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The Landscape of CEACAM5 Expression by Immunohistochemistry in NSCLC 免疫组化研究CEACAM5在非小细胞肺癌中的表达格局
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-11 DOI: 10.1016/j.jtocrr.2025.100943
Ying-Han R. Hsu MD, FRCPC , Amna Almutrafi MD , Katrina Hueniken MSc , Alhareth Azaizeh MD , Likun Hou MD, PhD , Quan Li PhD , Mackenzie Bates BSc , Nhu-An Pham PhD , Ming-Sound Tsao MD, FRCPC

Introduction

Carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) is a target of antibody-drug conjugate therapy for NSCLC. High expression of CEACAM5 has been reported in approximately 25% of patients with lung adenocarcinoma. However, CEACAM5 expression has not been systematically examined in a real-world and large patient population with NSCLC. There are also limited data on the prognostic impact of CEACAM5 protein expression.

Methods

We assessed CEACAM5 protein expression by immunohistochemistry in two separate cohorts of patients with NSCLC to include both routine clinical biopsy and resection specimens, using the anti-CEACAM5 clone 769 antibody assay protocol and scoring scheme for the tusamitamab ravtansine clinical trials. Expression levels were categorized as high (≥50% tumor cells at ≥2+ intensity), moderate (1%–49% tumor cells at ≥2+ intensity), and negative (0/1+ intensity) and scored independently by three thoracic pathologists. Interrater reliability was determined by Kendall’s coefficient of concordance and Fleiss’ kappa. Association with PD-L1 and driver mutation was calculated by Fisher exact or chi-square test. Correlation with recurrence-free survival and overall survival was determined by log-rank tests.

Results

The interrater reliability of CEACAM5 assessment was moderate among three pathologists. The overall prevalence of high CEACAM5 expression was 18%. CEACAM5 expression did not significantly correlate with tumor stage, PD-L1 expression, tumor mutation burden, and EGFR or KRAS mutations. There was no prognostic effect of CEACAM5 expression on recurrence-free survival or overall survival.

Conclusions

Our data revealed that 18% of routinely diagnosed clinical NSCLC samples had high CEACAM5 expression by immunohistochemistry, and its expression was not associated with oncogenic driver mutations or patient prognosis in a predominantly early stage NSCLC cohort.
癌胚抗原相关细胞粘附分子5 (CEACAM5)是非小细胞肺癌抗体-药物结合治疗的靶点。据报道,约25%的肺腺癌患者中高表达CEACAM5。然而,CEACAM5的表达尚未在现实世界和大型非小细胞肺癌患者群体中进行系统检查。关于CEACAM5蛋白表达对预后影响的数据也很有限。方法采用抗CEACAM5克隆769抗体检测方案和评分方案,在两组独立的非小细胞肺癌患者(包括常规临床活检和切除标本)中,通过免疫组织化学方法评估CEACAM5蛋白表达。表达水平分为高(≥50%肿瘤细胞≥2+强度)、中(1%-49%肿瘤细胞≥2+强度)和阴性(0/1+强度),由三名胸部病理学家独立评分。信度由Kendall’s concorda系数和Fleiss’kappa系数确定。通过Fisher精确检验或卡方检验计算PD-L1与驱动突变的相关性。通过log-rank检验确定与无复发生存期和总生存期的相关性。结果3名病理医师CEACAM5评估的互信度均为中等。CEACAM5高表达的总体患病率为18%。CEACAM5表达与肿瘤分期、PD-L1表达、肿瘤突变负荷、EGFR或KRAS突变无显著相关性。CEACAM5表达对无复发生存期或总生存期无预后影响。结论我们的数据显示,在以早期NSCLC为主的队列中,18%的常规诊断的临床NSCLC样本中CEACAM5高表达,且其表达与癌性驱动突变或患者预后无关。
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引用次数: 0
Curative-Intent Multimodality Treatment for NSCLC: Will Global Healthcare Systems Rise to the Challenge? A Perspective From the United Kingdom 非小细胞肺癌的多模式治疗:全球医疗保健系统将面临挑战吗?从英国的角度看问题
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-10-27 DOI: 10.1016/j.jtocrr.2025.100923
Matthew Evison MD, MRCP , Shobhit Baijal MBBS, BSc (Hons) , Mayuri Basnet MBBS, FRCPath , Tim Batchelor MSc, FRCS (CTh) , Karen Clayton MSc ACP , Lorraine Dallas BA , Alastair Greystoke PhD , Adam Januszewski PhD , Neal Navani PhD , Riyaz Shah PhD , Annabel Sharkey PhD, FRCS (CTh) , Jyotika Singh MBA
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引用次数: 0
Treatment Patterns, Prognostic Factors and Survival for ALK-Positive Advanced NSCLC In Australia: Results From the Australasian Thoracic Cancers Longitudinal Cohort Study and Biobank (AURORA) 澳大利亚alk阳性晚期NSCLC的治疗模式、预后因素和生存率:来自澳大利亚胸部癌症纵向队列研究和生物库(AURORA)的结果
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-10-27 DOI: 10.1016/j.jtocrr.2025.100924
Grace Chazan FRACP , Marliese Alexander PhD , Fanny Franchini PhD , Maarten IJzerman PhD , Roma Shah MPH , Ani John PhD , Tim Spelman PhD , Malinda Itchins PhD , Nick Pavlakis PhD , Adnan Nagrial PhD , Lydia Warburton FRACP , Samantha Bowyer FRACP , Steven Kao PhD , Sagun Parakh PhD , Benjamin J. Solomon PhD

Introduction

Advanced lung cancer has historically been associated with poor survival. However, with the advent of targeted therapies, outcomes are improving. Among patients with ALK-rearranged advanced NSCLC (ALK+ aNSCLC), real-world data on treatment patterns, prognostic factors, and survival in the era of contemporary therapy remain limited.

Methods

We conducted a retrospective observational cohort study using deidentified patient, disease, and outcomes data from the AUstralasian thoRacic cancers lOngitudinal cohoRt study and biobAnk (AURORA; ACTRN12625000038493). Eligible patients were diagnosed with ALK+ aNSCLC between 2006 and 2025.

