ESMO Open最新文献

英文中文

Real-world 5-year outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC 不可切除的III期NSCLC放化疗后使用durvalumab的真实5年预后。

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-04 DOI: 10.1016/j.esmoop.2026.106070

N. Girard , J. Bar , P. Baas , C. Chouaid , D.C. Christoph , J.K. Field , R. Fietkau , M.C. Garassino , P. Garrido Lopez , V. Gregorc , V.D. Haakensen , T.J.N. Hiltermann , S. Kao , F. McDonald , F. Mornex , M. Moskovitz , S. Peters , S. Siva , B. Solomon , Y. Qiao , A.R. Filippi

Background

Consolidation durvalumab is standard of care treatment for patients with unresectable, stage III non-small-cell lung cancer without progression after chemoradiotherapy. Additional study is warranted to investigate the long-term efficacy of this regimen in real-world settings.

Methods

PACIFIC-R (NCT03798535) was an international, observational, cohort study of patients who started durvalumab 10 mg/kg intravenously every 2 weeks within an AstraZeneca-initiated early access program between September 2017 and December 2018. Data were extracted retrospectively from medical records to describe the real-world effectiveness of consolidation durvalumab in patients with unresectable non-small-cell lung cancer without progression after chemoradiotherapy. The primary endpoints were real-world progression-free survival (rwPFS) and overall survival (OS).

Results

Median age was 65.0 years (range 26-88 years); most patients [747/1153 (64.8%)] were male and current [300/1153 (26.0%)] or former [750/1153 (65.0%)] smokers. Among patients with reported data, most had Eastern Cooperative Oncology Group performance status <2 [743/755 (98.4%)], stage IIIB/C disease [584/1090 (53.6%)], non-squamous histology [746/1137 (65.6%)], and programmed death-ligand 1 expression on ≥1% of tumor cells [572/791 (72.3%)]. Median follow-up (censored patients) was 63.5 months for rwPFS and 67.5 months for OS. Median rwPFS was 24.3 months [95% confidence interval (CI) 20.3-28.4 months]; 5-year rwPFS was 35.2% (95% CI 32.4% to 38.1%). Median OS was 59.0 months (95% CI 52.7-64.3 months); 5-year OS was 49.2% (95% CI 46.2% to 52.2%). Encouraging results were observed across subgroups, including among patients who received durvalumab after either concurrent or sequential chemoradiotherapy [median rwPFS (95% CI): 25.8 months (20.9-31.8 months) versus 23.2 months (16.9-29.5 months); median OS: 63.1 months (57.3-73.5 months) versus 47.1 months (35.3-58.1 months)], and irrespective of programmed death-ligand 1 expression [on ≥1% versus <1% of tumor cells; median rwPFS (95% CI): 25.5 months (19.1-32.8 months) versus 16.3 months (10.9-27.5 months); median OS: 62.4 months (55.0 months-not estimable) versus 43.3 months (31.6-60.7) months].

Conclusions

PACIFIC-R provides mature data on OS and rwPFS from a large, real-world cohort, supporting consolidation durvalumab as a standard of care in this setting.

背景：巩固durvalumab是化疗后无进展的不可切除III期非小细胞肺癌患者的标准护理治疗。需要进一步的研究来调查该方案在现实环境中的长期疗效。方法：PACIFIC-R （NCT03798535）是一项国际观察性队列研究，研究对象是在2017年9月至2018年12月期间，在阿斯利康启动的早期准入项目中，每2周静脉注射durvalumab 10mg /kg的患者。回顾性地从医疗记录中提取数据，以描述巩固durvalumab在放化疗后无进展的不可切除非小细胞肺癌患者中的实际有效性。主要终点是真实世界无进展生存期（rwPFS）和总生存期（OS）。结果：中位年龄65.0岁（范围26 ~ 88岁）；大多数患者[747/1153(64.8%)]为男性，目前[300/1153(26.0%)]或曾经[750/1153(65.0%)]吸烟。结论：PACIFIC-R提供了来自大型真实队列的OS和rwPFS的成熟数据，支持巩固durvalumab作为这种情况下的标准治疗。

