JTO Clinical and Research Reports最新文献_第9页

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

JTO Clinical and Research Reports

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

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

JTO Clinical and Research Reports

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

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

JTO Clinical and Research Reports

Pub Date : 2025-05-09 DOI: 10.1016/j.jtocrr.2025.100840

Mariona Riudavets MD, PhD , David Planchard MD, PhD

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

JTO Clinical and Research Reports

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

Turtle Study: A Phase 2 Study of Durvalumab Plus Carboplatin and Etoposide in Elderly Patients With Extensive-Stage SCLC (LOGiK 2003) 海龟研究：Durvalumab联合卡铂和依托泊苷治疗老年大分期SCLC患者的2期研究（LOGiK 2003）

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-04-21 DOI: 10.1016/j.jtocrr.2025.100836

Hidenobu Ishii MD, PhD , Koichi Azuma MD, PhD , Yuta Yamanaka MD , Hiroshige Yoshioka MD, PhD , Yukihiro Toi MD , Naoki Shingu MD , Katsuhiko Naoki MD, PhD , Masaki Okamoto MD, PhD , Yuko Tsuchiya-Kawano MD, PhD , Taishi Harada MD , Hiroyuki Inoue MD, PhD , Hiroshi Ishii MD, PhD , Kazunori Tobino MD, PhD , Chiho Nakashima MD, PhD , Yoshifusa Koreeda MD , Yasushi Hisamatsu MD , Shinsuke Tsumura MD , Takashi Inagaki MD , Keiko Mizuno MD, PhD , Takayuki Shimose MMath , Isamu Okamoto MD, PhD

Introduction

The combination of immune checkpoint inhibitors with chemotherapy is the standard treatment for extensive-stage (ES) SCLC. However, its safety for elderly patients is not fully validated. We evaluated the safety and efficacy of durvalumab plus carboplatin and etoposide in elderly patients with ES-SCLC.

Methods

In this prospective, single-arm, multicenter, phase 2 clinical trial, patients with ES-SCLC aged above or equal to 75 years received chemotherapy with up to four cycles of durvalumab 1500 mg on day 1, carboplatin at a dose equivalent to an area under the curve of 5 on day 1, and etoposide 80 mg/m² on days 1 to 3 every 3 weeks as induction therapy. Maintenance therapy with durvalumab 1500 mg was administered every 4 weeks until disease progression or unacceptable toxicity. The primary end point was safety, and key secondary end points were objective response rate, progression-free survival, overall survival, quality of life, and Geriatric Assessment.

Results

Between August 2021 and February 2023, 40 patients were enrolled at 17 institutions and 38 were assessable for safety and efficacy. Grade 3 or higher adverse events occurred in 36 patients (94.6%). The most common adverse events were hematologic, including grade 3 or higher neutropenia (76.3%) and febrile neutropenia (15.8%). The objective response rate, median progression-free survival, and median overall survival were 89.5%, 5.4 months, and 16.1 months, respectively. No decrease in quality of life or functional assessment scores was observed after treatment.

Conclusion

Durvalumab plus carboplatin and etoposide was tolerable and expected to be effective in elderly patients with ES-SCLC.

免疫检查点抑制剂联合化疗是广泛期（ES） SCLC的标准治疗方法。然而，其对老年患者的安全性尚未得到充分验证。我们评估了durvalumab联合卡铂和依托泊苷治疗老年ES-SCLC患者的安全性和有效性。方法在这项前瞻性、单臂、多中心、2期临床试验中，年龄大于或等于75岁的ES-SCLC患者接受了长达4个周期的化疗，第1天为durvalumab 1500mg，第1天为卡铂，剂量相当于曲线下面积5，第1天为依托泊苷80mg /m2，每3周为第1天至第3天作为诱导治疗。每4周给予durvalumab 1500mg维持治疗，直到疾病进展或不可接受的毒性。主要终点是安全性，关键次要终点是客观缓解率、无进展生存期、总生存期、生活质量和老年评估。结果在2021年8月至2023年2月期间，来自17家机构的40名患者入组，其中38名患者可进行安全性和有效性评估。36例（94.6%）患者发生3级或以上不良事件。最常见的不良事件是血液学，包括3级及以上的中性粒细胞减少（76.3%）和发热性中性粒细胞减少（15.8%）。客观缓解率、中位无进展生存期和中位总生存期分别为89.5%、5.4个月和16.1个月。治疗后未观察到生活质量或功能评估评分下降。结论durvalumab联合卡铂和依托泊苷治疗老年ES-SCLC患者是可耐受的，且有望有效。

