Research Papers:

Alectinib after failure to crizotinib in patients with ALK-positive non-small cell lung cancer: results from the Spanish early access program

Reyes Bernabé-Caro _, Pilar Garrido, Rosario García-Campelo, Ramón Palmero, Ángel Artal, Cristina Bayona, Delvys Rodríguez-Abreu, Marta López-Brea, Alfredo Paredes, David Vicente, José Miguel Sánchez Torres, Margarita Majem, Pilar Diz, Rocío Gordo, Margarita Coca and Javier de Castro

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Oncotarget. 2022; 13:812-827. https://doi.org/10.18632/oncotarget.28244

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Reyes Bernabé-Caro1, Pilar Garrido2, Rosario García-Campelo3, Ramón Palmero4, Ángel Artal5, Cristina Bayona6, Delvys Rodríguez-Abreu7, Marta López-Brea8, Alfredo Paredes9, David Vicente10, José Miguel Sánchez Torres11, Margarita Majem12, Pilar Diz13, Rocío Gordo14, Margarita Coca14 and Javier de Castro15

1 Department of Medical Oncology, Hospital Virgen del Rocío, Sevilla, Spain

2 Department of Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, Spain

3 Department of Medical Oncology, Hospital Universitario A Coruña, A Coruña, Spain

4 Department of Medical Oncology, ICO Bellvitge, Hospitalet Llobregat, Barcelona, Spain

5 Department of Medical Oncology, Hospital Universitario Miguel Servet, Zaragoza, Spain

6 Department of Medical Oncology, Hospital General Yague, Burgos, Spain

7 Department of Medical Oncology, Hospital Insular de Gran Canaria, Las Palmas de Gran Canaria, Spain

8 Department of Medical Oncology, Hospital Marqués de Valdecilla, Santander, Spain

9 Department of Medical Oncology, Hospital Universitario Donostia, Donostia-San Sebastián, Spain

10 Department of Medical Oncology, Hospital Universitario Virgen Macarena, Sevilla, Spain

11 Department of Medical Oncology, Hospital Universitario La Princesa, Madrid, Spain

12 Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

13 Department of Medical Oncology, Complejo Asistencial Universitario de León, León, Spain

14 Roche Farma, S.A., Madrid, Spain

15 Department of Medical Oncology, Hospital Universitario La Paz, Madrid, Spain

Correspondence to:

Reyes Bernabé-Caro, email: [email protected]

Keywords: ALK-positive NSCLC; ALK inhibitor; crizotinib; alectinib; unselected patient

Received: April 08, 2022     Accepted: May 19, 2022     Published: June 15, 2022

Copyright: © 2022 Bernabé-Caro et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


This retrospective observational study analyzed the clinical characteristics, treatment patterns and outcomes of 120 patients with advanced ALK-positive non-small-cell lung cancer (ALK+ NSCLC) according to data collected between November 2019 and October 2020 in 38 Spanish hospitals. Patients had progressed after 1–5 prior treatment lines (which included crizotinib in any prior line) and received subsequent therapy with alectinib in a local expanded access program. Median age was 58.7 years, 50% of patients were female, 64.1% had ECOG PS of 0–1, 85% presented stage IV, 95% had adenocarcinoma histology and 20.8% had brain metastases. After a median 9.6 months of alectinib treatment, objective response rate (ORR) was 54.5%, disease control rate (DCR) was 80%, median progression-free survival (PFS) was 9.4 months and median overall survival (OS) was 24.1 months. Patients with brain metastases achieved an intracranial DCR of 71.4%. Adverse events (AEs) were reported in 35.8% of patients (14.2% of AEs were grade ≥3). Over 40% of patients received some treatment after alectinib, most frequently lorlatinib (65.2%) and brigatinib (32.6%). This study provides information on real-world treatment patterns and confirms the tolerability and prolonged PFS and OS observed with alectinib in clinical trials, in unselected pretreated patients with advanced ALK+ NSCLC.

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