Lee Dae Ho, Han Ji-Youn, Yu Sun Young, Kim Hyae Young, Nam Byung-Ho, Hong Eun Kyung, Kim Heung Tae, Lee Jin Soo
Research Institute and Hospital, Research Institute for National Cancer Control and Evaluation, Gyeonggi, Korea.
J Thorac Oncol. 2006 Nov;1(9):965-71.
This prospective trial was conducted to evaluate the role of gefitinib in never-smokers with advanced or metastatic adenocarcinoma of the lung.
The main inclusion criteria were stage IIIB/IV adenocarcinoma of the lung and status as a lifetime never-smoker. Patients received a 250-mg single oral daily dose of gefitinib until disease progression, unacceptable toxicity, or patient's refusal. Tumor response was assessed after every two 4-week cycles according to the World Health Organization response criteria. Additional analyses were performed to identify predictors of response and survival.
Between August 2003 and March 2005, 72 Korean patients were enrolled; 55 chemotherapy naive, 17 previously treated; 6 male, 66 female; and ECOG PS 0/1/2, 24/42/4. All patients were assessed for response, toxicity, quality of life, and survival. Overall objective tumor response rate was 55.6% (95% confidence interval [CI], 43.4-67.3%). With a median follow-up of 23 months, the median survival time was 19.7 months (95% CI, 18.5-21.0 months) with a 1-year survival rate of 76.3%. The median duration of response was 6.8 months (95% CI, 4.7-9.0 months). Therapy-related improvement of symptoms and quality of life was observed within 2 to 4 weeks after the commencement of therapy in the responders. In a multivariate Cox proportional hazard model, good performance status and no prior history of chemotherapy were the two significant predictors of better survival (p = 0.005 and 0.042).
Gefitinib showed very promising antitumor activity and survival outcome in Korean never-smokers with adenocarcinoma of the lung. It seems to be a good alternative to standard chemotherapy as a first-line therapy for this subgroup.
开展这项前瞻性试验以评估吉非替尼在晚期或转移性肺腺癌非吸烟患者中的作用。
主要纳入标准为ⅢB/Ⅳ期肺腺癌且终生不吸烟。患者每日口服250mg吉非替尼单剂量，直至疾病进展、出现不可接受的毒性或患者拒绝。每两个4周周期后根据世界卫生组织反应标准评估肿瘤反应。进行了额外分析以确定反应和生存的预测因素。
2003年8月至2005年3月，纳入72例韩国患者；55例未接受过化疗，17例曾接受过治疗；6例男性，66例女性；东部肿瘤协作组体能状态（ECOG PS）为0/1/2的患者分别有24/42/4例。对所有患者评估了反应、毒性、生活质量和生存情况。总体客观肿瘤反应率为55.6%（95%置信区间[CI]，43.4 - 67.3%）。中位随访23个月，中位生存时间为19.7个月（95%CI，18.5 - 21.0个月），1年生存率为76.3%。中位反应持续时间为6.8个月（95%CI，4.7 - 9.0个月）。在反应者中，治疗开始后2至4周内观察到与治疗相关的症状和生活质量改善。在多变量Cox比例风险模型中，良好的体能状态和无化疗史是生存较好的两个显著预测因素（p = 0.005和0.042）。
吉非替尼在韩国肺腺癌非吸烟患者中显示出非常有前景的抗肿瘤活性和生存结果。对于该亚组患者，它似乎是标准化疗作为一线治疗的良好替代方案。
