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Lung Cancer Screening Eligibility, Uptake, and Adherence in Puerto Rico, 2022 波多黎各肺癌筛查的资格、吸收和依从性,2022
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-26 DOI: 10.1016/j.jtocrr.2025.100852
Maira A. Castañeda-Avila PhD, MS , Eduardo J. Santiago-Rodríguez PhD, MPH , William Rodríguez-Cintrón MD, MPH , Coral Olazagasti MD , Efrén J. Flores MD , Estelamari Rodríguez MD, MPH , Ana I. Velázquez Mañana MD, MSc , Yomayra Otero-Domínguez MD, MS , Eduardo R. Núñez MD, MS

Importance

Lung cancer screening (LCS) with yearly low-dose computed tomography reduces lung cancer mortality, but uptake remains low. Puerto Rico, a U.S. territory, faces significant barriers to LCS implementation, but data on LCS eligibility and use are limited.

Objective

This study aimed to estimate the number of individuals eligible for LCS in Puerto Rico and assess the prevalence of LCS use and up-to-date status compared with U.S. Hispanic and non-Hispanic populations.

Design, Setting, and Participants

This cross-sectional study analyzed data from the 2022 Behavioral Risk Factor Surveillance System, a population-based telephone survey. Adults eligible for LCS per 2021 U.S. Preventive Services Task Force guidelines (aged 50–80 years, ≥20 pack-year smoking history, current or recent smokers) from Puerto Rico and the United States were included.

Exposures

Participants were categorized into three groups: Puerto Rico residents, U.S. Hispanic, and U.S. non-Hispanic populations.

Primary Outcomes and Measures

The primary outcomes and measures were self-reported receipt of initial LCS (ever had chest CT for screening) and being up to date with LCS (i.e., chest CT in the past year). Multivariable Poisson models estimated adjusted prevalence ratios for LCS outcomes.

Results

After population weighting, 94,955 individuals were eligible for LCS in Puerto Rico, compared with 12.8 million in the U.S., representing 7.9% and 11.9% of their respective populations. The prevalence of self-reported LCS use was 28.4% in Puerto Rico, 27.6% among U.S. Hispanics, and 31.5% among U.S. non-Hispanics. Being up to date with LCS was lower among Puerto Rico residents (9.8%) than among U.S. Hispanics (17.3%) and non-Hispanics (18.1%). Multivariable models found Puerto Rico residents were less likely to be up to date with LCS than were U.S. non-Hispanics (adjusted prevalence ratios, 0.54; 95% CI 0.29–0.99).

Conclusions and Relevance

Fewer than 10% of eligible individuals in Puerto Rico self-reported being up to date with LCS, indicating they are almost half as likely to self-report as eligible individuals in the United States, highlighting significant gaps in care. Implementing high-quality LCS in Puerto Rico is critical to reducing lung cancer mortality and providing equitable lung cancer care.
肺癌筛查(LCS)每年进行低剂量计算机断层扫描可降低肺癌死亡率,但吸收率仍然很低。波多黎各是美国领土,在实施LCS方面面临重大障碍,但关于LCS资格和使用的数据有限。目的本研究旨在估计波多黎各有资格接受LCS治疗的人数,并与美国西班牙裔和非西班牙裔人群进行比较,评估LCS使用的流行程度和最新状况。设计、环境和参与者本横断面研究分析了2022年行为风险因素监测系统的数据,这是一项基于人群的电话调查。根据2021年美国预防服务工作组指南(年龄50-80岁,吸烟史≥20包年,当前或近期吸烟者),来自波多黎各和美国的符合LCS条件的成年人被纳入研究对象。参与者被分为三组:波多黎各居民、美国西班牙裔和美国非西班牙裔人口。主要结果和测量方法主要结果和测量方法是自我报告的初始LCS(曾经做过胸部CT筛查)和最新的LCS(即过去一年的胸部CT)。多变量泊松模型估计LCS结果的校正患病率。结果在人口加权后,波多黎各有94955人符合LCS资格,而美国有1280万人,分别占其人口的7.9%和11.9%。自我报告的LCS使用率在波多黎各为28.4%,在美国西班牙裔中为27.6%,在美国非西班牙裔中为31.5%。波多黎各居民更新LCS的比例(9.8%)低于美国西班牙裔(17.3%)和非西班牙裔(18.1%)。多变量模型发现,波多黎各居民更新LCS的可能性低于美国非西班牙裔居民(调整患病率比,0.54;95% ci 0.29-0.99)。结论和相关性在波多黎各,只有不到10%的符合条件的个人自我报告最新的LCS,这表明他们自我报告的可能性几乎是美国符合条件个人的一半,突出了护理方面的重大差距。在波多黎各实施高质量的LCS对于降低肺癌死亡率和提供公平的肺癌治疗至关重要。
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引用次数: 0
Evaluation of the Safety, Pharmacokinetics, and Antitumor Activity of Tusamitamab Ravtansine in Patients With Nonsquamous NSCLC With High or Moderate Expression of Carcinoembryonic Antigen-Related Cell Adhesion Molecule 5 Tusamitamab Ravtansine在癌胚抗原相关细胞粘附分子高或中度表达的非鳞状NSCLC患者中的安全性、药代动力学和抗肿瘤活性评价
IF 3.5 Q2 ONCOLOGY Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100844
Anas Gazzah MD , Charles Ricordel MD, PhD , Antoine Italiano MD, PhD , Byoung Chul Cho MD, PhD , Emiliano Calvo MD, PhD , Dong-Wan Kim MD, PhD , Carole Helissey MD , Jin-Soo Kim MD, PhD , Maria Vieito Villar MD , Francois Ghiringhelli HDR , Victor Moreno MD, PhD , Sophie Cousin MD , Luis Paz-Ares MD, PhD , Nathalie Fagniez Pharm D , Mustapha Chadjaa MD , Anne-Laure Bauchet DECVP, PhD , Christine Soufflet MD , Nina Masson MSc , Fabrice Barlesi MD, PhD

Introduction

Tusamitamab ravtansine is an antibody-drug conjugate targeting cells expressing carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) with a maytansinoid payload, DM4. This phase 1b dose-expansion study (NCT02187848) evaluated its safety, pharmacokinetics, and preliminary antitumor activity in patients with nonsquamous NSCLC (NSq NSCLC).

