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

Oncotarget. 2022 Jun 15:13:812-827. doi: 10.18632/oncotarget.28244. eCollection 2022.

Abstract

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.

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

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Anaplastic Lymphoma Kinase / metabolism
  • Brain Neoplasms* / drug therapy
  • Brain Neoplasms* / secondary
  • Carbazoles
  • Carcinoma, Non-Small-Cell Lung* / pathology
  • Crizotinib / adverse effects
  • Female
  • Humans
  • Lung Neoplasms* / pathology
  • Male
  • Middle Aged
  • Piperidines
  • Protein Kinase Inhibitors / adverse effects

Substances

  • Carbazoles
  • Piperidines
  • Protein Kinase Inhibitors
  • Crizotinib
  • Anaplastic Lymphoma Kinase
  • alectinib