晚期或转移性/复发性食管鳞状细胞癌一线治疗本迈斯托巴特+安罗替尼和化疗:一项多中心2期研究

IF 40.8 1区 医学 Q1 BIOCHEMISTRY & MOLECULAR BIOLOGY Signal Transduction and Targeted Therapy Pub Date : 2024-11-08 DOI:10.1038/s41392-024-02008-7
Ning Li, Jin Xia, Xiaohui Gao, Jianwei Zhou, Yonggui Hong, Donghai Cui, Xuesong Zhao, Tao Wu, Yanzhen Guo, Junsheng Wang, Suxia Luo
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引用次数: 0

摘要

尽管一线免疫化疗改善了晚期食管鳞状细胞癌(ESCC)患者的预后,但更有效的策略仍需进一步研究。这项多中心 II 期研究(ClinicalTrials.gov NCT05013697)评估了苯麦司托巴(一种新型 PD-L1 抑制剂)联合安罗替尼(多靶点 TKI)和化疗治疗晚期或转移性/复发性 ESCC 的可行性。符合条件的患者接受4-6个周期(21天)的苯美斯托巴(1200毫克)、安罗替尼(10毫克)加紫杉醇(135毫克/平方米)/顺铂(60-75毫克/平方米)化疗,然后继续接受苯美斯托巴和安罗替尼化疗。主要终点是根据 RECIST v1.1 评估的无进展生存期(PFS)。次要终点是肿瘤反应、总生存期(OS)和根据不良事件(AEs)评估的安全性。2021年9月至2023年11月,50名患者入组并接受了研究治疗。截至2024年4月1日,中位随访时间为23.7个月,中位PFS为14.9个月(95% CI,11.4-无法估计[NE]),1年PFS为58.5%(95% CI,41.9%-71.9%)。在 50 名患者中,确诊客观反应率为 72.0%,疾病控制率为 84.0%。36 名应答者的中位应答持续时间为 16.2 个月(95% CI,10.2-NE)。截至截止日期,仍有 31 名患者存活;未达到中位 OS(95% CI,13.2 个月-NE),1 年 OS 为 74.8%(95% CI,59.8%-84.8%)。46例(92.0%)患者报告了治疗相关的AE,其中37例(74.0%)为≥3级。总体而言,本迈斯托巴特联合安罗替尼和化疗对晚期或转移性/复发性ESCC具有良好的疗效和可接受的毒性。
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First-line benmelstobart plus anlotinib and chemotherapy in advanced or metastatic/recurrent esophageal squamous cell carcinoma: a multi-center phase 2 study

Although first-line immunochemotherapy has improved prognosis for patients with advanced esophageal squamous cell carcinoma (ESCC), more effective strategies still require further investigation. This multi-center, phase II study (ClinicalTrials.gov NCT05013697) assessed the feasibility of benmelstobart (a novel PD-L1 inhibitor) plus anlotinib (multitargeted TKI) and chemotherapy in advanced or metastatic/recurrent ESCC. Eligible patients received 4–6 cycles (21-day) of benmelstobart (1200 mg), anlotinib (10 mg) plus paclitaxel (135 mg/m2)/cisplatin (60–75 mg/m2), then maintained with benmelstobart and anlotinib. Primary endpoint was progression-free survival (PFS) assessed according to RECIST v1.1. Secondary endpoints were tumor response, overall survival (OS), and safety assessed by adverse events (AEs). From September 2021 to November 2023, 50 patients were enrolled and received study treatment. With median follow-up of 23.7 months as of April 1, 2024, median PFS was 14.9 months (95% CI, 11.4-not estimable [NE]) and the 1-year PFS was 58.5% (95% CI, 41.9%–71.9%). Among 50 patients, confirmed objective response rate was 72.0% and disease control rate was 84.0%. Median duration of response of 36 responders was 16.2 months (95% CI, 10.2-NE). At the cutoff date, 31 patients remained alive; median OS was not reached (95% CI, 13.2 months-NE) with 1-year OS of 74.8% (95% CI, 59.8%–84.8%). Forty-six (92.0%) patients reported treatment-related AEs, with 37 (74.0%) were grade ≥3. Overall, benmelstobart plus anlotinib and chemotherapy showed promising efficacy and acceptable toxicity in advanced or metastatic/recurrent ESCC.

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来源期刊
Signal Transduction and Targeted Therapy
Signal Transduction and Targeted Therapy Biochemistry, Genetics and Molecular Biology-Genetics
CiteScore
44.50
自引率
1.50%
发文量
384
审稿时长
5 weeks
期刊介绍: Signal Transduction and Targeted Therapy is an open access journal that focuses on timely publication of cutting-edge discoveries and advancements in basic science and clinical research related to signal transduction and targeted therapy. Scope: The journal covers research on major human diseases, including, but not limited to: Cancer,Cardiovascular diseases,Autoimmune diseases,Nervous system diseases.
期刊最新文献
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