Methods

Patients aged above or equal to 18 years with advanced or metastatic NSq NSCLC, life expectancy more than or equal to 12 weeks, and high (≥2+ intensity in ≥50% of tumor cells) or moderate (≥2+ intensity in 1%–49% of tumor cells) CEACAM5 expression (assessed by immunohistochemistry) received intravenous tusamitamab ravtansine 100 mg/m2 every 2 weeks.

Results

A total of 64 patients with high and 28 with moderate CEACAM5 expression received a median of 8.0 (1–69) and 4.5 (1–38) treatment cycles, respectively. High expressors had 13 confirmed partial responses and 28 stable diseases (objective response rate, 20.3%; 95% confidence interval [CI]: 12.3%–31.7%, p < 0.0001); median duration of response was 6.7 months, and median time to progression was 3.7 months (95% CI: 2.7–5.1 mo). Moderate expressors had two confirmed partial responses (objective response rate, 7.1%; 95% CI: 2.0%–22.7%, p = 0.4117) and 15 stable diseases.
Treatment-emergent adverse events (AEs) occurred in 78.3% of patients (72/92), 37.0% (34/92) of patients required dose modifications, and 5.4% (5/92) discontinued treatment. The most common treatment-emergent AEs included asthenia (37.0%), keratitis (29.3%), and dyspnea (23.9%). Corneal AEs occurred in 38.0% (35/92), typically grade 1/2, reversible, and manageable by dose modifications.

