点抑制剂（ICI）如nivolumab用于二线治疗而得到改善。由于III期试验仅包括选定的患者，我们在此研究了与纳武利尤单抗在“真实的生活”晚期NSCLC患者中的疗效和安全性相关的临床因素。对2015年2月至2016年12月期间在两家法国学术医院前瞻性纳入并接受纳武利尤单抗治疗的所有连续晚期NSCLC患者的临床和组织学特征、治疗和生存数据进行了检查。纳入67例患者，大多数为男性（69%），当前或既往吸烟者（87%），PS <2（73%）。中位年龄为68.5岁，42%的患者年龄≥70岁。根据单变量和多变量分析，仅PS 2（OR = 0. 17，95% CI 0. 03 - 0. 99，p = 0. 049）和既往治疗线数量（OR = 0. 33，95% CI 0. 13 - 0. 85，p = 0. 022）与肿瘤控制显著负相关。更差的无进展生存期（PFS）与PS 2（HR = 5.17，95% CI 1.99-13.43，p = 0.001）和使用类固醇（HR = 3.27，95% CI 1.39-7.69，p = 0.006）显著相关。总生存率较差与症状性脑转移相关（HR = 3.15，95% CI 1.23-8.85，p = 0.029）。47例患者（70%）发生治疗相关不良事件，症状性脑转移与≥3级毒性显著相关（OR = 8.13，95% CI 1.21-55.56，p = 0.031）。年龄和营养状况与缓解、PFS、OS或毒性无关。我们的研究结果表明，纳武利尤单抗对PS 2和症状性脑转移患者没有益处或安全性。
The prognosis of advanced non-small-cell lung cancer (NSCLC) has been improved by development of immune checkpoint inhibitors (ICIs) such as nivolumab for second-line treatment. As phase III trials include only selected patients, we here investigated the clinical factors associated with efficacy and safety of nivolumab in ‘real life’ patients with advanced NSCLC. Clinical and histological characteristics, therapies and survival data of all consecutive patients with advanced NSCLC included prospectively and treated by nivolumab in two French academic hospitals between February 2015 and December 2016 were examined. Sixty-seven patients were included, mostly male (69%), current or former smokers (87%) with PS <2 (73%). Median age was 68.5 years and 42% were aged ≥70 years. According to uni- and multi-variate analyses, only PS 2 (OR = 0.17, 95% CI 0.03–0.99, p = 0.049) and number of previous treatment lines (OR = 0.33, 95% CI 0.13–0.85, p = 0.022) were significantly negatively associated with tumor control. Worse progression-free survival (PFS) was significantly associated with PS 2 (HR = 5.17, 95% CI 1.99–13.43, p = 0.001) and use of steroids (HR = 3.27, 95% CI 1.39–7.69, p = 0.006). Worse overall survival was associated with symptomatic brain metastasis (HR = 3.15, 95% CI 1.23–8.85, p = 0.029). Treatment-related adverse events occurred in 47 patients (70%), symptomatic brain metastasis being significantly associated with Grade ≥3 toxicity (OR = 8.13, 95% CI 1.21–55.56, p = 0.031). Age and nutritional status were not associated with response, PFS, OS or toxicity. Our results suggest that nivolumab is not beneficial or safe for patients with PS 2 and symptomatic brain metastases.
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影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
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DOI：
10.1038/nrc3239
发表时间：
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DOI：
10.1016/s1470-2045(16)30053-5
发表时间：
2016-07
期刊：
The Lancet. Oncology
影响因子：
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作者：
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Kluger HM
影响因子：
20.4
作者：
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