Results

Of the 4776 patients with thoracic malignancies enrolled across eight sites (as of April 2025), 218 met the inclusion criteria—the largest reported Australian cohort of ALK+ aNSCLC. All patients were treated in academic centers. The median age was 55 years; 54% were female, 66% were never-smokers, and 41% had participated in a clinical trial. The median overall survival was 90.8 months (95% CI: 69.8–not reached). Nearly all patients (99%) received an ALK inhibitor; 83% in the first-line setting. Treatment sequences evolved over time. Most (68%) received at least two lines of therapy; 21% received 4 or more lines. Smoking status, age, and Eastern Cooperative Oncology Group Performance Status were prognostically associated with survival.

Conclusion

This study highlights the remarkable survival achievable in the real-world setting for some patients with ALK+ aNSCLC, compared with historical cohorts. Several clinical factors associated with survival were identified. Larger studies are needed to investigate how treatment sequences may be optimized to further improve survival outcomes.
晚期肺癌历来与低生存率相关。然而,随着靶向治疗的出现,结果正在改善。在ALK重排晚期NSCLC (ALK+ aNSCLC)患者中,当代治疗时代有关治疗模式、预后因素和生存率的真实数据仍然有限。方法:我们进行了一项回顾性观察性队列研究,使用来自澳大利亚胸部癌症纵向队列研究和生物样本库(AURORA; ACTRN12625000038493)的未确定患者、疾病和结局数据。2006年至2025年间诊断为ALK+ aNSCLC的合格患者。结果在8个地点(截至2025年4月)入组的4776例胸部恶性肿瘤患者中,218例符合纳入标准,这是澳大利亚报道的最大的ALK+ aNSCLC队列。所有患者均在学术中心接受治疗。中位年龄为55岁;其中54%为女性,66%从不吸烟,41%参加过临床试验。中位总生存期为90.8个月(95% CI: 69.8 -未达到)。几乎所有患者(99%)接受了ALK抑制剂治疗;83%在一线。治疗顺序随着时间的推移而演变。大多数(68%)接受了至少两种治疗;21%的人收到了4条或更多的邮件。吸烟状况、年龄和东部肿瘤合作组表现状况与生存预后相关。结论:与历史队列相比,本研究强调了一些ALK+ aNSCLC患者在现实环境中可实现的显着生存率。确定了与生存相关的几个临床因素。需要更大规模的研究来研究如何优化治疗序列以进一步提高生存结果。
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引用次数: 0
Patient-Reported Symptoms and Quality of Life With Sacituzumab Govitecan Versus Docetaxel in Metastatic NSCLC: The Phase 3, Randomized EVOKE-01 Trial Sacituzumab Govitecan与Docetaxel治疗转移性NSCLC患者报告的症状和生活质量:3期随机EVOKE-01试验
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-10-30 DOI: 10.1016/j.jtocrr.2025.100929
Niels Reinmuth MD , Sébastien Couraud MD, PhD , Luis Paz-Ares MD, PhD , Marina Chiara Garassino MD , Shobhit Baijal MBBS, BSc , Davey Daniel MD , Pilar Garrido MD, PhD , Terufumi Kato MD , Ivor Percent MD , Achim Rittmeyer MD , Hector Soto Parra MD , Sabeen Mekan MD , Mira Patel PhD , Matthew Radford PhD , Eric Zhang PhD , Christopher G. Pelligra MS , Shien Guo PhD , Enriqueta Felip MD, PhD

Introduction

In the phase 3 EVOKE-01 trial (NCT05089734), sacituzumab govitecan (SG) exhibited a numerical improvement in overall survival and tolerability compared with docetaxel in patients with metastatic NSCLC previously treated with platinum-based chemotherapy and programmed cell death protein (ligand) 1 inhibitors, although results were not statistically significant. This analysis evaluated health-related quality of life (HRQoL) data from EVOKE-01.

Methods

Patients (N = 603) were randomized 1:1 to SG (n = 299) or docetaxel (n = 304) in 21-day cycles. HRQoL was assessed by the NSCLC Symptom Assessment Questionnaire (NSCLC-SAQ), European Organization for Research and Treatment of Cancer Quality of Life questionnaire–Core 30 (QLQ-C30), and EuroQol 5 Dimension 3-level questionnaire. Least square mean changes from baseline at week 25, time to first meaningful deterioration or death, and time to confirmed deterioration were analyzed.

Results

SG exhibited significantly and meaningfully better effects than docetaxel on NSCLC-SAQ shortness of breath (SoB), fatigue, total score, and on QLQ-C30 role functioning, fatigue, and dyspnea. Time to first meaningful deterioration or death favored SG over docetaxel for NSCLC-SAQ SoB (hazard ratio [95% confidence interval ]: 0.75 [0.61–0.91]), fatigue (0.70 [0.57–0.86]), and total score (0.80 [0.66–0.97]); QLQ-C30 fatigue (0.80 [0.66–0.96]) and dyspnea (0.74 [0.60–0.90]); and EuroQol visual analog scale (0.79 [0.65–0.96]). The time to confirmed deterioration favored SG over docetaxel for NSCLC-SAQ SoB (0.59 [0.44–0.77]) and fatigue (0.70 [0.52–0.95]), and QLQ-C30 fatigue (0.75 [0.59–0.95]).

