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吉非替尼作为台湾南部晚期或转移性非小细胞肺癌患者的一线治疗药物。

Gefitinib as first-line therapy for advanced or metastatic non-small cell lung cancer patients in southern Taiwan.

机构信息

Department of Respiratory Care, College of Medicine, Chang Gung University, Chiayi, Taiwan.

出版信息

Kaohsiung J Med Sci. 2010 Jan;26(1):1-7. doi: 10.1016/S1607-551X(10)70001-2.

DOI:10.1016/S1607-551X(10)70001-2
PMID:20040466
Abstract

Gefitinib, a selective epidermal growth factor receptor tyrosine kinase inhibitor, is effective in treating patients with non-small cell lung cancer (NSCLC) after unsuccessful chemotherapy. However, survival outcomes and predictors for its effectiveness in chemotherapy-naive NSCLC patients are still not clear. The goal of this study was to investigate the response and survival rates and identify the predictive factors for patients with advanced or metastatic disease receiving gefitinib as first-line therapy. We retrospectively analyzed the response and survival rates of patients with advanced or metastatic NSCLC who had received gefitinib as first-line therapy across six medical institutes in Southern Taiwan between May 2004 and April 2006. The relationship between the response and survival rates to the known predictive factors for gefitinib response and survival was also investigated. A total of 97 patients (65 females and 32 males) were enrolled in this study. Seventy-four patients (76%) had never smoked. Eighty-eight patients (91%) had adenocarcinoma or bronchioloalveolar cell carcinoma. The objective response rate was 56% and the disease control rate (partial response plus stable disease) was 76%. Only poor performance status (Eastern Cooperative Oncology Group score, 3-4) was statistically significantly associated with overall response in this study. The 1-year survival rate was 77%. We suggest that first-line gefitinib monotherapy is promising in some subgroups of Asian patients with NSCLC. Further randomized controlled studies are needed to validate the effectiveness of first-line gefitinib therapy.

摘要

吉非替尼是一种选择性表皮生长因子受体酪氨酸激酶抑制剂,对化疗失败的非小细胞肺癌(NSCLC)患者有效。然而,对于化疗初治的 NSCLC 患者,其生存结局和有效性的预测因素仍不清楚。本研究的目的是探讨接受吉非替尼一线治疗的晚期或转移性疾病患者的反应率和生存率,并确定其预测因素。我们回顾性分析了 2004 年 5 月至 2006 年 4 月台湾南部六家医疗机构接受吉非替尼一线治疗的晚期或转移性 NSCLC 患者的反应率和生存率。还研究了已知的吉非替尼反应和生存预测因素与反应率和生存率之间的关系。本研究共纳入 97 例患者(65 例女性和 32 例男性)。74 例患者(76%)从不吸烟。88 例患者(91%)为腺癌或细支气管肺泡细胞癌。客观缓解率为 56%,疾病控制率(部分缓解加稳定疾病)为 76%。仅较差的体能状态(东部肿瘤协作组评分 3-4)与总体反应在本研究中具有统计学显著相关性。1 年生存率为 77%。我们建议,吉非替尼一线单药治疗在某些亚洲 NSCLC 患者亚组中具有前景。需要进一步的随机对照研究来验证一线吉非替尼治疗的有效性。

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本文引用的文献

1
EGFR mutation of tumor and serum in gefitinib-treated patients with chemotherapy-naive non-small cell lung cancer.吉非替尼治疗的初治非小细胞肺癌患者肿瘤及血清中的表皮生长因子受体(EGFR)突变
J Thorac Oncol. 2006 Mar;1(3):260-7. doi: 10.1016/s1556-0864(15)31577-x.
2
Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer.吉非替尼作为中国晚期非小细胞肺癌患者的一线治疗药物。
Lung Cancer. 2006 Nov;54(2):193-9. doi: 10.1016/j.lungcan.2006.07.013. Epub 2006 Sep 22.
3
Survival outcome and predictors of gefitinib antitumor activity in East Asian chemonaive patients with advanced nonsmall cell lung cancer.
东亚初治晚期非小细胞肺癌患者吉非替尼抗肿瘤活性的生存结果及预测因素
Cancer. 2006 Oct 15;107(8):1873-82. doi: 10.1002/cncr.22220.
4
Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations.吉非替尼用于未经化疗的晚期非小细胞肺癌表皮生长因子受体基因突变患者的前瞻性II期研究。
J Clin Oncol. 2006 Jul 20;24(21):3340-6. doi: 10.1200/JCO.2005.05.4692. Epub 2006 Jun 19.
5
First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study.吉非替尼一线单药治疗晚期非小细胞肺癌患者:一项II期研究。
J Clin Oncol. 2006 Jan 1;24(1):64-9. doi: 10.1200/JCO.2005.02.5825.
6
Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer).吉非替尼联合最佳支持治疗用于既往治疗过的难治性晚期非小细胞肺癌患者:一项随机、安慰剂对照、多中心研究(肺癌中易瑞沙生存评估)的结果
Lancet. 2005;366(9496):1527-37. doi: 10.1016/S0140-6736(05)67625-8.
7
Clinicopathologic significance of the mutations of the epidermal growth factor receptor gene in patients with non-small cell lung cancer.非小细胞肺癌患者表皮生长因子受体基因突变的临床病理意义
Clin Cancer Res. 2005 Oct 1;11(19 Pt 1):6816-22. doi: 10.1158/1078-0432.CCR-05-0441.
8
Gefitinib treatment for non-small cell lung cancer -- a study including patients with poor performance status.吉非替尼治疗非小细胞肺癌——一项纳入体能状态较差患者的研究。
J Formos Med Assoc. 2005 Aug;104(8):557-62.
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Mutations in the tyrosine kinase domain of the EGFR gene associated with gefitinib response in non-small-cell lung cancer.表皮生长因子受体(EGFR)基因酪氨酸激酶结构域的突变与非小细胞肺癌中吉非替尼的反应相关。
Lung Cancer. 2005 Oct;50(1):25-33. doi: 10.1016/j.lungcan.2005.05.017.
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Epidermal growth factor receptor gene mutations and increased copy numbers predict gefitinib sensitivity in patients with recurrent non-small-cell lung cancer.表皮生长因子受体基因突变和拷贝数增加可预测复发性非小细胞肺癌患者对吉非替尼的敏感性。
J Clin Oncol. 2005 Oct 1;23(28):6829-37. doi: 10.1200/JCO.2005.01.0793. Epub 2005 Jul 5.