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A perspective: the integration of ctDNA into Response Evaluation Criteria in Solid Tumours 1.1 for phase II immunotherapy clinical trials. 透视:将ctDNA纳入《实体瘤反应评估标准1.1》,用于II期免疫疗法临床试验。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-03-01 Epub Date: 2024-01-10 DOI: 10.2217/imt-2023-0184
Tulay Kus, Irfan Cicin

A consensus guideline, iRECIST, was developed by the Response Evaluation Criteria in Solid Tumours (RECIST) working group for the use of the modified RECIST version 1.1 in cancer immunotherapy trials. iRECIST was designed to separate pseudoprogression from real progression. However, this is not the only ambiguous situation. In clinical immunotherapy trials, stable disease may reflect three tumor responses, including real stable disease, progressive disease and responsive disease. The prediction of a "true complete/partial response" is also important. Much data has accumulated showing that ctDNA can guide decisions at this point; thus, integrating ctDNA into the RECIST 1.1 criteria may help to distinguish a true tumor response type earlier in patients treated with immunotherapy; however, prospectively designed validation studies are needed.

实体瘤反应评估标准(RECIST)工作组制定了一项名为 iRECIST 的共识指南,用于在癌症免疫疗法试验中使用修改后的 RECIST 1.1 版。然而,这并不是唯一模糊不清的情况。在临床免疫疗法试验中,稳定期疾病可能反映三种肿瘤反应,包括真正的稳定期疾病、进展期疾病和反应性疾病。预测 "真正的完全/部分反应 "也很重要。已积累的大量数据显示,ctDNA 可以在这一点上指导决策;因此,将 ctDNA 纳入 RECIST 1.1 标准可能有助于更早地区分接受免疫疗法治疗的患者的真正肿瘤反应类型;不过,还需要进行前瞻性设计的验证研究。
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引用次数: 0
Efficacy and safety of pembrolizumab combined with albumin-bound paclitaxel and nedaplatin for advanced esophageal squamous cell carcinoma. pembrolizumab与白蛋白结合型紫杉醇和奈达铂联合治疗晚期食管鳞状细胞癌的有效性和安全性。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-03-01 Epub Date: 2024-01-10 DOI: 10.2217/imt-2023-0188
Fang Yan, Longpei Chen, Mingzhen Ying, Jie Li, Qiang Fu

Objective: This research aimed to assess the efficacy and safety of pembrolizumab (PBL) combined with albumin-bound paclitaxel (ab-Pac) and nedaplatin (NDP) for advanced esophageal squamous cell carcinoma (ESCC). Methods: A total of 47 ESCC patients were administered PBL or NDP on day 1 and ab-Pac on days 1 and 8, every 21 days for one cycle. Tumor and toxicities were evaluated every two cycles and every cycle, respectively. Results: The objective response rate was 68.1% and the disease control rate was 100%. The median follow-up was 16.7 months; median progression-free and overall survival were 12.6 and 19.9 months, respectively. Conclusion: The combination of PBL with ab-Pac and NDP proved to be an effective and safe treatment regimen for advanced ESCC.

研究目的本研究旨在评估pembrolizumab(PBL)联合白蛋白结合型紫杉醇(ab-Pac)和奈达铂(NDP)治疗晚期食管鳞状细胞癌(ESCC)的有效性和安全性。研究方法对47名ESCC患者在第1天使用PBL或NDP,在第1天和第8天使用ab-Pac,每21天为一个周期。每两个周期和每个周期分别对肿瘤和毒性进行评估。结果客观反应率为68.1%,疾病控制率为100%。中位随访时间为 16.7 个月;中位无进展生存期和总生存期分别为 12.6 个月和 19.9 个月。结论事实证明,PBL与ab-Pac和NDP联合治疗晚期ESCC是一种有效、安全的治疗方案。
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引用次数: 0
SAFFRON-103: a phase Ib study of sitravatinib plus tislelizumab in anti-PD-(L)1 refractory/resistant advanced melanoma. SAFFRON-103:西曲替尼联合替赛珠单抗治疗抗PD-(L)1难治/耐药晚期黑色素瘤的Ib期研究。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-03-01 Epub Date: 2024-01-10 DOI: 10.2217/imt-2023-0130
Xuan Wang, Hongming Pan, Jiuwei Cui, Xiao Chen, Won-Hee Yoon, Matteo S Carlino, Xin Li, Hui Li, Juan Zhang, Jingchao Sun, Jun Guo, Chuanliang Cui

