■Sintilimab是针对程序性细胞死亡蛋白1的抗体。我们评估了sintilimab联合白蛋白结合(nab)-紫杉醇治疗复发性或转移性宫颈癌的疗效和安全性。
■这个多中心,开放标签,单臂,II期研究(ClinicalTrials.gov标识符NCT04341883)纳入了复发或转移性宫颈癌患者,这些患者在至少一线全身治疗后进展.患者每3周接受一次Sintilimab200mg和nab-紫杉醇260mg/m2体表面积。主要终点是研究人员根据实体瘤版本1.1的反应评估标准评估的客观反应率(ORR)。关键次要终点是无进展生存期(PFS),总生存期(OS),响应持续时间(DoR),和安全。
■从2020年1月13日至2022年2月21日,招募了27名患者并接受了治疗。患者年龄中位数为50岁(范围,34-68岁)。按数据截止(2022年5月22日),在意向治疗人群中,ORR为44.4%(95%CI,24.4%-64.5%)。疾病控制率为88.9%(95%CI,70.8%-97.6%)。中位PFS为5.2个月(95%CI,2.7-7.7个月)。平均DoR为3.8个月(95%CI,0.7-6.9个月),中位OS为13.1个月(95%CI,5.8-20.4个月).治疗相关的3级或4级不良事件(AE)发生在44.4%的患者中,最常见的不良事件是中性粒细胞计数减少(22.2%),白细胞计数减少(14.8%),贫血(7.4%)。最常见的潜在免疫相关不良事件是1-2级甲状腺功能减退症(18.5%),中性粒细胞减少症(11.1%),和皮疹(7.4%)。
■Sintilimab联合nab-紫杉醇治疗在晚期宫颈癌患者中显示出有希望的抗肿瘤活性和可控的毒性。需要更大的随机对照试验进行验证。
■创新生物制品公司,有限公司;CSPS控股有限公司,Ltd.
UNASSIGNED: Sintilimab is an antibody against programmed cell death protein 1. We assessed the efficacy and safety of
sintilimab plus albumin-bound (nab)-paclitaxel for the treatment of recurrent or metastatic cervical cancer.
UNASSIGNED: This multicenter, open-label, single-arm, phase II
study (ClinicalTrials.gov identifier NCT04341883) enrolled patients with recurrent or metastatic cervical cancer who progressed after at least one line of systemic therapy. The patients received
sintilimab 200 mg and nab-paclitaxel 260 mg/m2 body surface area every 3 weeks. The primary endpoint was objective response rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors version 1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety.
UNASSIGNED: From January 13, 2020 to February 21, 2022, 27 patients were enrolled and received treatment. Median patient age was 50 years (range, 34-68 years). By data cut-off (May 22, 2022), in intention-to-treat population, ORR was 44.4% (95% CI, 24.4%-64.5%). The disease control rate was 88.9% (95% CI, 70.8%-97.6%). Median PFS was 5.2 months (95% CI, 2.7-7.7 months). Median DoR was 3.8 months (95% CI, 0.7-6.9 months), and median OS was 13.1 months (95% CI, 5.8-20.4 months). Treatment-related grade 3 or 4 adverse events (AEs) occurred in 44.4% of the patients, and the most common AEs were decreased neutrophil count (22.2%), decreased white blood cell count (14.8%), and anemia (7.4%). The most common potential immune-related AEs were grade 1-2 hypothyroidism (18.5%), neutropenia (11.1%), and rash (7.4%).
UNASSIGNED: Sintilimab plus nab-paclitaxel treatment shows promising antitumor activity and manageable toxicity in patients with advanced cervical cancer. Larger randomized controlled trials are required for validation.
UNASSIGNED: Innovent Biologics Co., Ltd.; Csps Holdings Co., Ltd.