Conclusions

Tusamitamab ravtansine demonstrated a favorable safety profile, objective responses, and antitumor activity in patients with high CEACAM5-expressing NSq NSCLC.
tusamitamab ravtansine是一种抗体-药物偶联物,靶向表达癌胚抗原相关细胞粘附分子5 (CEACAM5)的细胞,具有美坦素类有效载荷DM4。这项1b期剂量扩展研究(NCT02187848)评估了其在非鳞状NSCLC (NSq NSCLC)患者中的安全性、药代动力学和初步抗肿瘤活性。方法年龄≥18岁的晚期或转移性NSq NSCLC患者,预期寿命≥12周,CEACAM5高表达(≥50%肿瘤细胞≥2+强度)或中等表达(≥1%-49%肿瘤细胞≥2+强度)(免疫组化评估),每2周静脉注射tusamitamab ravtansine 100mg /m2。结果CEACAM5高表达患者64例,中等表达患者28例,治疗周期中位数分别为8.0(1-69)和4.5(1-38)。高表达者13例确诊部分缓解,28例病情稳定(客观缓解率20.3%,95%可信区间[CI]: 12.3% ~ 31.7%, p < 0.0001);中位缓解持续时间为6.7个月,中位进展时间为3.7个月(95% CI: 2.7-5.1个月)。中度表达者有2例确诊部分缓解(客观缓解率为7.1%;95% CI: 2.0% ~ 22.7%, p = 0.4117), 15例病情稳定。78.3%的患者(72/92)发生了治疗后出现的不良事件(ae), 37.0%(34/92)的患者需要调整剂量,5.4%(5/92)的患者停止治疗。最常见的治疗突发事件包括虚弱(37.0%)、角膜炎(29.3%)和呼吸困难(23.9%)。角膜不良事件发生率为38.0%(35/92),通常为1/2级,可逆,通过剂量调整可控制。结论usamitamab ravtansine在ceacam5高表达NSq NSCLC患者中具有良好的安全性、客观疗效和抗肿瘤活性。
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引用次数: 0
Parallel Phase II Clinical Trials of Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma 塞利那索治疗晚期胸腺瘤和胸腺癌的平行II期临床试验
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100848
Chul Kim MD , Vanya Aggarwal MD , Gedske Daugaard MD, DMSc , Tianzhi Tang MD , Jaeil Ahn PhD , Benjamin Besse MD, PhD , Nicolas Girard MD, PhD , Giuseppe Giaccone MD, PhD , Peter Meidahl Petersen MD, PhD
<div><h3>Introduction</h3><div>Thymic epithelial tumors (TETs) are rare and include thymomas (T) and thymic carcinomas (TC). Effective treatment options are needed for patients with progressive disease after platinum-based chemotherapy. Preclinical studies demonstrated antitumor activity of selinexor, an inhibitor of the nuclear receptor exportin-1 (XPO1/CRM1), supporting the clinical development of XPO1-targeted therapy for the treatment of TETs. To further assess the safety and efficacy of selinexor in TETs, we conducted two coordinated parallel phase II clinical trials.</div></div><div><h3>Methods</h3><div>This report includes two nearly identical phase II trials, designed to run in parallel, conducted in the United States (NCT03193437) and Europe (Denmark and France; NCT03466827). Analysis was performed on data pooled from both trials. Both trials were nonrandomized, open-label, two-armed phase II trials (arm A: thymoma, arm B: thymic carcinoma) with the same study design. Patients with histologically confirmed, advanced, inoperable TETs who had progressive disease after treatment with at least one platinum-containing chemotherapy regimen were included. In each 4-week cycle, patients received selinexor 60 mg twice weekly for 3 weeks. To improve tolerability, the starting dose was reduced to 40 mg twice weekly during the study. The primary objective was overall response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1, with secondary objectives including progression free survival (PFS), overall survival (OS), and adverse events (AEs) assessed per Common Terminology Criteria for Adverse Event version 4.03.</div></div><div><h3>Results</h3><div>A total of 31 patients were enrolled between the two trials: 16 with T and 15 with TC. The median age was 57 (range: 41–81) years, with 17 men and 14 women. The median number of previous systemic therapies was 2 (range: 1–9). The starting dose was 60 mg twice weekly for 29 patients (93.5%) and 40 mg twice weekly for two patients (6.5%). There was one complete response in the TC group (ORR 6.7%; 95% confidence interval [CI]: 1.2%–29.8%) and two partial responses (ORR 12.5%; 95% CI: 3.5%–36.0%) in the T group. Stable disease as the best response was observed in 11 patients (68.6%) with T and 12 patients (80%) with TC. The median duration of selinexor therapy was 4.5 (range: 0.1–44.3) months. The most common treatment-related adverse events (TRAEs) were nausea (83.8%), vomiting (45.2%), anemia (41.9%), fatigue (38.7%), and asthenia (38.7%). The most common grade 3 or higher TRAEs were anemia (16.1%), thrombocytopenia (12.9%), and asthenia (12.9%). Furthermore, 20 patients (64.5%) required dose reductions due to AEs and 20 patients (64.5%) required dose interruptions. In the T group, the median PFS was 13.6 months (95% CI: 6.3–44.3), and the median OS was not reached. In the TC group, the median PFS was 7.8 months (95% CI: 4.3–15.5) and the median OS was 15.5 months (95% CI: 13.0–29.9).
胸腺上皮肿瘤(TETs)是罕见的,包括胸腺瘤(T)和胸腺癌(TC)。在以铂为基础的化疗后,病情进展的患者需要有效的治疗方案。临床前研究表明,核受体输出素-1 (XPO1/CRM1)抑制剂selinexor具有抗肿瘤活性,支持XPO1靶向治疗TETs的临床开发。为了进一步评估selinexor在TETs中的安全性和有效性,我们进行了两项协调平行的II期临床试验。方法:本报告包括两个几乎相同的II期试验,设计为并行运行,分别在美国(NCT03193437)和欧洲(丹麦和法国;NCT03466827)。对两项试验的汇总数据进行分析。两项试验均为非随机、开放标签、双臂II期试验(A组:胸腺瘤,B组:胸腺癌),具有相同的研究设计。组织学证实的晚期不能手术的tet患者在接受至少一种含铂化疗方案治疗后病情进展。在每个4周的周期中,患者接受selinexor 60mg,每周2次,持续3周。为了提高耐受性,在研究期间,起始剂量减少到40毫克,每周两次。主要目标是根据实体瘤1.1的反应评价标准评估总体缓解率(ORR),次要目标包括根据不良事件通用术语标准4.03评估的无进展生存期(PFS)、总生存期(OS)和不良事件(ae)。结果两项试验共纳入31例患者:T组16例,TC组15例。中位年龄为57岁(范围:41-81岁),男性17人,女性14人。既往全身治疗的中位数为2次(范围:1-9次)。起始剂量为60 mg,每周两次,29例(93.5%),40 mg,每周两次,2例(6.5%)。TC组有1例完全缓解(ORR 6.7%;95%可信区间[CI]: 1.2%-29.8%)和两个部分反应(ORR 12.5%;95% CI: 3.5%-36.0%)。在11例(68.6%)T患者和12例(80%)TC患者中,病情稳定为最佳反应。selinexor治疗的中位持续时间为4.5个月(范围:0.1-44.3个月)。最常见的治疗相关不良事件(TRAEs)是恶心(83.8%)、呕吐(45.2%)、贫血(41.9%)、疲劳(38.7%)和虚弱(38.7%)。最常见的3级及以上trae是贫血(16.1%)、血小板减少(12.9%)和虚弱(12.9%)。此外,20名患者(64.5%)因ae需要减少剂量,20名患者(64.5%)需要中断剂量。T组中位PFS为13.6个月(95% CI: 6.3-44.3),中位OS未达到。TC组中位PFS为7.8个月(95% CI: 4.3-15.5),中位OS为15.5个月(95% CI: 13.0-29.9)。由于总体orr较低和预算限制,试验过早停止。结论selinexor在晚期TETs患者中表现出适度的抗癌活性。由于trae发生率高,治疗变得复杂,导致频繁的剂量减少和中断。
{"title":"Parallel Phase II Clinical Trials of Selinexor in Patients With Advanced Thymoma and Thymic Carcinoma","authors":"Chul Kim MD ,&nbsp;Vanya Aggarwal MD ,&nbsp;Gedske Daugaard MD, DMSc ,&nbsp;Tianzhi Tang MD ,&nbsp;Jaeil Ahn PhD ,&nbsp;Benjamin Besse MD, PhD ,&nbsp;Nicolas Girard MD, PhD ,&nbsp;Giuseppe Giaccone MD, PhD ,&nbsp;Peter Meidahl Petersen MD, PhD","doi":"10.1016/j.jtocrr.2025.100848","DOIUrl":"10.1016/j.jtocrr.2025.100848","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Introduction&lt;/h3&gt;&lt;div&gt;Thymic epithelial tumors (TETs) are rare and include thymomas (T) and thymic carcinomas (TC). Effective treatment options are needed for patients with progressive disease after platinum-based chemotherapy. Preclinical studies demonstrated antitumor activity of selinexor, an inhibitor of the nuclear receptor exportin-1 (XPO1/CRM1), supporting the clinical development of XPO1-targeted therapy for the treatment of TETs. To further assess the safety and efficacy of selinexor in TETs, we conducted two coordinated parallel phase II clinical trials.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This report includes two nearly identical phase II trials, designed to run in parallel, conducted in the United States (NCT03193437) and Europe (Denmark and France; NCT03466827). Analysis was performed on data pooled from both trials. Both trials were nonrandomized, open-label, two-armed phase II trials (arm A: thymoma, arm B: thymic carcinoma) with the same study design. Patients with histologically confirmed, advanced, inoperable TETs who had progressive disease after treatment with at least one platinum-containing chemotherapy regimen were included. In each 4-week cycle, patients received selinexor 60 mg twice weekly for 3 weeks. To improve tolerability, the starting dose was reduced to 40 mg twice weekly during the study. The primary objective was overall response rate (ORR) assessed by Response Evaluation Criteria in Solid Tumors 1.1, with secondary objectives including progression free survival (PFS), overall survival (OS), and adverse events (AEs) assessed per Common Terminology Criteria for Adverse Event version 4.03.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;A total of 31 patients were enrolled between the two trials: 16 with T and 15 with TC. The median age was 57 (range: 41–81) years, with 17 men and 14 women. The median number of previous systemic therapies was 2 (range: 1–9). The starting dose was 60 mg twice weekly for 29 patients (93.5%) and 40 mg twice weekly for two patients (6.5%). There was one complete response in the TC group (ORR 6.7%; 95% confidence interval [CI]: 1.2%–29.8%) and two partial responses (ORR 12.5%; 95% CI: 3.5%–36.0%) in the T group. Stable disease as the best response was observed in 11 patients (68.6%) with T and 12 patients (80%) with TC. The median duration of selinexor therapy was 4.5 (range: 0.1–44.3) months. The most common treatment-related adverse events (TRAEs) were nausea (83.8%), vomiting (45.2%), anemia (41.9%), fatigue (38.7%), and asthenia (38.7%). The most common grade 3 or higher TRAEs were anemia (16.1%), thrombocytopenia (12.9%), and asthenia (12.9%). Furthermore, 20 patients (64.5%) required dose reductions due to AEs and 20 patients (64.5%) required dose interruptions. In the T group, the median PFS was 13.6 months (95% CI: 6.3–44.3), and the median OS was not reached. In the TC group, the median PFS was 7.8 months (95% CI: 4.3–15.5) and the median OS was 15.5 months (95% CI: 13.0–29.9). ","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 9","pages":"Article 100848"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144672261","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Phase I Dose-Escalation Clinical Trial of Bronchoscopic Cryoimmunotherapy in Advanced-Stage NSCLC 支气管镜下低温免疫治疗晚期NSCLC的I期剂量递增临床试验
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100849
Jun-Chieh J. Tsay MD, MS , Antonio Velez MD , Destiny Collazo BS , Isaac Laniado MD , Jamie Bessich MD , Vivek Murthy MD , Andrew DeMaio MD , Samaan Rafeq MD , Benjamin Kwok MD , Fares Darawshy MD , Ray Pillai MD , Kendrew Wong MD , Yonghua Li MD, PhD , Rosemary Schluger RN , Alena Lukovnikova BS , Sofia Roldan BS , Matt Blaisdell BS , Fernanda Paz , Kelsey Krolikowski BS , Katherine Gershner MD , Daniel H. Sterman MD