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IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/j.esmoop.2025.106003

Sung-Young Oh , Hye Ryeon Kim , Ki Hyang Kim , Hyo Jin Lee , Kyoung-Eun Lee , Young Saing Kim , Jung Hun Kang , Seong Hoon Shin , Chi Hoon Maeng , Jong Gwang Kim , Sang-Cheol Lee , Jaekyung Cheon

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PP143 Redox-modulatory and MET-inhibitory triad: Synergistic cytotoxicity of L-cysteine, NAC, and MET inhibition in cervical cancer cells 氧化还原调节和MET抑制三位一体：l -半胱氨酸、NAC和MET抑制在宫颈癌细胞中的协同细胞毒性

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/j.esmoop.2025.105980

Yingqiu Xie , Aigerim Tassanbiyeva , Aruzhan Onggarbek

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IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/S2059-7029(26)00042-6

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PP198 Lactic acid bacteria enhance antitumor immunity in bladder cancer via modulation of the tumor microenvironment PP198乳酸菌通过调节肿瘤微环境增强膀胱癌的抗肿瘤免疫

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/j.esmoop.2025.105986

Woo Kyun Bae , Hyun Jin Bang , Hye Kyung Lee , Myong-Suk Park , Misun Yun , Lothar Hennighausen , Priscilla A. Furth , Ik-Joo Chung , Sang-Hee Cho

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PP398 Improved cancer coping from a psych educational web-based intervention for advanced cancer survivors: A randomized controlled trial 基于网络的心理教育干预对晚期癌症幸存者癌症应对能力的改善：一项随机对照试验

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/j.esmoop.2025.106014

Nurul Huda , Malissa Kay Shaw , Bayu Satria Wiratama , Eka Febriyanti

引用次数: 0

PP301 The global and regional burden of early-onset gastric cancer in adolescents and adults aged 15–49 years (1990–2021): An analysis of incidence, mortality, and DALYs with projections to 2030 15-49岁青少年和成人早发性胃癌的全球和区域负担（1990-2021）：到2030年预测的发病率、死亡率和DALYs分析

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-02-28 DOI: 10.1016/j.esmoop.2025.106002

Yantao Tian, Yujuan Jiang, Jinghua Chen

引用次数: 0

Phase II trial, multicenter, first-line paclitaxel-avelumab treatment of inoperable angiosarcoma (KCSG UN 18-15)☆ II期临床试验，多中心，一线紫杉醇-阿韦单抗治疗不能手术的血管肉瘤（KCSG UN 18-15）☆

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-01-22 DOI: 10.1016/j.esmoop.2025.106018

H.R. Kim , M. Kim , M.J. Kang , J.E. Kim , Y.J. Kim , K. Park , W.K. Bae , M.-W. Lee , J.-Y. Hong , Y.S. Kim , S.-A. Im , J. Lee , S.Y. Oh

Background

Angiosarcomas are rare tumors of vascular or lymphatic origin with clinically heterogeneous presentation and behavior, predominantly originating in the skin of the head and neck and the breast area. Given their location and/or rapid progression, surgical resection is frequently not feasible, even in those with localized diseases. Conventional cytotoxic chemotherapy has proven largely ineffective against angiosarcoma. In this prospective, phase II study, we evaluated the efficacy and toxicity of paclitaxel plus avelumab as first-line therapy for unresectable angiosarcoma.

Patients and methods

This study included patients with unresectable locally advanced or metastatic angiosarcomas, who did not receive systemic treatment. Paclitaxel (80 mg/m²) was intravenously infused on days 1, 8, and 15 of every 28-days cycle; avelumab (10 mg/kg) was intravenously infused every 2 weeks. Treatment continued until disease progression, unacceptable toxicity, death, or withdrawal of consent, whichever occurred first. The primary endpoint was the objective response rate (ORR); secondary endpoints included overall survival (OS), progression-free survival (PFS), and safety profiles.

