Fan Yun, Huang Zhi-yu, Yu Hai-feng, Luo Lü-hong
Department of Chemotherapy, Zhejiang Provincial Tumor Hospital, Hangzhou 310022, China.
Zhonghua Zhong Liu Za Zhi. 2010 Nov;32(11):859-63.
OBJECTIVE: Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) such as gefitinib and erlotinib are used as standard 2(nd)/3(rd) line therapy in previously treated advanced non-small cell lung cancer (NSCLC). However, the optimal treatment for patients who experienced disease progression after chemotherapy and EGFR-TKI is unclear. The aim of this study was to explore the efficacy and safety of a salvage chemotherapy in advanced NSCLC patients who failed the previous treatment of platinum-based chemotherapy and EGFR-TKI. METHODS: Clinicopathological data of 55 cases of advanced NSCLC patients who failure of first-line platinum-based chemotherapy and subsequent treatment with TKI were collected and analyzed. The patients were of PS = 0-2, and with normal vital organ function. Patients received salvage chemotherapy until disease progression or unacceptable toxicity or the patient refused to continue receiving treatment. A chart review assessed the key outcomes including the objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS). RESULTS: Fifty-five patients were enrolled in this study from march 2007 to october 2009. The median age of patients was 55 years (range: 34 - 72), 60.0% were males, PS 0-1 patients were 65.5%, stage IV patients were 100%; 34.5% had a TKI treatment duration ≥ 6 months. Twenty-four patients received pemetrexed as salvage chemotherapy, 21 received docetaxal and 10 had other chemotherapy. All patients were evaluable for efficacy. Among them, 7 (12.7%) patients achieved PR, 21 (38.2%) patients SD, and 27 (49.1%) patients PD, with ORR of 12.7% and DCR of 50.9%. The median follow-up duration was 5.5 months, and the median PFS was 2.0 months. The ORR and PFS were not significantly related with gender, PS and chemotherapy regimens (all P > 0.05), but patients with EGFR-TKI treatment ≥ 6 months achieved a significantly better ORR and DCR than those < 6 months (ORR: 21.1% vs. 8.3%, P = 0.012; DCR: 73.3% vs. 38.9%, P = 0.017), mPFS was significant longer in the patients received ≥ 6 months of EGFR-TKI (4.5 vs. 2.0 months, P = 0.008). The toxicity was acceptable and there were no treatment-related deaths. CONCLUSION: Advanced NSCLC patients failed with the previous treatment of first-line platinum-based chemotherapy and EGFR-TKI may benefit from salvage chemotherapy, especially in patients who received ≥ 6 months of EGFR-TKI. The toxicity of the salvage chemotherapy is acceptable.
目的：表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），如吉非替尼和厄洛替尼，被用作既往接受过治疗的晚期非小细胞肺癌（NSCLC）的标准二线/三线治疗。然而，对于化疗和EGFR-TKI治疗后疾病进展的患者，最佳治疗方案尚不清楚。本研究的目的是探讨挽救性化疗在一线铂类化疗和EGFR-TKI治疗失败的晚期NSCLC患者中的疗效和安全性。 方法：收集并分析55例一线铂类化疗失败且随后接受TKI治疗的晚期NSCLC患者的临床病理资料。患者的体力状况评分为0-2分，重要器官功能正常。患者接受挽救性化疗，直至疾病进展、出现不可接受的毒性或患者拒绝继续接受治疗。通过查阅病历评估主要结局，包括客观缓解率（ORR）、疾病控制率（DCR）和无进展生存期（PFS）。 结果：2007年3月至2009年10月，55例患者纳入本研究。患者的中位年龄为55岁（范围：34-72岁），男性占60.0%，体力状况评分为0-1分的患者占65.5%，IV期患者占100%；34.5%的患者TKI治疗时间≥6个月。24例患者接受培美曲塞作为挽救性化疗，21例接受多西他赛，10例接受其他化疗。所有患者均可评估疗效。其中，7例（12.7%）患者达到部分缓解（PR），21例（38.2%）患者疾病稳定（SD），27例（49.1%）患者疾病进展（PD），ORR为12.7%，DCR为50.9%。中位随访时间为5.5个月，中位PFS为2.0个月。ORR和PFS与性别、体力状况评分和化疗方案均无显著相关性（均P>0.05），但EGFR-TKI治疗≥6个月的患者ORR和DCR显著优于治疗时间<6个月的患者（ORR：21.1%对8.3%，P=0.012；DCR：73.3%对38.9%，P=0.017），接受EGFR-TKI治疗≥6个月的患者mPFS显著更长（4.5对2.0个月，P=0.008）。毒性可接受，且无治疗相关死亡。 结论：一线铂类化疗和EGFR-TKI治疗失败的晚期NSCLC患者可能从挽救性化疗中获益，尤其是接受EGFR-TKI治疗≥6个月的患者。挽救性化疗的毒性可接受。
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