Annals of Oncology最新文献

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106P Predilection of metastatic sites in ESR1-mutated breast cancer: A systematic review and meta-analysis esr1突变乳腺癌转移部位的p偏好：一项系统回顾和荟萃分析

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.1240

J.B. Tenggara , C. Tanadi , A.A. Suryohusodo , M. Trisya , R. Adiwinata , M.P.T. Sari

引用次数: 0

12P TIME-TNBC: A landmark-based dynamic prediction model for patients with triple-negative breast cancer 12P TIME-TNBC：基于里程碑的三阴性乳腺癌患者动态预测模型

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.846

Q. Shang , K. Xu , S. Luo , X. Wang

引用次数: 0

47eP Clinicopathologic characteristics of HER2-low localized breast cancer in Tunisia: A comparative study of HER2 1+ and HER2 2+/FISH-negative subgroups 突尼斯HER2低局限性乳腺癌的临床病理特征：HER2 1+和HER2 2+/ fish阴性亚组的比较研究

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.881

W. Ben Kridis , C. Belfekih Hassen , I. Hammouda , N. Toumi , K. Chaabene , T. Boudawara , J. Daoud , A. Khanfir

引用次数: 0

54eP Oncotype DX test for early-stage HR-positive HER2-negative breast cancer in a low-middle income country: Lack of accessibility and the urgent need for treatment-group classification 中低收入国家早期hr阳性her2阴性乳腺癌的54eP Oncotype DX检测：缺乏可及性和迫切需要治疗组分类

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.888

T.T. Le , T.H. Nguyen

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57eP Reducing diagnostic delays for neoadjuvant-eligible breast cancer: A fast-track pathology model from a Chinese tertiary center 减少符合新佐剂条件的乳腺癌的诊断延迟：来自中国三级中心的快速病理模型

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.891

H. Chen , J. Li , Y. Shen , C. Pan , Y. Chen

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93P Efficacy and safety of mecapegfilgrastim for prophylaxis of dalpiciclib-induced neutropenia in patients with advanced HR+/HER2- breast cancer: A multicenter, open-label, randomized controlled phase II trial meapeg非格昔汀预防晚期HR+/HER2-乳腺癌患者达匹昔立诱导的中性粒细胞减少症的疗效和安全性：一项多中心、开放标签、随机对照II期试验

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.928

J. Liu , Y. Wang , L. Ding , J. Zhao , S. Ma , H. Xie , Y. Bai , L.Z. Hua , M. Lu , L. Zhang , G. Hu , J. Ye , Z. Zhai , G. Liu , H. Yu , L. Jin , Y. Wang , S. Chen , Z. Feng , X. Liu

引用次数: 0

65MO Neoadjuvant HLX11 versus European Union (EU)-sourced pertuzumab in human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-negative early or locally advanced, breast cancer (BC): A double-blind, randomised phase III equivalence study 65MO新佐剂HLX11与欧盟（EU）来源的帕妥珠单抗治疗人表皮生长因子受体2 （HER2）阳性，激素受体（HR）阴性的早期或局部晚期乳腺癌（BC）：一项双盲，随机III期等效研究

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.900

Q. Liu , Y. Yang , J. Zhang , J. Zhu , D. Song , T. Huang , X. Ma , Q. Mo , X. Du , C. Xie , Y. Ren , F. Li , B. Zhang , X. Wang , Z. Niu , Y. Fan , H. Yu , J. Li , Q. Wang , E. Song

引用次数: 0

Randomized, double-blind, phase III LEAP-003 study of first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab for unresectable or metastatic melanoma☆ 随机、双盲、III期leap003研究：一线Lenvatinib + Pembrolizumab与安慰剂+ Pembrolizumab治疗不可切除或转移性黑色素瘤

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.08.008

A. Arance , M.-A. Berciano-Guerrero , J. Guo , M.S. Carlino , P.A. Ascierto , M. Burotto , L. Mortier , P. Queirolo , V. Chiarion-Sileni , J. Schachter , X. Zhang , J. Martin-Liberal , M. Del Vecchio , C.E. Okpara , C. Dutcus , J. Zhang , S.J. Diede , T. Neff , G.V. Long

Background

Lenvatinib plus pembrolizumab demonstrated antitumor activity in advanced melanoma after prior anti-programmed cell death protein or ligand 1 [PD-(L)1] therapy in LEAP-004. Here, we report results from LEAP-003 (NCT03820986) which evaluated first-line lenvatinib plus pembrolizumab versus placebo plus pembrolizumab in unresectable advanced melanoma.