Introduction

Outcomes for NSCLC remain suboptimal. Recent data suggest that cryoablation can generate antitumor immune effects. In this first-in-human phase I clinical trial, we investigated the safety and feasibility of bronchoscopic cryoimmunotherapy (BCI) delivered during standard-of-care bronchoscopy and explored associated systemic immune responses.

Methods

Subjects with known or suspected advanced-stage NSCLC were recruited. BCI was delivered in dose-escalated freeze-thaw cycles to determine maximum dose tolerance. Feasibility assessment was determined with a pre-set goal of achieving successful BCI in more than or equal to 80% of subjects. Safety was assessed by review of BCI-related complications, including grades 2 to 3 bleeding, pneumothorax requiring intervention, and National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 to 5 adverse events. Pre- and post-BCI blood samples were collected to explore changes in the systemic immune profile.

Results

Subjects with predominantly clinical TNM stage 3 or 4 adenocarcinoma or squamous cell carcinoma were enrolled. We reached the maximum dose of 30 seconds with 100% feasibility and no BCI-related adverse events. In peripheral blood analysis, we observed a significant decrease in derived neutrophil-to-lymphocyte ratio in the high-dose BCI group in comparison to the low-dose BCI cohort. We also observed increases in inflammatory cytokines—GM-CSF, IFN-γ, IL-1β, IL-17A, and IL-2—and effector memory T cells post-BCI.

Conclusion

BCI is safe and feasible. In addition, we provide preliminary evidence that at higher dose levels there is a systemic immune response consistent with a cytotoxic profile. Further immune analyses will determine the potential of BCI as an adjunctive therapy in combination with immune checkpoint inhibition in NSCLC treatment.
NSCLC的预后仍然不理想。最近的研究表明,冷冻消融术可以产生抗肿瘤的免疫作用。在这项首次人体I期临床试验中,我们调查了在标准支气管镜检查期间进行支气管镜冷冻免疫治疗(BCI)的安全性和可行性,并探讨了相关的全身免疫反应。方法招募已知或疑似晚期非小细胞肺癌的受试者。BCI以剂量递增的冻融循环递送,以确定最大剂量耐受。可行性评估确定了一个预先设定的目标,即在超过或等于80%的受试者中实现成功的脑机接口。安全性通过bci相关并发症评估,包括2 - 3级出血、需要干预的气胸,以及国家癌症研究所不良事件通用术语标准3 - 5级不良事件。收集脑损伤前和脑损伤后的血液样本,以探讨全身免疫谱的变化。结果研究对象主要为临床TNM 3期或4期腺癌或鳞状细胞癌。我们达到了30秒的最大剂量,100%的可行性,没有脑接口相关的不良事件。在外周血分析中,我们观察到与低剂量BCI组相比,高剂量BCI组衍生中性粒细胞与淋巴细胞比率显著降低。我们还观察到脑损伤后炎症细胞因子- gm - csf、IFN-γ、IL-1β、IL-17A和il -2以及效应记忆T细胞的增加。结论脑机接口是安全可行的。此外,我们提供的初步证据表明,在较高剂量水平下,存在与细胞毒性相符的全身免疫反应。进一步的免疫分析将确定BCI与免疫检查点抑制联合作为非小细胞肺癌治疗辅助疗法的潜力。
{"title":"A Phase I Dose-Escalation Clinical Trial of Bronchoscopic Cryoimmunotherapy in Advanced-Stage NSCLC","authors":"Jun-Chieh J. Tsay MD, MS ,&nbsp;Antonio Velez MD ,&nbsp;Destiny Collazo BS ,&nbsp;Isaac Laniado MD ,&nbsp;Jamie Bessich MD ,&nbsp;Vivek Murthy MD ,&nbsp;Andrew DeMaio MD ,&nbsp;Samaan Rafeq MD ,&nbsp;Benjamin Kwok MD ,&nbsp;Fares Darawshy MD ,&nbsp;Ray Pillai MD ,&nbsp;Kendrew Wong MD ,&nbsp;Yonghua Li MD, PhD ,&nbsp;Rosemary Schluger RN ,&nbsp;Alena Lukovnikova BS ,&nbsp;Sofia Roldan BS ,&nbsp;Matt Blaisdell BS ,&nbsp;Fernanda Paz ,&nbsp;Kelsey Krolikowski BS ,&nbsp;Katherine Gershner MD ,&nbsp;Daniel H. Sterman MD","doi":"10.1016/j.jtocrr.2025.100849","DOIUrl":"10.1016/j.jtocrr.2025.100849","url":null,"abstract":"<div><h3>Introduction</h3><div>Outcomes for NSCLC remain suboptimal. Recent data suggest that cryoablation can generate antitumor immune effects. In this first-in-human phase I clinical trial, we investigated the safety and feasibility of bronchoscopic cryoimmunotherapy (BCI) delivered during standard-of-care bronchoscopy and explored associated systemic immune responses.</div></div><div><h3>Methods</h3><div>Subjects with known or suspected advanced-stage NSCLC were recruited. BCI was delivered in dose-escalated freeze-thaw cycles to determine maximum dose tolerance. Feasibility assessment was determined with a pre-set goal of achieving successful BCI in more than or equal to 80% of subjects. Safety was assessed by review of BCI-related complications, including grades 2 to 3 bleeding, pneumothorax requiring intervention, and National Cancer Institute Common Terminology Criteria for Adverse Events grade 3 to 5 adverse events. Pre- and post-BCI blood samples were collected to explore changes in the systemic immune profile.</div></div><div><h3>Results</h3><div>Subjects with predominantly clinical TNM stage 3 or 4 adenocarcinoma or squamous cell carcinoma were enrolled. We reached the maximum dose of 30 seconds with 100% feasibility and no BCI-related adverse events. In peripheral blood analysis, we observed a significant decrease in derived neutrophil-to-lymphocyte ratio in the high-dose BCI group in comparison to the low-dose BCI cohort. We also observed increases in inflammatory cytokines—GM-CSF, IFN-γ, IL-1β, IL-17A, and IL-2—and effector memory T cells post-BCI.</div></div><div><h3>Conclusion</h3><div>BCI is safe and feasible. In addition, we provide preliminary evidence that at higher dose levels there is a systemic immune response consistent with a cytotoxic profile. Further immune analyses will determine the potential of BCI as an adjunctive therapy in combination with immune checkpoint inhibition in NSCLC treatment.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100849"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144480623","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Prospective Exploratory Study of Functional Immunity Assessed by Pretreatment Interferon Gamma Release Assay in Relation to Different Systemic Therapies in Patients With Advanced-Stage NSCLC 一项前瞻性探索性研究,通过预处理干扰素γ释放法评估晚期非小细胞肺癌患者不同全身治疗的功能免疫
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100845
Hsu-Ching Huang MD , Han-Jhih Chang MS , Chi-Lu Chiang MD , Hsin-Yi Huang MS , Yung-Hung Luo MD , Yuh-Min Chen MD , Tsu-Hui Shiao MD , Chao-Hua Chiu MD

