Meta-analysis of incidence and risk of severe adverse events and fatal adverse events with crizotinib monotherapy in patients with ALK-positive NSCLC

Qian Zhu, Hao Hu, Feng Jiang, Chang Ying Guo, Xiong Wen Yang, Xi Liu and Yu Kang Kuang _

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Oncotarget. 2017; 8:75372-75380. https://doi.org/10.18632/oncotarget.18536

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Qian Zhu1,*, Hao Hu2,*, Feng Jiang3,*, Chang Ying Guo3, Xiong Wen Yang4, Xi Liu3 and Yu Kang Kuang2,3

1Department of Biotherapy, Sun Yat-sen University Cancer Center, Guangzhou 510060, Guangdong, China

2Department of Thoracic Surgery, Medical College of Nanchang University, Nanchang 330000, Jiangxi, China

3Department of Thoracic Surgery, Jiangxi Province Tumor Hospital, Nanchang 330006, Jiangxi, China

4Department of Lung Cancer Center, First People's Hospital Chenzhou, Chenzhou 423000, Hunan, China

*These authors contributed equally to this work

Correspondence to:

Yu Kang Kuang, email: [email protected]

Keywords: crizotinib, severe adverse effects, fatal adverse effects, non-small cell lung cancer, anaplastic lymphoma kinase

Received: February 08, 2017     Accepted: June 04, 2017     Published: June 17, 2017


Background: 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. 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 Methods: A 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.

Results: 1,924 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.

Conclusions: Crizotinib may not increase the risk of SAEs and FAEs in patients with ALK positive NSCLC compared with chemotherapy.

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