吉非替尼治疗晚期复治性非小细胞肺癌的临床研究

目的探讨应用吉非替尼(IRESSA)治疗晚期非小细胞肺癌(NSCLC)患者的疗效及其对生活质量的影响。方法既往化疗失败的Ⅲb-Ⅳ期NSCLC患者41例,其中二线化疗失败者占85.4%(35/41)。IRESSA 250 mg口服,每日1次,服药至病情进展或出现不能耐受的不良反应。患者分别在治疗后1个月、2个月和以后每3个月复查。结果本组41例患者均可评价疗效,其中PR 18例,SD 14例,PD 9例,有效率为43.9%(18/41),疾病控制率(PR SD)为78.0%(32/41)。男性患者和女性患者的有效率分别为42.1%和45.5%(P>0.05)。至随访结束,41例患者中,有22例(53.7%)存活,其中位生存时间(MST)为10.1个月;19例死亡患者的疾病进展时间(TTP)为2.7个月,MST为5.0个月;PR患者的MST为13.3个月。全组患者症状改善率为78.0%。服药28 d,KPS评分提高20±5分,无Ⅲ-Ⅳ度毒性反应。结论IRESSA单药对化疗失败的晚期NSCLC疗效确切,并可用于一般状况评分较差的患者,其不良反应轻,是二三线用药的良好选择。

Gefitinib in the treatment of refractory non-small cell lung cancer

OBJECTIVE: To observe the efficacy, median survival time, time to progression, quality of life and adverse effect of gefitinib (IRESSA) in the treatment for refractory advanced non-small cell lung cancer (NSCLC). METHODS: Forty-one patients with stage III b to IV NSCLC who had previously treated with 2-7 cycles of platinum-based chemotherapy were enrolled into the study, 85.4% of the patients had received second line chemotherapy. The regimen was oral intake of gefitinib 250 mg once daily until the disease progression or intolerable toxic reaction occurred. The patients were required to receive tumor assessment before the treatment, one month, two months and every three months after IRESSA administration. RESULTS: All 41 patients were evaluable for therapeutic effect. Partial response rate (PR), stable disease (SD) and progression of disease (PD) was 43.9% (18/41), 34.1% (14/41) and 22.0% (9/41), respectively. No complete regression was observed. The overall response rate was 43.9% (18/41) with a rate of 42.1% in the male and 45.5% in the female (P > 0.05). The disease control rate (PR + SD) was 78.0% (32/41). Twenty-two of the 41 patients (53.7%, 22/41) were still alive with MST of 10.1 months when the follow-up ended in Nov. 2006. TP and MST of dead patients was 2.7 and 5.0 months, respectively. The rate of symptom improvement was 78% for all patients with MST of 13.3 months for PR patients. The performance status (Karnofsky) was improved (20 +/- 5) after 28-day treatment. III-IV degree toxicity was not observed. CONCLUSION: IRESSA is effective and safe for the advanced NSCLC patients with poor performance status who previously failed in the second or third line chemotherapy.