Uhm Ji Eun, Park Byeong-Bae, Ahn Myung-Ju, Lee Jeeyun, Ahn Jin Seok, Kim Sang We, Kim Heung-Tae, Lee Jong Seog, Kang Jin Hyung, Cho Jae Yong, Song Hong Suk, Park Se Hoon, Sohn Chang Hak, Shin Sang Won, Choi Jin Hyuck, Park Keunchil
Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
J Thorac Oncol. 2009 Sep;4(9):1136-43. doi: 10.1097/JTO.0b013e3181b270a7.
Erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) is an oral, epidermal growth factor receptor tyrosine kinase inhibitor that has antitumor activity and good tolerability in non-small cell lung cancer (NSCLC). In particular, higher response rates have been reported in Asian patients than in Western patients. The aim of this study conducted by the Korean Cancer Study Group was to evaluate the efficacy and tolerability of erlotinib monotherapy as a palliative treatment for advanced NSCLC patients in Korea.
Patients with histologically or cytologically confirmed stage IIIB or IV NSCLC including recurrent or metastatic disease, with performance status from 0 to 3, were eligible either if they had received any anticancer treatment except epidermal growth factor receptor inhibitors or if they were unsuitable for chemotherapy because of poor performance status. Enrolled patients were treated with oral erlotinib at a dose of 150 mg daily until disease progression or development of intolerable toxicity.
A total of 120 patients were enrolled between January 2005 and May 2006. Forty-four patients (36.7%) were female and 72 patients were current or former smoker. Fifty percent of patients had received one prior palliative chemotherapy regimens and 34.2% had two or more prior palliative regimens. The overall tumor response rate was 24.2% (95% confidence interval [CI], 16.8-32.8%) with 4 complete responses and 25 partial responses, and the disease control rate was 56.7%. The favorable clinical variables for tumor response were female (P = 0.001), never smokers (P = 0.041), and adenocarcinoma (P = 0.001). The most common adverse event was skin rash (78% of which grade 3 or 4 skin rash occurred in 13.3% of the patients). With a median follow-up of 23.6 months, the median time to progression was 2.7 months (95% CI, 2.2-3.2), and the median overall survival was 12.9 months (95% CI, 6.9-18.8). By multivariate analysis, female and development of skin rash were significantly associated with longer time to progression and overall survival.
Erlotinib monotherapy showed significant antitumor activity and an acceptable tolerability profile as a palliative treatment in advanced NSCLC patients in Korea, especially in females, never smokers, and patients with adenocarcinoma histology.
厄洛替尼（特罗凯，OSI制药公司，纽约州梅尔维尔）是一种口服的表皮生长因子受体酪氨酸激酶抑制剂，在非小细胞肺癌（NSCLC）中具有抗肿瘤活性且耐受性良好。特别是，据报道亚洲患者的缓解率高于西方患者。韩国癌症研究小组开展这项研究的目的是评估厄洛替尼单药作为韩国晚期NSCLC患者姑息治疗的疗效和耐受性。
组织学或细胞学确诊为IIIB期或IV期NSCLC（包括复发或转移性疾病）、体能状态为0至3的患者，如果他们接受过除表皮生长因子受体抑制剂之外的任何抗癌治疗，或者因体能状态差而不适合化疗，则符合入选标准。入选患者接受口服厄洛替尼治疗，剂量为每日150毫克，直至疾病进展或出现无法耐受的毒性。
2005年1月至2006年5月期间共纳入120例患者。44例（36.7%）为女性，72例为现吸烟者或既往吸烟者。50%的患者接受过一种既往姑息化疗方案，34.2%的患者接受过两种或更多种既往姑息方案。总体肿瘤缓解率为24.2%（95%置信区间[CI]，16.8 - 32.8%），其中4例完全缓解，25例部分缓解，疾病控制率为56.7%。肿瘤缓解的有利临床变量为女性（P = 0.001）、从不吸烟者（P = 0.041）和腺癌（P = 0.001）。最常见的不良事件是皮疹（其中78%为3级或4级皮疹出现在13.3%的患者中）。中位随访23.6个月，中位疾病进展时间为2.7个月（95% CI，2.2 - 3.2），中位总生存期为12.9个月（95% CI，6.9 - 1 .8）。通过多因素分析，女性和皮疹的出现与更长的疾病进展时间和总生存期显著相关。
在韩国晚期NSCLC患者中，厄洛替尼单药作为姑息治疗显示出显著的抗肿瘤活性和可接受的耐受性，尤其是在女性、从不吸烟者以及腺癌组织学类型的患者中。