Conclusions

These exploratory results suggest that SG may benefit HRQoL over docetaxel, supporting SG as an active therapeutic agent for metastatic NSCLC post platinum-based and programmed cell death protein (ligand) 1 inhibitor therapy.
在3期EVOKE-01试验(NCT05089734)中,与之前接受过铂基化疗和程序性细胞死亡蛋白(配体)1抑制剂治疗的转移性非小细胞肺癌患者相比,sacituzumab govitecan (SG)在总生存率和耐受性方面表现出数值改善,尽管结果没有统计学意义。该分析评估了来自EVOKE-01的健康相关生活质量(HRQoL)数据。方法603例患者以1:1的比例随机分为SG (N = 299)和多西他赛(N = 304),每21 d为一个周期。HRQoL采用NSCLC症状评估问卷(NSCLC- saq)、欧洲癌症研究与治疗组织生活质量问卷- core 30 (QLQ-C30)、EuroQol 5维度3级问卷进行评估。分析第25周基线的最小二乘平均值变化、到第一次有意义恶化或死亡的时间以及到确认恶化的时间。结果ssg在NSCLC-SAQ呼吸短促(SoB)、疲劳、总分、QLQ-C30功能功能、疲劳、呼吸困难等方面均优于多西他赛。距NSCLC-SAQ SoB首次有意义恶化或死亡的时间较多西他赛更有利于SG(风险比[95%可信区间]:0.75[0.61-0.91])、疲劳(0.70[0.57-0.86])和总分(0.80 [0.66-0.97]);QLQ-C30疲劳(0.80[0.66-0.96])和呼吸困难(0.74 [0.60-0.90]);EuroQol视觉模拟量表(0.79[0.65 ~ 0.96])。对于NSCLC-SAQ的SoB(0.59[0.44-0.77])和疲劳(0.70[0.52-0.95]),以及QLQ-C30的疲劳(0.75[0.59 - 0.95]),证实恶化的时间优于多西他赛。这些探索性结果表明,SG可能比多西他赛更有利于HRQoL,支持SG作为转移性非小细胞肺癌铂基和程序性细胞死亡蛋白(配体)1抑制剂治疗后的有效药物。
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引用次数: 0
First Report of Response to Tarlatamab in a Patient With Histologic-Transformed SCLC From ALK-Rearranged NSCLC: Case Report alk重排非小细胞肺癌组织学转化SCLC患者对塔拉他单抗反应的首次报道:病例报告
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-12 DOI: 10.1016/j.jtocrr.2025.100941
Kaiwen Wang PharmD , Ceylan Altintas Taslic MD , Patricia de Groot MD , Mitchell A. Parma MD , Alvaro Guimaraes Paula MD , Melody Caranto MSN , Komal Shah MD , Mukulika Bose PhD , Cole Ruoff BS , Loukia G. Karacosta PhD , Lauren A. Byers MD , Carl M. Gay MD, PhD , Jianjun Zhang MD, PhD , John V. Heymach MD, PhD , Bingnan Zhang MD, MBA
Small cell transformation has been described as a resistance mechanism to targeted therapy treated in patients with EGFR-mutated NSCLC and less often reported with those with other actionable oncogenic alterations, including ALK-rearranged NSCLC. Given lack of standard-of-care treatments for patients with actionable oncogenic alteration NSCLC transformed to SCLC, this remains a challenge and unmet need for treating these patients.
Here, we present a case of a patient with ALK-rearranged NSCLC with transformation to SCLC, who has progressed on several lines of therapies and successfully treated with tarlatamab to elicit and maintain clinical benefit, including intracranial response.
小细胞转化已被描述为egfr突变的非小细胞肺癌患者对靶向治疗的一种耐药机制,而对于具有其他可操作的致癌改变的患者,包括alk重排的非小细胞肺癌,报道较少。由于缺乏可操作的致癌改变患者的标准治疗方法,NSCLC转化为SCLC,这仍然是治疗这些患者的挑战和未满足的需求。在这里,我们报告了一例alk重排NSCLC转化为SCLC的患者,该患者已经在几条治疗线上取得进展,并成功地用塔拉他单抗治疗,以引起和维持临床获益,包括颅内反应。
{"title":"First Report of Response to Tarlatamab in a Patient With Histologic-Transformed SCLC From ALK-Rearranged NSCLC: Case Report","authors":"Kaiwen Wang PharmD ,&nbsp;Ceylan Altintas Taslic MD ,&nbsp;Patricia de Groot MD ,&nbsp;Mitchell A. Parma MD ,&nbsp;Alvaro Guimaraes Paula MD ,&nbsp;Melody Caranto MSN ,&nbsp;Komal Shah MD ,&nbsp;Mukulika Bose PhD ,&nbsp;Cole Ruoff BS ,&nbsp;Loukia G. Karacosta PhD ,&nbsp;Lauren A. Byers MD ,&nbsp;Carl M. Gay MD, PhD ,&nbsp;Jianjun Zhang MD, PhD ,&nbsp;John V. Heymach MD, PhD ,&nbsp;Bingnan Zhang MD, MBA","doi":"10.1016/j.jtocrr.2025.100941","DOIUrl":"10.1016/j.jtocrr.2025.100941","url":null,"abstract":"<div><div>Small cell transformation has been described as a resistance mechanism to targeted therapy treated in patients with <em>EGFR</em>-mutated NSCLC and less often reported with those with other actionable oncogenic alterations, including <em>ALK</em>-rearranged NSCLC. Given lack of standard-of-care treatments for patients with actionable oncogenic alteration NSCLC transformed to SCLC, this remains a challenge and unmet need for treating these patients.</div><div>Here, we present a case of a patient with <em>ALK</em>-rearranged NSCLC with transformation to SCLC, who has progressed on several lines of therapies and successfully treated with tarlatamab to elicit and maintain clinical benefit, including intracranial response.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"7 2","pages":"Article 100941"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145981051","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
Biomarker Testing and Patterns of Treatment in Patients with NSCLC: An International Association for The Study of Lung Cancer Analysis of American Society of Clinical Oncology CancerLinQ Discovery Data 非小细胞肺癌患者的生物标志物检测和治疗模式:美国临床肿瘤学会肺癌研究国际协会linq发现数据
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-02-28 DOI: 10.1016/j.jtocrr.2025.100816
Madhusmita Behera PhD , Gregory Joseph MS , Manali Rupji MS , Zhonglu Huang MS , Becky Bunn MS , Murry W. Wynes PhD , Jeffrey Switchenko PhD , Giorgio V. Scagliotti MD , Ming S. Tsao MD , Chandra P. Belani MD , Lecia V. Sequist MD , Suresh S. Ramalingam MD

Introduction

Precision medicine has resulted in improved outcomes for non small cell lung cancer (NSCLC), whereas biomarker testing is considered critical for guiding treatment decisions for advanced-stage NSCLC, and adoption of testing in routine practice is variable. We studied the utilization of biomarker testing in advanced NSCLC.

