晚期非小细胞肺癌EGFR敏感突变型患者酪氨酸激酶抑制药的疗效和安全性

EGFR-TKI maintenance therapy for advanced non-small-cell lung cancer with positive EGFR mutation

目的：观察晚期非小细胞肺癌表皮生长因子受体（ EGFR）敏感突变型患者酪氨酸激酶抑制药（ EGFR-tyrosine-kinase inhibitor，EGFR-TKI）的疗效和安全性。方法32例EGFR敏感突变型晚期非小细胞肺癌患者一线化疗后给予EGFR-TKI维持治疗。观察近期疗效、无进展生存期（progression-free-survival， PFS）、总生存期（overall survival， OS）及不良反应。结果全组CR 3例，PR 7例，SD 18例，PD 4例。有效率RR 31．3％，疾病控制率DCR 87．5％；中位PFS 14．9个月（95％CI：11．93～17．87个月）；中位OS 25．1个月（95％CI：20．8～29．3个月）。全组无重度不良反应发生，治疗耐受良好。皮疹发生率37．5％，腹泻发生率15．6％。结论晚期非小细胞肺癌EGFR敏感突变型患者EGFR-TKI维持治疗安全有效。

Objective To investigate the efficacy and safety of EGFR-tyrosine-kinase inhibitor （ EGFR-TKI ） as maintenance therapy in patients with advanced non-small-cell lung cancer （ NSCLC） and positive EGFR mutation.Methods Thirty-two patients who suffered from advanced NSCLC with EGFR mutation-positive were given EGFR-TKIS （ Gefitinib, Taceva or Icotinib ） as mainte-nance therapy following first-line chemotherapy and no disease progression .Clinical efficacy , progression-free survival （ PFS） , overall survival （OS） and adverse events were analyzed.Results Complete remission（CR）, partial remission（PR）, stable disease（SD） and progressing disease（PD）were observed in 3, 7, 18 and 4 cases, respectively.Response rate （RR） was 31.3%and disease con-trol rate （DCR） was 87.5%in the group.Median PFS was 14.9 months（95%CI：11.93-17.87） and mOS was 25.1 months （95%CI：20.8-29.3）.The most common adverse events were rash （37.5%） and diarrhea （15.6%）.Conclusions EGFR-TKIs as ma-intenance therapy in the patients with advanced NSCLC and EGFR mutation-positive is effective and safe .