ESMO Open最新文献_第3页

Corrigendum to “Adjuvant immunotherapy in the modern management of resectable melanoma: current status and outlook to 2028” “辅助免疫治疗在可切除黑色素瘤的现代管理中的应用：现状和2028年的展望”的更正

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2026-01-01 DOI: 10.1016/j.esmoop.2025.105492

M. Donia , H. Jespersen , M. Jalving , R. Lee , H. Eriksson , C. Hoeller , M. Hernberg , I. Gavrilova , L. Kandolf , G. Liszkay , H. Helgadottir , A. Zhukavets , D. Pjanova , I. Marquez-Rodas , B. Neyns , H. Westgeest , I. Pourmir , P. Sobczuk , E. Ellebaek , T. Amaral

引用次数: 0

A phase II, multicenter, open-label, single-arm study of berzosertib plus topotecan in patients with relapsed platinum-resistant small-cell lung cancer (DDRiver SCLC 250)☆ 一项II期、多中心、开放标签、单臂研究：berzosertib + topotecan治疗复发的铂耐药小细胞肺癌（DDRiver SCLC 250）

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-19 DOI: 10.1016/j.esmoop.2025.105918

A. Navarro , A. Thomas , Y. Cheng , Y. Chen , N. Reguart , T. Yoshida , S. Cousin , X. Dong , N. Yamamoto , F. Cappuzzo , R. Hallwachs , J. Bolleddula , B. Sarholz , T. Grombacher , M. Otte , I. Gounaris , J. Ferrer , C. Moulin , L. Paz-Ares

Background

Small-cell lung cancer (SCLC) is characterized by high genomic instability. Proteins involved in maintaining genomic stability, such as ataxia telangiectasia and Rad3-related (ATR) and topoisomerase 1, are promising therapeutic targets in SCLC. Berzosertib, a highly potent, selective, intravenously administered ATR inhibitor, has demonstrated promising antitumor activity in patients with platinum-resistant SCLC.

Materials and methods

This phase II, multicenter, open-label, single-arm study (NCT04768296) included patients with relapsed platinum-resistant SCLC who received berzosertib (210 mg/m² on days 2, 5) and topotecan (1.25 mg/m² on days 1-5) intravenously in 21-day cycles until disease progression. Primary endpoints were objective response rate (ORR per RECIST v1.1), assessed by an Independent Review Committee. Key secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety.

Results

A preplanned interim analysis for futility after the first 40 patients had completed their second on-treatment tumor assessment (or dropped out/died prematurely) revealed a low probability of reaching the predefined efficacy threshold, leading to premature study termination. At the final analysis (n = 73), four patients achieved confirmed partial response, resulting in an ORR of 5.5%. The median PFS was 2.2 months [95% confidence interval (CI) 1.5-2.7 months], and the median OS was 6.4 months (95% CI 4.2-7.6 months). No new safety concerns were observed, with the safety profile of berzosertib and topotecan combination therapy being consistent with the known risk profile of the respective monotherapies.

Conclusions

No added clinical benefit of berzosertib and topotecan combination was observed over topotecan monotherapy in patients with platinum-resistant SCLC.

背景：小细胞肺癌（SCLC）具有高度的基因组不稳定性。参与维持基因组稳定性的蛋白质，如共济失调毛细血管扩张和rad3相关（ATR）和拓扑异构酶1，是SCLC有希望的治疗靶点。Berzosertib是一种高效、选择性、静脉给药的ATR抑制剂，在铂耐药SCLC患者中显示出有希望的抗肿瘤活性。材料和方法：这项II期、多中心、开放标签、单臂研究（NCT04768296）纳入了复发的铂耐药SCLC患者，这些患者接受了berzosertib （210 mg/m2，第2,5天）和topotecan （1.25 mg/m2，第1-5天）的静脉注射，每21天一次，直到疾病进展。主要终点是客观缓解率（每RECIST v1.1的ORR），由独立审查委员会评估。关键次要终点包括无进展生存期（PFS）、总生存期（OS）和安全性。结果在前40例患者完成第二次治疗期肿瘤评估（或退出/过早死亡）后进行的一项预先计划的无效期中分析显示，达到预先设定的疗效阈值的可能性很低，导致研究过早终止。在最终分析中（n = 73）， 4例患者获得了部分缓解，ORR为5.5%。中位PFS为2.2个月[95%可信区间（CI） 1.5-2.7个月]，中位OS为6.4个月（95% CI 4.2-7.6个月）。没有观察到新的安全性问题，莪术和拓扑替康联合治疗的安全性与各自单一治疗的已知风险一致。结论在铂耐药SCLC患者中，山莨菪碱与拓扑替康联合治疗未获得比拓扑替康单药治疗更多的临床获益。

