Anlotinib added to third generation EGFR tyrosine kinase inhibitor therapy for advanced NSCLC patients with oligo-progression: a retrospective study (ALTER-L058)
Year: 2025
Type: article
Study design: Observational Study
Abstract: Objective To investigate the efficacy of anlotinib, an antiangiogenic multikinase inhibitor, as an add-on therapy to first-line epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI) for patients with EGFR -mutant non-small cell lung cancer (NSCLC) who were previously untreated before first-line EGFR TKI but subsequently developed oligoprogression. Methods This multicenter, retrospective cohort study (ALTER-L058) analyzed data from the electronic health records-derived de-identified systems at 16 cancer centers in China. Adult patients between 18 and 75 years of age with histologically or cytologically confirmed locally advanced or metastatic NSCLC who received first-line third-generation EGFR TKI monotherapy and had an oligoprogressive disease were included. Eligible patients received anlotinib (8, 10 or 12 mg) on days 1–14 of each 3-week cycle for ≥6 cycles. Tumor response was assessed radiologically by investigators per RECIST, version 1.1. The primary outcome was investigators-assessed progression-free survival, calculated from the date of medication initiation for the oligoprogressive disease to the first documented progressive disease or death. Results Between January 2020 and December 2023, 100 patients received EGFR TKI plus anlotinib and 50 received EGFR TKI. At the data cutoff (20 November 2024), the median progression-free survival was 9.23 months (95% CI, 8.94–10.87) with EGFR TKI plus anlotinib versus 5.42 months (95% CI, 4.83–6.80) with EGFR TKI (hazard ratio [HR] = 0.38, 95% CI, 0.26–0.56; log rank test, P < 0.0001), meeting the primary endpoint. Anlotinib was generally well tolerated, with manageable adverse events. Conclusion Anlotinib, when added onto EGFR TKI therapy following gradual progression or oligo-progression, conferred significant PFS benefits upon EGFR mutant NSCLC patients, supporting adding anlotinib to ongoing first-line EGFR TKI therapy for oligoprogressive disease.
Source: Frontiers in Pharmacology
Institutions: Tongji University, Shanghai East Hospital, Peking University Cancer Hospital, First Affiliated Hospital of Zhengzhou University, Second People Hospital of Hunan, Qilu Hospital of Shandong University, Chinese Academy of Medical Sciences & Peking Union Medical College, Affiliated Hospital of Xuzhou Medical College, Chengdu Fifth People's Hospital, Guangzhou First People's Hospital, Tang Du Hospital, Air Force Medical University, First Affiliated Hospital of Bengbu Medical College, University of Science and Technology of China, Tengzhou Central People's Hospital, Qingdao University, Yuhuangding Hospital, Affiliated Hospital of Qingdao University, Liaoning Cancer Hospital & Institute, Hubei Cancer Hospital
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,801
OpenAlex ID: W4415983606