Results

The final analysis included 32 patients (21 male and 11 female). The median age was 63.5 years (range 27-82 years). The ORR was 50.0% (n = 16), including one complete response. Median OS and PFS were 14.5 [95% confidence interval (CI) 9.4-24.6 months] and 6.0 (95% CI 5.4-9.5 months), respectively. Among patients who received at least one treatment dose (n = 33), adverse events (AEs) of any grade were reported in 90.9% (n = 30), and severe AEs in 12.1% (n = 4), including one death. The most common hematologic and non-hematologic AEs were neutropenia (n = 13, 39.4%) and pain (n = 12, 36.4%). Immune-related pneumonitis was reported in two patients.

Conclusion

Avelumab plus weekly paclitaxel demonstrated preliminary evidence of efficacy and tolerability in inoperable angiosarcoma. Given the rarity of angiosarcoma, further multicenter, collaborative, and translational studies are warranted.

背景：血管肉瘤是一种罕见的起源于血管或淋巴的肿瘤，临床表现和行为均不相同，主要起源于头颈部皮肤和乳房区域。考虑到它们的位置和/或进展迅速，手术切除通常是不可行的，即使是那些局部疾病。传统的细胞毒性化疗已被证明对血管肉瘤基本无效。在这项前瞻性II期研究中，我们评估了紫杉醇联合avelumab作为一线治疗不可切除血管肉瘤的疗效和毒性。患者和方法本研究纳入了未接受全身治疗的不可切除的局部晚期或转移性血管肉瘤患者。紫杉醇（80 mg/m2）在每28 d周期的第1、8、15天静脉输注；Avelumab （10mg /kg）每2周静脉输注一次。治疗持续至疾病进展、不可接受的毒性、死亡或撤回同意，以先发生者为准。主要终点为客观缓解率（ORR）；次要终点包括总生存期（OS）、无进展生存期（PFS）和安全性。结果共纳入32例患者，其中男21例，女11例。中位年龄为63.5岁（范围27-82岁）。ORR为50.0% (n = 16)，包括1例完全缓解。中位OS和PFS分别为14.5[95%可信区间（CI） 9.4-24.6个月]和6.0 （95% CI 5.4-9.5个月）。在接受至少一个治疗剂量（n = 33）的患者中，90.9% （n = 30）报告了任何级别的不良事件（ae）， 12.1% （n = 4）报告了严重ae，包括1例死亡。最常见的血液学和非血液学ae是中性粒细胞减少症（n = 13, 39.4%）和疼痛（n = 12, 36.4%）。2例患者报告免疫相关性肺炎。结论avelumab联合每周紫杉醇治疗不能手术的血管肉瘤具有初步的疗效和耐受性。鉴于血管肉瘤的罕见性，进一步的多中心、合作和转化研究是必要的。

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引用次数: 0

Artificial intelligence-powered real-time multimodal model for predicting recurrence and survival in head and neck cancer: a multicenter, multinational study 预测头颈癌复发和生存的人工智能实时多模态模型：一项多中心、多国研究

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-01-27 DOI: 10.1016/j.esmoop.2025.106046

H.A. Jung , R. Merkin , A.L. Feng , D. Lee , K. Lee , S. Park , J.-M. Sun , S.-H. Lee , J.S. Ahn , M.-J. Ahn , L.J. Wirth , J.C. Park

Background

Head and neck squamous-cell carcinoma (HNSCC) accounts for ∼5.3% of cancer-related mortality worldwide, with an estimated 890 000 new diagnoses and 450 000 deaths annually. Despite curative-intent therapy, 10% to 50% of patients experience recurrence. Prognosis for recurrent or metastatic disease is poor, with limited treatment options, underscoring the need for accurate prognostic models to guide treatment escalation or de-escalation and avoid over-treatment.