Aim: Investigate TKI sitravatinib plus anti-PD-1 antibody tislelizumab in patients with unresectable/advanced/metastatic melanoma with disease progression on/after prior first-line anti-PD-(L)1 monotherapy. Methods: Open-label, multicenter, multicohort study (NCT03666143). Patients in the melanoma cohort (N = 25) received sitravatinib once daily plus tislelizumab every 3 weeks. The primary end point was safety and tolerability. Results: Treatment-emergent adverse events (TEAEs) occurred in all patients, with ≥grade 3 TEAEs in 52.0%. Most TEAEs were mild-or-moderate in severity, none were fatal, and few patients discontinued treatment owing to TEAEs (12.0%). Objective response rate was 36.0% (95% CI: 18.0-57.5). Median progression-free survival was 6.7 months (95% CI: 4.1-not estimable). Conclusion: Sitravatinib plus tislelizumab had manageable safety/tolerability in patients with anti-PD-(L)1 refractory/resistant unresectable/advanced/metastatic melanoma, with promising antitumor activity. Clinical Trial Registration: NCT03666143 (ClinicalTrials.gov).

目的:研究TKI西曲替尼联合抗PD-1抗体tislelizumab用于既往接受过一线抗PD-(L)1单药治疗且疾病进展的不可切除/晚期/转移性黑色素瘤患者。研究方法开放标签、多中心、多队列研究(NCT03666143)。黑色素瘤队列中的患者(N = 25)每天接受一次西曲拉替尼治疗,每3周加用一次替赛珠单抗。主要终点是安全性和耐受性。研究结果所有患者都发生了治疗突发不良事件(TEAEs),52.0%的患者发生了≥3级的TEAEs。大多数 TEAE 的严重程度为轻度或中度,无死亡病例,因 TEAE 而中断治疗的患者很少(12.0%)。客观反应率为36.0%(95% CI:18.0-57.5)。中位无进展生存期为 6.7 个月(95% CI:4.1-无法估计)。结论在抗PD-(L)1难治/耐药的不可切除/晚期/转移性黑色素瘤患者中,西曲伐替尼联合替赛珠单抗具有可控的安全性/耐受性,并具有良好的抗肿瘤活性。临床试验注册:NCT03666143(ClinicalTrials.gov)。
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引用次数: 0
Effect of sublingual immunotherapy on clinical and laboratory autoimmunity. 舌下免疫疗法对临床和实验室自身免疫的影响
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-03-01 Epub Date: 2024-01-12 DOI: 10.2217/imt-2023-0231
Andrzej Bozek, Szymon Mućka, Martyna Miodonska, Anna Zlik, Magdalena Mroz-Dybowska

Background: There still are few data on the long-term safety of sublingual immunotherapy (SLIT). The aim of this study was to assess the appearance of autoimmune diseases in patients before and after SLIT. Materials & methods: New cases of autoimmune diseases were monitored. Patients in the SLIT group (n = 816) were compared with controls (n = 1096). Results: The new incidences of autoimmune diseases in the SLIT group were lower compared with the control group: 18 (2.2%) versus 58 (5.3%); p < 0.05. Systemic lupus erythematosus, psoriasis and Hashimoto appeared much more often in the control group. Conclusion: SLIT had no significant effect on the induction of autoimmune diseases.

背景:有关舌下免疫疗法(SLIT)长期安全性的数据仍然很少。本研究旨在评估舌下免疫疗法前后患者出现自身免疫性疾病的情况。材料与方法:监测自身免疫性疾病的新病例。将 SLIT 组患者(n = 816)与对照组(n = 1096)进行比较。结果与对照组相比,SLIT 组的自身免疫性疾病新发病率较低:18(2.2%)对 58(5.3%);P 结论:SLIT 对自身免疫疾病的发病率没有显著影响:SLIT对诱发自身免疫性疾病没有明显影响。
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引用次数: 0
Insights into the maturation heterogeneity of tumor-associated tertiary lymphoid structures in cancer immunotherapy. 洞察肿瘤相关三级淋巴结构在癌症免疫疗法中的成熟异质性。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-12-19 DOI: 10.2217/imt-2023-0196
Wenhao Xu, Jianfeng Yang, Shiqi Ye, Wangrui Liu, Jiahe Lu, Aihetaimujiang Anwaier, Hailiang Zhang, Dingwei Ye
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引用次数: 0
Combination of methotrexate with oral disease-modifying antirheumatic drugs in psoriatic arthritis: a systematic review. 银屑病关节炎中甲氨蝶呤与口服改变病情抗风湿药的联合治疗:系统综述。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-12-19 DOI: 10.2217/imt-2023-0139
Tyng-Shiuan Hsieh, Tsen-Fang Tsai