Methods

The American Society of Clinical Oncology (ASCO) CancerLinQ Discovery data set was queried to identify patients diagnosed with lung cancer between 2010 and 2018. Data on demographics, tumor stage, histology, and treatments were extracted, and receipt of biomarker testing was investigated as the primary outcome. Univariate association of each clinicopathological variable with the biomarker testing outcome was performed using a chi-square test for categorical variables and an analysis of variance test for numerical variables. A multivariable logistic regression analysis with backward selection at an alpha of 0.05 was reported. All analyses were conducted using SAS 9.4.

Results

A total of 37,925 patients with stage IV NSCLC were analyzed. The patients had a median age of 65 years; meanwhile, 51% of the participants were male individuals, 68% were white, and 33.5% had adenocarcinoma. Approximately 22% of all patients with NSCLC had biomarker testing results. Among the patients with adenocarcinoma, 49% had biomarker testing results available. In the stage IV group, 47% were treated with chemotherapy, 16% with immunotherapy, and 3.5% with targeted therapy. On multivariable analysis, female patients were more likely to have molecular testing compared with male patients (OR = 1.29, 95% confidence interval [CI]: 1.21–1.36, p < 0.001). Compared with white patients, black patients were less likely to have biomarker testing (OR = 0.89, 95% CI: 0.81–0.97, p = 0.009), and Asians were more likely to undergo testing (OR = 2.21, 95% CI: 1.78–2.73, p < 0.001). Hispanic patients were more likely to undergo biomarker testing than non-Hispanic (OR = 1.23, 95% CI: 1.01–1.50, p = 0.03). In addition, treatment with immunotherapy (OR = 1.86, 95% CI: 1.72–2.02, p < 0.001) and targeted therapy (OR = 2.52, 95% CI: 2.21–2.88, p < 0.001) were associated with a significantly higher likelihood of having biomarker testing. These results were also confirmed in a subgroup analysis of patients with adenocarcinoma.

Conclusion

In this analysis of a United States–based real-world data set of patients with stage IV NSCLC, the Asian race and female sex were associated with a higher likelihood of having biomarker testing performed. The overall percentage of patients undergoing testing remained suboptimal.
精准医学已经改善了非小细胞肺癌(NSCLC)的预后,而生物标志物检测被认为是指导晚期NSCLC治疗决策的关键,在常规实践中采用检测是可变的。我们研究了生物标志物检测在晚期非小细胞肺癌中的应用。方法查询美国临床肿瘤学会(ASCO) CancerLinQ Discovery数据集,以确定2010年至2018年诊断为肺癌的患者。提取了人口统计学、肿瘤分期、组织学和治疗方面的数据,并将接受生物标志物检测作为主要结果进行了调查。每个临床病理变量与生物标志物检测结果的单变量关联使用分类变量卡方检验和数值变量方差分析检验。采用逆向选择的多变量logistic回归分析,alpha值为0.05。所有分析均采用SAS 9.4进行。结果共分析了37925例IV期NSCLC患者。患者的中位年龄为65岁;与此同时,51%的参与者是男性,68%是白人,33.5%患有腺癌。大约22%的NSCLC患者有生物标志物检测结果。在腺癌患者中,49%的人有生物标志物检测结果。在IV期组中,47%接受化疗,16%接受免疫治疗,3.5%接受靶向治疗。在多变量分析中,女性患者比男性患者更有可能进行分子检测(OR = 1.29, 95%可信区间[CI]: 1.21-1.36, p < 0.001)。与白人患者相比,黑人患者较少接受生物标志物检测(OR = 0.89, 95% CI: 0.81-0.97, p = 0.009),而亚洲人更容易接受检测(OR = 2.21, 95% CI: 1.78-2.73, p < 0.001)。西班牙裔患者比非西班牙裔患者更有可能接受生物标志物检测(OR = 1.23, 95% CI: 1.01-1.50, p = 0.03)。此外,免疫治疗(OR = 1.86, 95% CI: 1.72-2.02, p < 0.001)和靶向治疗(OR = 2.52, 95% CI: 2.21-2.88, p < 0.001)与进行生物标志物检测的可能性显著升高相关。这些结果也在腺癌患者的亚组分析中得到证实。在对美国IV期NSCLC患者真实数据集的分析中,亚洲种族和女性与进行生物标志物检测的可能性较高相关。接受检测的患者总体百分比仍未达到理想水平。
{"title":"Biomarker Testing and Patterns of Treatment in Patients with NSCLC: An International Association for The Study of Lung Cancer Analysis of American Society of Clinical Oncology CancerLinQ Discovery Data","authors":"Madhusmita Behera PhD ,&nbsp;Gregory Joseph MS ,&nbsp;Manali Rupji MS ,&nbsp;Zhonglu Huang MS ,&nbsp;Becky Bunn MS ,&nbsp;Murry W. Wynes PhD ,&nbsp;Jeffrey Switchenko PhD ,&nbsp;Giorgio V. Scagliotti MD ,&nbsp;Ming S. Tsao MD ,&nbsp;Chandra P. Belani MD ,&nbsp;Lecia V. Sequist MD ,&nbsp;Suresh S. Ramalingam MD","doi":"10.1016/j.jtocrr.2025.100816","DOIUrl":"10.1016/j.jtocrr.2025.100816","url":null,"abstract":"<div><h3>Introduction</h3><div>Precision medicine has resulted in improved outcomes for non small cell lung cancer (NSCLC), whereas biomarker testing is considered critical for guiding treatment decisions for advanced-stage NSCLC, and adoption of testing in routine practice is variable. We studied the utilization of biomarker testing in advanced NSCLC.</div></div><div><h3>Methods</h3><div>The American Society of Clinical Oncology (ASCO) CancerLinQ Discovery data set was queried to identify patients diagnosed with lung cancer between 2010 and 2018. Data on demographics, tumor stage, histology, and treatments were extracted, and receipt of biomarker testing was investigated as the primary outcome. Univariate association of each clinicopathological variable with the biomarker testing outcome was performed using a chi-square test for categorical variables and an analysis of variance test for numerical variables. A multivariable logistic regression analysis with backward selection at an alpha of 0.05 was reported. All analyses were conducted using SAS 9.4.</div></div><div><h3>Results</h3><div>A total of 37,925 patients with stage IV NSCLC were analyzed. The patients had a median age of 65 years; meanwhile, 51% of the participants were male individuals, 68% were white, and 33.5% had adenocarcinoma. Approximately 22% of all patients with NSCLC had biomarker testing results. Among the patients with adenocarcinoma, 49% had biomarker testing results available. In the stage IV group, 47% were treated with chemotherapy, 16% with immunotherapy, and 3.5% with targeted therapy. On multivariable analysis, female patients were more likely to have molecular testing compared with male patients (OR = 1.29, 95% confidence interval [CI]: 1.21–1.36, <em>p</em> &lt; 0.001). Compared with white patients, black patients were less likely to have biomarker testing (OR = 0.89, 95% CI: 0.81–0.97, <em>p</em> = 0.009), and Asians were more likely to undergo testing (OR = 2.21, 95% CI: 1.78–2.73, <em>p</em> &lt; 0.001). Hispanic patients were more likely to undergo biomarker testing than non-Hispanic (OR = 1.23, 95% CI: 1.01–1.50, <em>p</em> = 0.03). In addition, treatment with immunotherapy (OR = 1.86, 95% CI: 1.72–2.02, <em>p</em> &lt; 0.001) and targeted therapy (OR = 2.52, 95% CI: 2.21–2.88, <em>p</em> &lt; 0.001) were associated with a significantly higher likelihood of having biomarker testing. These results were also confirmed in a subgroup analysis of patients with adenocarcinoma.</div></div><div><h3>Conclusion</h3><div>In this analysis of a United States–based real-world data set of patients with stage IV NSCLC, the Asian race and female sex were associated with a higher likelihood of having biomarker testing performed. The overall percentage of patients undergoing testing remained suboptimal.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"7 2","pages":"Article 100816"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145929321","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
Pathologic Responses to Stereotactic Ablative Radiotherapy in Combination With Nivolumab for Early Stage NSCLC: A Phase 2 Study 立体定向消融放疗联合纳武单抗治疗早期NSCLC的病理反应:一项2期研究
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-12 DOI: 10.1016/j.jtocrr.2025.100940
Gustavo Schvartsman MD, PhD , Yasmin M. Amirato MD , Frederico Monfardini MSc , Gustavo Prado dos Santos BSc , Diogo B.D. Gomes MD , Ludmila de O. M. Koch MD , Benoit J. Bibas MD, PhD , Oswaldo Gomes Jr. MD , Paulo V. Campregher MD, PhD , Patrícia Severino PhD , Luciana C. Marti PhD , Vitor R. Paes MD , Laura Leaden PhD , Rodrigo C. Chate MD , Jose M. Ribas MD, PhD , Victor.A.R. Sousa MD , Patrícia Taranto MD , Fernando Moura MD, PhD , Ricardo M. Terra MD, PhD , Ana Carolina Pires de Rezende MD , Marcos N. Samano MD, PhD

