- 期刊
Real-World Crizotinib Use for Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer under First-Year National Health Insurance Coverage in Taiwan
Crizotinib在台灣健保給付的第一年於ALK(+)晚期非小細胞肺癌患者之使用
摘要
Background: Crizotinib is effective in treating advanced non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) rearrangement [ALK(+)]. It has been approved by the National Health Insurance (NHI) administration in Taiwan for second-line treatment since September 2015. The clinical benefits and adverse effects of crizotinib in Taiwanese NSCLC patients have not yet been well investigated. Patients and Methods: We enrolled patients who applied for NHI-covered crizotinib treatment for ALK(+) NSCLC from September 1^(st), 2015 to September 30^(th), 2016 at National Taiwan University Hospital. ALK gene rearrangement was detected by immunohistochemistry or fluorescence in situ hybridization. The patients' demographics, cancer status, crizotinib treatment response, drug-related adverse effects and survival were analyzed. Results: Twenty-seven patients received crizotinib for ALK(+) advanced NSCLC during the study period. The tumor response rate was 26% and the disease control rate was 63%. The median progression-free survival (PFS) was 5.4 months; the median overall survival after crizotinib has not been reached yet. The PFS of patients with brain metastases before crizotinib treatment did not differ from the PFS of those without brain metastases. The crizotinib PFS between patients with brain progression and those with non-brain progression did not differ significantly. Nine (33%) patients were given a reduced dosage or discontinued crizotinib because of severe drug-related adverse effects. Conclusions: In real-world practice, crizotinib is effective as a second-line treatment for advanced ALK(+) NSCLC. However, side effects are not uncommon. The response rate is lower and the PFS is shorter than that of clinical trial patients.
並列摘要
前言：Crizotinib可有效治療晚期有ALK基因重組([ALK(+)]之非小細胞肺癌。2015年9月起二線crizotinib治療已納入台灣全民健保給付，然而crizotinib在台灣健保病患的治療效果及副作用仍然尚不清楚。方法：分析台灣台大醫院於2015年9月1日至2016年9月30日，申請使用全民健保crizotinib治療晚期ALK(+)非小細胞肺癌病患之臨床特徵、腫瘤狀況、crizotinib治療的反應以及副作用。結果：在研究期間總共有27位ALK(+)晚期非小細胞肺癌病患接受健保crizotinib治療，腫瘤的反應率為26%，疾病控制率為63%，中位數無病存活期(PFS)為5.4個月，中位數存活期(OS)則尚未達到。無論病患在crizotinib治療前有無腦部轉移，PFS並無顯著差異；無論病患在crizotinib治療後無論是否發生腦部轉移，PFS亦無顯著差異。有9位(33%)病患在治療中因為副作用需要減量或停藥。結論：在現實臨床的病患，crizotinib對台灣晚期ALK(+)非小細胞肺癌的病患是有效的二線治療。然而腫瘤反應率及PFS均較臨床試驗差，治療相關的副作用也不少見。