Efficacy and safety of anlotinib plus penpulimab as second-line treatment for small cell lung cancer:A multicenter,open-label,single-arm phase Ⅱ trial

Background:Currently,the need for new therapeutic strategies involving programmed cell death protein-1(PD-1)monoclonal antibodies in the second-line setting of small cell lung cancer(SCLC)is urgent.This study aimed to evaluate the efficacy and safety of anlotinib plus penpulimab as a second-line treatment for patients with SCLC who progressed after first-line platinum-based chemotherapy.Methods:This study included the patients from Cohort 4 of a single-arm,open-label,multicenter,phase II clinical trial.A safety run-in phase was performed under anlotinib(10/12 mg quaque die[QD],days 1–14)plus penpulimab(200 mg intravenously[IV],day 1)in a 21-day cycle,followed by the formal trial in which the patients received anlotinib(12 mg QD,days 1–14)plus penpulimab(200 mg IV,day 1)in a 21-day cycle.The primary endpoint of the safety run-in phase was safety.The primary endpoint of the formal trial phase was the objective response rate(ORR).Results:From April 28,2020,to November 24,2020,21 patients were enrolled from 11 hospitals,including 2 in the safety run-in phase and 19 in the formal trial phase.In the formal trial phase,the ORR was 42.1%(8/19;95%confidence interval[CI]:17.7–66.6%).The median progression-free survival was 4.8 months(95%CI:2.9–11.3 months),and the median overall survival was 13.0 months(95%CI:4.6–not applicable[NA]months).The incidence of grade 3 treatment-related adverse events(TRAEs)was 52.4%(11/21),and the incidence of treatment-related serious adverse events(AEs)was 28.6%(6/21).Two AE-related deaths occurred.The most common AEs were hypertension(57.1%,12/21),hypothyroidism(42.9%,9/21),and hypertriglyceridemia(38.1%,8/21).Conclusions:In patients with SCLC who progressed after first-line platinum-based chemotherapy,the second-line anlotinib plus penpulimab treatment demonstrates promising anti-cancer activity and a manageable safety profile,which warrants further investigation.

基于真实世界的派安普利单抗临床应用及安全性分析

目的 探讨基于真实世界派安普利单抗的临床应用及安全性。方法 收集某肿瘤专科医院2022年4月至12月使用派安普利单抗的患者13例,回顾性分析其基本信息、临床诊断、用药信息等临床应用情况及安全性。结果 13例患者中,男女性别比为1∶1.6,年龄(61.1±14.5)岁,53.85%的患者合并慢性疾病。派安普利单抗在临床使用中存在超适应证(100.00%)、联用其他抗肿瘤药物(76.92%)等超药品说明书用药情况;药品不良反应(ADR)发生率为23.08%,其中,3级ADR 2例,分别为腹泻和肝功能损伤。结论 派安普利单抗发生的ADR与药品说明书中的ADR类似,应进一步扩大样本量,把握使用指征,确保安全、合理用药。

PD-1抑制剂导致大疱性类天疱疮3例报道及文献分析

程序性细胞死亡受体1(programmed cell death receptor 1,PD-1)及其配体(PD-1 ligand,PD-L1)抑制剂已成为治疗恶性肿瘤的重要手段,主要不良反应为免疫相关不良反应(immune-related adverse event,irAE)。大疱性类天疱疮(bullous pemphigoid,BP)为其中一种皮肤相关的不良反应,主要表现为瘙痒、丘疹痒斑块,随后发展成水疱,发生机制可能与其增加机体的免疫应答有关,基于BP的治疗措施主要以激素为主,但仍有其他传统药物治疗有效的报道。本文报道3例PD-1诱发的BP,并对其发病机制、治疗策略、潜在的生物标志物进行了回顾总结。

派安普利联合安罗替尼治疗局部晚期和转移性头颈部肿瘤的效果

目的:探究派安普利联合安罗替尼治疗局部晚期和转移性头颈部肿瘤的疗效和毒副反应。方法:选取2022年10月—2023年6月本院收治的头颈部肿瘤患者92例作为研究对象,随机分成常规组和联合组,每组46例。常规组接受安罗替尼单药治疗,联合组接受派安普利联合安罗替尼治疗,比较两组临床疗效、免疫功能和毒副反应发生率。结果:联合组ORR、DCR均高于常规组(P<0.05);两组治疗后CD4^(+)、CD4^(+)/CD8^(+)均低于同组治疗前,且联合组高于常规组(P<0.05);两组毒副反应发生率比较,差异无统计学意义(P>0.05)。结论:派安普利联合安罗替尼对局部晚期和转移性头颈部肿瘤患者具备良好的疗效,有助于改善免疫功能,可为临床治疗提供参考。