Interstitial Lung Disease Associated with Crizotinib in Patients with Advanced Non-Small-Cell Lung Cancer: Independent Review of Four PROFILE Trials

Interstitial lung disease (ILD) is a potentially serious side effect associated with crizotinib, a tyrosine kinase inhibitor for ALK-positive advanced non-small-cell lung cancer. In this retrospective review of 1669 patients who received crizotinib in four clinical trials, an expert independent review committee determined that the incidence of ILD was 1.2% overall, 1.3% in Caucasians, and 1.2% in Asians but higher at 3.7% in Japanese patients. Mortality rate due to ILD was 50%. ILD associated with crizotinib, although rare, can occur at any time and requires close monitoring.

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