Introduction

Predictive markers for chemotherapy and immunotherapy response in advanced NSCLC are limited, and no objective tool exists to assess immune function, which is critical for treatment outcomes. This study prospectively evaluated the interferon gamma (IFN-γ) release assay (IGRA) as a potential predictor of treatment response and a tool for assessing immune function.

Methods

We enrolled patients with stage IV NSCLC undergoing first-line chemotherapy, EGFR tyrosine kinase inhibitor (TKI) therapy, or any line of single-agent immunotherapy, alongside stage I controls. Peripheral blood samples were collected pre- and post-treatment for IGRA testing using the QuantiFERON-TB Gold In-Tube (QFT-GIT) kit. Phytohemagglutinin-stimulated IFN-γ (PSIG) responses were measured by both QFT-GIT and in-house enzyme-linked immunosorbent assay, with stage IV patients categorized into high- and low-PSIG response groups based on median pretreatment values.

Results

A total of 117 patients were analyzed (32 surgery, 30 EGFR TKI, 25 chemotherapy, 30 immunotherapy). The median PSIG response was significantly higher in stage I patients than stage IV (1420 pg/mL versus 960 pg/mL; p = 0.032). In stage IV, those with driver mutations had higher pretreatment PSIG responses (1278 pg/mL versus 288 pg/mL; p = 0.004). Kaplan–Meier analysis suggested a trend toward longer progression-free and overall survival in the EGFR TKI and immunotherapy groups with higher PSIG responses, though not statistically significant.

