Comparison of Gefitinib Monotherapy and Chemotherapy with Cisplatin and Gemcitabine in Chemonaive Patients with Advanced Non-small Cell Lung Cancer: A Case-Control Study

比較Gefitinib與Cisplatin和Gemcitabine合併治療用於未經治療的晚期非小細胞肺癌之差異－病例對照研究

陳焜結(Kun-Chieh Chen) ； 張基晟(Gee-Chen Chang) ； 楊宗穎(Tsung-Ting Yang) ； 郭英調(Benjamin Ing-Tiau Kuo) ； 林京珮(Ching-Pei Lin) ； 許正園(Jeng-Yuan Hsu)

《胸腔醫學》 19卷5期 (2004/10) Pp. 340-345

https://doi.org/10.29806/TM.200410.0004

摘要

背景：肺癌是目前世界各國主要的癌症死因。對於晚期的非小細胞癌患者，含鉑的合併化學治療是目前治療方式的主流，但化學治療相對也伴隨許多令人不悅的副作用。口服Gefitinib是一種不同於化療的抗癌藥物。我們以病例對照的方式，分析合併化療與口服Gefitinib用於非小細胞肺癌病人的第一線治療的療效和安全性。
方法：本研究自西元2002年2月至2003年6月共收集23位第一線接受口服Gefitiulb治療（每日250mg）的病人，及另外一組46位接受第一線合併化學治療(cisplatin and gemcitabine)的病人，進行病例對照研究分析，比較兩組病人的療效及安全性。
結果：二組在腫瘤反應率（病例組為56.5%；對照組為45.7%）及存活時間上(Median overall survival病例組為9.9個月，對照組為13.8個月)，均無統計上分別。
結論：由本研究推論，口服Gefitinib在非小細胞肺癌病人的第一線治療應具有臨床價值。

關鍵字

Gefitinib ； 未經化學藥物治療 ； 非小細胞肺癌

並列摘要

Background: Lung cancer is the leading cause of cancer death in the world. In advanced NSCLC, chemotherapy is the standard treatment strategy, but it has unfavorable side effects. Gefitinib is an orally active, selective inhibitor of EGFR-tyrosine kinase, which is commonly expressed in solid human tumors of an epithelial origin. In clinical trials, monotherapy with gefitinib in pretreated advanced NSCLC has been shown to provide favorable anti-tumor activity and safety. Treatment with gefitinib is not typically associated with the characteristic adverse events of chemotherapy. We performed a case-control study to compare the efficacy of gefitinib and chemotherapy with cisplatin and gemcitabine in chemotherapy-naive NSCLC patients.
Methods: Between Feb 2002 and June 2003, we enrolled 23 patients with chemo-naive lung cancer who underwent treatment with gefitinib 250mg daily, and 46 patients, matched by sex, age, cell type, and disease stage, who received first-line chemotherapy with cisplatin and gemcitabine.
Results: In this study, no statistically significant difference between the gefitinib treatment group and the control group was detected in the response rate (56.5% vs 45.7%), median progression-free survival (6.97months vs 6.97months), and median overall survival (9.9 months vs 13.8 months). The adverse effects in the gefitinib group were relatively mild and tolerable.
Conclusion: Gefitinib has acceptable antitumor activity and safety in chemo-naive lung cancer patients. Further studies are required to validate these findings.

並列關鍵字

Gefitinib ； chemotherapy-naïve ； non-small cell lung cancer