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引用次数: 0

Retreatment With Nivolumab and Ipilimumab in Pleural Mesothelioma Following Disease Progression After a Durable Response: Case Series Nivolumab和Ipilimumab治疗胸膜间皮瘤在持续缓解后疾病进展：病例系列

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-04-21 DOI: 10.1016/j.jtocrr.2025.100835

Illaa Smesseim MD , Paul Baas MD, PhD , Jacobus A. Burgers MD, PhD

The CheckMate 743 trial established nivolumab and ipilimumab as the standard first-line treatment for unresectable pleural mesothelioma. However, optimal management following disease progression after a durable response to dual immunotherapy remains unclear. We report two cases of patients with pleural mesothelioma (epithelioid subtype) initially treated with nivolumab-ipilimumab, achieving prolonged disease control. Both patients experienced disease progression several years after treatment discontinuation and were subsequently retreated with nivolumab-ipilimumab on regulatory approval. In both cases, retreatment resulted in stable disease for at least 12 months. However, immune-related toxicities occurred, with one patient developing recurrent colitis and the other experiencing nephrotic syndrome, ultimately leading to treatment discontinuation. These cases suggest that retreatment with dual immunotherapy may be a viable strategy for selected patients with previous durable responses, although the risk of immune-related toxicity remains significant. Given the lack of prospective data, further research is needed to determine whether rechallenge with nivolumab-ipilimumab offers superior outcomes compared with chemotherapy or best supportive care in this setting. Rechallenging patients with pleural mesothelioma with nivolumab-ipilimumab after a durable response is feasible but associated with immune-related toxicity.

CheckMate 743试验建立了nivolumab和ipilimumab作为不可切除胸膜间皮瘤的标准一线治疗方法。然而，在对双重免疫治疗产生持久反应后，疾病进展后的最佳管理仍不清楚。我们报告了两例胸膜间皮瘤（上皮样亚型）患者最初使用尼伏单抗-伊匹单抗治疗，实现了长期的疾病控制。两名患者在停药几年后均出现疾病进展，随后经监管部门批准使用尼伏单抗-伊匹单抗进行治疗。在这两个病例中，再治疗导致疾病稳定至少12个月。然而，发生了免疫相关的毒性，一名患者出现复发性结肠炎，另一名患者出现肾病综合征，最终导致治疗中断。这些病例表明，尽管免疫相关毒性的风险仍然很大，但对于先前有持久反应的选定患者，双重免疫治疗可能是一种可行的策略。鉴于缺乏前瞻性数据，需要进一步的研究来确定在这种情况下，与化疗或最佳支持治疗相比，nivolumab-ipilimumab的再挑战是否能提供更好的结果。对胸膜间皮瘤患者在持久反应后再用纳武单抗-伊匹单抗治疗是可行的，但与免疫相关的毒性有关。

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引用次数: 0

Combination Therapy With MET Tyrosine Kinase Inhibitor and EGFR Tyrosine Kinase Inhibitor in Patients With MET-Overexpressed EGFR-Mutant Lung Adenocarcinoma MET酪氨酸激酶抑制剂和EGFR酪氨酸激酶抑制剂联合治疗MET过表达EGFR突变型肺腺癌

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-04-09 DOI: 10.1016/j.jtocrr.2025.100832

Jia-Jun Wu MD , Zhe-Rong Zheng MD , Tse-Hsien Lo MD , Cheng-Hsiang Chu MD , Kun-Chieh Chen MD, PhD , Gee-Chen Chang MD, PhD

Introduction

Dysregulated MET signaling, such as MET overexpression or MET amplification (METamp), is a important mechanism of resistance to EGFR tyrosine kinase inhibitors (TKIs) in patients with EGFR-mutant lung adenocarcinoma (LUAD). Combination therapy with EGFR TKIs and MET TKIs has revealed efficacy in these patients. This study aimed to analyze the real-world experience of TKI combination in patients with EGFR-mutant MET-overexpressed LUAD.