Conclusions

Patients with advanced-stage NSCLC exhibited reduced lymphocyte function, and patients with driver mutations correlated to less exhausted lymphocyte. IGRA demonstrates potential as a clinical tool for assessing immune function in these patients.
晚期非小细胞肺癌化疗和免疫治疗反应的预测标志物有限,没有客观的工具来评估免疫功能,而免疫功能对治疗结果至关重要。本研究前瞻性地评估了干扰素γ (IFN-γ)释放试验(IGRA)作为治疗反应的潜在预测因子和评估免疫功能的工具。方法:我们招募了正在接受一线化疗、EGFR酪氨酸激酶抑制剂(TKI)治疗或任何单药免疫治疗的IV期NSCLC患者,以及I期对照。采用QuantiFERON-TB金管(QFT-GIT)试剂盒采集外周血样本进行IGRA检测。采用QFT-GIT和内部酶联免疫吸附法测量植物血凝素刺激的IFN-γ (PSIG)反应,根据中位预处理值将IV期患者分为高PSIG反应组和低PSIG反应组。结果共分析117例患者,其中手术32例,EGFR TKI 30例,化疗25例,免疫治疗30例。I期患者的PSIG应答中位数显著高于IV期(1420 pg/mL vs 960 pg/mL;P = 0.032)。在IV期,驱动突变患者有更高的预处理PSIG反应(1278 pg/mL vs 288 pg/mL;P = 0.004)。Kaplan-Meier分析显示,EGFR TKI组和免疫治疗组的无进展生存期和总生存期较长,PSIG反应较高,但无统计学意义。结论晚期非小细胞肺癌患者淋巴细胞功能降低,驱动突变患者淋巴细胞耗竭程度较低。IGRA显示了作为评估这些患者免疫功能的临床工具的潜力。
{"title":"A Prospective Exploratory Study of Functional Immunity Assessed by Pretreatment Interferon Gamma Release Assay in Relation to Different Systemic Therapies in Patients With Advanced-Stage NSCLC","authors":"Hsu-Ching Huang MD ,&nbsp;Han-Jhih Chang MS ,&nbsp;Chi-Lu Chiang MD ,&nbsp;Hsin-Yi Huang MS ,&nbsp;Yung-Hung Luo MD ,&nbsp;Yuh-Min Chen MD ,&nbsp;Tsu-Hui Shiao MD ,&nbsp;Chao-Hua Chiu MD","doi":"10.1016/j.jtocrr.2025.100845","DOIUrl":"10.1016/j.jtocrr.2025.100845","url":null,"abstract":"<div><h3>Introduction</h3><div>Predictive markers for chemotherapy and immunotherapy response in advanced NSCLC are limited, and no objective tool exists to assess immune function, which is critical for treatment outcomes. This study prospectively evaluated the interferon gamma (IFN-γ) release assay (IGRA) as a potential predictor of treatment response and a tool for assessing immune function.</div></div><div><h3>Methods</h3><div>We enrolled patients with stage IV NSCLC undergoing first-line chemotherapy, EGFR tyrosine kinase inhibitor (TKI) therapy, or any line of single-agent immunotherapy, alongside stage I controls. Peripheral blood samples were collected pre- and post-treatment for IGRA testing using the QuantiFERON-TB Gold In-Tube (QFT-GIT) kit. Phytohemagglutinin-stimulated IFN-γ (PSIG) responses were measured by both QFT-GIT and in-house enzyme-linked immunosorbent assay, with stage IV patients categorized into high- and low-PSIG response groups based on median pretreatment values.</div></div><div><h3>Results</h3><div>A total of 117 patients were analyzed (32 surgery, 30 EGFR TKI, 25 chemotherapy, 30 immunotherapy). The median PSIG response was significantly higher in stage I patients than stage IV (1420 pg/mL versus 960 pg/mL; <em>p</em> = 0.032). In stage IV, those with driver mutations had higher pretreatment PSIG responses (1278 pg/mL versus 288 pg/mL; <em>p =</em> 0.004). Kaplan–Meier analysis suggested a trend toward longer progression-free and overall survival in the EGFR TKI and immunotherapy groups with higher PSIG responses, though not statistically significant.</div></div><div><h3>Conclusions</h3><div>Patients with advanced-stage NSCLC exhibited reduced lymphocyte function, and patients with driver mutations correlated to less exhausted lymphocyte. IGRA demonstrates potential as a clinical tool for assessing immune function in these patients.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100845"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Post-discontinuation Survival in Patients With Advanced NSCLC Receiving Immune Checkpoint Inhibitors: A Pooled Analysis of Prospective Cohort Studies 接受免疫检查点抑制剂的晚期非小细胞肺癌患者停药后生存率:前瞻性队列研究的汇总分析
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-15 DOI: 10.1016/j.jtocrr.2025.100847
Yusuke Inoue MD, PhD , Yoshihiro Kitahara MD , Masato Karayama MD, PhD , Kazuhiro Asada MD, PhD , Koji Nishimoto MD, PhD , Shun Matsuura MD, PhD , Dai Hashimoto MD, PhD , Masato Fujii MD, PhD , Takashi Matsui MD, PhD , Nao Inami MD , Mikio Toyoshima MD, PhD , Hiroyuki Matsuda MD, PhD , Masaki Ikeda MD, PhD , Mitsuru Niwa MD, PhD , Yusuke Kaida MD, PhD , Masaki Sato MD, PhD , Yasuhiro Ito MD , Hideki Yasui MD, PhD , Yuzo Suzuki MD, PhD , Hironao Hozumi MD, PhD , Takafumi Suda MD, PhD

Introduction

The safety of discontinuing immune checkpoint inhibitors (ICIs) because of a durable response in patients with advanced NSCLC remains uncertain, and post-discontinuation survival outcomes based on the reason for cessation are not well defined.

Methods

A pooled analysis was conducted using data from four prospective cohort studies involving 835 patients with advanced NSCLC who discontinued ICIs. Patients were categorized based on discontinuation reasons: durable response; immune-related adverse events (irAEs) (subcategorized by tumor response at discontinuation); non-irAE adverse events; disease progression; and other causes.

Results

Disease progression was the most common reason for ICI discontinuation (N = 528 [63.2%]), followed by irAEs (N = 187 [22.4%]) and tumor response (N = 23 [2.8%]). Regarding response status at ICI discontinuation due to irAEs, complete/partial response (CR/PR) was the most frequent (N = 85), followed by stable disease/not evaluable (SD/NE, N = 69) and disease progression (N = 33). After a median post-discontinuation follow-up of 15.8 months (interquartile range, 6.9–23.2), patients who discontinued because of a response had excellent outcomes, with no deaths and only three progression-free survival events. While post-discontinuation overall survival was comparable between the irAE-CR/PR and irAE-SD/NE groups, ICI therapy ≥12 months was associated with improved post-ICI discontinuation survival in the irAE-CR/PR group.

