PD-1抑制剂与同期放化疗联合治疗对于局部晚期宫颈癌合并盆腔和/或盆腔冠脉淋巴结转移的疗效和安全性:一项回顾性队列研究。
Efficacy and safety of PD-1 inhibitor combined with concurrent chemoradiotherapy in locally advanced cervical cancer with pelvic and/or para-aortic lymph node metastases: a retrospective cohort study.
发表日期:2023 Aug
作者:
Chaoxia Liu, Xiaomin Ran, Ziyi Wang, Keqiang Zhang
来源:
Cell Death & Disease
摘要:
标准化疗放疗后,盆腔和/或腹主动脉淋巴结转移的局部晚期宫颈癌患者预后仍不佳。已推荐将程序性细胞死亡受体-1(PD-1)抑制剂作为复发宫颈癌的一线治疗。PD-1抑制剂联合同步化疗放疗在局部晚期宫颈癌中的疗效尚不确定。本研究旨在探讨应用PD-1抑制剂联合同步化疗放疗治疗盆腔和/或腹主动脉淋巴结转移的局部晚期宫颈癌患者的疗效和安全性。本回顾性研究纳入了2020年4月1日至2022年3月31日期间在湖南癌症医院接受PD-1抑制剂加化疗放疗/放疗的盆腔和/或腹主动脉淋巴结阳性疾病的患者。收集基线临床病理特征、治疗和临床结果。主要临床结果包括客观缓解率(ORR)、无进展生存期(PFS)和治疗相关不良事件(TRAEs)。总共纳入了29名患者。平均年龄为55.8 [标准差(SD): 8.8]岁。大多数患者为III期A-IIIB期疾病(72.4%)和鳞状细胞癌(93.1%)。所有患者均有淋巴结转移,其中24人(82.8%)有多发转移,11人(37.9%)有腹主动脉淋巴结转移。在29名患者中,18人在同步化疗放疗或放疗期间接受了信替利单抗,11人接受了卡瑞利珠单抗。放疗后3个月的ORR为96.6% [95%置信区间(CI): 0.828,0.993](包括15个完全缓解和13个部分缓解)。截止数据(2022年8月31日)时,中位随访时间为14 (范围5-30)个月。中位PFS尚不成熟。估计的1年和2年PFS率分别为85.3% (95% CI: 60.1%, 95.2%)和76.8% (95% CI: 47.0%, 91.2%)。27名患者(93.1%)出现了任何等级的TRAEs,最常见的是白细胞计数下降(82.8%),贫血(58.6%)和乏力(48.3%)。有8名患者(27.6%)发生了3级或更高级别的TRAEs。无治疗相关死亡发生。PD-1抑制剂联合同步化疗放疗在盆腔和/或腹主动脉淋巴结转移的局部晚期宫颈癌患者中显示出了肿瘤应答和PFS的潜在益处。
The prognosis remains poor after standard chemoradiotherapy in locally advanced cervical cancer patients with pelvic and/or para-aortic lymph node metastases. Programmed cell death receptor-1 (PD-1) inhibitors have been recommended as the first-line treatment for recurrent cervical cancer. The efficacy of PD-1 inhibitor combined with concurrent chemoradiotherapy in locally advanced cervical cancer was still uncertain. This study aimed to explore the efficacy and safety of PD-1 inhibitors combined with concurrent chemoradiotherapy in locally advanced cervical cancer patients with pelvic and/or para-aortic lymph node metastases.This retrospective study included patients with pelvic and/or para-aortic lymph node positive diseases [International Federation of Gynecology and Obstetrics (FIGO) stage IIB-IVA] who had received PD-1 inhibitors plus chemoradiotherapy/radiotherapy between April 1, 2020, and March 31, 2022 at the Hunan Cancer Hospital. The baseline clinicopathological characteristics, treatment, and clinical outcomes were collected. The major clinical outcomes were objective response rate (ORR), progression-free survival (PFS), and treatment-related adverse events (TRAEs).A total of 29 patients were included. The mean age was 55.8 [standard deviation (SD): 8.8] years. Most patients had stage IIIA-IIIB disease (72.4%) and squamous cell carcinoma (93.1%). All patients had lymph node metastases, including 24 (82.8%) with multiple metastases and 11 (37.9%) with para-aortic lymph node metastases. Among the 29 patients, 18 received sintilimab and 11 received camrelizumab concurrently with chemoradiotherapy or radiotherapy. The ORR was 96.6% [95% confidence interval (CI): 0.828, 0.993] at 3 months after radiotherapy (including 15 complete responses and 13 partial responses). At the data cutoff (August 31, 2022), the median follow-up was 14 (range, 5-30) months. The median PFS was not mature. The estimated 1- and 2-year PFS rates were 85.3% (95% CI: 60.1%, 95.2%) and 76.8% (95% CI: 47.0%, 91.2%), respectively. TRAEs of any grade occurred in 27 (93.1%) patients, most commonly as a decrease in white blood counts (82.8%), anemia (58.6%), and fatigue (48.3%). TRAEs of grade 3 or greater occurred in eight (27.6%) patients. There were no treatment-related deaths.PD-1 inhibitor combined with concurrent chemoradiotherapy showed potential benefit in term of tumor response and PFS in locally advanced cervical cancer patients with pelvic and/or para-aortic lymph node metastases.