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引用次数: 0

The impact of immune checkpoint inhibitors on gonadal function in patients with solid tumors 免疫检查点抑制剂对实体瘤患者性腺功能的影响

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-18 DOI: 10.1016/j.esmoop.2025.105916

B. van Dijk , K. de Joode , Y.V. Louwers , H.M.W. Verheul , R.H.J. Mathijssen , L. Chaker , R. van der Wal , S.A.A. van den Berg , M. Dinkelman-Smit , J.A. Visser , A.A.M. van der Veldt

引用次数: 0

TQB2440 compared with reference pertuzumab for HER2-positive, ER/PgR-negative, early or locally advanced breast cancer: a multicenter, randomized, double-blind, parallel-controlled, phase III equivalence trial TQB2440与参考帕妥珠单抗比较治疗her2阳性、ER/ pgr阴性、早期或局部晚期乳腺癌：一项多中心、随机、双盲、平行对照的III期等效试验

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-15 DOI: 10.1016/j.esmoop.2025.105853

S. Wang , N. Li , Q. Cheng , Y. Ren , X. Cao , J. Huang , C. Liu , H. Yang , L. Wei , Z. Song , H. Zhao , Q. Zhang

Background

This randomized, double-blind study aimed to establish the equivalence of TQB2440 (a pertuzumab biosimilar) versus the reference pertuzumab, in the combination of trastuzumab and docetaxel, for patients with human epidermal growth factor receptor 2 (HER2)-positive early or locally advanced breast cancer.

Materials and methods

Patients were randomly assigned (1 : 1) to receive four cycles of neoadjuvant therapy, either TQB2440 or the reference pertuzumab each plus trastuzumab and docetaxel, followed by surgery and adjuvant treatment. The primary endpoint was total pathological complete response (tpCR) by an independent review committee (IRC), with equivalence margins of 0.76-1.32. Secondary endpoints included breast pathological complete response (bpCR) by IRC, tpCR/bpCR by the investigator, breast-conserving surgery (BCS) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), and safety.

Results

From 21 October 2020 to 14 August 2022, 412 patients were assigned to TQB2440 (207 patients) or reference pertuzumab (205 patients). The IRC-assessed tpCR was 58.9% with TQB2440 and 58.1% with the reference pertuzumab. The relative risk was 1.02 (90% confidence interval 0.89-1.16), which was entirely within the predefined equivalence margins. The IRC-assessed bpCR (67.6% versus 63.9%), investigator-assessed tpCR (60.4% versus 58.1%), bpCR (65.7% versus 62.0%), BCS rate (13.0% versus 13.2%), and ORR (73.9% versus 67.3%) were comparable in the two groups. At the data cut-off, the median EFS and DFS were not reached. Safety, pharmacokinetics (PK), and immunogenicity profiles were similar between the two groups.

Conclusion

TQB2440 showed equivalent efficacy, comparable safety, PK, and immunogenicity profiles to reference pertuzumab in the neoadjuvant treatment of patients with HER2-positive early or locally advanced breast cancer.

背景：这项随机双盲研究旨在确定TQB2440（一种帕妥珠单抗生物类似药）与参考帕妥珠单抗联合曲妥珠单抗和多西他赛治疗人类表皮生长因子受体2 （HER2）阳性早期或局部晚期乳腺癌患者的等效性。材料和方法：患者被随机分配（1:1）接受4个周期的新辅助治疗，TQB2440或参考帕妥珠单抗各加曲妥珠单抗和多西他赛，然后进行手术和辅助治疗。主要终点是独立审查委员会（IRC）的总病理完全缓解（tpCR），等效边际为0.76-1.32。次要终点包括IRC的乳腺病理完全缓解（bpCR）、研究者的tpCR/bpCR、保乳手术（BCS）率、客观缓解率（ORR）、无事件生存期（EFS）、无病生存期（DFS）和安全性。结果：从2020年10月21日至2022年8月14日，412例患者被分配到TQB2440（207例）或参考帕妥珠单抗（205例）。irc评估的tpCR在TQB2440组为58.9%，在帕妥珠单抗组为58.1%。相对风险为1.02(90%置信区间0.89-1.16)，完全在预定义的等效范围内。irc评估的bpCR（67.6%比63.9%）、研究者评估的tpCR（60.4%比58.1%）、bpCR（65.7%比62.0%）、BCS率（13.0%比13.2%）和ORR（73.9%比67.3%）在两组中具有可比性。在数据截止时，未达到中位EFS和DFS。安全性、药代动力学（PK）和免疫原性在两组之间相似。结论：TQB2440在her2阳性早期或局部晚期乳腺癌患者的新辅助治疗中具有与参考帕妥珠单抗相当的疗效、相当的安全性、PK和免疫原性。

