What is the role of crizotinib (Xalkori) in the treatment of non-small cell lung cancer (NSCLC)?

Updated: Aug 21, 2019
  • Author: Maurie Markman, MD, MS; Chief Editor: Keith K Vaux, MD  more...
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The benefit of testing for ALK rearrangements was demonstrated in phase I and phase II trials of the ALK inhibitor crizotinib (Xalkori). [11, 12] Results from these trials formed the basis of crizotinib’s accelerated approval in the United States, along with a companion diagnostic to evaluate ALK rearrangements on FISH.

In these trials, patients with the EML4-ALK fusion, nearly all of whom had progressed despite at least 1 prior line of therapy, showed response rates of approximately 50 to 60% crizotinib. Response duration was 42-48 weeks. [11, 12]

Because phase III trials are still underway and survival data are not yet available, researchers conducted a retrospective, nonrandomized analysis comparing patients enrolled in the 2 trials with historical controls to estimate the clinical benefit of crizotinib therapy. [33] In patients who received crizotinib as second-line therapy, the 1-year overall survival rate was 70% and the 2-year overall survival rate was 55%. By contrast, ALK -positive matched controls had a 1-year survival of 44% and a 2-year survival of 12%, whereas ALK -negative controls had a 1-year survival of 47% and a 2-year survival of 32%. These data suggest that the presence of the ALK gene fusion itself does not confer a poorer outcome but that the use of crizotinib in ALK -positive patients can improve outcomes.

Based on these data, testing for ALK rearrangement is recommended in patients with metastatic NSCLC adenocarcinoma, and the ALK inhibitor crizotinib is recommended for ALK-positive patients.

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