Conclusions

Discontinuation of ICIs because of a durable tumor response is rare in real-world settings but represents a feasible strategy for patients with advanced NSCLC. Patients in the irAE-CR/PR group had favorable post-ICI discontinuation survival if they received ICI therapy lasting ≥12 months.
在晚期NSCLC患者中,由于持续反应而停用免疫检查点抑制剂(ICIs)的安全性仍不确定,基于停药原因的停药后生存结局也没有很好的定义。方法采用四项前瞻性队列研究的数据进行汇总分析,涉及835例停止使用ICIs的晚期NSCLC患者。根据停药原因对患者进行分类:持续反应;免疫相关不良事件(irAEs)(按停药时肿瘤反应分类);非irae不良事件;疾病进展;还有其他原因。结果疾病进展是ICI停药最常见的原因(N = 528[63.2%]),其次是irAEs (N = 187[22.4%])和肿瘤反应(N = 23[2.8%])。关于因irAEs而停药的缓解状态,完全缓解/部分缓解(CR/PR)最为常见(N = 85),其次是疾病稳定/不可评估(SD/NE, N = 69)和疾病进展(N = 33)。在中位停药后随访15.8个月(四分位数范围为6.9-23.2)后,因缓解而停药的患者有很好的结局,没有死亡,只有3个无进展生存事件。虽然irAE-CR/PR组和irAE-SD/NE组停药后总生存期相当,但irAE-CR/PR组ICI治疗≥12个月与ICI停药后生存期改善相关。结论:由于持久的肿瘤反应而停用ICIs在现实环境中是罕见的,但对于晚期NSCLC患者来说是一种可行的策略。如果接受持续≥12个月的ICI治疗,irAE-CR/PR组患者的ICI停药后生存率较高。
{"title":"Post-discontinuation Survival in Patients With Advanced NSCLC Receiving Immune Checkpoint Inhibitors: A Pooled Analysis of Prospective Cohort Studies","authors":"Yusuke Inoue MD, PhD ,&nbsp;Yoshihiro Kitahara MD ,&nbsp;Masato Karayama MD, PhD ,&nbsp;Kazuhiro Asada MD, PhD ,&nbsp;Koji Nishimoto MD, PhD ,&nbsp;Shun Matsuura MD, PhD ,&nbsp;Dai Hashimoto MD, PhD ,&nbsp;Masato Fujii MD, PhD ,&nbsp;Takashi Matsui MD, PhD ,&nbsp;Nao Inami MD ,&nbsp;Mikio Toyoshima MD, PhD ,&nbsp;Hiroyuki Matsuda MD, PhD ,&nbsp;Masaki Ikeda MD, PhD ,&nbsp;Mitsuru Niwa MD, PhD ,&nbsp;Yusuke Kaida MD, PhD ,&nbsp;Masaki Sato MD, PhD ,&nbsp;Yasuhiro Ito MD ,&nbsp;Hideki Yasui MD, PhD ,&nbsp;Yuzo Suzuki MD, PhD ,&nbsp;Hironao Hozumi MD, PhD ,&nbsp;Takafumi Suda MD, PhD","doi":"10.1016/j.jtocrr.2025.100847","DOIUrl":"10.1016/j.jtocrr.2025.100847","url":null,"abstract":"<div><h3>Introduction</h3><div>The safety of discontinuing immune checkpoint inhibitors (ICIs) because of a durable response in patients with advanced NSCLC remains uncertain, and post-discontinuation survival outcomes based on the reason for cessation are not well defined.</div></div><div><h3>Methods</h3><div>A pooled analysis was conducted using data from four prospective cohort studies involving 835 patients with advanced NSCLC who discontinued ICIs. Patients were categorized based on discontinuation reasons: durable response; immune-related adverse events (irAEs) (subcategorized by tumor response at discontinuation); non-irAE adverse events; disease progression; and other causes.</div></div><div><h3>Results</h3><div>Disease progression was the most common reason for ICI discontinuation (<em>N</em> = 528 [63.2%]), followed by irAEs (<em>N</em> = 187 [22.4%]) and tumor response (<em>N</em> = 23 [2.8%]). Regarding response status at ICI discontinuation due to irAEs, complete/partial response (CR/PR) was the most frequent (<em>N</em> = 85), followed by stable disease/not evaluable (SD/NE, <em>N</em> = 69) and disease progression (<em>N</em> = 33). After a median post-discontinuation follow-up of 15.8 months (interquartile range, 6.9–23.2), patients who discontinued because of a response had excellent outcomes, with no deaths and only three progression-free survival events. While post-discontinuation overall survival was comparable between the irAE-CR/PR and irAE-SD/NE groups, ICI therapy ≥12 months was associated with improved post-ICI discontinuation survival in the irAE-CR/PR group.</div></div><div><h3>Conclusions</h3><div>Discontinuation of ICIs because of a durable tumor response is rare in real-world settings but represents a feasible strategy for patients with advanced NSCLC. Patients in the irAE-CR/PR group had favorable post-ICI discontinuation survival if they received ICI therapy lasting ≥12 months.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 8","pages":"Article 100847"},"PeriodicalIF":3.0,"publicationDate":"2025-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144330153","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum to ‘Primary Results from IMscin002: A Study to Evaluate Patient Preferences and Perceptions of Health Care Professionals for Atezolizumab Subcutaneous Versus Intravenous for the Treatment of NSCLC’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100815] “IMscin002的主要结果:一项评估患者偏好和卫生保健专业人员对Atezolizumab皮下与静脉注射治疗非小细胞肺癌的看法的研究”的勘误[JTO临床和研究报告第6卷第5期(2025)100815]
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-09 DOI: 10.1016/j.jtocrr.2025.100842
Federico Cappuzzo MD , Zanete Zvirbule MD , Ernesto Korbenfeld MD , Jaroslaw Kolb-Sielecki MD , Dolores Isla MD, PhD , Aleksandra Szczesna MD, PhD , Amparo Yovanna Castro Sanchez PhD , Alberto Bustillos MD , Xiaoyan Liu PhD , Fiona Young MbChB , Nadia Tosti PhD , Marta Freitas Monteiro MSc, PhD , Margarita Majem MD, PhD
{"title":"Erratum to ‘Primary Results from IMscin002: A Study to Evaluate Patient Preferences and Perceptions of Health Care Professionals for Atezolizumab Subcutaneous Versus Intravenous for the Treatment of NSCLC’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100815]","authors":"Federico Cappuzzo MD ,&nbsp;Zanete Zvirbule MD ,&nbsp;Ernesto Korbenfeld MD ,&nbsp;Jaroslaw Kolb-Sielecki MD ,&nbsp;Dolores Isla MD, PhD ,&nbsp;Aleksandra Szczesna MD, PhD ,&nbsp;Amparo Yovanna Castro Sanchez PhD ,&nbsp;Alberto Bustillos MD ,&nbsp;Xiaoyan Liu PhD ,&nbsp;Fiona Young MbChB ,&nbsp;Nadia Tosti PhD ,&nbsp;Marta Freitas Monteiro MSc, PhD ,&nbsp;Margarita Majem MD, PhD","doi":"10.1016/j.jtocrr.2025.100842","DOIUrl":"10.1016/j.jtocrr.2025.100842","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 7","pages":"Article 100842"},"PeriodicalIF":3.0,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144203728","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum to ‘Model-Based Cost-Utility Analysis of Combined Low-Dose Computed Tomography Screening for Lung Cancer, Chronic Obstructive Pulmonary Disease, and Cardiovascular Disease’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100813] “基于模型的低剂量计算机断层扫描联合筛查肺癌、慢性阻塞性肺病和心血管疾病的成本-效用分析”的勘误[JTO临床与研究报告第6卷第5期(2025)100813]
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-09 DOI: 10.1016/j.jtocrr.2025.100841
Carina M. Behr PhD , Maarten J. IJzerman PhD , Michelle M.A. Kip PhD , Harry J.M. Groen MD, PhD , Marjolein A. Heuvelmans MD, PhD , Maarten van den Berge MD, PhD , Pim van der Harst MD, PhD , Marleen Vonder PhD , Rozemarijn Vliegenthart MD, PhD , Hendrik Koffijberg PhD
{"title":"Erratum to ‘Model-Based Cost-Utility Analysis of Combined Low-Dose Computed Tomography Screening for Lung Cancer, Chronic Obstructive Pulmonary Disease, and Cardiovascular Disease’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100813]","authors":"Carina M. Behr PhD ,&nbsp;Maarten J. IJzerman PhD ,&nbsp;Michelle M.A. Kip PhD ,&nbsp;Harry J.M. Groen MD, PhD ,&nbsp;Marjolein A. Heuvelmans MD, PhD ,&nbsp;Maarten van den Berge MD, PhD ,&nbsp;Pim van der Harst MD, PhD ,&nbsp;Marleen Vonder PhD ,&nbsp;Rozemarijn Vliegenthart MD, PhD ,&nbsp;Hendrik Koffijberg PhD","doi":"10.1016/j.jtocrr.2025.100841","DOIUrl":"10.1016/j.jtocrr.2025.100841","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 7","pages":"Article 100841"},"PeriodicalIF":3.0,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144203228","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum to ‘Targeting DLL3: A New Weapon in Lung Neuroendocrine Tumors?’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100796] 靶向DLL3:治疗肺神经内分泌肿瘤的新武器?[JTO临床与研究报告第6卷第5期(2025)100796]
IF 3 Q2 ONCOLOGY Pub Date : 2025-05-09 DOI: 10.1016/j.jtocrr.2025.100840
Mariona Riudavets MD, PhD , David Planchard MD, PhD
{"title":"Erratum to ‘Targeting DLL3: A New Weapon in Lung Neuroendocrine Tumors?’ [JTO Clinical and Research Reports Volume 6 Issue 5 (2025) 100796]","authors":"Mariona Riudavets MD, PhD ,&nbsp;David Planchard MD, PhD","doi":"10.1016/j.jtocrr.2025.100840","DOIUrl":"10.1016/j.jtocrr.2025.100840","url":null,"abstract":"","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 7","pages":"Article 100840"},"PeriodicalIF":3.0,"publicationDate":"2025-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144203729","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Novel Approach to Proficiency Testing Reveals Significant Variations in Biomarker Practice Leading to Critical Differences in Lung Cancer Management 能力测试的新方法揭示了生物标志物实践的显著差异,导致肺癌管理的关键差异
IF 3 Q2 ONCOLOGY Pub Date : 2025-04-22 DOI: 10.1016/j.jtocrr.2025.100837
Kassandra R. Bisson MHSc , Andrea Beharry MLT , Normand Blais MD , Michael D. Carter MD, PhD , Parneet K. Cheema MD , Patrice Desmeules MD , John G. Garratt RT , Barbara Melosky MD , Bryan Lo PhD , Stephanie Snow MD , Basile Tessier-Cloutier MD , Edwin Tio MD , Stephen Yip MD, PhD , Jennifer R. Won PhD , Brandon S. Sheffield MD