Participants and methods

Participants with unresectable stage III or IV melanoma, previously untreated with PD-(L)1 inhibitors were randomly assigned 1 : 1 to pembrolizumab 200 mg intravenously every 3 weeks plus either lenvatinib 20 mg or placebo orally once daily. Dual primary endpoints were progression-free survival (PFS) per RECIST v1.1 by blinded independent central review and overall survival (OS). PFS was formally tested at the first interim analysis; OS at the final analysis. An external data monitoring committee regularly reviewed safety and efficacy. Three interim analyses and a final analysis were planned.

Results

Overall, 674 participants were assigned to lenvatinib plus pembrolizumab (n = 334) or placebo plus pembrolizumab (n = 340). Median PFS at first interim analysis was 8.4 months for lenvatinib plus pembrolizumab versus 4.0 months for placebo plus pembrolizumab [hazard ratio (HR) 0.72, 95% confidence interval (CI) 0.59-0.88, P = 0.0008]. This benefit was not maintained at final analysis (HR 0.83, 95% CI 0.69-1.00). Median OS at final analysis was 25.8 months for lenvatinib plus pembrolizumab versus 39.5 months for placebo plus pembrolizumab (HR 1.20, 95% CI 0.97-1.48, P = 0.9521). Grade 3-5 treatment-related adverse events occurred in 58.7% of participants receiving lenvatinib plus pembrolizumab versus 29.0% receiving placebo plus pembrolizumab.

Conclusions

Lenvatinib plus pembrolizumab did not provide additional benefit versus placebo plus pembrolizumab in participants with unresectable advanced melanoma. Thus, the trial was terminated early, and the third interim analysis became the final analysis. Immunotherapy remains the standard of care for advanced melanoma.

背景：Lenvatinib + pembrolizumab在LEAP-004中先前抗pd -(L)1治疗后显示出对晚期黑色素瘤的抗肿瘤活性。在此，我们报告了jump -003 （NCT03820986）的结果，该结果评估了一线lenvatinib + pembrolizumab与安慰剂+ pembrolizumab在不可切除的晚期黑色素瘤中的疗效。参与者和方法：不可切除的III期或IV期黑色素瘤患者，既往未接受PD-1或PD-L1检查点抑制剂治疗，随机按1:1分配，每3周静脉注射派姆单抗200mg，加lenvatinib 20mg或安慰剂，每日口服一次。双主要终点是盲法独立中心评价的RECIST v1.1无进展生存期（PFS）和总生存期（OS）。在第一次中期分析中对PFS进行了正式测试；OS在最后的分析。一个外部数据监测委员会定期审查安全性和有效性。计划进行三次中期分析和最后分析。结果：总体而言，674名参与者被分配到lenvatinib + pembrolizumab （n = 334）或安慰剂+ pembrolizumab （n = 340）。首次中期分析时，lenvatinib + pembrolizumab的中位PFS为8.4个月，而安慰剂+ pembrolizumab的中位PFS为4.0个月（HR, 0.72; 95% CI, 0.59-0.88; P = 0.0008）。在最终分析中，这一益处没有得到维持（HR, 0.83; 95% CI, 0.69-1.00）。最终分析时，lenvatinib + pembrolizumab的中位OS为25.8个月，而安慰剂+ pembrolizumab的中位OS为39.5个月（HR, 1.20; 95% CI, 0.97-1.48; P = 0.9521）。接受lenvatinib + pembrolizumab治疗的患者发生3-5级治疗相关不良事件的比例为58.7%，而接受安慰剂+ pembrolizumab治疗的患者为29.0%。结论：Lenvatinib + pembrolizumab与安慰剂+ pembrolizumab相比，在不可切除的晚期黑色素瘤患者中没有提供额外的益处。因此，试验提前终止，第三次中期分析成为最终分析。免疫疗法仍然是晚期黑色素瘤的标准治疗方法。

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引用次数: 0

Effect of 5 years of CT-scan and CEA follow-up on survival endpoints in patients with colorectal cancer: the PRODIGE-13 FFCD phase III trial 5年ct扫描和CEA随访对结直肠癌患者生存终点的影响。

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.09.004

C. Lepage , J.-M. Phelip , L. Cany , E. Barbier , S. Manfredi , P. Deguiral , M. Laly , M. Baconnier , M. Jary , J.-P. Latrive , E. Terrebonne , A. Lièvre , M. Jafari , M. Ben Abdelghani , J.-F. Ain , G. Breysacher , I. Boillot-Benedetto , A. Pelaquier , P. Prost , J. Ezenfis , Didier Rieder

Background

Intensive follow-up of patients after curative surgery for colorectal cancer is recommended by various scientific societies. However, these recommendations are based mainly on expert opinions, while the results of the few clinical trials are controversial. Moreover, no survival benefit has been demonstrated to date.