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引用次数: 0

Corrigendum to ‘Improving chemotherapy-induced peripheral neuropathy in cancer patients using a combined qigong and self-administered acupressure intervention: a randomized controlled trial’ “使用气功和自我穴位按摩联合干预改善化疗诱导的癌症患者周围神经病变：一项随机对照试验”的更正：[ESMO开放卷10，第9期，2025年9月，105565]。

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-15 DOI: 10.1016/j.esmoop.2025.105937

D.S.T. Cheung , W.F. Yeung , P.H. Chau , S.Y. Chan , W.L. Chan , C.H. Yeh , L. Lao , Z. Zhang , C.C. Lin

引用次数: 0

Montelukast as a novel therapeutic approach in metastatic uveal melanoma harboring a CYSLTR2 mutation: a translational case report 孟鲁司特作为一种新的治疗方法转移性葡萄膜黑色素瘤携带CYSLTR2突变：翻译病例报告

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-06 DOI: 10.1016/j.esmoop.2025.105921

D. Smarsly , N. Kreuzberg , C. Langhorst , M. Scheffler , U. Siebolts , S. Lennartz , P. Koll , A.-C. Glaser , C. Franklin

Background

Uveal melanoma (UM), the most common primary intraocular malignancy in adults, has limited systemic treatment options in the metastatic setting. Recent insights into cysteinyl leukotriene receptors (CysLTRs)—particularly CYSLTR2 mutations (prevalence 2%-4%)—suggest new therapeutic approaches for patients who progress despite standard therapies.

Case

We report the case of a 59-year-old male with metastatic UM harboring a CYSLTR2 mutation. The patient experienced progression after multiple systemic treatments, including immune checkpoint inhibitors (ipilimumab/nivolumab, pembrolizumab), chemotherapy (dacarbazine, gemcitabine/treosulfan), and local radiotherapy. Lacking human leukocyte antigen-A∗02:01, he was ineligible for tebentafusp. In November 2022, next-generation sequencing identified a CYSLTR2 mutation. Based on molecular tumor board recommendation, off-label treatment with montelukast, a selective CysLT1 receptor antagonist, was initiated in March 2024. At that time, the patient had widespread metastases. Montelukast led to sustained disease stabilization for >12 months, with excellent tolerability and no reported adverse events. The observed effect may be explained by inhibition of CYSLTR1 and modulation of CYSLTR2 signaling in the mutated receptor context.

Conclusion

This is the first published case suggesting a potential role for leukotriene receptor antagonists in CYSLTR2-mutant UM. These findings support further preclinical and clinical investigation of montelukast as a repurposed therapy in this challenging disease entity.

背景：小叶黑色素瘤（UM）是成人最常见的原发性眼内恶性肿瘤，其转移性的全身治疗选择有限。最近对半胱氨酸白三烯受体（CysLTRs）的研究，特别是CYSLTR2突变（患病率为2%-4%），为标准治疗进展的患者提供了新的治疗方法。我们报告一例59岁男性转移性UM携带CYSLTR2突变。患者在接受多种全身治疗后出现进展，包括免疫检查点抑制剂（ipilimumab/nivolumab, pembrolizumab），化疗（达卡巴嗪，吉西他滨/曲硫丹）和局部放疗。由于缺乏人白细胞抗原a * 02:01，他不适合使用tebentafusp。2022年11月，新一代测序发现了CYSLTR2突变。基于分子肿瘤委员会的建议，孟鲁司特（一种选择性CysLT1受体拮抗剂）的适应症外治疗于2024年3月启动。当时，患者有广泛的转移。孟鲁司特导致疾病持续稳定12个月，具有良好的耐受性，无不良事件报告。观察到的效果可能是由于在突变受体背景下抑制CYSLTR1和调节CYSLTR2信号传导。这是首次报道白三烯受体拮抗剂在cysltr2突变型UM中的潜在作用。这些发现支持了孟鲁司特作为这种具有挑战性的疾病实体的重新用途治疗的进一步临床前和临床研究。

