Wang Bin, Zhang Xiang-ru, Chu Da-tong
Department of Medical Oncology, Cancer Institute (Hospital), Chinese Academy of Medical Science, Peking Union Medical Collage, Beijing 100021, China.
Zhonghua Zhong Liu Za Zhi. 2004 Dec;26(12):742-5.
To evaluate the antitumor efficacy, time to tumor progression (TTP) and toxicity of Iressa (ZD1839)-a selective epidermal growth factor receptor tyrosine kinase inhibitor in advanced non-small-cell lung cancer (NSCLC) patients who have failed to respond previous chemotherapy.
Fifty-two patients with grade IV NSCLC previously treated with chemotherapy (77.0% of patients after second line therapy) received 250 mg of Iressa orally once daily until disease progression or development of intolerable toxic reaction. They were required to receive tumor-evaluation before the treatment, one month after Iressa administration and every other month thereafter.
Without complete regression being observed, partial response (PR) rate was 21.2% (11/52), stable disease (SD) 32.7% (17/52), disease control rate (PR + SD) 53.8%, progression of disease (PD) 46.2% (24/52); median time to tumor progression (TTP) was 3.5 month. Among them, 22 patients were followed up over one year and the 1-year survival rate was 31.8%. Symptomatic improvement rate was 52.9%. The most common adverse effects were skin reactions and diarrhea which were generally mild (grade 1 or 2). Only one patient withdrew from the trial because of grade III hepatic toxicity with increase in ALT and AST.
Iressa has significant antitumor activity in advanced NSCLC patients who have previously failed in second or third line chemotherapy. It greatly alleviates tumor related symptoms. Adverse effects are generally tolerable. IRESSA is suitable for patients with poor performance status (ECOG > 2).
评估易瑞沙（ZD1839）——一种选择性表皮生长因子受体酪氨酸激酶抑制剂，对既往化疗无效的晚期非小细胞肺癌（NSCLC）患者的抗肿瘤疗效、肿瘤进展时间（TTP）及毒性。
52例IV期NSCLC患者，此前均接受过化疗（77.0%的患者接受过二线治疗），每日口服250mg易瑞沙，直至疾病进展或出现无法耐受的毒性反应。要求患者在治疗前、服用易瑞沙1个月后及此后每隔1个月接受肿瘤评估。
未观察到完全缓解，部分缓解（PR）率为21.2%（11/52），疾病稳定（SD）率为32.7%（17/52），疾病控制率（PR+SD）为53.8%，疾病进展（PD）率为46.2%（24/52）；中位肿瘤进展时间（TTP）为3.5个月。其中，22例患者随访超过1年，1年生存率为31.8%。症状改善率为52.9%。最常见的不良反应为皮肤反应和腹泻，一般为轻度（1级或2级）。仅1例患者因III级肝毒性伴ALT和AST升高退出试验。
易瑞沙对既往二线或三线化疗失败的晚期NSCLC患者具有显著的抗肿瘤活性。它能极大地缓解肿瘤相关症状。不良反应一般可耐受。易瑞沙适用于体能状态较差（ECOG>2）的患者。
