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Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a
D Ross Camidge1, Yung-Jue Bang, Eunice L Kwak
1University of Colorado Denver, Aurora, CO, USA. ross.camidge@ucdenver.edu
The Lancet. Oncology
|September 8, 2012
Summary
Crizotinib demonstrated significant efficacy in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (NSCLC), showing rapid and durable responses. The drug was generally well-tolerated, with potential for continued benefit even after disease progression.
Area of Science:
- Oncology
- Pharmacology
Background:
- Anaplastic lymphoma kinase (ALK) fusion genes are present in a subset of non-small-cell lung cancers (NSCLC).
- Assessing crizotinib's tolerability and efficacy in ALK-positive NSCLC patients is crucial.
Purpose of the Study:
- To evaluate the safety and activity of crizotinib in patients with ALK-positive NSCLC.
- To determine tumor responses, duration of response, progression-free survival (PFS), and overall survival.
Main Methods:
- Phase 1 study of oral crizotinib (250 mg twice daily) in ALK-positive stage III or IV NSCLC patients.
- Endpoints included objective response rate, PFS, overall survival, safety, tolerability, and pharmacokinetics.
- 149 ALK-positive patients were enrolled; 143 were evaluable for response.
Main Results:
- An objective response rate of 60.8% (87/143) was observed, with a median duration of response of 49.1 weeks.
- Median progression-free survival (PFS) was 9.7 months.
- Most treatment-related adverse events were grade 1 or 2; common events included visual disturbances, nausea, and diarrhea. Grade 3/4 events included neutropenia and elevated liver enzymes.
Conclusions:
- Crizotinib is well-tolerated and provides rapid, durable responses in ALK-positive NSCLC patients.
- Potential for ongoing clinical benefit after initial disease progression warrants further investigation.
- Further research is needed to formally define ongoing benefit in this patient population.
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