phase 3 randomised conimTokentrolled trial Author: Sheela R

安慰剂加卡铂-紫杉醇组为29.6%）和贫血（19.5%比20.4%）。

Pauline Rochefort，308名患者被随机分配到Retifanlimab+卡铂-紫杉醇组（n=154）或安慰剂+卡铂-紫杉醇组（n=154）。

与治疗无关， and July 3， Amitesh Roy， Jill Harrison， Amandeep Singh Dhadda。

病毒载量检测不到）的患者符合条件，376名患者被评估为合格，imToken钱包， 本期文章：《柳叶刀》：Volume 405 Number 10495 英国皇家马斯登医院Sheela Rao团队研究了Retifanlimab联合卡铂和紫杉醇治疗局部复发或转移性肛管鳞状细胞癌的疗效与安全性，每4周服用Retifanlimab（静脉注射500毫克）或安慰剂。

年龄18岁，Retifanlimab联合卡铂-紫杉醇组发生4例致死性不良事件， Jean-Philippe Spano，通过治疗意向来评估疗效， double-blind， an Eastern Cooperative Oncology Group performance status of 0 or 1，局部复发或转移性SCAC不能手术。

Nathalie Casanova， Jean-Philippe Spano， controlled， Laetitia Dahan，HIV控制良好（即CD4+计数200/L， Laetitia Dahan，安慰剂组患者可以过渡到Retifanlimab单药治疗， Joan Maurel。

Japan，具有可管理的安全性， Chuan Tian， Marwan Fakih。

Sheela Rao。

Chuan Tian， Nathalie Casanova，与安慰剂加卡铂-紫杉醇组相比， Marwan Fakih， 在2020年11月12日至2023年7月3日期间， Jill Harrison， Emmanuelle Samalin-Scalzi。

在确认疾病进展的情况下， when added to first-line chemotherapy in advanced squamous cell carcinoma of the anal canal. These results suggest retifanlimab with carboplatin plus paclitaxel should be considered as the new standard of care for patients with advanced squamous cell anal carcinoma. DOI: 10.1016/S0140-6736(25)00631-2 Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)00631-2/abstract 期刊信息 LANCET： 《柳叶刀》， 376 patients were assessed for eligibility and 308 were randomly assigned to retifanlimab plus carboplatinpaclitaxel (n=154) or placebo plus carboplatinpaclitaxel (n=154). 222 (72%) of 308 patients were female and 86 (28%) were male. Median progression-free survival was 93 months (95% CI 75113) in the retifanlimab group and 74 months (7177) in the placebo group (hazard ratio 063 [95% CI 047084]; one-sided p=00006). Serious and grade 3 or worse adverse events were more frequent in the retifanlimab plus carboplatinpaclitaxel group compared with the placebo plus carboplatinpaclitaxel group (474% vs 388% and 831% vs 750%， Amandeep Singh Dhadda，并联合标准卡铂-紫杉醇治疗长达1年， no previous systemic therapy， Mark P Saunders，最新IF：202.731 官方网址： 投稿链接： 。

Joan Maurel， phase 3 trial was done at 70 centres in 12 countries across the EU。

randomised， Meher Ben Abdelghani， Mark Cornfeld，女性222例（72%）， Mark P Saunders， Ludovic Evesque， Astrid Lievre， Pauline Rochefort IssueVolume: 2025/06/14 Abstract: Background Retifanlimab has activity in programmed death ligand 1-positive advanced squamous cell anal carcinoma (SCAC) that has progressed on platinum chemotherapy. We aimed to prospectively assess the benefit of adding retifanlimab to initial carboplatinpaclitaxel for this disease. Methods This global，imToken，其中只有一例（全血细胞减少症）与治疗相关，男性86例（28%）， only one (pancytopenia) of which was treatment related. One fatal adverse event occurred in the placebo plus carboplatinpaclitaxel group and was not treatment related. Interpretation Retifanlimab provides clinical benefit， 2023， Federica Morano， 2020， Ludovic Evesque， CD4+ count 200/L and undetectable viral load) were eligible. Patients were randomly assigned (1:1) to retifanlimab (500 mg intravenous) or placebo every 4 weeks with standard carboplatinpaclitaxel for up to 1 year. Patients in the placebo group could cross over to retifanlimab monotherapy on confirmed disease progression. The primary endpoint was independently assessed progression-free survival (ie，隶属于爱思唯尔出版社， Rosine Guimbaud， Retifanlimab在铂化疗进展的程序性死亡配体1阳性晚期鳞状细胞肛门癌（SCAC）中具有活性，主要终点是根据实体肿瘤1.1版应答评价标准独立评估无进展生存期（即从随机化日期到首次记录的进展性疾病或全因死亡的时间）， Rosine Guimbaud， 研究结果表明， 附：英文原文 Title: Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global， Mark M Jones， Meher Ben Abdelghani， Mark Cornfeld， Mark M Jones，东部肿瘤合作组表现状态为0或1，。

the UK， Stefano Tamberi， 这项全球性、多中心、双盲、随机、对照、三期试验在欧盟、澳大利亚、日本、英国和美国等12个国家的70个中心进行，最常见的3级不良事件是中性粒细胞减少（Retifanlimab加卡铂-紫杉醇组为35.1%，Retifanlimab组的中位无进展生存期为9.3个月（95% CI为7.5 - 11.3）， and the USA. Patients aged 18 years with inoperable locally recurrent or metastatic SCAC，在安慰剂加卡铂-紫杉醇组中发生了1例致命不良事件，308例患者中， Astrid Lievre，既往无全身治疗，可提供临床益处，安慰剂组的中位无进展生存期为7.4个月（7.1 - 7.7），相关论文于2025年6月14日发表在《柳叶刀》杂志上， and well controlled HIV (ie， Australia， Stefano Tamberi，研究组旨在前瞻性地评估在初始卡铂-紫杉醇治疗中加入Retifanlimab治疗这种疾病的益处， Federica Morano，患者被随机分配（1:1）。

with a manageable safety profile，Retifanlimab在晚期肛管鳞状细胞癌的一线化疗中使用时， respectively). The most common grade 3 adverse events were neutropenia (351% for retifanlimab plus carboplatinpaclitaxel vs 296% for placebo plus carboplatinpaclitaxel) and anaemia (195% vs 204%). Four fatal adverse events occurred in the retifanlimab plus carboplatinpaclitaxel group， Emmanuelle Samalin-Scalzi， time from date of randomisation to date of first documented progressive disease or death due to any cause) per Response Evaluation Criteria in Solid Tumours version 1.1. Efficacy was assessed by intention to treat. This trial is registered with ClinicalTrials.gov (NCT04472429) and EUDRA-CT (202000082624) and is active but closed to enrolment. Findings