Methods

This retrospective cohort study included patients with advanced EGFR-mutant LUAD who progressed after EGFR TKIs and were treated with combination therapy of EGFR TKIs and MET TKIs (capmatinib or tepotinib). Immunohistochemistry was used to detect MET overexpression.

Results

This study included 27 patients, with a median age of 69 years; 40.7% of the patients were male individuals, and 88.9% never smoked. Overall, the treatment response of the TKI combination reported 29.6% (eight of 27) partial response, 55.6% (15 of 27) stable disease, a median progression-free survival of 7.3 months, and an overall survival of 26.9 months. The adverse events were mostly grade 1 to 2, with only one patient experiencing a grade 3 or greater event, which was peripheral edema. The most common adverse events were hypoalbuminemia (44.4%), increased creatinine (44.4%), and peripheral edema (44.4%). Eight patients underwent next-generation sequencing analysis, and two (25.0%) of them had METamp. Three patients (37.5%) had TP53 mutations, which were the most common concurrent alterations. Those with positive METamp had significantly longer median progression-free survival than those without (25.3 versus 5.8 mo; p = 0.034).

Conclusions

The TKI combination reported clinical activities in patients with advanced EGFR-mutant LUAD resistant to EGFR TKIs and mild toxicity in those with MET overexpression.

MET信号失调，如MET过表达或MET扩增（METamp），是EGFR突变型肺腺癌（LUAD）患者对EGFR酪氨酸激酶抑制剂（TKIs）耐药的重要机制。EGFR TKIs和MET TKIs联合治疗在这些患者中显示出疗效。本研究旨在分析egfr突变met过表达LUAD患者联合TKI的现实体验。方法本回顾性队列研究纳入EGFR TKIs后进展的晚期EGFR突变LUAD患者，并接受EGFR TKIs和MET TKIs联合治疗（卡马替尼或替波替尼）。免疫组织化学检测MET过表达。结果本研究纳入27例患者，中位年龄69岁；40.7%的患者为男性，88.9%的患者从不吸烟。总体而言，TKI联合治疗反应报告29.6%（27例中8例）部分缓解，55.6%（27例中15例）疾病稳定，中位无进展生存期为7.3个月，总生存期为26.9个月。不良事件大多为1 - 2级，只有1例患者出现3级或以上的不良事件，即外周水肿。最常见的不良事件是低白蛋白血症（44.4%）、肌酐升高（44.4%）和外周水肿（44.4%）。8例患者进行了新一代测序分析，其中2例（25.0%）患有METamp。3例患者（37.5%）有TP53突变，这是最常见的并发改变。METamp阳性患者的中位无进展生存期明显长于未阳性患者(25.3个月对5.8个月；P = 0.034)。结论TKI联合治疗对EGFR TKIs耐药的晚期EGFR突变LUAD患者有临床活性，对MET过表达患者毒性较轻。

{"title":"Combination Therapy With MET Tyrosine Kinase Inhibitor and EGFR Tyrosine Kinase Inhibitor in Patients With MET-Overexpressed EGFR-Mutant Lung Adenocarcinoma","authors":"Jia-Jun Wu MD , Zhe-Rong Zheng MD , Tse-Hsien Lo MD , Cheng-Hsiang Chu MD , Kun-Chieh Chen MD, PhD , Gee-Chen Chang MD, PhD","doi":"10.1016/j.jtocrr.2025.100832","DOIUrl":"10.1016/j.jtocrr.2025.100832","url":null,"abstract":"<div><h3>Introduction</h3><div>Dysregulated <em>MET</em> signaling, such as MET overexpression or <em>MET</em> amplification (<em>MET</em>amp), is a important mechanism of resistance to EGFR tyrosine kinase inhibitors (TKIs) in patients with <em>EGFR</em>-mutant lung adenocarcinoma (LUAD). Combination therapy with EGFR TKIs and MET TKIs has revealed efficacy in these patients. This study aimed to analyze the real-world experience of TKI combination in patients with <em>EGFR</em>-mutant MET-overexpressed LUAD.</div></div><div><h3>Methods</h3><div>This retrospective cohort study included patients with advanced <em>EGFR</em>-mutant LUAD who progressed after EGFR TKIs and were treated with combination therapy of EGFR TKIs and MET TKIs (capmatinib or tepotinib). Immunohistochemistry was used to detect MET overexpression.</div></div><div><h3>Results</h3><div>This study included 27 patients, with a median age of 69 years; 40.7% of the patients were male individuals, and 88.9% never smoked. Overall, the treatment response of the TKI combination reported 29.6% (eight of 27) partial response, 55.6% (15 of 27) stable disease, a median progression-free survival of 7.3 months, and an overall survival of 26.9 months. The adverse events were mostly grade 1 to 2, with only one patient experiencing a grade 3 or greater event, which was peripheral edema. The most common adverse events were hypoalbuminemia (44.4%), increased creatinine (44.4%), and peripheral edema (44.4%). Eight patients underwent next-generation sequencing analysis, and two (25.0%) of them had <em>MET</em>amp. Three patients (37.5%) had <em>TP53</em> mutations, which were the most common concurrent alterations. Those with positive <em>MET</em>amp had significantly longer median progression-free survival than those without (25.3 versus 5.8 mo; <em>p</em> = 0.034).</div></div><div><h3>Conclusions</h3><div>The TKI combination reported clinical activities in patients with advanced <em>EGFR</em>-mutant LUAD resistant to EGFR TKIs and mild toxicity in those with MET overexpression.</div></div>","PeriodicalId":17675,"journal":{"name":"JTO Clinical and Research Reports","volume":"6 6","pages":"Article 100832"},"PeriodicalIF":3.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143912809","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