Background: Oral conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), especially methotrexate, are the cornerstone of treating psoriatic arthritis (PsA). The use of csDMARDs with biologics has increased their efficacy in psoriasis. However, the combination of two oral DMARDs in patients with PsA has not been adequately reviewed. In this study, we explore the combinational use of methotrexate with DMARDs in PsA patients. Materials & methods: A review was conducted using Medline (PubMed), Embase, Web of Science and the Cochrane Library, covering articles up to February 2023. Results & conclusion: Nine studies comprising 1993 participants were included. The evidence supporting combination therapy remains limited. Combinational therapy could be considered in patients with inadequate response to monotherapy or no access to biologics.

背景:口服传统合成改变病情抗风湿药(csDMARDs),尤其是甲氨蝶呤,是治疗银屑病关节炎(PsA)的基石。将 csDMARDs 与生物制剂结合使用提高了它们对银屑病的疗效。然而,关于两种口服DMARDs在PsA患者中的联合应用还没有充分的研究。在本研究中,我们探讨了甲氨蝶呤与 DMARDs 在 PsA 患者中的联合应用。材料与方法:使用 Medline (PubMed)、Embase、Web of Science 和 Cochrane 图书馆对截至 2023 年 2 月的文章进行了综述。结果与结论:共纳入九项研究,共有 1993 名参与者。支持联合疗法的证据仍然有限。对单一疗法反应不佳或无法使用生物制剂的患者可考虑采用联合疗法。
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引用次数: 0
Immunotherapy for head and neck squamous cell carcinoma: current status and perspectives. 头颈部鳞状细胞癌的免疫疗法:现状与展望。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-12-21 DOI: 10.2217/imt-2023-0174
Amaury Daste, Mathieu Larroquette, Nyere Gibson, Matthieu Lasserre, Charlotte Domblides

Immune checkpoint inhibitors (ICIs) have revolutionized the treatment of several solid cancers, including head and neck squamous cell carcinoma (HNSCC). First approved for second-line settings, ICIs are now used for the first-line treatment of HNSCCs, mainly in combination with standard chemotherapy. This review focuses on the results of the main phase III studies evaluating ICIs in recurrent or metastatic HNSCCs. The efficacy and indications according to the PD-L1 status, the main predictive biomarker, are discussed. The results of trials assessing ICI efficacy for locally advanced disease, including the neoadjuvant setting are also discussed. Finally, therapeutic combinations that are potential treatments for HNSCCs, including ICIs and targeted therapies such as anti-EGFR agents, are presented.

免疫检查点抑制剂(ICIs)彻底改变了包括头颈部鳞状细胞癌(HNSCC)在内的多种实体瘤的治疗方法。ICIs 最初被批准用于二线治疗,现在已被用于 HNSCC 的一线治疗,主要是与标准化疗联合使用。本综述重点介绍评估 ICIs 治疗复发性或转移性 HNSCC 的主要 III 期研究结果。根据主要预测生物标志物 PD-L1 的状态讨论了其疗效和适应症。此外,还讨论了评估 ICI 对局部晚期疾病(包括新辅助治疗)疗效的试验结果。最后,还介绍了可能治疗 HNSCC 的疗法组合,包括 ICI 和抗EGFR 等靶向疗法。
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引用次数: 0
The role of filgotinib in ulcerative colitis and Crohn's disease. 非戈替尼在溃疡性结肠炎和克罗恩病中的作用。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-11-27 DOI: 10.2217/imt-2023-0116
Jacopo Fanizza, Ferdinando D'Amico, Gaetano Lauri, Samuel J Martinez-Dominguez, Mariangela Allocca, Federica Furfaro, Alessandra Zilli, Gionata Fiorino, Tommaso Lorenzo Parigi, Simona Radice, Laurent Peyrin-Biroulet, Silvio Danese

Filgotinib is an oral small molecule that selectively inhibits JAK1. It is already approved for the treatment of moderately to severely active ulcerative colitis (UC). Ongoing studies are evaluating the efficacy and safety of filgotinib in Crohn's disease (CD). The purpose of this review is to summarize the available data regarding filgotinib in the management of UC and CD. We used Pubmed, Embase and clinicaltrials.gov websites to search all available data and currently ongoing studies regarding the efficacy and safety of filgotinib in inflammatory bowel diseases. Filgotinib is an effective and safe drug for the management of biologic-naive and biologic-experienced patients with moderate-to-severe UC. The same efficacy results have not been achieved in CD.

