奥西替尼治疗32例晚期非小细胞肺癌的疗效观察

Efficacy of Osimertinib in 32 patients with advanced non-small cell lung cancer

关键词:  奥西替尼  非小细胞肺癌  临床疗效

Key words:  Osimertinib  non-small cell lung cancer  clinical effect

摘要:

目的 观察和评价奥西替尼用于治疗晚期非小细胞肺癌（NSCLC）的疗效。方法 收集2014年9月至2018年2月经病理学或细胞组织学确诊的Ⅳ期或术后复发转移的，经过一代EGFR-TKIs治疗进展后均接受奥西替（80 mg 1次/d口服）治疗的晚期NSCLC患者32例的临床资料。观察药物的近期疗效及患者中位无进展生存期（PFS）。结果 32例患者中，部分缓解（PR）13例（40.6%），疾病稳定（SD）16例（50.0%），疾病进展（PD）3例（9.4%），总体客观缓解率（ORR）达40.6%，总体疾病控制率（DCR）达90.6%。全组人群中位PFS为9.3个月。奥西替尼的疗效与性别、吸烟状态、ECOG评分等各临床特征均无明显关系（P>0.05）。PFS与治疗方式（治疗线数）有关（P<0.05），ORR与T790M突变状态有关（P<0.05）。奥西替尼治疗的脑膜转移患者15例中，部分缓解6例，疾病稳定7例，进展2例，ORR为40.0%，DCR为86.7%。所有32例服用奥西替尼的患者出现的主要不良反应中，腹泻和皮疹最常见，其中1~2级腹泻9例（28.1%），1~2级皮疹6例（18.7%），未出现间质性肺炎，全组患者均无因不良反应而停药或减量。结论 奥西替尼对于一代EGFR-TKI治疗的晚期非小细胞肺癌耐药后的治疗有效，且耐受性好。

Abstract:

Objective To observe and evaluate the efficacy of Osimertinib in the treatment of advanced non-small cell lung cancer (NSCLC). Methods A retrospective analysis was performed on 32 patients with advanced NSCLC, who were confirmed as stage IV or postoperative recurrence and metastasis by pathology or cytology in our hospital from September 2014 to February 2018. All patients were treated with Osimertinib 80mg once daily after the treatment of first generation of EGFR-TKIs. The short-term efficacy and median progress free survival (PFS) were observed. Results Among the 32 patients, 13 patients (40.6%) had partial response, 16 patients (50.0%) were stable, and 3 patients (9.4%) had progressive disease. The overall objective response rate (ORR) was 40.6% and the overall disease control rate (DCR) was up to 90.6%. The median progression-free survival was 9.3 months in the entire group. The efficacy of Osimertinib was not related to the clinical characteristics such as gender, smoking status and ECOG score (P>0.05). Progression-free survival was associated with treatment sequence (P<0.05). ORR was associated with T790M mutation status (P<0.05). Osimertinib was used to treat 15 patients with meningeal metastases with an ORR of 40% and a DCR of 86.7%. The main clinically relevant toxicity in 32 patients was diarrhea and rash. Diarrhea occurred in 9 patients (28.1%) including grade 1and grade 2, rash occurred in 6 patients (18.7%) including grade 1 and grade 2. No interstitial pneumonia was found, and nobody stopped taking the medicine or reduced the dose due to adverse drug reactions. Conclusion Osimertinib is effective and well tolerated in the NSCLC patients who had drug resistance to the first generation of EGFR-TKIs.