Abstract
BackgroundNumerous clinical trials show crizotinib has promising efficacy for anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients which trigger the substitution of traditional chemotherapy to be the current standard first-line treatment for these patients. Conversely, few reports systematically analyze toxicity of crizotinib. Hence, we performed a first meta-analysis to determine the risk of crizotinib-related severe adverse events (SAEs) and fatal adverse events (FAEs) in ALK positive NSCLC patients.Materials and MethodsA systematic literature search was conducted through December 2016 to identify clinical trials that reported crizotinib monotherapy in ALK-positive NSCLC patients. Data on crizotinib-related SAEs and FAEs were extracted from each study and pooled to determine the overall incidence and risk. Random-effects or fixed-effects models were conducted to calculate the summary incidence, relative risk (RR), and 95% CIs on basis of the heterogeneity of included studies.Results1,924 patients from 11 clinical trials were included. The overall incidence of SAEs and FAEs with crizotinib was 19.9% (95% CI, 14.1% to 23.7%; P < 0.001) and 1.4% (95% CI, 0.9% to 2.1%; P < 0.001), respectively. Meanwhile, Asian patients have lower incidence of SAEs (11.5%, 95% CI: 7.9% to 16.5%). However, significant differences of SAEs (RR: 0.97, 95% CI, 0.79 to 1.18; P = 0.76) and FAEs (RR: 2.24, 95% CI, 0.49 to 10.30; P = 0.30) were not detected between crizotinib monotherapy and chemotherapy.ConclusionsCrizotinib may not increase the risk of SAEs and FAEs in patients with ALK positive NSCLC compared with chemotherapy.
Highlights
Lung cancer is the leading cause of cancer morbidity and mortality in the world [1]
Crizotinib may not increase the risk of severe adverse events (SAEs) and fatal adverse events (FAEs) in patients with anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) compared with chemotherapy
85% of lung cancer cases are characterized as non-small cell lung cancer (NSCLC) cases [2] and anaplastic lymphoma kinase (ALK) positive is therein non-negligible, occurring in 2 to 7% of all NSCLC [3]
Summary
85% of lung cancer cases are characterized as non-small cell lung cancer (NSCLC) cases [2] and anaplastic lymphoma kinase (ALK) positive is therein non-negligible, occurring in 2 to 7% of all NSCLC [3]. Few reports systematically analyze severe and fatal toxicity of crizotinib. We performed this meta-analysis to estimate the incidence and risk of SAEs and FAEs with crizotinib among ALK-positive NSCLC patients. Numerous clinical trials show crizotinib has promising efficacy for anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC) patients which trigger the substitution of traditional chemotherapy to be the current standard first-line treatment for these patients. We performed a first meta-analysis to determine the risk of crizotinib-related severe adverse events (SAEs) and fatal adverse events (FAEs) in ALK positive NSCLC patients
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