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Heart rate decrease during crizotinib treatment and potential correlation to clinical response.

Sai-Hong Ignatius Ou1, Wilson P Tong, Michele Azada

  • 1Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, CA, USA. ignatius.ou@uci.edu

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|March 19, 2013
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Summary

Crizotinib treatment for ALK-rearranged NSCLC commonly causes sinus bradycardia (SB), a slower heart rate. Patients experiencing SB showed better treatment response, suggesting a potential link between heart rate changes and crizotinib efficacy.

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Area of Science:

  • Oncology
  • Cardiology
  • Pharmacology

Background:

  • Crizotinib is a targeted therapy for anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC).
  • Sinus bradycardia (SB), characterized by a heart rate below 60 bpm, is a known potential side effect of crizotinib.
  • The clinical significance of SB during crizotinib therapy, including its frequency, timing, and association with treatment outcomes, requires further investigation.

Purpose of the Study:

  • To determine the frequency and timing of sinus bradycardia (SB) in patients treated with crizotinib.
  • To identify patient characteristics associated with the development of SB during crizotinib therapy.
  • To explore the potential correlation between heart rate (HR) changes, specifically SB, and clinical response to crizotinib in advanced NSCLC.

Main Methods:

  • A retrospective chart review was conducted.
  • Data collected included the timing and frequency of SB, patient demographics, and clinical response to crizotinib.
  • Analysis focused on patients enrolled in crizotinib trials (PROFILE 1001 and PROFILE 1005).

Main Results:

  • Forty-two patients with ALK-rearranged or MET-amplified NSCLC treated with crizotinib were analyzed.
  • An average decrease of 26.1 bpm in heart rate was observed during crizotinib treatment.
  • 69% of patients experienced at least one episode of SB, with the lowest HR occurring at a median of 18.6 weeks.
  • Patients who experienced SB were older, had lower baseline HR, and were on crizotinib longer.
  • Significantly greater overall response rates and tumor shrinkage were observed in patients who experienced SB.

Conclusions:

  • A decrease in heart rate and the occurrence of sinus bradycardia are common during crizotinib treatment for NSCLC.
  • The observed correlation between HR decrease and improved clinical response warrants further study.
  • It remains to be determined if this association reflects a biomarker of drug efficacy or a cumulative dose-dependent effect.