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引用次数: 0

Letter re: Multimodal AI-based risk stratification for distant metastasis in nasopharyngeal carcinoma 字母re：鼻咽癌远处转移的多模式人工智能风险分层

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-01 DOI: 10.1016/j.esmoop.2025.105917

X. Liu , B. Zhang

引用次数: 0

Real-world evaluation of interstitial lung disease/pneumonitis in patients treated with trastuzumab deruxtecan for HER2-positive advanced or recurrent gastric cancer: a postmarketing surveillance study in Japan 接受曲妥珠单抗治疗her2阳性晚期或复发性胃癌患者间质性肺病/肺炎的真实世界评估：日本上市后监测研究

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-01 DOI: 10.1016/j.esmoop.2025.105914

H. Kawakami , K. Uchino , W. Hashimoto , K. Muro

Background

Interstitial lung disease (ILD)/pneumonitis is an important identified risk associated with trastuzumab deruxtecan (T-DXd) treatment, but there are few reports of T-DXd-related ILD in a real-world setting.

Materials and methods

This observational, multicenter, all-patient postmarketing surveillance study in patients with gastric cancer treated with T-DXd in a real-world setting in Japan investigated the incidence and characteristics of drug-related ILD and factors of interest associated with its incidence. All patients who initiated T-DXd treatment for human epidermal growth factor receptor 2 (HER2)-positive unresectable advanced or recurrent gastric cancer between September 2020 and December 2021 were enrolled and observed until T-DXd therapy termination or completion of 12 months of treatment. All potential ILD cases occurring during or after T-DXd treatment were reported by the investigators and evaluated. The primary outcome was adjudicated drug-related ILD.

Results

In the safety analysis set (n = 1070), 77.4% were males and the median age was 70 years (range 23-100 years). The median treatment duration of T-DXd was 3.9 months (range 0.7-12.0 months). The incidence of any grade, grade ≥3, and grade 5 adjudicated drug-related ILD was 9.6%, 2.8%, and 1.2%, respectively. The median time from first T-DXd treatment to the first onset of adjudicated drug-related ILD episode was 2.9 months (range 0.3-11.5 months). The most common imaging pattern at the onset of adjudicated drug-related ILD was organizing pneumonia (62.1%), followed by hypersensitivity pneumonitis (20.4%) and diffuse alveolar damage (7.8%). Age (≥75 years), medical history and/or comorbidity of ILD, radiation pneumonitis, and chronic obstructive pulmonary disease (COPD) or emphysema were identified as factors of interest for ILD incidence.

Conclusion

The incidence of ILD with T-DXd in the real-world setting was similar to that observed in clinical trials, indicating no new ILD-related safety signals. Further investigation of the identified factors may offer insights into ILD incidence in high-risk populations.

背景：间质性肺病(ILD)/肺炎是曲妥珠单抗德鲁德替康（T-DXd）治疗相关的重要风险，但在现实环境中很少有T-DXd相关ILD的报道。材料和方法这项观察性、多中心、全患者上市后监测研究在日本的真实世界环境中对接受T-DXd治疗的胃癌患者进行了调查，调查了药物相关ILD的发病率和特征以及与其发病率相关的相关因素。所有在2020年9月至2021年12月期间接受T-DXd治疗的人表皮生长因子受体2 （HER2）阳性不可切除的晚期或复发性胃癌患者被纳入并观察，直到T-DXd治疗终止或完成12个月的治疗。研究者报告并评估了在T-DXd治疗期间或之后发生的所有潜在ILD病例。主要结局是确定与药物相关的ILD。结果安全性分析集中（n = 1070），男性占77.4%，中位年龄为70岁（23 ~ 100岁）。T-DXd的中位治疗时间为3.9个月（0.7-12.0个月）。任何级别、≥3级和5级药物相关ILD的发生率分别为9.6%、2.8%和1.2%。从首次T-DXd治疗到首次确诊药物相关ILD发作的中位时间为2.9个月（范围0.3-11.5个月）。确诊的药物相关性ILD发病时最常见的影像学表现为组织性肺炎（62.1%），其次是过敏性肺炎（20.4%）和弥漫性肺泡损伤（7.8%）。年龄（≥75岁）、病史和/或ILD的合并症、放射性肺炎、慢性阻塞性肺疾病（COPD）或肺气肿被确定为ILD发病率的相关因素。结论在现实环境中，T-DXd合并ILD的发生率与临床试验中观察到的相似，表明没有新的ILD相关安全信号。对已确定因素的进一步调查可能有助于了解高风险人群ILD的发病率。

