Department of Respiratory Medicine, Tohoku University, Sendai, Japan.
Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai, Japan.
Eur J Cancer. 2023 May;185:83-93. doi: 10.1016/j.ejca.2023.02.023. Epub 2023 Mar 2.
This multicenter phase 2 trial evaluated the safety and efficacy of osimertinib and platinum-based chemotherapy (OPP) in patients with previously untreated EGFR-mutated advanced non-squamous non-small cell lung cancer (NSCLC).
Patients received osimertinib 80 mg once daily (QD), with either cisplatin 75 mg/m (arm A) or carboplatin (area under the curve [AUC] = 5; arm B), plus pemetrexed 500 mg/m for four cycles and maintenance therapy of osimertinib 80 mg QD with pemetrexed 500 mg/m every 3 weeks. The primary end-points were safety and objective response rate (ORR), and the secondary end-points were complete response rate (CRR), disease control rate (DCR), and progression-free survival (PFS).
In total, 67 patients (34 in arm A and 33 in arm B) were enrolled between July 2019 and February 2020. At the data cutoff (28th February 2022), 35 (52.2%) patients had discontinued the protocol treatment, including 10 (14.9%) due to adverse events. No treatment-related deaths occurred. In the full analysis set, the ORR, CRR, and DCR were 90.9% (95% confidence interval [CI], 84.0-97.8), 3.0% (0.0-7.2), and 97.0% (92.8-100.0), respectively. Based on updated survival data (data cutoff on August 31, 2022, median follow-up time: 33.4 months), the median PFS was 31.0 months (95% CI, 26.8 months-not reached) and median overall survival was not reached.
This is the first study to show that OPP has excellent efficacy with acceptable toxicity in previously untreated EGFR-mutated advanced non-squamous NSCLC patients.
这项多中心 2 期临床试验评估了奥希替尼联合铂类化疗（OPP）在未经治疗的表皮生长因子受体（EGFR）突变型晚期非鳞状非小细胞肺癌（NSCLC）患者中的安全性和疗效。
患者接受奥希替尼 80mg 每日一次（QD），联合顺铂 75mg/m²（A 组）或卡铂（曲线下面积[AUC] = 5；B 组），加培美曲塞 500mg/m²，连用 4 个周期，奥希替尼 80mg QD 联合培美曲塞 500mg/m²，每 3 周一次维持治疗。主要终点为安全性和客观缓解率（ORR），次要终点为完全缓解率（CRR）、疾病控制率（DCR）和无进展生存期（PFS）。
共有 67 例患者（A 组 34 例，B 组 33 例）于 2019 年 7 月至 2020 年 2 月入组。截至数据截止日期（2022 年 2 月 28 日），35 例（52.2%）患者已停止方案治疗，其中 10 例（14.9%）因不良事件而停止。无治疗相关死亡。在全分析集，ORR、CRR 和 DCR 分别为 90.9%（95%置信区间[CI]，84.0-97.8）、3.0%（0.0-7.2）和 97.0%（92.8-100.0）。基于更新的生存数据（数据截止日期为 2022 年 8 月 31 日，中位随访时间：33.4 个月），中位 PFS 为 31.0 个月（95%CI，26.8 个月-未达到），中位总生存期未达到。
这是第一项表明奥希替尼联合铂类化疗在未经治疗的 EGFR 突变型晚期非鳞状 NSCLC 患者中具有良好疗效且毒性可接受的研究。