Patients and methods

PRODIGE-13 is a cooperative prospective multicentre controlled phase III trial evaluating by factorial plan the impact of (i) intensive radiological monitoring [alternating abdominal ultrasound (US)/computed tomography (CT) scan/3 months] versus standard monitoring (US/3 months and thoracic radiography/6 months) and (ii) carcinoembryonic antigen (CEA) assessment versus no assessment, in the follow-up of resected stage II or III colorectal cancer with no evidence of residual disease on baseline postsurgical investigation in France and Belgium. The primary endpoint was 5-year overall survival (OS).

Results

Altogether, 2009 patients were randomly assigned. Among them, 16% had rectal cancer, and 44% left colon cancer; 75.9% were <75 years old. With a median follow-up of 7.8 years, cancer recurred in 22.3% of patients (local 10.5%, metastatic 72.9%, both 16.6%). The 5-year OS rates were 82.1% [95% confidence interval (CI) 78.5% to 85.2%] in group A (intensive imaging + CEA) versus 84.1% (95% CI 80.5% to 87.0%) in group B (intensive imaging alone), versus 83.6% (95% CI 80.1% to 86.6%) in group C (standard imaging + CEA) versus 79.5% (95% CI 75.7% to 82.8%) in group D (standard imaging alone) [P (log-rank) = 0.170]. Median OS was not reached in the four groups. Five-year relapse-free survival (RFS) was 73.8% in the CT-scan surveillance group versus 69.3% in the no-CT-scan group [hazard ratio (HR) 0.89, 95% CI 0.76-1.03, P = 0.108]. Five-year RFS was 71.3% in the CEA surveillance group versus 71.8% in the no-CEA group (HR 1.00, 95% CI 0.86-1.16, P = 0.959).

Conclusions

Among patients with stage II or III colorectal cancer, after curative surgery, the implementation of CEA and/or CT-scan surveillance did not provide any benefit in 5-year OS for the overall population of the study.

背景：大肠癌根治性手术后患者的强化随访是各科学学会推荐的。然而，这些建议主要基于专家意见，而少数临床试验的结果是有争议的。此外，到目前为止，还没有证据表明对生存有好处。患者及方法：PRODIGE-13是一项合作的前瞻性多中心对照III期试验，通过因子计划评估1)强化放射监测（交替腹部超声（US)/ ct扫描/3m）与标准监测（US/3m和胸部x线摄影/6m）和ii）癌胚抗原（CEA）评估与不评估的影响。在法国和比利时对切除的II期或III期结直肠癌进行随访，在基线术后调查中没有残留疾病的证据。主要终点是5年总生存期（OS）。结果：共纳入2009例患者。其中16%的人患有直肠癌，44%的人患有结肠癌；75.9%年龄在75岁以下。中位随访7.8年，22.3%的患者癌症复发（局部10.5%，转移性72.9%，两者均为16.6%）。A组（强化影像+ CEA） 5年OS为82.1% (95%CI [78.5;85.2])， B组（单独强化影像）84.1% (95%CI [80.5;87.0])， C组（标准影像+ CEA） 5年OS为83.6% (95%CI [80.1;86.6])， D组（单独标准影像）5年OS为79.5% (95%CI [75.7;82.8]) （p(logrank)= 0.170）。四组患者的中位OS均未达到，ct扫描监测组5年无复发生存率（RFS）为73.8%，未扫描组为69.3% （HR 0.89 [0.76;1.03]; p=0.108）。CEA监测组5年RFS为71.3%，无CEA监测组为71.8% （HR 1.00[0.86;1.16]; 0.959）。结论：在II期或III期结直肠癌患者中，在根治性手术后，CEA和/或ct扫描监测的实施并没有为该研究的总体人群的5年总生存率提供任何益处。

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引用次数: 0

An unforeseen, existential threat to oncological research in Europe 欧洲肿瘤研究面临的不可预见的生存威胁。

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.09.009

J.-Y. Blay , A. Cervantes , F. André , S. Peters , N. Harbeck , E. Azambuja , G. Curigliano

引用次数: 0

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