Lin Wei-Chun, Chiu Chao-Hua, Liou Jia-Ling, Chen Yuh-Min, Perng Reury-Perng, Tsai Chun-Ming
Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan.
Lung Cancer. 2006 Nov;54(2):193-9. doi: 10.1016/j.lungcan.2006.07.013. Epub 2006 Sep 22.
This phase II single arm, open label study was designed to evaluate the efficacy and toxicity of oral gefitinib (250mg) daily in previously untreated patients with advanced non-small-cell lung cancer (NSCLC).
Eligible patients had stage IIIB or IV NSCLC with adequate organ functions, and were chemonaïve. All eligible patients were treated with oral administration of 250mg of gefitinib until intolerable toxicity, disease progression or death occurred. Responses were assessed after every 8 weeks of therapy.
For a total of 53 patients, the objective response rate (ORR) was 32.1% and overall disease control rate (DCR) was 52.8%. Median overall and progression-free survivals (PFS) were 9.4 (95% CI, 8.8-13.3) and 3.2 months (95% CI, 1.1-5.2) months, and 1-year survival rate was 41.5%. Patients with adenocarcinoma (n=35) had a higher response rate. Adenocarcinoma, female gender (n=24), and response to gefitinib were predictive factors for better survival. The most commonly seen adverse events (AEs) were skin toxicity (54.7%), diarrhea (43.4%) and nail change (16.9%). Most AEs were mild to moderate and considered manageable. Drug-related interstitial pneumonia was clinically diagnosed in four cases (7.5%).
Oral gefitinib, as compared to conventional chemotherapy, has comparable effect but less toxicity as a first-line treatment in Chinese patients who have advanced NSCLC, especially in those with adenocarcinoma histology. A further phase III prospective study comparing gefitinib to standard chemotherapy to define the efficacy of gefitinib is appropriate in advanced NSCLC patients.
本II期单臂、开放标签研究旨在评估口服吉非替尼（250mg）每日一次在既往未接受治疗的晚期非小细胞肺癌（NSCLC）患者中的疗效和毒性。
符合条件的患者为具有足够器官功能的IIIB期或IV期NSCLC，且未接受过化疗。所有符合条件的患者口服250mg吉非替尼，直至出现无法耐受的毒性、疾病进展或死亡。每8周治疗后评估反应。
总共53例患者，客观缓解率（ORR）为32.1%，疾病总体控制率（DCR）为52.8%。中位总生存期和无进展生存期（PFS）分别为9.4（95%CI，8.8 - 13.3）和3.2个月（95%CI，1.1 - 5.2），1年生存率为41.5%。腺癌患者（n = 35）的缓解率更高。腺癌、女性（n = 24）以及对吉非替尼的反应是生存较好的预测因素。最常见的不良事件（AE）为皮肤毒性（54.7%）、腹泻（43.4%）和指甲改变（16.9%）。大多数AE为轻至中度，认为可管理。4例（7.5%）临床诊断为药物相关间质性肺炎。
对于晚期NSCLC中国患者，尤其是组织学类型为腺癌的患者，口服吉非替尼作为一线治疗与传统化疗相比效果相当，但毒性较小。开展进一步的III期前瞻性研究，将吉非替尼与标准化疗进行比较以明确吉非替尼的疗效，对于晚期NSCLC患者是合适的。
