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比较吉非替尼与厄洛替尼在既往化疗失败的非小细胞肺癌患者中的疗效。

Comparison of gefitinib versus erlotinib in patients with nonsmall cell lung cancer who failed previous chemotherapy.

机构信息

Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Cancer. 2010 Jun 15;116(12):3025-33. doi: 10.1002/cncr.25130.

Abstract

BACKGROUND

Gefitinib and erlotinib are commonly used for salvage therapy in patients with nonsmall cell lung cancer (NSCLC) who have progressed on prior therapies. Although both agents have similar structure and have demonstrated efficacy in NSCLC, gefitinib and erlotinib have not been directly compared in terms of efficacy and other clinical outcomes in patients with NSCLC who have failed prior chemotherapy. This prompted us to analyze the clinical outcomes between gefitinib-treated and erlotinib-treated patients with metastatic or recurrent NSCLC.

METHODS

A total of 467 patients with metastatic or recurrent NSCLC who had progressed on prior therapies and received gefitinib or erlotinib therapy between January 2006 and December 2008 were retrospectively reviewed. By using a matched-pair case-control study design, 171 pairs of gefitinib-treated and erlotinib-treated patients were matched according to sex, Eastern Cooperative Oncology Group (ECOG) performance status, histologic type, and smoking history.

RESULTS

The median age of all patients was 58 years (range, 20-85 years), and the median ECOG performance status was 1 (range, 0-3). Of 342 patients, 294 (86%) received an epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor as second-line or third-line therapy, whereas the remaining 14% had received >2 prior chemotherapy regimens before starting EGFR TK inhibitor therapy. The confirmed overall response rate was 35.1%, and the disease control rate was 64%. With 13.2 months of follow-up, the median overall survival (OS) for the total 342 patients was 12.4 months (95% confidence interval [95% CI], 10.66-14.14 months), and the median progression-free survival (PFS) was 3.2 months (95% CI, 2.65-3.75 months). The overall response rates and disease control rates in the gefitinib-treated and erlotinib-treated groups were 38% versus 32.2% (P = .273) and 63.2% versus 64.9%, respectively (P = .677). There was no statistically significant difference noted with regard to OS (median, 12.6 vs 12.1 months; P = 0.99) and PFS (median, 4.6 vs 2.7 months; P = .06) between the gefitinib-treated and erlotinib-treated groups.

CONCLUSIONS

This retrospective analysis shows that gefitinib and erlotinib appear to have similar antitumor activity in terms of response rate and OS in pretreated patients with metastatic or recurrent NSCLC. Further prospective studies are warranted to elucidate any potential differences in toxicity and in dose intensity between gefitinib- and erlotinib-treated patients.

摘要

背景

吉非替尼和厄洛替尼常用于治疗先前治疗进展的非小细胞肺癌(NSCLC)患者的挽救治疗。尽管这两种药物具有相似的结构,并且在 NSCLC 中都显示出疗效,但在先前接受化疗的 NSCLC 患者中,吉非替尼和厄洛替尼在疗效和其他临床结局方面尚未进行直接比较。这促使我们分析接受吉非替尼或厄洛替尼治疗的转移性或复发性 NSCLC 患者的临床结局。

方法

回顾性分析了 2006 年 1 月至 2008 年 12 月期间,先前治疗进展后接受吉非替尼或厄洛替尼治疗的 467 例转移性或复发性 NSCLC 患者。采用匹配的病例对照研究设计,根据性别、东部合作肿瘤组(ECOG)体能状态、组织学类型和吸烟史,将 171 对接受吉非替尼和厄洛替尼治疗的患者进行匹配。

结果

所有患者的中位年龄为 58 岁(范围,20-85 岁),中位 ECOG 体能状态为 1 级(范围,0-3 级)。在 342 例患者中,294 例(86%)接受了表皮生长因子受体(EGFR)酪氨酸激酶(TK)抑制剂作为二线或三线治疗,而其余 14%的患者在开始 EGFR TK 抑制剂治疗前接受了>2 种先前的化疗方案。确认的总缓解率为 35.1%,疾病控制率为 64%。在 13.2 个月的随访中,342 例患者的中位总生存期(OS)为 12.4 个月(95%置信区间[95%CI],10.66-14.14 个月),中位无进展生存期(PFS)为 3.2 个月(95%CI,2.65-3.75 个月)。吉非替尼组和厄洛替尼组的总缓解率和疾病控制率分别为 38%和 32.2%(P=0.273)和 63.2%和 64.9%(P=0.677)。吉非替尼组和厄洛替尼组的 OS(中位,12.6 个月 vs 12.1 个月;P=0.99)和 PFS(中位,4.6 个月 vs 2.7 个月;P=0.06)均无统计学差异。

结论

这项回顾性分析表明,在先前接受治疗的转移性或复发性 NSCLC 患者中,吉非替尼和厄洛替尼在反应率和 OS 方面似乎具有相似的抗肿瘤活性。需要进一步的前瞻性研究来阐明吉非替尼和厄洛替尼治疗患者在毒性和剂量强度方面是否存在任何潜在差异。

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