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尼达尼布联合多西他赛在尼达尼布 NPU 项目中一线化疗和二线免疫治疗后晚期肺腺癌患者中的疗效。

Efficacy of nintedanib and docetaxel in patients with advanced lung adenocarcinoma treated with first-line chemotherapy and second-line immunotherapy in the nintedanib NPU program.

机构信息

Clinica Universidad de Navarra, Calle Marquesado de Santa Marta nº1, 28027, Madrid, Spain.

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.

出版信息

Clin Transl Oncol. 2019 Sep;21(9):1270-1279. doi: 10.1007/s12094-019-02053-7. Epub 2019 Feb 15.

DOI:10.1007/s12094-019-02053-7
PMID:30771085
Abstract

PURPOSE

Both nintedanib/docetaxel and anti-PD-1/PD-L1 immunotherapies have demonstrated efficacy as second-line treatment of patients with advanced lung adenocarcinoma. This is the first report on the efficacy of the nintedanib/docetaxel combination following first-line platinum-based chemotherapy and subsequent immunotherapy in a real-world setting.

METHODS/PATIENTS: From May 2014 to December 2015, 390 patients in 108 Spanish centres enrolled in the nintedanib named patient use program. Inclusion criteria were advanced lung adenocarcinoma with progressive disease following at least one line of platinum-based doublet chemotherapy. The objective was to evaluate the efficacy of the nintedanib/docetaxel combination in patients who also received immunotherapy.

RESULTS

Eleven patients met the inclusion criteria; with a median age of 67 years. PD-L1 expression was positive in six patients. Median progression-free survival (PFS) of first-line platinum-based chemotherapy was 3.3 months (95% CI 1.9-4.6). Second-line immunotherapy was pembrolizumab (36.5%), atezolizumab (36.5%) or nivolumab (27%). Median PFS of second-line immunotherapy was 2.3 months (95% CI 0-6.1). The overall response rate (ORR) to second-line immunotherapy was 18% with a disease-control rate (DCR) of 45%. Median PFS of nintedanib/docetaxel was 3.2 months (95% CI 1.9-4.5). Best response was partial response in four patients (36%), stable disease in five patients (46%), and progressive disease in two patients (18%), for an ORR of 36% and a DCR of 82%.

CONCLUSION

Our experience suggests an encouraging efficacy of nintedanib/docetaxel in patients with adenocarcinoma NSCLC pretreated with platinum-based doublet chemotherapy and immunotherapy, reinforcing the importance of an optimal therapeutic sequence for managing advanced lung adenocarcinoma.

摘要

目的

尼达尼布/多西他赛和抗 PD-1/PD-L1 免疫疗法均已被证明作为晚期肺腺癌二线治疗的疗效。这是首例在真实环境下报告的尼达尼布/多西他赛联合方案在一线基于铂类的化疗和后续免疫治疗后在晚期肺腺癌中的疗效。

方法/患者:2014 年 5 月至 2015 年 12 月,来自西班牙 108 个中心的 390 名患者参加了尼达尼布的患者使用计划。纳入标准为在至少一线含铂的双药化疗后疾病进展的晚期肺腺癌。目的是评估尼达尼布/多西他赛联合方案在接受免疫治疗的患者中的疗效。

结果

11 名患者符合纳入标准,中位年龄为 67 岁。6 名患者 PD-L1 表达阳性。一线含铂化疗的中位无进展生存期(PFS)为 3.3 个月(95%CI 1.9-4.6)。二线免疫治疗为帕博利珠单抗(36.5%)、阿替利珠单抗(36.5%)或纳武利尤单抗(27%)。二线免疫治疗的中位 PFS 为 2.3 个月(95%CI 0-6.1)。二线免疫治疗的总缓解率(ORR)为 18%,疾病控制率(DCR)为 45%。尼达尼布/多西他赛的中位 PFS 为 3.2 个月(95%CI 1.9-4.5)。最佳反应为 4 名患者(36%)部分缓解,5 名患者(46%)疾病稳定,2 名患者(18%)疾病进展,ORR 为 36%,DCR 为 82%。

结论

我们的经验表明,尼达尼布/多西他赛在接受过含铂双药化疗和免疫治疗的腺癌 NSCLC 患者中具有令人鼓舞的疗效,这进一步强调了为管理晚期肺腺癌制定最佳治疗顺序的重要性。

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