Introduction

Stereotactic ablative radiotherapy (SABR) is routinely used in patients with early stage NSCLC who are not candidates for surgery. Despite excellent local tumor control, it is associated with a high rate of regional and distant recurrences. Combining stereotactic radiotherapy with PD-1 inhibitors has demonstrated encouraging results for patients with curative intent, but how it affects the tumor microenvironment and pathologic response remains unclear.

Methods

We designed a phase II, open-label, single-arm study aimed to evaluate the efficacy and safety of neoadjuvant nivolumab combined with SABR in patients with NSCLC measuring up to 4 cm, without positive lymph nodes. Patients were required to be eligible for surgery, with adequate pulmonary and cardiovascular function. Nivolumab was administered at 360 mg every 21 days for three doses, combined with SABR, which was initiated concomitantly with the first cycle. Patients subsequently underwent surgical resection 10 weeks after the last dose of radiation. The primary end point was the pathologic complete response (pCR) rate at surgery. Secondary end points included major pathologic response (MPR) rate, safety, event-free survival, and overall survival at 12 months and a comprehensive biomarker analysis.

Results

A total of 25 patients were enrolled between November 2019 and February 2022. The mean age was 68 years, and 68% were female. The mean tumor size at baseline was 2.47 cm. A total of 24 patients fully completed the experimental therapy and proceeded with surgery. The primary end point of pCR was achieved by 19 of 24 patients (79.2%; 95% confidence interval: 57%–92%, p value 0.0875, in the per-protocol analysis). MPR was observed in 20 cases (83.3%; 95% confidence interval: 61.8%–94%). Four patients have not achieved an MPR, with one of them presenting with 100% residual viable tumor. No patient relapsed to date, with 12-month event-free survival and overall survival of 84%, with median not reached for both. One patient died from alcoholic hepatitis, unrelated to the treatment, and did not undergo resection. Two patients died from surgical complications.