Introduction

Timely access to quality biomarker testing in NSCLC is critical to patient outcomes. The Canadian Pathology Quality Assurance provides external quality assurance (EQA) to laboratories in Canada. The Canadian Pathology Quality Assurance has recently developed a novel approach to molecular biomarker EQA testing, assessing accuracy, turnaround time, and interpretation of reports. This study reports the results of the first end-to-end biomarker EQA challenge in NSCLC.

Methods

Three challenge specimens were made using NSCLC tissue and paired with clinical vignettes mimicking referred-in cases. Participants were to provide all required molecular testing (immunohistochemistry and gene sequencing) and submit final reports for each case, while being timed. Reports were assessed by molecular pathologists and medical oncologists who recommended a systemic treatment based on vignettes and reports.

Results

A total of 13 Canadian laboratories participated. The turnaround time of molecular reporting ranged from five to 57 (median 22.5) calendar days. Two laboratories (15%) reported their results within 2 weeks. Four laboratories (31%) reported the results of their biomarkers after more than 30 days.
Only three laboratories received optimal status (23%). One laboratory (8%) failed due to a critical genotyping error, three (23%) received a suboptimal status due to inappropriately long turnaround times, and the remaining six (69%) received an adequate status.

Conclusions

This report demonstrates the utility of this proficiency testing style compared with standard laboratory self-reporting. The approach has elucidated substantial differences in the quality of NSCLC biomarker results produced by Canadian laboratories. Ongoing efforts to improve turnaround times and clarity of reporting, including regular external measurement, are tools that can improve patient outcomes in NSCLC.
及时获得高质量的非小细胞肺癌生物标志物检测对患者预后至关重要。加拿大病理学质量保证为加拿大的实验室提供外部质量保证(EQA)。加拿大病理质量保证组织最近开发了一种新的分子生物标志物EQA测试方法,评估准确性、周转时间和报告解释。本研究报告了NSCLC中首个端到端生物标志物EQA挑战的结果。方法采用非小细胞肺癌(NSCLC)组织制作3个攻毒标本,并与模拟转诊病例的临床标本配对。参与者提供所有必需的分子检测(免疫组织化学和基因测序),并提交每个病例的最终报告,同时计时。报告由分子病理学家和医学肿瘤学家评估,他们建议基于小片段和报告进行系统治疗。结果加拿大共有13家实验室参与。分子报告的周转时间从5到57(中位数22.5)日历天不等。2个实验室(15%)在2周内报告结果。四家实验室(31%)在30多天后报告了其生物标志物的结果。只有三个实验室获得了最佳状态(23%)。1个实验室(8%)由于严重的基因分型错误而失败,3个实验室(23%)由于不适当的长周转时间而处于次优状态,其余6个实验室(69%)处于适当状态。结论与标准实验室自我报告相比,本报告证明了这种能力测试方式的实用性。该方法阐明了加拿大实验室产生的NSCLC生物标志物结果质量的实质性差异。正在进行的改善周转时间和报告清晰度的努力,包括定期的外部测量,是可以改善NSCLC患者预后的工具。
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引用次数: 0
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JTO Clinical and Research Reports
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