Methods

We conducted a multicenter prognostic study of patients undergoing curative-intent surgery at Samsung Medical Center and Massachusetts Eye and Ear Infirmary/Massachusetts General Hospital from 2008 to 2024. Baseline clinicopathologic variables were integrated with longitudinal laboratory measurements from surveillance. A random 80/20 split defined development and internal-validation cohorts. Using XGBoost, we trained two models to predict recurrence-free survival (RFS) and overall survival (OS) at 1, 2, 3, 4, and 5 years from each visit.

Results

A total of 975 patients with HNSCC (oral cavity, oropharyngeal, hypopharyngeal, and laryngeal subsites) were included. The areas under the curve (AUCs) for predicting 1-, 2-, 3-, 4-, and 5-year RFS from the surveillance time point were 0.785 (sensitivity, 72.8%; specificity, 71.5%), 0.831 (79.7%; 73.7%), 0.788 (74.0%; 73.3%), 0.769 (72.6%; 70.5%), and 0.795 (72.1%; 74.7%), respectively. For OS prediction, AUCs were 0.788 (72.1%; 73.6%), 0.797 (75.7%; 71.8%), 0.796 (81.0%; 68.4%), 0.820 (77.5%; 76.5%), and 0.815 (75.8%; 75.8%), respectively. In subgroup analysis, the model showed strong OS prediction in human papilloma virus (HPV)-positive oropharyngeal cancer, with AUCs of 0.943, 0.736, 0.699, 0.835, and 0.765 at 1-, 2-, 3-, 4-, and 5-years, respectively. In non-HPV-positive HNSCC, OS AUCs ranged from 0.780 to 0.813 and RFS AUCs from 0.774 to 0.830 across the same time points.

Conclusions and relevance

In this multicenter study, an artificial intelligence (AI)-powered model using multimodal and longitudinal data accurately predicted RFS and OS at multiple time points following curative-intent surgery for HNSCC.

背景头颈部鳞状细胞癌（HNSCC）占全球癌症相关死亡率的5.3%，估计每年有89万例新诊断和45万例死亡。尽管进行了治疗，但仍有10%至50%的患者出现复发。复发或转移性疾病的预后较差，治疗选择有限，强调需要准确的预后模型来指导治疗升级或降级并避免过度治疗。方法：我们对2008年至2024年在三星医疗中心和马萨诸塞州眼耳医院/马萨诸塞州总医院接受治疗目的手术的患者进行了多中心预后研究。基线临床病理变量与监测的纵向实验室测量相结合。随机的80/20划分定义了开发和内部验证队列。使用XGBoost，我们训练了两个模型来预测每次就诊后1、2、3、4和5年的无复发生存期（RFS）和总生存期（OS）。结果共纳入975例HNSCC患者（口腔、口咽、下咽和喉部亚区）。从监测时间点预测1年、2年、3年、4年和5年RFS的曲线下面积（aus）分别为0.785（敏感性72.8%、特异性71.5%）、0.831（79.7%、73.7%）、0.788（74.0%、73.3%）、0.769（72.6%、70.5%）和0.795（72.1%、74.7%）。OS预测auc分别为0.788（72.1%;73.6%）、0.797（75.7%;71.8%）、0.796（81.0%;68.4%）、0.820（77.5%;76.5%）、0.815（75.8%;75.8%）。在亚组分析中，该模型对人乳头瘤病毒（HPV）阳性口咽癌的OS预测较强，1年、2年、3年、4年和5年的auc分别为0.943、0.736、0.699、0.835和0.765。在非hpv阳性的HNSCC中，同一时间点的OS auc范围为0.780至0.813，RFS auc范围为0.774至0.830。结论和相关性在这项多中心研究中，使用多模态和纵向数据的人工智能（AI）驱动模型准确预测了HNSCC治疗意图手术后多个时间点的RFS和OS。