Outcomes in Patients With Resectable Stage III NSCLC Who Did Not Have Definitive Surgery After Neoadjuvant Treatment—A Retrospective Analysis of the SAKK Trials 16/96, 16/00, 16/01, 16/08, and 16/14: A Brief Report 可切除的III期非小细胞肺癌患者在新辅助治疗后未进行最终手术的结果——对SAKK试验16/96、16/00、16/01、16/08和16/14的回顾性分析：简要报告

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-04-09 DOI: 10.1016/j.jtocrr.2025.100834

Sabine Raimann MD , Sämi Schär PhD , Stefanie Hayoz PhD , Matthias Guckenberger MD , Tobias Finazzi MD, PhD , Isabelle Opitz MD , Sabine Schmid MD , Michael Mark MD , Alfredo Addeo MD , Laetitia A. Mauti MD, PhD , Daniel C. Betticher MD , Hans-Beat Ris MD , Roger Stupp MD , Alessandra Curioni-Fontecedro MD , Solange Peters MD, PhD , Martin Früh MD , Sacha I. Rothschild MD, PhD , Miklos Pless MD , David König MD

Introduction

Neoadjuvant or perioperative treatment, including an immune checkpoint inhibitor (ICI), has emerged as a new standard for patients with resectable stage III NSCLC. Nevertheless, approximately 20% of patients who start neoadjuvant chemo-immunotherapy will not undergo definitive surgery. Little is known about these patients.

Methods

We analyzed outcomes of patients without definitive surgery from five Swiss Group for Clinical Cancer Research (SAKK) trials that investigated different neoadjuvant treatment modalities in patients with resectable stage III-N2 NSCLC. Study treatment included neoadjuvant cisplatin-docetaxel chemotherapy (with or without radiotherapy), either combined with peri-operative durvalumab in the SAKK 16/14 trial (n = 68) or without an ICI (non-ICI trials, n = 431).

Results

Of the 499 patients, 102 (20%) did not have definitive surgery. Cancellation of surgery occurred in a similar proportion of patients with or without neoadjuvant ICI (19% versus 21%, p = 0.9). Reasons were in non-ICI trials and SAKK 16/14: disease progression (47% and 54%), nonresectability (18% and 8%), medical reasons (17% and 31%), and unknown (18% and 8%), respectively. Of these patients, no patient in SAKK 16/14 and 17 patients (19%) in the non-ICI trials received curative-intended salvage therapy. Three-year overall survival was higher in patients who had definitive surgery compared with those who did not: 78% versus 32% (SAKK 16/14) and 54% versus 10% (non-ICI trials).

Conclusions

In our pooled analysis, patients with definitive surgery had higher survival rates than those without definitive surgery. Prognosis in patients without definitive surgery seems to have improved in the era of ICI.

