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安罗替尼作为广泛期小细胞肺癌一线化疗联合巩固放疗后的维持治疗。

Anlotinib as Maintenance Therapy After First-Line Chemotherapy Combined with Consolidation Radiation for Extensive-Stage Small Cell Lung Cancer.

作者信息

Ma Jinbo, Ma Xiaoyan, Zhang Wei, Hu Shanliang, Zang Rukun, Wu Xiaolong, Song Jie

机构信息

Department of Radiation Oncology, Yantai Yuhuangding Hospital, Qingdao University, Yantai, P.R. China.

Department of Respiratory Medicine, Yantai Affiliated Hospital, Yantai Yuhuangding Hospital, Qingdao University, Yantai, P.R. China.

出版信息

Technol Cancer Res Treat. 2025 Jan-Dec;24:15330338251317571. doi: 10.1177/15330338251317571.

Abstract

BACKGROUND

Small cell lung cancer is sensitive to chemotherapy and radiotherapy, but local recurrence and distant metastasis occur shortly after treatment. This study aimed to evaluate the real-world value of anlotinib as a maintenance therapy in patients with extensive-stage small cell lung cancer (ES-SCLC) after first-line chemotherapy and consolidative thoracic radiotherapy (CTRT).

PATIENTS AND METHODS

A total of 150 patients with ES-SCLC treated with first-line chemotherapy and CTRT from April 2017 to December 2021 were retrospectively analyzed. After the completion of chemoradiotherapy, patients received anlotinib according to their desire. The primary endpoints were progression-free survival (PFS) and overall survival (OS) after the first diagnosis, and the secondary endpoints were prognostic factors and safety.

RESULTS

The ORR and DCR of patients with ES-SCLC were 50.0% and 80.3%, respectively, in the anlotinib group and 42.9% and 69.0% in the no-maintenance therapy group. The 3-year OS rates were 27.6% and 12.6% in the anlotinib and observation groups (HR = 2.52,  = 0.003), and the median OS times were 23.8 months and 15.3 months. The 3-year PFS rates were 18.2% and 8.8% in the anlotinib and observation groups (HR = 1.76,  = 0.034) with median PFS times of 11.5 months and 8.8 months. After stratification on the basis of clinical response, patients who achieved CR plus PR after chemoradiotherapy had a longer median OS in the anlotinib and observation groups (34.0 months 24.8 months, HR = 2.40,  = 0.009). There were higher incidence rates of hand-foot syndrome (27.3% 10.5%,  = 0.001), gingival bleeding/hemoptysis (18.5% 4.8%,  = 0.015) and rash (33.3% 4.8%,  < 0.001) in the anlotinib group than in the observation group.

CONCLUSION

Maintenance therapy with anlotinib improved the survival of patients with ES-SCLC after first-line chemotherapy and CTRT. Owing to the small sample size of the real-world trial, the reliability of our study needs to be confirmed in more studies.

摘要

背景

小细胞肺癌对化疗和放疗敏感,但治疗后不久就会出现局部复发和远处转移。本研究旨在评估安罗替尼作为一线化疗和巩固性胸部放疗(CTRT)后广泛期小细胞肺癌(ES-SCLC)患者维持治疗的真实世界价值。

患者与方法

回顾性分析2017年4月至2021年12月期间接受一线化疗和CTRT治疗的150例ES-SCLC患者。放化疗完成后,患者根据自身意愿接受安罗替尼治疗。主要终点为首次诊断后的无进展生存期(PFS)和总生存期(OS),次要终点为预后因素和安全性。

结果

安罗替尼组ES-SCLC患者的客观缓解率(ORR)和疾病控制率(DCR)分别为50.0%和80.3%,无维持治疗组分别为42.9%和69.0%。安罗替尼组和观察组的3年总生存率分别为27.6%和12.6%(HR = 2.52,P = 0.003),中位总生存时间分别为23.8个月和15.3个月。安罗替尼组和观察组的3年无进展生存率分别为18.2%和8.8%(HR = 1.76,P = 0.034),中位无进展生存时间分别为11.5个月和8.8个月。根据临床反应分层后,放化疗后达到完全缓解(CR)加部分缓解(PR)的患者在安罗替尼组和观察组中的中位总生存期更长(34.0个月对24.8个月,HR = 2.40,P = 0.009)。安罗替尼组手足综合征(27.3%对10.5%,P = 0.001)、牙龈出血/咯血(18.5%对4.8%,P = 0.015)和皮疹(33.3%对4.8%,P < 0.001)的发生率高于观察组。

结论

安罗替尼维持治疗改善了一线化疗和CTRT后ES-SCLC患者的生存。由于真实世界试验的样本量较小,我们研究的可靠性需要在更多研究中得到证实。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ae7/11786289/381b79fe1a35/10.1177_15330338251317571-fig1.jpg

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