{"title":"Real-world evaluation of interstitial lung disease/pneumonitis in patients treated with trastuzumab deruxtecan for HER2-positive advanced or recurrent gastric cancer: a postmarketing surveillance study in Japan","authors":"H. Kawakami , K. Uchino , W. Hashimoto , K. Muro","doi":"10.1016/j.esmoop.2025.105914","DOIUrl":"10.1016/j.esmoop.2025.105914","url":null,"abstract":"<div><h3>Background</h3><div>Interstitial lung disease (ILD)/pneumonitis is an important identified risk associated with trastuzumab deruxtecan (T-DXd) treatment, but there are few reports of T-DXd-related ILD in a real-world setting.</div></div><div><h3>Materials and methods</h3><div>This observational, multicenter, all-patient postmarketing surveillance study in patients with gastric cancer treated with T-DXd in a real-world setting in Japan investigated the incidence and characteristics of drug-related ILD and factors of interest associated with its incidence. All patients who initiated T-DXd treatment for human epidermal growth factor receptor 2 (HER2)-positive unresectable advanced or recurrent gastric cancer between September 2020 and December 2021 were enrolled and observed until T-DXd therapy termination or completion of 12 months of treatment. All potential ILD cases occurring during or after T-DXd treatment were reported by the investigators and evaluated. The primary outcome was adjudicated drug-related ILD.</div></div><div><h3>Results</h3><div>In the safety analysis set (<em>n</em> = 1070), 77.4% were males and the median age was 70 years (range 23-100 years). The median treatment duration of T-DXd was 3.9 months (range 0.7-12.0 months). The incidence of any grade, grade ≥3, and grade 5 adjudicated drug-related ILD was 9.6%, 2.8%, and 1.2%, respectively. The median time from first T-DXd treatment to the first onset of adjudicated drug-related ILD episode was 2.9 months (range 0.3-11.5 months). The most common imaging pattern at the onset of adjudicated drug-related ILD was organizing pneumonia (62.1%), followed by hypersensitivity pneumonitis (20.4%) and diffuse alveolar damage (7.8%). Age (≥75 years), medical history and/or comorbidity of ILD, radiation pneumonitis, and chronic obstructive pulmonary disease (COPD) or emphysema were identified as factors of interest for ILD incidence.</div></div><div><h3>Conclusion</h3><div>The incidence of ILD with T-DXd in the real-world setting was similar to that observed in clinical trials, indicating no new ILD-related safety signals. Further investigation of the identified factors may offer insights into ILD incidence in high-risk populations.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 12","pages":"Article 105914"},"PeriodicalIF":8.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Breast surgery and systemic treatment continuation for patients with de novo metastatic breast cancer and locoregional oligoprogression: a cohort study☆ 新发转移性乳腺癌和局部少进展患者的乳房手术和全身持续治疗：一项队列研究

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-01 DOI: 10.1016/j.esmoop.2025.105920

C. Valenza , N. Bianco , M. Milano , D. Trapani , S. Di Bella , A. Sciandivasci , I. Minchella , C. Sangalli , V. Galimberti , M. Intra , P. Veronesi , E. Munzone , M. Colleoni , G. Curigliano

Background

The role of breast surgery in patients with de novo metastatic breast cancer (mBC) and locoregional oligoprogression, either in the breast or locoregional lymph nodes, who previously had a response to systemic treatment is unknown. This approach may allow maintenance of the same systemic treatment and prolong the time to treatment failure.

Patients and methods

We conducted a cohort study including consecutive patients with de novo mBC, after a locoregional oligoprogression, who underwent breast surgery and continued the same systemic treatment at the European Institute of Oncology. The primary endpoint was postsurgery progression-free survival (pS-PFS).