Conclusions

The neoadjuvant combination of three doses of nivolumab and SABR produced a high pCR rate in stage I NSCLC. Further research is warranted to evaluate this treatment modality in patients with medically inoperable NSCLC and whether surgery could be safely omitted for patients who are candidates for resection.
立体定向消融放疗(SABR)通常用于不适合手术的早期非小细胞肺癌患者。尽管有良好的局部肿瘤控制,但它与区域和远处复发率高有关。立体定向放疗联合PD-1抑制剂对有治愈意图的患者已显示出令人鼓舞的结果,但其如何影响肿瘤微环境和病理反应尚不清楚。方法:我们设计了一项II期、开放标签、单臂研究,旨在评估新辅助纳武单抗联合SABR治疗4厘米以下无淋巴结阳性NSCLC患者的疗效和安全性。患者必须符合手术条件,具有足够的肺和心血管功能。Nivolumab每21天给药360mg,共3次,与SABR联合,与第一个周期一起开始。患者在最后一次放疗后10周接受手术切除。主要终点为手术时的病理完全缓解率(pCR)。次要终点包括主要病理反应(MPR)率、安全性、无事件生存期、12个月总生存期和综合生物标志物分析。结果2019年11月至2022年2月共入组25例患者。平均年龄为68岁,女性占68%。基线时平均肿瘤大小为2.47 cm。共有24例患者完全完成了实验治疗并进行了手术。24例患者中有19例达到了pCR的主要终点(79.2%;95%可信区间:57%-92%,p值0.0875,按方案分析)。MPR 20例(83.3%,95%可信区间:61.8% ~ 94%)。4例患者未达到MPR,其中1例呈现100%残存存活肿瘤。到目前为止,没有患者复发,12个月无事件生存期和总生存期为84%,中位数均未达到。一名患者死于酒精性肝炎,与治疗无关,没有进行手术切除。两名患者死于手术并发症。结论在I期NSCLC中,新辅助联合三剂量纳武单抗和SABR可产生较高的pCR率。需要进一步的研究来评估这种治疗方式在医学上不能手术的非小细胞肺癌患者中的应用,以及是否可以安全地省略手术。
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引用次数: 0
FDG-PET/CT SUVmax Predicts Recurrence Risk of Resected Pleuropulmonary Solitary Fibrous Tumors FDG-PET/CT SUVmax预测切除胸膜肺孤立性纤维性肿瘤复发风险
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-02-01 Epub Date: 2025-12-13 DOI: 10.1016/j.jtocrr.2025.100942
Matthew Aizpuru MD , Jennifer M. Boland MD , Brendan W. Lunn MD , Sahar A. Saddoughi MD, PhD , K. Robert Shen MD , Stephen D. Cassivi MD , Dennis A. Wigle MD , Janani S. Reisenauer MD , Luis F. Tapias MD

Objectives

Risk stratification of pleuropulmonary solitary fibrous tumors (SFTs) is based on post-resection histopathologic scoring systems. We queried whether preoperative 18-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) maximum standardized uptake values (SUVmax) had prognostic value for recurrence or metastasis.

Methods

Retrospective review of patients who underwent FDG-PET/CT before resection of SFT between January 2002 and June 2023. Independent review of slides by a pulmonary pathologist and radiologist review of FDG-PET/CT were performed. Statistical analyses included nonparametric tests for correlations, receiver-operating characteristic (ROC) curves, and Kaplan-Meier analysis.

Results

There were 34 patients with a preoperative FDG-PET/CT before SFT resection. Median tumor SUVmax was 2.3 (range: 0.9–38.7). Recurrence occurred in five patients (14.7%) (three local, two metastatic). Tumor SUVmax was associated with tumor size (p < 0.001), parietal pleural origin (p = 0.027), hypercellularity (p = 0.049), mitoses (p < 0.001), and Ki67 (p = 0.015). SUVmax correlated with the modified Demicco score (p < 0.001) and Tapias score (p < 0.001). Prediction of recurrence was excellent with SUVmax (area under ROC curve [AUC] = 0.872, p < 0.001), Tapias score (AUC = 0.914, p < 0.001), and modified Demicco score (AUC = 0.821, p < 0.001). Time-dependent ROC analysis identified SUVmax more than or equal to 2.4 as high risk for recurrence. Recurrence-free survival at 1, 3, 5, and 10 years was 92.9%, 83.6%, 69.6%, and 46.4%, respectively, in patients with SUVmax more than or equal to 2.4, but it was 100% at all time points with SUVmax less than 2.4 (p = 0.002). SUVmax was not associated with overall survival in this small cohort.

