ArticleBMC cancer2025
Efficacy and safety analysis of lorlatinib for ALK-positive advanced NSCLC: a multicentre real-world study in China.
Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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1 citing paper in PubMed.
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5 authors.
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Abstract
backgroundLorlatinib, a third-generation Anaplastic lymphoma kinase (ALK)-tyrosine kinase inhibitors (TKI), has demonstrated excellent curative effect in clinical studies to overcome mutations resistant to first- and second-generation ALK-TKIs. It also has improved blood-brain barrier crossing and reduced brain metastases.
methods44 patients were selected who received Lorlatinib as initial treatment for first-diagnosis ALK-positive non-small-cell lung cancer (NSCLC) or who received Lorlatinib as a back-line treatment after developing resistance with first- and second-generation ALK-TKIs. The primary study endpoints are objective response rate (ORR) and disease control rate (DCR).
resultsFor the 44 patients, the overall ORR[95% confidence intervals (CI)]was 59% (95% CI: 51-69), the DCR was 93% (95% CI: 36-56). In the first-line treatment group(n = 15), lorlatinib showned an ORR 93% (95% CI: 52-81), and the DCR was 100% (95% CI: 47-78). Additionally, 29 patients who received sequential Lorlatinib after progression on at least one first- or second-generation ALK-TKI showned an ORR of 41% (95% CI: 41-63) and a DCR of 90% (95% CI: 20-40). Lorlatinib demonstrated strong intracranial efficacay, with an overall intracranial objective response rate (IC-ORR) of 74% (95% CI: 67-92) and an intracranial disease control rate (IC-DCR) of 96% (95% CI: 53-81) in 23 patients with brain metastase. Among them, the IC-ORR and IC-DCR of 7 patients who received Lorlatinib as first-line therapy were both 100% (95% CI: 89-103). For 16 patients who had received at least one ALK-TKI, the IC-ORR with Lorlatinib was 63% (95% CI: 51-90), and the IC-DCR was 94% (95% CI: 27-70). 44 patients treated with Lorlatinib, all at a starting dose of 100 mg/day, 77% experienced adverse events, with the most common associated adverse event being hyperlipidaemia, However the overall grading was mild to moderate, with only one case of a reduction in dosage to 75 mg.
conclusionsThis real-world evidence demonstrates that Lorlatinib exhibits significant clinical efficacy and intracranial anti-tumor activity in the treatment of ALK + NSCLC patients, whether in first-line or post-first-line treatment, while being well tolerated.
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