Results

Fifty-nine patients were included: 28 (47%) had hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease, 30 (51%) HER2-positive, and 1 (2%) triple-negative. The median pre-oligoprogression PFS was 15.2 months [95% confidence interval (CI) 12.0-18.4 months]. After a median follow-up of 54.1 months (95% CI 44.2-64.0 months), the median pS-PFSs was 15.0 months (95% CI 5.1-24.9 months), and was significantly longer in patients with HER2-positive disease or with a pre-oligoprogression PFS ≥12 months.

Conclusions

This study suggests that selected patients with de novo mBC and locoregional oligoprogression can benefit from breast surgery while maintaining the same systemic treatment, particularly in the setting of HER2-positive disease or a pre-oligoprogression PFS >1 year.

背景：乳房手术在先前对全身治疗有反应的新发转移性乳腺癌（mBC）和局部区域少进展患者中的作用尚不清楚，无论是在乳房还是局部区域淋巴结。这种方法可以维持相同的全身治疗，并延长治疗失败的时间。患者和方法我们进行了一项队列研究，包括在局部肿瘤少进展后复发的连续患者，这些患者在欧洲肿瘤研究所接受了乳房手术并继续相同的全身治疗。主要终点是术后无进展生存期（pS-PFS）。结果纳入59例患者：激素受体（HR）阳性/人表皮生长因子受体2 （HER2）阴性28例（47%），HER2阳性30例（51%），三阴性1例（2%）。少进展前的中位PFS为15.2个月[95%可信区间（CI） 12.0-18.4个月]。在中位随访54.1个月（95% CI 44.2-64.0个月）后，中位ps -PFS为15.0个月（95% CI 5.1-24.9个月），并且在her2阳性疾病或PFS≥12个月的前少进展患者中显着延长。结论：本研究表明，在维持相同的全身治疗的同时，选定的新发乳腺癌和局部少进展患者可以从乳房手术中获益，特别是在her2阳性疾病或少进展前PFS 1年的情况下。

{"title":"Breast surgery and systemic treatment continuation for patients with de novo metastatic breast cancer and locoregional oligoprogression: a cohort study☆","authors":"C. Valenza , N. Bianco , M. Milano , D. Trapani , S. Di Bella , A. Sciandivasci , I. Minchella , C. Sangalli , V. Galimberti , M. Intra , P. Veronesi , E. Munzone , M. Colleoni , G. Curigliano","doi":"10.1016/j.esmoop.2025.105920","DOIUrl":"10.1016/j.esmoop.2025.105920","url":null,"abstract":"<div><h3>Background</h3><div>The role of breast surgery in patients with <em>de novo</em> metastatic breast cancer (mBC) and locoregional oligoprogression, either in the breast or locoregional lymph nodes, who previously had a response to systemic treatment is unknown. This approach may allow maintenance of the same systemic treatment and prolong the time to treatment failure.</div></div><div><h3>Patients and methods</h3><div>We conducted a cohort study including consecutive patients with <em>de novo</em> mBC, after a locoregional oligoprogression, who underwent breast surgery and continued the same systemic treatment at the European Institute of Oncology. The primary endpoint was postsurgery progression-free survival (pS-PFS).</div></div><div><h3>Results</h3><div>Fifty-nine patients were included: 28 (47%) had hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative disease, 30 (51%) HER2-positive, and 1 (2%) triple-negative. The median pre-oligoprogression PFS was 15.2 months [95% confidence interval (CI) 12.0-18.4 months]. After a median follow-up of 54.1 months (95% CI 44.2-64.0 months), the median pS-PFSs was 15.0 months (95% CI 5.1-24.9 months), and was significantly longer in patients with HER2-positive disease or with a pre-oligoprogression PFS ≥12 months.</div></div><div><h3>Conclusions</h3><div>This study suggests that selected patients with <em>de novo</em> mBC and locoregional oligoprogression can benefit from breast surgery while maintaining the same systemic treatment, particularly in the setting of HER2-positive disease or a pre-oligoprogression PFS >1 year.</div></div>","PeriodicalId":11877,"journal":{"name":"ESMO Open","volume":"10 12","pages":"Article 105920"},"PeriodicalIF":8.3,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145733451","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Radiomic signatures to estimate survival in patients with advanced hepatocellular carcinoma treated with sorafenib: Cancer and Leukemia Group B 80802 (Alliance) 放射组学特征用于评估接受索拉非尼治疗的晚期肝细胞癌患者的生存：癌症和白血病B组80802（联盟）