Conclusions

Tumor metabolic activity on FDG-PET/CT is predictive of SFT recurrence. Preoperative SUVmax correlates with known histopathologic high-risk features and validated risk scores. Preoperative FDG-PET/CT should be performed before SFT resection to assist in prognostication.
目的胸膜肺孤立性纤维性肿瘤(SFTs)的风险分层是基于术后组织病理学评分系统。我们询问术前18-氟脱氧葡萄糖正电子发射断层扫描/计算机断层扫描(FDG-PET/CT)最大标准化摄取值(SUVmax)是否具有复发或转移的预后价值。方法回顾性分析2002年1月至2023年6月间行SFT切除术前FDG-PET/CT检查的患者。肺病理学家对切片进行独立复查,放射科医生对FDG-PET/CT进行复查。统计分析包括相关性的非参数检验、受试者工作特征(ROC)曲线和Kaplan-Meier分析。结果34例患者行SFT切除术前FDG-PET/CT检查。中位肿瘤SUVmax为2.3(范围:0.9-38.7)。复发5例(14.7%)(3例局部,2例转移)。肿瘤SUVmax与肿瘤大小(p < 0.001)、胸膜壁起源(p = 0.027)、高细胞性(p = 0.049)、有丝分裂(p < 0.001)和Ki67 (p = 0.015)相关。SUVmax与改良Demicco评分(p < 0.001)和Tapias评分(p < 0.001)相关。SUVmax (ROC曲线下面积[AUC] = 0.872, p < 0.001)、Tapias评分(AUC = 0.914, p < 0.001)和改良Demicco评分(AUC = 0.821, p < 0.001)预测复发效果良好。时间相关ROC分析确定SUVmax大于或等于2.4为高复发风险。SUVmax≥2.4的患者1年、3年、5年和10年无复发生存率分别为92.9%、83.6%、69.6%和46.4%,而SUVmax≤2.4的患者在所有时间点无复发生存率均为100% (p = 0.002)。在这个小队列中,SUVmax与总生存率无关。结论FDG-PET/CT显示肿瘤代谢活性可预测SFT复发。术前SUVmax与已知的组织病理学高危特征和有效的风险评分相关。术前应在SFT切除术前进行FDG-PET/CT检查,以辅助预后。
{"title":"FDG-PET/CT SUVmax Predicts Recurrence Risk of Resected Pleuropulmonary Solitary Fibrous Tumors","authors":"Matthew Aizpuru MD ,&nbsp;Jennifer M. Boland MD ,&nbsp;Brendan W. Lunn MD ,&nbsp;Sahar A. Saddoughi MD, PhD ,&nbsp;K. Robert Shen MD ,&nbsp;Stephen D. Cassivi MD ,&nbsp;Dennis A. Wigle MD ,&nbsp;Janani S. Reisenauer MD ,&nbsp;Luis F. Tapias MD","doi":"10.1016/j.jtocrr.2025.100942","DOIUrl":"10.1016/j.jtocrr.2025.100942","url":null,"abstract":"<div><h3>Objectives</h3><div>Risk stratification of pleuropulmonary solitary fibrous tumors (SFTs) is based on post-resection histopathologic scoring systems. We queried whether preoperative 18-fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) maximum standardized uptake values (SUVmax) had prognostic value for recurrence or metastasis.</div></div><div><h3>Methods</h3><div>Retrospective review of patients who underwent FDG-PET/CT before resection of SFT between January 2002 and June 2023. Independent review of slides by a pulmonary pathologist and radiologist review of FDG-PET/CT were performed. Statistical analyses included nonparametric tests for correlations, receiver-operating characteristic (ROC) curves, and Kaplan-Meier analysis.</div></div><div><h3>Results</h3><div>There were 34 patients with a preoperative FDG-PET/CT before SFT resection. Median tumor SUVmax was 2.3 (range: 0.9–38.7). Recurrence occurred in five patients (14.7%) (three local, two metastatic). Tumor SUVmax was associated with tumor size (<em>p</em> &lt; 0.001), parietal pleural origin (<em>p</em> = 0.027), hypercellularity (<em>p</em> = 0.049), mitoses (<em>p</em> &lt; 0.001), and Ki67 (<em>p</em> = 0.015). SUVmax correlated with the modified Demicco score (<em>p</em> &lt; 0.001) and Tapias score (<em>p</em> &lt; 0.001). Prediction of recurrence was excellent with SUVmax (area under ROC curve [AUC] = 0.872, <em>p</em> &lt; 0.001), Tapias score (AUC = 0.914, <em>p</em> &lt; 0.001), and modified Demicco score (AUC = 0.821, <em>p</em> &lt; 0.001). Time-dependent ROC analysis identified SUVmax more than or equal to 2.4 as high risk for recurrence. Recurrence-free survival at 1, 3, 5, and 10 years was 92.9%, 83.6%, 69.6%, and 46.4%, respectively, in patients with SUVmax more than or equal to 2.4, but it was 100% at all time points with SUVmax less than 2.4 (<em>p</em> = 0.002). SUVmax was not associated with overall survival in this small cohort.</div></div><div><h3>Conclusions</h3><div>Tumor metabolic activity on FDG-PET/CT is predictive of SFT recurrence. Preoperative SUVmax correlates with known histopathologic high-risk features and validated risk scores. Preoperative FDG-PET/CT should be performed before SFT resection to assist in prognostication.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"7 2","pages":"Article 100942"},"PeriodicalIF":3.5,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145980965","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
Gut Dysbiosis as a Potential Guide for Immunotherapy (Dis)Continuation After 2 Years in NSCLC: A Brief Report 肠道生态失调作为非小细胞肺癌2年后继续免疫治疗(Dis)的潜在指南:简要报告
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-29 DOI: 10.1016/j.jtocrr.2025.100928
Adele Bonato MD , Claudia Parisi MD , Priscilla Cascetta MD , Anna Reni MD , May-Lucie Meyer MD , Mariona Riudavets MD, PhD , David Planchard MD, PhD , Benjamin Besse MD, PhD , Jordi Remon MD , Francesco Facchinetti MD, PhD , Lorenzo Belluomini MD, PhD , Lisa Derosa MD, PhD , Fabrice Barlesi MD, PhD

Background

Although most phase III pivotal trials have set the duration of immune checkpoint blockers (ICB) for advanced NSCLC at 2 years, the criteria for safely discontinuing ICB remain undefined. Growing evidence links ICB efficacy to gut microbiota, positioning gut microbial taxonomic profiling as a promising biomarker to guide treatment decisions. We performed a retrospective analysis exploring clinical outcomes and the utility of multiomic decision-making tools in patients with NSCLC at Gustave Roussy who completed 24 months of ICB-based therapy without disease progression (PD).

Methods

Patients receiving ICB between July 2016 and January 2023 were identified from the ONCOBIOTICS (NCT04567446) and STING (NCT04932525) study datasets. We selected those who reached 24 months of treatment without disease progression. Clinical characteristics and multiomic assessments, including gut microbiota profiling (TOPOSCORE by whole-genome sequencing), positron emission tomography–18-fluorodeoxyglucose imaging, and circulating tumor DNA, collected at 24 months, were analyzed. Key outcomes included overall survival (OS), progression-free survival (PFS), and PFS rates at 24 months after the completion of 2 years of ICB, stratified by molecular, metabolic, and microbial signatures.

Results

Out of 123 patients treated for at least 18 months, 35 completed 24 months, with 31 eligible for the analysis. Of these, 68% continued ICB, whereas 32% discontinued therapy at the physician’s decision. Clinical characteristics were similar across groups. After a median follow-up of 59.1 months, OS and PFS did not differ significantly between those who discontinued and those who continued treatment (OS p = 0.9012). Among all multiomic tools, gut microbiota composition exhibited a trend (though not statistically significant) association with PFS rates at 24 months after the completion of 2 years of ICB. Patients with a favorable microbiota profile had a higher rate of sustained response at 24 months compared with those with dysbiotic signatures (81% versus 44%, respectively, p = 0.0870).