非哥替尼是一种口服小分子,选择性抑制JAK1。它已被批准用于治疗中度至重度活动性溃疡性结肠炎(UC)。正在进行的研究正在评估非戈替尼治疗克罗恩病(CD)的有效性和安全性。本综述的目的是总结关于非歌替尼治疗UC和CD的现有数据。我们使用Pubmed、Embase和clinicaltrials.gov网站搜索所有可用的数据和目前正在进行的关于非歌替尼治疗炎症性肠病的有效性和安全性的研究。非哥替尼是一种有效和安全的药物,用于治疗中至重度UC的生物新手和生物经验患者。在乳糜泻中没有达到相同的疗效结果。
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引用次数: 0
Radiation and resolve: unlocking the synergistic potential of radioimmunotherapy in advanced lung cancer management. 放射与决心:释放放射免疫疗法在晚期肺癌治疗中的协同潜力。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-12-06 DOI: 10.2217/imt-2023-0268
Yi Zhang, Zheng Li, Bingwen Zou

Plain language summary This editorial talks about combining radiation therapy (using high-energy rays to kill cancer cells) and immunotherapy (boosting the body's immune system to fight cancer) to treat advanced lung cancer. When used together, these therapies can work better to kill more cancer cells and help patients live longer. But, there's still a lot we don't know. For instance, we need to figure out the best timing and doses for these treatments, and which patients will benefit the most. The article stresses that more research is needed to answer these questions and make this combined treatment a more effective option for advanced lung cancer patients.

这篇社论谈到了结合放射疗法(使用高能射线杀死癌细胞)和免疫疗法(增强人体免疫系统来对抗癌症)来治疗晚期肺癌。当这些疗法一起使用时,可以更好地杀死更多的癌细胞,帮助患者延长寿命。但是,还有很多我们不知道的。例如,我们需要找出这些治疗的最佳时机和剂量,以及哪些患者将受益最大。文章强调,需要更多的研究来回答这些问题,并使这种联合治疗成为晚期肺癌患者更有效的选择。
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引用次数: 0
Toripalimab and fruquintinib therapy for colorectal cancer after failed multiline chemotherapies: a case report. 多线化疗失败后使用托利帕利单抗和福罗替尼治疗结直肠癌:病例报告。
IF 2.7 4区 医学 Q3 IMMUNOLOGY Pub Date : 2024-02-01 Epub Date: 2023-12-19 DOI: 10.2217/imt-2023-0235
Ling-Zhijie Kong, Ying Zheng, Kaichun Li

The options for treating metastatic colorectal cancer are limited after failure of second-line chemotherapy. In this case report, we present the outcome of a 59-year-old male patient who underwent radical resection for rectal cancer in November 2018 and hepatectomy for liver metastasis in January 2021. His metastatic rectal cancer presented a remarkable response to the combination of fruquintinib and toripalimab after the failure of multiline chemotherapies. The patient achieved partial response within 3 months and clinical complete response of pulmonary masses within 12 months. As of now, the patient maintains a good quality of life, and the progression-free survival has been more than 17 months. In conclusion, the combination of fruquintinib and PD-1 inhibitors can improve the prognosis of metastatic colorectal cancer.

二线化疗失败后,治疗转移性结直肠癌的选择非常有限。在本病例报告中,我们介绍了一名 59 岁男性患者的治疗结果,他于 2018 年 11 月接受了直肠癌根治性切除术,并于 2021 年 1 月接受了肝转移灶肝切除术。他的转移性直肠癌在多线化疗失败后,对夫鲁喹替尼和托瑞帕利单抗的联合治疗出现了显著反应。患者在 3 个月内获得部分反应,在 12 个月内获得肺部肿块的临床完全反应。目前,患者生活质量良好,无进展生存期已超过 17 个月。总之,fruquintinib和PD-1抑制剂的联合治疗可以改善转移性结直肠癌的预后。
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引用次数: 0
期刊
Immunotherapy
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