IF 8.3 2区医学 Q1 ONCOLOGY

ESMO Open

Pub Date : 2025-12-01 DOI: 10.1016/j.esmoop.2025.105848

L. Dercle , S. Geyer , A.B. Nixon , F. Innocenti , Q. Shi , S.B. Jacobson , L. Luk , A. Liu , H. Yang , Y. Wen , B. Zhao , T. Eche , F.-Z. Mokrane , M. Yang , J. Meyerhardt , E.M. O’Reilly , A.P. Venook , A.B. El-Khoueiry , L.H. Schwartz , G.K. Abou-Alfa

Background

Current methods to evaluate therapeutic response in patients with hepatocellular carcinoma (HCC) rely on tumor size and density, which do not always correlate well with survival. We used pretreatment clinical and radiomics variables to predict overall survival (OS) in the randomized phase III CALGB 80802 (Alliance) trial, investigating the efficacy of sorafenib + doxorubicin versus sorafenib alone.

Materials and methods

Using machine learning, we analyzed baseline and first follow-up computed tomography (CT) images and associated clinical metadata from patients imaged in February 2010-May 2015, up to November 2015 with follow-up. Adult patients with HCC (n = 129) were randomly assigned to training (n = 92) and validation (n = 37) sets. We assessed the performance of a signature combining CT imaging features and clinical variables using hazard ratios to estimate OS after week 10 (first follow-up).

Results

Most patients were male (86.6%) and had bilirubin <2 mg/dl (98.4%), albumin >3.5 g/dl (69.0%), and moderately differentiated HCC (34.1%). Median (interquartile range) age: 58 years (63-71 years), alpha-fetoprotein (AFP): 2.5 ng/ml (26-282 ng/ml), international normalized ratio: 1 (1.1-1.2), Child–Pugh score: 5 (5-6). The highest-performing parsimonious training set signature combined clinical and radiomics features at baseline and week 10. In the validation set, the hazard ratio was 2398 (95% confidence interval 121-47 371) (P < 0.001). The signature’s variables, ranked by importance, included baseline clinical features [albumin (1), AFP (2), Child–Pugh (4)], baseline radiomics features [component 17 (3), component 1 (5), component 9 (7), tumor volume (8)], and week 10 radiomics features [delta tumor volume (6)].

Conclusion

OS can be accurately predicted in patients with HCC receiving sorafenib by combining certain radiomics features with clinical metadata, centered primarily on baseline characteristics.

背景：目前评估肝细胞癌（HCC）患者治疗反应的方法依赖于肿瘤大小和密度，这并不总是与生存率有很好的相关性。在随机III期CALGB 80802 （Alliance）试验中，我们使用预处理临床和放射组学变量来预测总生存期（OS），研究索拉非尼+阿霉素与索拉非尼单用的疗效。材料和方法：使用机器学习，我们分析了基线和首次随访的计算机断层扫描（CT）图像以及相关的临床元数据，这些数据来自2010年2月至2015年5月随访的患者。成年HCC患者（n = 129）被随机分配到训练组（n = 92）和验证组（n = 37）。我们评估了结合CT成像特征和临床变量的特征的表现，使用风险比来估计第10周（第一次随访）后的OS。结果：多数患者为男性（86.6%），胆红素3.5 g/dl(69.0%)，中分化型HCC（34.1%）。年龄中位数（四分位数间距）：58岁（63-71岁），甲胎蛋白（AFP）： 2.5 ng/ml (26-282 ng/ml)，国际标准化比值：1 (1.1-1.2)，Child-Pugh评分：5（5-6）。在基线和第10周，表现最好的节俭训练集签名结合了临床和放射组学特征。在验证集中，风险比为2398(95%置信区间121 ~ 47371)（P < 0.001）。签名变量按重要性排序，包括基线临床特征[白蛋白(1)、AFP(2)、Child-Pugh(4)]、基线放射组学特征[组分17(3)、组分1(5)、组分9(7)、肿瘤体积(8)]和第10周放射组学特征[δ肿瘤体积(6)]。结论：将放射组学特征与主要以基线特征为中心的临床元数据相结合，可以准确预测接受索拉非尼治疗的HCC患者的OS。

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引用次数: 0