Evaluation of efficacy and safety of crizotinib and its prognostic factors in patients with ALK-positive advanced non-small cell lung cancer / 国际肿瘤学杂志

ABSTRACT

Objective To investigate the efficacy and safety of crizotinib in patients with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC),and focuse on analysis of its prognostic factors.Methods Fifty patients with advanced (stage m B-Ⅳ) ALK-positive NSCLC confirmed by cytology or histology in Peking Union Medical Collage Hospital from January 2013 to September 2016 were collected.The relevant clinical imformation and treatment protocols were recorded.The efficacy and safety of crizotinib were followed up,and its prognostic factors were analyzed.Results At the end of follow-up,the median progression free survival (PFS) of progressed patients (n =24) was 9.6 months (95％ CI8.3-10.9 months),of which five patients died.The median follow-up time of non-progressed patients (n =26) was 10.7 months.The most common adverse event was abnormal liver function (48.0％,24/50).In the single factor analysis of Kaplan-Meier,younger or equal to 40 years old patients had a longer PFS (P =0.017),and the COX regression analysis (Enter method) also had statistical significance differences (HR =6.1,95％ CI1.4-27.5,P =0.018).However,gender (HR =0.8,95％ CI0.2-2.6,P =0.697),smoking history (HR =1.5,95％ CI0.4-5.6,P =0.524),pathology (HR =1.1,95％ CI0.3-4.2,P =0.922),tumor stage (HR =1.7,95％ CI0.4-8.4,P =0.502),epidermal growth factor receptor (EGFR) mutant type (HR =0.4,95％ CI0.4-4.3,P =0.461),EGFR unknown (HR =1.3,95％ CI0.3-6.1,P =0.727),Eastern Cooperative Oncology Group Performance Status (ECOG) PS score (HR =2.0,95％ CI0.6-6.8,P =0.290),the status of previous treatment (HR =0.6,95％ CI0.2-1.8,P =0.385) and brain metastasis (HR=0.7,95％CI0.1-3.2,P=0.628) were not associated with disease progression Conclusion Crizotinib has good efficacy and is safe and well-tolerated to advanced ALK-positive NSCLC patients,and age is the independent prognostic factor.