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上海市胸科医院肺部肿瘤临床医学中心 陆 舜 李子明
【摘要】背景 随着晚期 非小细胞肺癌( NSCLC )一线治疗取得很大的进步 ，人们越来越需要更有效的二线治疗方案。关于 吉非替尼( ZD1839 ， IRESSA ， Gefitinib ，易瑞沙)的 Ⅱ 期临床研究发现日裔患者接受吉非替尼治疗后的疗效优于非日裔患者。但是关于吉非替尼与安慰剂随机对照的 Ⅲ 期临床研究- ISEL 试验的结果却表明：无论对所有患者，还是对腺癌患者，吉非替尼与安慰剂相比未能延长生存。但是亚组分析显示亚裔患者获得生存优势。人们想到：是否人种差异对于吉非替尼的疗效影响特别大呢？ 目的 回顾性分析亚裔晚期 NSCLC 患者使用吉非替尼的临床研究，了解亚裔患者使用吉非替尼后的疗效与毒性反应。 方法 对来自中国、日本、韩国、台湾等国家和地区超过 2000 例的晚期 NSCLC 患者进行回顾性分析。 结果与讨论 根据大部分研究的报道结果，发现吉非替尼治疗后达到的客观缓解率超过 25 %；疾病控制率超过 60 %；中位疾病进展时间( TTP )超过 6 个月 , 中位疾病进展时间( TTP )超过 3 个月。 这些研究显示：女性、不吸烟、腺型、 PS 评分好、多发肺转移的患者接受 吉非替尼治疗的疗效较好。亚裔患者对吉非替尼的耐受性较好。这些研究还发现日裔患者间质性肺炎的发生率要高于非日裔患者，但是原因不详。最近人们对相关分子生物学与基因指标预测吉非替尼缓解情况进行研究。
[Abstract] Background Improvement in first-line therapy of advanced non-small cell lung cancer(NSCLC) have increased the need for the effective second-line treatment options. In a phase Ⅱtrial of Gefitinib (Iressa), great efficacy was observed in Japanese compared with non-Japanese patients. Furthermore, results from a placebo-controlled phase Ⅲ trial (ISEL) showed that treatment with Gefitinib was not associated with a improvement in survival in either the overall or adenocarcinoma co-primary populations, although there was marked heterogeneity in survival outcomes between patient group, with patients of Asian origin achieving a significant survival benefit with Gefitinib compared with placebo. Objective To review the benefit: risk profile of Gefitinib in Asian patients with advanced NSCLC. Method We reviewed a total of > 2000 patients with refractory NSCLC in China , Japan , Korea , Taiwan by searching Medline and EMBASE database. Results and discussion In the majority of these reports, objective response > 25% and disease control rates of > 60% have been described. Treatment with Gefitinib resulted in a median survival time of > 6 months and median time to progression > 3 months. Female gender, adenocarcinoma history, non-smoking history, good PS and the presence of multiple lung metastases are associated with improved responsiveness to Gefitinib. Reflecting the results of previous clinical trials, the reports indicate that Gefitinib is generally well tolerated by Asian patients. The incidence of interstitial lung disease appears to higher in Japanese than non- Japanese patients, although the reason for this are not clear. Recent findings regarding cellular and genetic factors may underlie the increased responsiveness to Gefitinib among Asian patients are discussed.
【摘要】背景 随着晚期 非小细胞肺癌( NSCLC )一线治疗取得很大的进步 ，人们越来越需要更有效的二线治疗方案。关于 吉非替尼( ZD1839 ， IRESSA ， Gefitinib ，易瑞沙)的 Ⅱ 期临床研究发现日裔患者接受吉非替尼治疗后的疗效优于非日裔患者。但是关于吉非替尼与安慰剂随机对照的 Ⅲ 期临床研究- ISEL 试验的结果却表明：无论对所有患者，还是对腺癌患者，吉非替尼与安慰剂相比未能延长生存。但是亚组分析显示亚裔患者获得生存优势。人们想到：是否人种差异对于吉非替尼的疗效影响特别大呢？ 目的 回顾性分析亚裔晚期 NSCLC 患者使用吉非替尼的临床研究，了解亚裔患者使用吉非替尼后的疗效与毒性反应。 方法 对来自中国、日本、韩国、台湾等国家和地区超过 2000 例的晚期 NSCLC 患者进行回顾性分析。 结果与讨论 根据大部分研究的报道结果，发现吉非替尼治疗后达到的客观缓解率超过 25 %；疾病控制率超过 60 %；中位疾病进展时间( TTP )超过 6 个月 , 中位疾病进展时间( TTP )超过 3 个月。 这些研究显示：女性、不吸烟、腺型、 PS 评分好、多发肺转移的患者接受 吉非替尼治疗的疗效较好。亚裔患者对吉非替尼的耐受性较好。这些研究还发现日裔患者间质性肺炎的发生率要高于非日裔患者，但是原因不详。最近人们对相关分子生物学与基因指标预测吉非替尼缓解情况进行研究。
[Abstract] Background Improvement in first-line therapy of advanced non-small cell lung cancer(NSCLC) have increased the need for the effective second-line treatment options. In a phase Ⅱtrial of Gefitinib (Iressa), great efficacy was observed in Japanese compared with non-Japanese patients. Furthermore, results from a placebo-controlled phase Ⅲ trial (ISEL) showed that treatment with Gefitinib was not associated with a improvement in survival in either the overall or adenocarcinoma co-primary populations, although there was marked heterogeneity in survival outcomes between patient group, with patients of Asian origin achieving a significant survival benefit with Gefitinib compared with placebo. Objective To review the benefit: risk profile of Gefitinib in Asian patients with advanced NSCLC. Method We reviewed a total of > 2000 patients with refractory NSCLC in China , Japan , Korea , Taiwan by searching Medline and EMBASE database. Results and discussion In the majority of these reports, objective response > 25% and disease control rates of > 60% have been described. Treatment with Gefitinib resulted in a median survival time of > 6 months and median time to progression > 3 months. Female gender, adenocarcinoma history, non-smoking history, good PS and the presence of multiple lung metastases are associated with improved responsiveness to Gefitinib. Reflecting the results of previous clinical trials, the reports indicate that Gefitinib is generally well tolerated by Asian patients. The incidence of interstitial lung disease appears to higher in Japanese than non- Japanese patients, although the reason for this are not clear. Recent findings regarding cellular and genetic factors may underlie the increased responsiveness to Gefitinib among Asian patients are discussed.