Background: Epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer (NSCLC) is an important subtype of lung cancer. The incidence of malignant pericardial effusion (MPCE) in EGFR-mutant NSCLC patients is high. However, there are few researches on the treatmentof this type of patients.
Methods: We collected data on clinical characteristics and treatment of advanced NSCLC patients who harboring EGFR mutants and MPCE between January 2010 and December 2016. The treatments were divided into three groups: oral gefitinib combined with pericardial perfusion of hydroxycamptotheci (HCPT) group (gefitinib/HCPT); intravenous chemotherapy combined with pericardial perfusion of HCPT group (chemotherapy/HCPT) and gefitinib monotherapy group. And we retrospectively analyzed patients' outcomes in three groups.
Results: In 273 advanced NSCLC patients with EGFR mutations, 29 cases had pericardial effusion, among which 6 patients with small amount of pericardial effusion were excluded, and 23 patients were analyzed. Median pericardium progression free survival (PFS) was 247 days. PFS for gefitinib/HCPT group (460 days) was superior to PFS for chemotherapy/HCPT group (94 days, P=0.008) and gefitinib monotherapy group (131 days, P=0.032). As for the efficacy of primary pulmonary lesions, the efficacy in gefitinib/ HCPT group was superior to chemotherapy/HCPT group [objective response rate (ORR): 33.3% vs 12.5%; disease control rate (DCR): 86.7% vs 62.5%]. There is no difference of ORR and DCR between gefitinib/HCPT group and gefitinib monotherapy group. No obvious adverse reaction was observed in all three groups.
Conclusions: First-line gefitinib therapy combined with pericardial perfusion of HCPT can improve pericardium PFS for advanced NSCLC patients who harboring EGFR mutants andmalignantpericardial effusion. This finding should be confirmed further through multicenter, prospective clinical trials with large sample size.
背景与目的 表皮生长因子受体（epidermal growth factor receptor, EGFR）突变的非小细胞肺癌（non-small cell lung cancer, NSCLC）是肺癌的一个重要亚型。EGFR突变的NSCLC患者合并恶性心包积液的发生率较高，但目前针对此型肺癌患者治疗方案的研究较少。方法 本研究对我院2010年1月-2016年12月期间确诊的EGFR敏感突变的NSCLC合并恶性心包积液患者的临床资料和治疗情况进行回顾性分析，具体分为以下三组治疗模式：口服吉非替尼联合心包灌注羟基喜树碱组（吉非替尼/HCPT），静脉化疗联合心包灌注羟基喜树碱组（化疗/ HCPT）及吉非替尼单药组，探讨不同治疗模式患者病情的转归。结果 273例晚期EGFR敏感突变的NSCLC患者中，29例初诊时有心包积液，剔除6例少量心包积液无法取得细胞学分析的患者，共23例纳入分析。患者总中位心包内疾病无进展时间（progression-free survival, PFS）为247天；吉非替尼/HCPT组患者PFS（460天）优于化疗/HCPT组患者（94天），（P=0.008）；吉非替尼/HCPT组患者的PFS优于吉非替尼单药组患者（131天），（P=0.032）。同时对肺部原发灶的治疗分析显示：吉非替尼/HCPT组患者疗效优于化疗/HCPT组患者（客观有效率：33.3% vs 12.5%；疾病控制率： 86.7% vs 62.5%）；吉非替尼/HCPT组与吉非替尼单药组的患者，肺部肿瘤疗效无差异。且三组均未观察到明显的不良反应。结论 一线吉非替尼联合心包灌注羟基喜树碱治疗有助于延长EGFR突变合并恶性心包积液的晚期NSCLC患者心包内PFS，且患者耐受性好，无明显不良反应。因例数少，尚有待更多样本多中心前瞻性临床研究证实。.
Keywords: Gefitinib; Hydroxycamptothecine; Lung neoplasms; Malignant pericardialeffusion.