Anlotinib Plus Docetaxel is Promising in Advanced NSCLC Progressing on First-Line Immunotherapy: A Pooled Analysis of Two Randomized Trials.

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-05-12 DOI:10.1007/s12325-025-03170-2

Xingxiang Pu, Jiawei Shou, Zemin Xiao, Jun Chen, Maoliang Xiao, Qunyi Guo, Zhongxia Ma, Wei Hong, Qianzhi Wang, Yonghui Wang, Jia Li, Chuangzhou Rao, Jie Weng, Liqin Lu, Lin Wu, Yong Fang

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引用次数: 0

Abstract

Introduction: Therapeutic options for patients with advanced non-small cell lung cancer (NSCLC) after progression on immune checkpoint inhibitors (ICIs) remain a significant challenge. This analysis compared outcomes of anlotinib plus docetaxel versus docetaxel alone in this population using the pooled data from two prospective randomized trials (ALTER-L016; ALTER-L018).

Methods: Adult patients with EGFR/ALK/ROS1 wild-type advanced NSCLC progressing on first-line ICIs were eligible. Patients were randomly assigned to anlotinib plus docetaxel or docetaxel alone. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety.

Results: Seventy-one patients were included in this pooled analysis (L016, n = 39; L018, n = 32), of whom, 40 received anlotinib plus docetaxel and 31 received docetaxel. The median follow-up of all patients was 27.0 months. The median PFS was longer with anlotinib plus docetaxel than with docetaxel alone (5.4 months [95% CI 5.0-9.3] vs. 2.3 months [95% CI 1.4-2.9]; hazard ratio [HR], 0.34; 95% CI 0.18-0.63; P < 0.001). Both ORR (25.0% vs. 12.9%) and DCR (82.5% vs. 45.2%) were higher in the anlotinib plus docetaxel group than in the docetaxel group. Median OS was 16.2 months (95% CI 8.3-21.3) with anlotinib plus docetaxel versus 13.7 months (95% CI 4.6-22.3) with docetaxel (HR = 0.82; 95% CI 0.47-1.44; P = 0.488). Subsequent ICI therapy was associated with a longer OS. Grade 3 treatment-related adverse events occurred in 32.5% of patients receiving anlotinib plus docetaxel and 6.5% of patients receiving docetaxel.

Conclusion: Anlotinib plus docetaxel improved PFS but not OS versus docetaxel in patients with advanced NSCLC progressing on ICIs. Larger standardized phase 3 trials are needed to verify these findings.

Trial registration: ALTER-L016 (ClinicalTrials.gov identifier, NCT03726736). ALTER-L018 (ClinicalTrials.gov identifier, NCT03624309).

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安洛替尼加多西他赛在一线免疫治疗进展的晚期NSCLC中有希望：两项随机试验的汇总分析

免疫检查点抑制剂（ICIs）进展后晚期非小细胞肺癌（NSCLC）患者的治疗选择仍然是一个重大挑战。该分析使用来自两项前瞻性随机试验的汇总数据，比较了安洛替尼加多西他赛与单药多西他赛在该人群中的结果(ALTER-L016；ALTER-L018)。方法：EGFR/ALK/ROS1野生型晚期NSCLC进展为一线ICIs的成年患者。患者被随机分配到安洛替尼加多西他赛或单独多西他赛。主要终点为无进展生存期（PFS）。次要终点是总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和安全性。结果：71例患者纳入本合并分析(L016, n = 39；L018, n = 32)，其中安洛替尼联合多西他赛40例，多西他赛31例。所有患者的中位随访时间为27.0个月。安洛替尼联合多西他赛的中位PFS比单独多西他赛更长(5.4个月[95% CI 5.0-9.3] vs. 2.3个月[95% CI 1.4-2.9]；风险比[HR]， 0.34；95% ci 0.18-0.63；结论：与多西紫杉醇相比，安洛替尼联合多西紫杉醇改善了晚期NSCLC患者的PFS，但没有改善OS。需要更大规模的标准化第三期试验来验证这些发现。试验注册：ALTER-L016 （ClinicalTrials.gov识别码，NCT03726736）。ALTER-L018 （ClinicalTrials.gov识别码，NCT03624309）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.