Title

吉非替尼治療局部晚期或轉移性非小細胞肺癌在中國的臨床研究

Translated Titles

Efficacy of Gefitinib on Chinese Patients with Locally Advanced or Metastatic Non-small Cell Lung Cancer: A Clinical Trial

Authors

管忠震(Zhong-Zhen Guan);張力(Li Zhang);李龍芸(Long-Yun Li);蔣國梁(Guo-Liang Jiang);劉敘儀(Xu-Yi Liu);儲大同(Da-Tong Chu);趙洪雲(Hong-Yun Zhao);李瑋(Wei Li)

Key Words

肺腫瘤/藥物療法 ; 癌,非小細胞性 ; 吉非替尼/治療應用 ; 臨床研究 ; 療效 ; 中國人 ; Lung neoplasms/drug therapy ; Cancer, non-small cells ; Gefitinib/therapeutic application ; Clinical trial ; Effectiveness ; Chinese

PublicationName

癌症

Volume or Term/Year and Month of Publication

24卷8期(2005 / 08 / 05)

Page #

980 - 984

Content Language

簡體中文

Chinese Abstract

背景與目的:吉非替尼是一種有效的表皮生長因子受體酪氨酸激酶選擇性抑制劑,國外已批准用於治療局部晚期或轉移性的非小細胞肺癌(non-small cell lung cancer,NSCLC)。本項研究系吉非替尼治療中國NSCLC的註冊臨床研究,旨在評估吉非替尼對既往化學治療失敗的局部晚期或轉移性中國NSCLC患者的療效和安全性。方法:159例經病理學確診的NSCLC患者進入本研究。吉非替尼劑量為每次250mg,每天一次口服,直至腫瘤進展或出現不可耐受的不良事件。結果:全組客觀有效率為27.0%,疾病控制率為54.1%,中位無進展生存時間97天,中位生存期10個月,1年生存率44%。最常見的藥物相關不良事件為皮疹(44.0%)、皮膚瘙癢(15.7%)和腹瀉(10.1%),大部分為I~Ⅱ級,不需處理。結論:吉非替尼對既往化療失敗的中國局部晚期或轉移性NSCLC患者有較好的療效和安全性。

English Abstract

Background & Objective: Gefitinib, a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, has been approved to be used in treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in many countries. This study, a multicenter clinical trial, was designed to evaluate the efficacy of gefitinib on Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy, and explore its safety. Methods: A total of 159 pathologically-confirmed NSCLC patients were enrolled. Gefitinib was orally administered 250 mg once daily until disease progression or the occurrence of intolerable toxicity. Results: The objective response rate was 27.0%; the disease control rate was 54.1%. The median progression-free survival time was 97 days; the median overall survival time was 10.0 months; the 1-year survival rate was 44%. The most common drug-related adverse events were rash (44.0%), pruritus (15.7%), and diarrhea (10.1%), and most of them were grade 1-2 events with no need of further treatment. Conclusion: Gefitinib is effective and safe in treating Chinese patients with locally advanced or metastatic NSCLC after failure of previous chemotherapy.

Topic Category 醫藥衛生 > 內科