Conclusions

Discontinuing ICB after 24 months did not negatively impact OS in our real-world cohort. Although limited by the small sample size, these findings support the potential of gut microbiota profiling as a promising tool to guide ICB duration. Integrating a translational multiomic algorithm, in particular microbial signals, may help personalize treatment strategies and safely shorten immunotherapy courses.
尽管大多数III期关键试验已将晚期NSCLC的免疫检查点阻断剂(ICB)的持续时间设定为2年,但安全停用ICB的标准仍未明确。越来越多的证据表明ICB疗效与肠道微生物群有关,将肠道微生物分类分析定位为指导治疗决策的有前途的生物标志物。我们进行了一项回顾性分析,探讨了Gustave Roussy非小细胞肺癌患者的临床结果和多组决策工具的实用性,这些患者完成了24个月的基于icb的无疾病进展(PD)治疗。方法从ONCOBIOTICS (NCT04567446)和STING (NCT04932525)研究数据集中筛选出2016年7月至2023年1月接受ICB治疗的患者。我们选择了那些治疗24个月无疾病进展的患者。临床特征和多组学评估,包括肠道微生物群分析(全基因组测序TOPOSCORE),正电子发射断层扫描- 18-氟脱氧葡萄糖成像,以及24个月时收集的循环肿瘤DNA进行分析。主要结局包括总生存期(OS)、无进展生存期(PFS)和完成2年ICB后24个月的PFS率,并根据分子、代谢和微生物特征进行分层。结果123例患者治疗至少18个月,35例完成24个月,其中31例符合分析条件。其中,68%的患者继续进行ICB治疗,而32%的患者在医生的决定下停止治疗。各组临床特征相似。中位随访59.1个月后,停止治疗组和继续治疗组的OS和PFS无显著差异(OS p = 0.9012)。在所有多组学工具中,在完成2年ICB后的24个月,肠道微生物群组成与PFS率显示出趋势(尽管没有统计学意义)。具有良好微生物群特征的患者在24个月时的持续缓解率高于具有不良微生物群特征的患者(分别为81%对44%,p = 0.0870)。结论:在我们的真实队列中,24个月后停用ICB对OS没有负面影响。尽管受样本量小的限制,这些发现支持肠道微生物群分析作为指导ICB持续时间的有前途的工具的潜力。整合翻译多组算法,特别是微生物信号,可能有助于个性化治疗策略和安全地缩短免疫治疗疗程。
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引用次数: 0
Preoperative Immune-Related Adverse Events in Resectable NSCLC Treated With Neoadjuvant Nivolumab Plus Chemotherapy: A Multicenter Retrospective Analysis 可切除NSCLC术前新辅助纳武单抗加化疗免疫相关不良事件:一项多中心回顾性分析
IF 3.5 Q2 ONCOLOGY Pub Date : 2026-01-01 Epub Date: 2025-10-30 DOI: 10.1016/j.jtocrr.2025.100930
Takuya Watanabe MD , Kotaro Nomura MD , Shinkichi Takamori MD , Shinya Tane MD , Shuta Ohara MD , Hana Oiki MD , Shinya Katsumata MD , Makoto Endo MD , Satoshi Takamori MD , Marina Nakatsuka MD , Hironori Tenpaku MD , Ryuji Nakamura MD , Hirotsugu Notsuda MD , Kei Namba MD , Kentaro Minegishi MD , Masayuki Tanahashi MD , Masahiro Tsuboi MD , Junichi Soh MD , Mototsugu Shimokawa MD , Yasuhisa Ohde MD

Introduction

Preoperative immune-related adverse events (irAEs) during neoadjuvant chemoimmunotherapy for resectable non-small cell lung cancer (NSCLC) remain poorly characterized. We aimed to evaluate their frequency, clinical impact, and associated risk factors.

Methods

This prespecified subanalysis of the multicenter CReGYT-04 Neo-Venus study retrospectively examined 130 patients with resectable NSCLC (stage IIA-IIIB, Union for International Cancer Control, eighth edition) treated with neoadjuvant nivolumab plus platinum-doublet chemotherapy. Clinical data were collected from 29 Japanese institutions. Patients were stratified according to the presence or absence of preoperative irAEs. Exploratory logistic regression was used to identify predictive factors.

Results

Preoperative irAEs were observed in 18.5% of the patients (n = 24). Patients with irAEs had a significantly lower neoadjuvant therapy completion rate (58.3% versus 92.5%, p <0.001) and a higher incidence of cancelled surgery (21.7% versus 5.8%, p = 0.029) than those without irAEs. There were 18 patients (78.3%) with irAEs who underwent surgical resection. R0 resection was achieved in 94.4%. The postoperative complication rates and length of hospital stay were comparable between the groups. The major pathologic response rate (38.9% versus 63.1%) and pathologic complete response rate (27.8% versus 36.8%) were lower in patients with preoperative irAEs. Tumor size greater than 3.8 cm and eosinophil fraction greater than or equal to 2.0% were identified as exploratory predictors of preoperative irAEs.

Conclusion

Preoperative irAEs occurred in approximately 20% of patients with resectable NSCLC treated with neoadjuvant nivolumab plus chemotherapy and were associated with treatment discontinuation and cancellation of surgery. Nevertheless, curative-intent surgery remained feasible and achieved acceptable perioperative outcomes in most patients with preoperative irAEs.
在可切除的非小细胞肺癌(NSCLC)的新辅助化疗免疫治疗期间,术前免疫相关不良事件(irAEs)的特征仍然很差。我们的目的是评估其发生频率、临床影响和相关危险因素。方法:这项预先指定的多中心CReGYT-04 Neo-Venus研究回顾性分析了130例接受新辅助纳武单抗加铂双药化疗的可切除非小细胞肺癌(iiia - iiib期,国际癌症控制联盟,第八版)患者。临床数据收集自日本29家机构。根据术前是否有irae对患者进行分层。采用探索性逻辑回归确定预测因素。结果24例患者(18.5%)术后出现irae。irAEs患者的新辅助治疗完成率(58.3% vs . 92.5%, p <0.001)明显低于无irAEs患者,而取消手术的发生率(21.7% vs . 5.8%, p = 0.029)高于无irAEs患者。有18例(78.3%)的irae患者接受了手术切除。R0切除率为94.4%。术后并发症发生率和住院时间在两组间具有可比性。术前irae患者的主要病理缓解率(38.9%对63.1%)和病理完全缓解率(27.8%对36.8%)较低。肿瘤大小大于3.8 cm和嗜酸性粒细胞分数大于或等于2.0%被确定为术前irae的探索性预测因子。结论在接受新辅助纳武单抗加化疗的可切除NSCLC患者中,约20%的患者发生了术前irae,并且与治疗停止和手术取消有关。尽管如此,以治愈为目的的手术仍然是可行的,并且在大多数术前irae患者中获得了可接受的围手术期结果。
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