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引用次数: 0

Mutational patterns and ancestry-linked profiles in a large hepatocellular carcinoma and combined hepatocellular–cholangiocarcinoma cohort☆ 一个大型肝细胞癌和肝细胞胆管癌合并队列的突变模式和家谱。

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-02-01 Epub Date: 2026-01-20 DOI: 10.1016/j.esmoop.2025.106048

C. Gerdes , S. Rengarajan , K. Murugesan , J.S. Ross , S. Bartels , A. Vogel , A. Saborowski

Background

Despite significant therapeutic advancements, hepatocellular carcinoma (HCC) remains a highly fatal malignancy. To accelerate the development of targeted therapies, a comprehensive understanding of the spectrum of genomic alterations (GAs) is essential. Here, we present what is, to our knowledge, the largest genomic analysis of real-world HCC and combined HCC–cholangiocarcinoma (cHCC–CCA) patients.

Patients and methods

Tumor samples from 2372 HCC patients and 150 patients with cHCC–CCA underwent genomic profiling using the FoundationOne® platform covering >290 genes, as well as tumor mutational burden (TMB) and microsatellite status.

Results

Our comprehensive and representative analysis included 1793 male and 577 female patients across five genetic ancestries. Female patients exhibited lower frequencies of GAs in TERT, MYC, and CTNNB1, with higher rates of BAP1 GA. Patients of East Asian ancestry presented an increased frequency of TP53, MUTYH, and TET2 GAs, as well as a higher proportion of TMB-high tumors. Compared with HCC, cHCC–CCA exhibited higher frequencies of IDH1 (8.0% versus 0.3%), IDH2 (2.7% versus 0.04%), and FGFR2 (7.3% versus 0.3%) alterations. Potentially actionable alterations were detected in 19.5% of HCC patients and 34.7% of mixed histology. Histological re-assessment due to detection of GA uncommon for HCC was carried out in 117 patients, resulting in a change in diagnosis in 37 cases. Limitations include the absence of detailed clinical data and dependence on the CE-certified Foundation Medicine (FMI) platform for functional annotation of detected variants.

Conclusions

Our study represents one of the largest cohorts of HCC and cHCC–CCA patients with genomic data and highlights the critical role of integrated molecular diagnostics. Beyond uncovering therapeutic targets, next-generation sequencing profiling offers significant benefits in improving diagnostic accuracy for liver cancer.

背景：尽管治疗取得了重大进展，肝细胞癌（HCC）仍然是一种高度致命的恶性肿瘤。为了加速靶向治疗的发展，全面了解基因组改变（GAs）的谱是必不可少的。在这里，我们提出了，据我们所知，最大的真实HCC和HCC-胆管癌合并（cHCC-CCA）患者的基因组分析。患者和方法：使用FoundationOne®平台对2372例HCC患者和150例cHCC-CCA患者的肿瘤样本进行基因组分析，包括bbbb290个基因，以及肿瘤突变负担（TMB）和微卫星状态。结果：我们对5个遗传谱系的1793名男性和577名女性患者进行了全面且具有代表性的分析。女性患者在TERT、MYC和CTNNB1中GAs的发生率较低，而BAP1 GA的发生率较高。东亚血统的患者出现TP53、MUTYH和TET2 GAs的频率增加，以及tmb -高肿瘤的比例更高。与HCC相比，cHCC-CCA表现出更高的IDH1（8.0%比0.3%）、IDH2（2.7%比0.04%）和FGFR2（7.3%比0.3%）改变频率。在19.5%的HCC患者和34.7%的混合组织学患者中检测到潜在的可操作改变。117例患者因检测到HCC不常见的GA而进行组织学重新评估，其中37例导致诊断改变。局限性包括缺乏详细的临床数据和依赖ce认证的基础医学（FMI）平台对检测到的变异进行功能注释。结论：我们的研究代表了具有基因组数据的最大的HCC和cHCC-CCA患者队列之一，并强调了综合分子诊断的关键作用。除了发现治疗靶点，下一代测序分析在提高肝癌诊断准确性方面提供了显著的好处。

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