新辅助或围手术期治疗，包括免疫检查点抑制剂（ICI），已成为可切除的III期NSCLC患者的新标准。然而，大约20%开始新辅助化疗免疫治疗的患者不会接受最终手术。人们对这些病人知之甚少。方法：我们分析了瑞士临床癌症研究小组（SAKK）的五项研究，这些研究调查了可切除的III-N2期非小细胞肺癌患者的不同新辅助治疗方式。研究治疗包括新辅助顺铂-多西紫杉醇化疗（伴或不伴放疗），在SAKK 16/14试验（n = 68）中联合围手术期杜伐单抗或不伴ICI（非ICI试验，n = 431）。结果499例患者中，102例（20%）未行最终手术。有或没有新辅助ICI的患者取消手术的比例相似（19%对21%，p = 0.9）。在非ici试验和SAKK 16/14中，原因分别为：疾病进展（47%和54%）、不可切除（18%和8%）、医学原因（17%和31%）和未知（18%和8%）。在这些患者中，在SAKK 16/14试验中没有患者接受了治疗目的的挽救治疗，在非ici试验中有17例患者（19%）接受了治疗目的的挽救治疗。接受最终手术的患者的三年总生存率高于未接受手术的患者：78%对32% (SAKK 16/14)， 54%对10%（非ici试验）。结论在我们的汇总分析中，接受最终手术的患者生存率高于未接受最终手术的患者。在ICI时代，没有明确手术的患者预后似乎有所改善。

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引用次数: 0

Cost-Effectiveness of Adjuvant Osimertinib With and Without Chemotherapy for Surgically Resected NSCLC 手术切除的非小细胞肺癌的辅助化疗奥西替尼的成本-效果

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-04-09 DOI: 10.1016/j.jtocrr.2025.100833

Angelos Vasilopoulos BS , Alexander Pohlman MD , Ayham Odeh MD , K. Robert Shen MD , Julia M. Coughlin MD , Zaid M. Abdelsattar MD, MS, FACS

Introduction

Osimertinib is now approved as adjuvant therapy for stage IB to III NSCLC with EGFR mutations. Nevertheless, this treatment is lengthy and expensive. Its cost-effectiveness profile as monotherapy versus combination with chemotherapy is unknown. In this context, we investigate the cost-effectiveness of adjuvant osimertinib with and without chemotherapy for NSCLC.

Methods

A set of Markov models was established to predict the cost-effectiveness of these different regimens. Data were sourced from the ADAURA trial’s publications and protocols. Health outcomes were quantified as quality-adjusted life-years (QALYs). Costs and incremental cost-effectiveness ratios (ICERs) were estimated in U.S. dollars (USD) and USD per QALY, respectively. Deterministic and probabilistic sensitivity analyses were performed. Data from the Surveillance, Epidemiology, and End Results Program were used to predict additional costs to the U.S. health care system.

Results

Compared with treatment with chemotherapy alone, treatment with osimertinib plus chemotherapy yielded 5.86 QALYs with incremental costs of $414,607.69 (ICER = $380,347.85 per QALY). Treatment with osimertinib alone yielded 6.63 QALYs with an incremental cost of $402,224.32 (ICER = $213,447.59 per QALY). Osimertinib is only likely to be cost-effective if the willingness-to-pay threshold per QALY is $200,000 or more. The price of osimertinib had the strongest influence on cost-effectiveness. On the basis of Surveillance, Epidemiology, and End Results Program data, these practices may cost the U.S. health care system an additional 8.9 billion USD/year.

Conclusions

Adjuvant osimertinib alone is more cost-effective than combination therapy, but only if the willingness-to-pay is high. A reduction in the price of osimertinib would improve its cost-effectiveness profile.

奥西替尼现已被批准作为EGFR突变的IB至III期NSCLC的辅助治疗。然而，这种治疗既漫长又昂贵。其单药与联合化疗的成本效益情况尚不清楚。在这种情况下，我们研究了辅助奥希替尼加化疗和不加化疗治疗非小细胞肺癌的成本效益。方法建立一套马尔可夫模型，预测不同方案的成本-效果。数据来源于ADAURA试验的出版物和方案。健康结果被量化为质量调整生命年（QALYs）。成本和增量成本效益比（ICERs）分别以美元（USD）和每QALY美元估算。进行了确定性和概率敏感性分析。来自监测、流行病学和最终结果项目的数据被用来预测美国医疗保健系统的额外费用。结果与单独化疗治疗相比，奥西替尼联合化疗治疗获得5.86个QALY，增量成本为414,607.69美元（ICER = 380,347.85美元/ QALY）。单独使用奥西替尼治疗产生6.63个QALY，增量成本为402,224.32美元（ICER = 213,447.59美元/ QALY）。只有当每个QALY的支付意愿阈值达到或超过20万美元时，奥西替尼才可能具有成本效益。奥西替尼的价格对成本-效果的影响最大。根据监测、流行病学和最终结果项目的数据，这些做法可能会使美国医疗保健系统每年额外花费89亿美元。结论仅在患者支付意愿高的情况下，单独使用奥希替尼辅助治疗比联合治疗更具成本效益。奥西替尼价格的降低将改善其成本效益。

