Cumulative incidence rates for CNS and non-CNS progression in two phase II studies of alectinib in ALK-positive NSCLC

Shirish Gadgeel*, Alice T. Shaw, Fabrice Barlesi, Lucio Crino, James Chih-Hsin Yang, Anne-Marie C. Dingemans, Dong-Wan Kim, Filippo de Marinis, Mathias Schulz, Shiyao Liu, Ravindra Gupta, Ahmed Kotb, Sai-Hong Ignatius Ou

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


Background: We evaluated the cumulative incidence rate (CIR) of central nervous system (CNS) and non-CNS progression in alectinib-treated patients with anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) to determine the extent to which alectinib may treat or control CNS disease. Methods: Patients with crizotinib-pretreated locally advanced or metastatic disease received alectinib 600 mg orally twice daily in two phase II trials. All patients underwent baseline imaging and regular centrally reviewed scans. Results: At 24 months, the CIR for CNS progression was lower in patients without vs with baseline CNS metastases (8.0 vs 43.9%). Patients with baseline CNS disease and prior radiotherapy had a higher CIR of CNS progression than radiotherapy-naive patients (50.5 vs 27.4%) and a lower CIR of non-CNS progression (25.8 vs 42.5%). Adverse events leading to withdrawal occurred in 5.9% and 6.7% of patients with and without baseline CNS metastases, respectively. Conclusions: This analysis indicates a potential role for alectinib in controlling and preventing CNS metastases.
Original languageEnglish
Pages (from-to)38-42
Number of pages5
JournalBritish Journal of Cancer
Issue number1
Publication statusPublished - 9 Jan 2018


  • alectinib
  • ALK positive
  • central nervous system
  • cumulative incidence rates
  • disease progression
  • non-small-cell lung cancer
  • phase II

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