PDF(Pubmed)
Abstract：
UNASSIGNED: Patients with oligometastatic NSCLC benefit from locally ablative therapies (LAT); the role of adjuvant systemic therapies, however, remains less clear. In a single-arm, phase II clinical trial, we found that patients with oligometastatic NSCLC treated with a year of pembrolizumab after LAT had superior progression-free survival (PFS) compared with a historical control cohort. Herein, we present long-term follow-up on PFS and overall survival (OS).
UNASSIGNED: From February 1, 2015, to September 30, 2017, 45 patients with synchronous or metachronous oligometastatic (≤4 metastatic sites) NSCLC treated with LAT to all sites received adjuvant pembrolizumab every 21 days for up to 16 cycles. The primary efficacy end point was PFS from the start of pembrolizumab. Secondary end points included OS and safety. Median duration of follow-up was 66 months, and data cutoff was December 1, 2022.
UNASSIGNED: A total of 45 patients were enrolled and treated with pembrolizumab after LAT (median age, 64 y [range, 46-82]; 21 women [47%]; 31 with a solitary oligometastatic site [69%]). At the data cutoff, 32 patients had progressive disease, 19 patients had died, and 13 patients had no evidence of relapse. Median PFS was 19.7 months (95% confidence interval: 7.6-31.7 mo); median OS was not reached (95% confidence interval: 37.7 mo-not reached). OS at 5 years was 60.0% (SE, 7.4%). Metachronous oligometastatic disease was associated with improved OS and PFS through Cox proportional hazard models.
UNASSIGNED: Pembrolizumab after LAT for oligometastatic NSCLC results in promising PFS and OS with a tolerable safety profile.
UNASSIGNED: From February 1, 2015, to September 30, 2017, 45 patients with synchronous or metachronous oligometastatic (≤4 metastatic sites) NSCLC treated with LAT to all sites received adjuvant pembrolizumab every 21 days for up to 16 cycles. The primary efficacy end point was PFS from the start of pembrolizumab. Secondary end points included OS and safety. Median duration of follow-up was 66 months, and data cutoff was December 1, 2022.
UNASSIGNED: A total of 45 patients were enrolled and treated with pembrolizumab after LAT (median age, 64 y [range, 46-82]; 21 women [47%]; 31 with a solitary oligometastatic site [69%]). At the data cutoff, 32 patients had progressive disease, 19 patients had died, and 13 patients had no evidence of relapse. Median PFS was 19.7 months (95% confidence interval: 7.6-31.7 mo); median OS was not reached (95% confidence interval: 37.7 mo-not reached). OS at 5 years was 60.0% (SE, 7.4%). Metachronous oligometastatic disease was associated with improved OS and PFS through Cox proportional hazard models.
UNASSIGNED: Pembrolizumab after LAT for oligometastatic NSCLC results in promising PFS and OS with a tolerable safety profile.
摘要：
■寡转移性NSCLC患者受益于局部消融治疗（LAT）；辅助全身治疗的作用，然而,仍然不太清楚。在单臂中，II期临床试验,我们发现,与历史对照队列相比,LAT后接受一年pembrolizumab治疗的寡转移性NSCLC患者的无进展生存期(PFS)更优.在这里，我们对PFS和总生存期(OS)进行了长期随访.
■从2015年2月1日至2017年9月30日，45例同步或异时性寡转移（≤4个转移部位）NSCLC患者接受LAT治疗至所有部位，每21天接受一次pembrolizumab辅助治疗，为期16个周期。从pembrolizumab开始，主要疗效终点是PFS。次要终点包括OS和安全性。中位随访时间为66个月,数据截止日期为2022年12月1日。
■共纳入45例患者，在LAT后接受派姆单抗治疗（中位年龄，64y[范围，46-82]；21名女性[47%]；31名女性具有孤立的寡转移部位[69%]）。在数据截止时，32例患者有进行性疾病，19名患者死亡，13例患者无复发迹象.中位PFS为19.7个月（95％置信区间：7.6-31.7个月）；未达到中位OS（95％置信区间：37.7个月未达到）。5年时的OS为60.0%(SE，7.4%）。通过Cox比例风险模型，异时寡转移疾病与OS和PFS改善相关。
■Pembrolizumab在LAT治疗寡转移性NSCLC后可产生有希望的PFS和OS，具有可耐受的安全性。
■从2015年2月1日至2017年9月30日，45例同步或异时性寡转移（≤4个转移部位）NSCLC患者接受LAT治疗至所有部位，每21天接受一次pembrolizumab辅助治疗，为期16个周期。从pembrolizumab开始，主要疗效终点是PFS。次要终点包括OS和安全性。中位随访时间为66个月,数据截止日期为2022年12月1日。
■共纳入45例患者，在LAT后接受派姆单抗治疗（中位年龄，64y[范围，46-82]；21名女性[47%]；31名女性具有孤立的寡转移部位[69%]）。在数据截止时，32例患者有进行性疾病，19名患者死亡，13例患者无复发迹象.中位PFS为19.7个月（95％置信区间：7.6-31.7个月）；未达到中位OS（95％置信区间：37.7个月未达到）。5年时的OS为60.0%(SE，7.4%）。通过Cox比例风险模型，异时寡转移疾病与OS和PFS改善相关。
■Pembrolizumab在LAT治疗寡转移性NSCLC后可产生有希望的PFS和OS，具有可耐受的安全性。
