Background: Treatment of advanced ALK + NSCLC has improved with increasingly effective ALK tyrosine-kinase inhibitors (TKIs). We report real-world treatment patterns and outcomes from the Italian ATLAS registry. Methods: Clinical-pathological and treatment data were retrospectively and prospectively collected from 37 Italian centers. Results: 463 ALK + advanced NSCLC patients treated from 2019 to 2024 were included. 431 (93 %) patients received 1st line (1L) ALK TKIs, mostly alectinib (82.5 %). 1L treatment choice, reported in 142 cases, was driven by drug access as first (31 %) or subsequent lines (40.1 %) and by safety (21.8 %). Among 382 patients receiving 1L alectinib overall survival (OS) rate was 88.7 % and 73.3 % at 24 and 60 months, respectively. Median progression-free survival (mPFS) was 43.1 months (95 %CI: 29.5-57.0). Brain was a new site of progression in 11 (3.6 %) patients. Intracranial PFS rate was 73.1 % and 59.1 % at 24 and 36 months with a 64.7 % intracranial response rate. Grade ≥ 3 adverse events occurred in 41 (10.7 %) patients, mainly hepatic toxicity (13, 3.4 %) and asthenia (5, 1.3 %). At progression tissue and/or liquid biopsy were performed in 28 (23.5 %) and 20 (16.8 %) cases, respectively. Out of 80 patients receiving 2nd line therapy after alectinib, 67 (83.8 %) received lorlatinib achieving mPFS 7.5 (95 % CI: 6.2-8.8) and mOS 26.4 months (95 % CI: 19.1-33.7). 17 (15.5 %) patients died without second line therapy. Conclusions: Real-world data confirm the effectiveness and safety of alectinib, used as preferred upfront ALK-TKI. The recent 1L lorlatinib approval might change this scenario. Tissue/liquid biopsy at disease progression are underperformed in clinical practice.
Reale, M. L., Scattolin, D., Vitale, A., Passiglia, F., Grisanti, S., Macerelli, M., Galetta, D., Sini, C., Minuti, G., Citarella, F., Roca, E., Agustoni, F., Dodi, A., Cortinovis, D., Belluomini, L., Ricciardi, S., Veccia, A., Pizzutilo, E. G., Scotti, V., Alì, G., Mazzoni, F., Russo, A., Pignataro, D., Bulotta, A., Piovano, P., Sergi, C., Bettini, A., Genova, C., Pavan, A., Soto Parra, H. J., Ortega, C., Pozzessere, D., Vavalà, T., Chiari, R., Zannori, C., D'Aveni, A., Meoni, G., Giannarelli, D., Malapelle, U., Novello, S., Bria, E., Pasello, G., Advanced-stage ALK-positive non–small-cell lung cancer (NSCLC) patients: Real-world treatment patterns and outcomes from the Italian biomarker ATLAS database, <<LUNG CANCER>>, 2025; (209): N/A-N/A. [doi:10.1016/j.lungcan.2025.108762] [https://hdl.handle.net/10807/339036]
Advanced-stage ALK-positive non–small-cell lung cancer (NSCLC) patients: Real-world treatment patterns and outcomes from the Italian biomarker ATLAS database
Vitale, AntonioMembro del Collaboration Group
;Giannarelli, DianaData Curation
;Bria, EmilioSupervision
;
2025
Abstract
Background: Treatment of advanced ALK + NSCLC has improved with increasingly effective ALK tyrosine-kinase inhibitors (TKIs). We report real-world treatment patterns and outcomes from the Italian ATLAS registry. Methods: Clinical-pathological and treatment data were retrospectively and prospectively collected from 37 Italian centers. Results: 463 ALK + advanced NSCLC patients treated from 2019 to 2024 were included. 431 (93 %) patients received 1st line (1L) ALK TKIs, mostly alectinib (82.5 %). 1L treatment choice, reported in 142 cases, was driven by drug access as first (31 %) or subsequent lines (40.1 %) and by safety (21.8 %). Among 382 patients receiving 1L alectinib overall survival (OS) rate was 88.7 % and 73.3 % at 24 and 60 months, respectively. Median progression-free survival (mPFS) was 43.1 months (95 %CI: 29.5-57.0). Brain was a new site of progression in 11 (3.6 %) patients. Intracranial PFS rate was 73.1 % and 59.1 % at 24 and 36 months with a 64.7 % intracranial response rate. Grade ≥ 3 adverse events occurred in 41 (10.7 %) patients, mainly hepatic toxicity (13, 3.4 %) and asthenia (5, 1.3 %). At progression tissue and/or liquid biopsy were performed in 28 (23.5 %) and 20 (16.8 %) cases, respectively. Out of 80 patients receiving 2nd line therapy after alectinib, 67 (83.8 %) received lorlatinib achieving mPFS 7.5 (95 % CI: 6.2-8.8) and mOS 26.4 months (95 % CI: 19.1-33.7). 17 (15.5 %) patients died without second line therapy. Conclusions: Real-world data confirm the effectiveness and safety of alectinib, used as preferred upfront ALK-TKI. The recent 1L lorlatinib approval might change this scenario. Tissue/liquid biopsy at disease progression are underperformed in clinical practice.
| File | Dimensione | Formato | |
|---|---|---|---|
|
PIIS0169500225006543.pdf
accesso aperto
Licenza:
Creative commons
Dimensione
1.95 MB
Formato
Adobe PDF
|
1.95 MB | Adobe PDF | Visualizza/Apri |
I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
