| Title: |
Advanced-stage ALK-positive non–small-cell lung cancer (NSCLC) patients: Real-world treatment patterns and outcomes from the Italian biomarker ATLAS database |
| Authors: |
Reale, M; 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; 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; 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; Reale, Maria Lucia; Scattolin, Daniela; Vitale, Antonio; Passiglia, Francesco; Grisanti, Salvatore; Macerelli, Marianna; Galetta, Domenico; Sini, Claudio; Minuti, Gabriele; Citarella, Fabrizio; Roca, Elisa; Agustoni, Francesco; Dodi, Alessandra; Cortinovis, Diego; Belluomini, Lorenzo; Ricciardi, Serena; Veccia, Antonello; Pizzutilo, Elio Gregory; Scotti, Vieri; Alì, Greta; Mazzoni, Francesca; Russo, Alessandro; Pignataro, Daniele; Bulotta, Alessandra; Piovano, Pierluigi; Sergi, Concetta; Bettini, Anna; Genova, Carlo; Pavan, Alberto; Soto Parra, Hector José; Ortega, Cinzia; Pozzessere, Daniele; Vavalà, Tiziana; Chiari, Rita; Zannori, Cristina; D'Aveni, Alessandro; Meoni, Giulia; Giannarelli, Diana; Malapelle, Umberto; Novello, Silvia; Bria, Emilio; Pasello, Giulia |
| Publisher Information: |
Elsevier Ireland Ltd country:IE 2025 |
| Document Type: |
Electronic Resource |
| 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. |
| Index Terms: |
Alectinib; ALK; Lorlatinib; Non-small-cell lung cancer; Second-generation ALK TKI; Third-generation ALK TKI; info:eu-repo/semantics/article |
| URL: |
https://hdl.handle.net/10281/576067; info:eu-repo/semantics/altIdentifier/pmid/41027387; info:eu-repo/semantics/altIdentifier/wos/WOS:001603278400005; volume:209; issue:November 2025; journal:LUNG CANCER |
| Availability: |
Open access content. Open access content |
| Note: |
STAMPA; English |
| Other Numbers: |
ITBAO oai:boa.unimib.it:10281/576067; 10.1016/j.lungcan.2025.108762; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-105017158023; 1574047136 |
| Contributing Source: |
BICOCCA OPEN ARCH; From OAIster®, provided by the OCLC Cooperative. |
| Accession Number: |
edsoai.on1574047136 |
| Database: |
OAIster |