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引用次数: 0

The United States’ Early Experience With Lung Cancer Screening—Creation of a National Data Linkage: A Brief Report 美国肺癌筛查的早期经验——国家数据链接的创建：简要报告

IF 3 Q2 ONCOLOGY

JTO Clinical and Research Reports

Pub Date : 2025-03-20 DOI: 10.1016/j.jtocrr.2025.100825

V. Paul Doria-Rose DVM, PhD , Gerard A. Silvestri MD, MS , Danielle D. Durham PhD , Philip Connor BS , Lenka Goldman MSE , Lindsey Enewold PhD, MPH , Farhood Farjah MD, MPH , Eric A. Miller PhD, MSPH , Michael Simanowith MD , Robert A. Smith PhD , Louise M. Henderson PhD, MSPH , Raymond U. Osarogiagbon M.B.B.S., FASCO , Ella A. Kazerooni MD, MS , Andrew Ward PhD, MPH , Paul Pinsky PhD

Introduction

Lung cancer screening has been recommended by the United States Preventive Services Taskforce since 2013. The Centers for Medicare and Medicaid Services coverage decision in early 2015 required data submission to a Centers for Medicare and Medicaid Services–approved registry for facilities to receive payment for screening. Only the American College of Radiology’s Lung Cancer Screening Registry (LCSR) received approval for this purpose. Some LCSR elements, such as race, ethnicity, downstream diagnostic procedures, and cancer outcomes, were underreported.

Methods

To address underreporting, we linked data from the LCSR to Medicare and Surveillance, Epidemiology, and End Results cancer registry data from 2015 to 2021. We created two different cohorts of individuals aged 65 years and older: (1) those who were enrolled in Medicare fee-for-service plans with parts A and B coverage at the time of at least one LCSR-reported screen, and (2) Medicare beneficiaries (regardless of whether fee-for-service or managed care) living within a Surveillance, Epidemiology, and End Results catchment area at the time of at least one LCSR-reported screen. We compared the characteristics of individuals in the linked cohorts with those of all individuals in the LCSR aged 65 years and over.

Results

Demographic, smoking history, and screening examination data elements in the linked data were generally similar to those in the overall LCSR.

Conclusions

On the basis of these results, the linked populations seem to be generally representative of older individuals in the LCSR. These unique data linkages provide an unprecedented opportunity to better understand the early implementation of lung cancer screening in the United States.

自2013年以来，肺癌筛查已被美国预防服务工作组推荐。2015年初，医疗保险和医疗补助服务中心的覆盖范围决定要求向医疗保险和医疗补助服务中心批准的注册中心提交数据，以便接收筛查费用。只有美国放射学院的肺癌筛查登记处（LCSR）获得了这一目的的批准。一些LCSR因素，如种族、民族、下游诊断程序和癌症结局，被低估了。为了解决低报问题，我们将LCSR的数据与2015年至2021年的医疗保险和监测、流行病学和最终结果癌症登记数据联系起来。我们创建了两个不同的65岁及以上的个体队列：(1)在至少一次lcsr报告的筛查中登记了医疗保险按服务收费计划的A部分和B部分覆盖的人；(2)在至少一次lcsr报告的筛查中居住在监测、流行病学和最终结果集区内的医疗保险受益人（无论是否按服务收费或管理医疗）。我们将相关队列中个体的特征与65岁及以上LCSR中所有个体的特征进行了比较。结果关联数据中的人口学、吸烟史和筛查检查数据元素与总体LCSR数据元素基本相似。在这些结果的基础上，相关人群似乎普遍代表了LCSR中的老年人。这些独特的数据联系为更好地了解美国肺癌筛查的早期实施提供了前所未有的机会。

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引用次数: 0