Annals of Oncology最新文献

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43eP Risk of axillary nodal metastasis in HER2-positive and triple-negative breast cancer: Exploration for omission of sentinel lymph node biopsy her2阳性和三阴性乳腺癌腋窝淋巴结转移的43eP风险：前哨淋巴结活检遗漏的探讨

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.877

K-T. Hwang

引用次数: 0

38P The impact of aerobic and resistance exercise intervention for 12 weeks on interleukin-6, interleukin-10, cancer-related fatigue, and metabolic equivalent of task in patients with hormone receptor-positive breast cancer stage I-III at RSUP Dr. Sardjito, Yogyakarta 在RSUP，有氧和阻力运动干预12周对激素受体阳性乳腺癌I-III期患者白细胞介素-6、白细胞介素-10、癌症相关疲劳和代谢当量任务的影响

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.872

M.D.L.Q. Mozhaf , Y. Kartika Astari , S.H. Hutajulu , D.K. Paramita , A.B. Hartopo , M.S. Hardianti , K. Widayati , J. Kurnianda , I. Purwanto

引用次数: 0

Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008☆ 辅助放疗与放化疗在中危早期宫颈癌根治性子宫切除和淋巴结切除术后的随机III期试验：来自NRG Oncology/GOG-263/KGOG1008的结果

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.09.003

S.Y. Ryu , W. Deng , K. Albuquerque , W.-J. Koh , J. Mayadev , A. Heugel , B.-J. Kim , D.-Y. Kim , C.-H. Cho , J.-W. Kim , J.H. No , R.S. Mannel , K. Miller , D. Fabian , D.M. Chase , K.M. Gil , W. Small Jr. , W. Rodgers , C.A. Leath III , B.J. Monk

Background

To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.

Methods

Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m² were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).

Results

Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB₁ and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.

Conclusion

Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.

背景：确定与放射治疗（RT）相比，每周一次的顺铂辅助放化疗（CRT）是否能改善病理证实的中度危险早期宫颈癌根治性子宫切除术和淋巴结切除术后的无复发生存率（RFS）。方法：术后I-IIA期宫颈癌患者，病理上注意到的中间危险因素包括毛细血管淋巴间隙（CLS）受损伤、间质浸润和肿瘤大小，随机按1:1的比例分配，接受辅助CRT或RT （NCT01101451）。患者接受了适形放疗或调强放疗。在CRT组中，每6周给予顺铂40mg /m2， RFS是随机和符合条件的患者的主要终点。次要终点包括总生存期（OS）、生活质量（QOL）和不良事件（AE）。结果：340例随机患者中，316例符合条件，大多数为FIGO (2009) IB1期和鳞状细胞癌组织学。316例患者中有292例（92.4%）接受了28组放疗，中位剂量为50.4 Gy，中位治疗持续时间为39天。CRT组3年RFS为88.5%，RT组为85.4%。RFS[风险比（HR） 0.698, 95% CI 0.408-1.192, p=0.09]和OS [HR 0.586, 95% CI: 0.286-1.199, p= 0.07]均优于单纯RT。CRT组和RT组3级和4级ae发生率分别为43%和15% （p < 0.01）。与RT组相比，CRT组的生活质量在开始治疗后出现短暂下降，并在36周后恢复到治疗前水平。结论：虽然RFS和OS有利于CRT，但在RT期间添加顺铂并没有统计学意义上改善具有中间病理危险因素的宫颈癌根治性子宫切除术和淋巴结切除术后的RFS和OS。CRT增加了3级和4级ae，但生活质量短暂下降。

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引用次数: 0

Mechanism-enhanced population science: strengthening population studies through functional insights 机制强化的人口科学：通过机制洞察加强人口研究。

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.08.006

T. Pandya , Y. Cao , K. Smith-Byrne , C. Swanton

引用次数: 0

A temporal paradox in the proposed risk-adjusted surveillance algorithm for metastatic colorectal cancer 转移性结直肠癌风险调整监测算法的时间悖论

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.09.013

H. Tian , R. Zhang , D. Zhang

引用次数: 0

177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase III trial☆ 177u - dotatate与大剂量长效奥曲肽治疗晚期1-2级分化良好的胃肠胰腺神经内分泌肿瘤（XT-XTR008-3-01）：一项开放标签、随机化的III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.2025.08.3758

J. Xu , J. Chen , S. Song , L. Song , R. Wang , J. Hao , X. Du , D. Cao , Y. Gao , X. Lan , A. Yang , W. Miao , H. Xu , Y. Chen , L. Li , H. Shi , X. Yuan , F. Ye , J. Wang , N. Xu , P. Wang

Background

The phase III trial, XT-XTR008-3-01, was a randomised controlled trial (RCT) that evaluated the efficacy and safety of XTR008, a novel no-carrier-added lutetium-177 (¹⁷⁷Lu)–Dotatate, for the first time in a later-line therapy setting for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of all origins.

Patients and methods

Patients with grade 1-2, unresectable, locally advanced or metastatic GEP-NETs who had progressed within the last 12 months before randomisation were randomly allocated 1 : 1 to XTR008 (four cycles every 8 weeks) or octreotide 60 mg (every 4 weeks), stratified by primary tumour site (pancreatic versus non-pancreatic), pathological tumour grade (1 versus 2), and duration of prior somatostatin analogues treatment (≤6 versus >6 months). The primary endpoint was progression-free survival (PFS) by a blinded independent review committee. The key secondary endpoints included overall response rate (ORR); overall survival (OS); quality of life, evaluated using the European Organisation for Research and Treatment of Cancer quality of life questionnaires QLQ-C30 and QLQ-GI.NET21; safety; pharmacokinetics; and dosimetry.

Results

Patients (N = 196) were randomized to XTR008 (n = 99) or control (n = 97). Primary tumour sites: pancreas (59%), rectum (28%), midgut (7%). Median follow-up: 11.1 months [interquartile range (IQR) 8.5-11.5, XTR008] versus 10.2 months (IQR 8.5-11.9 months, control). With 78 PFS events, median PFS was not reached [95% confidence interval (CI) 16.13 months to not estimated] versus 5.8 months (95% CI 5.65-8.41 months); stratified hazard ratio (HR) 0.06 (P < 0.0001). ORR: 43.4% (95% CI 33.50% to 53.77%) versus 1.0% (95% CI 0.03% to 5.61%). OS data were immature for both groups, with XTR008 showing a longer survival trend (HR 0.24, P = 0.0550). Treatment-related adverse events: 98% versus 89%; serious adverse events: 16.3% versus 12.5% (6.1% versus 3.1% drug-related). Myelodysplastic syndrome and grade ≥3 renal toxicity occurred in 1% of patients in the XTR008 group; no acute myeloid leukaemia or drug-related deaths occurred.

Conclusions

XTR008 monotherapy showed superior efficacy versus high-dose long-acting repeatable (LAR) octreotide monotherapy in advanced GEP-NET tumours of all origins in a later-line treatment setting, with manageable safety, supporting its use as a new treatment option.

背景：III期试验XT-XTR008-3-01是一项随机对照试验（RCT），评估了XTR008的有效性和安全性，XTR008是一种新型无载体添加的镥-177 (177Lu)-Dotatate，首次用于各种来源的胃肠胰神经内分泌肿瘤（GEP-NETs）的后期治疗设置。患者和方法：随机化前12个月内进展的1-2级，不可切除，局部晚期或转移性GEP-NETs患者被随机分配为1:1至XTR008（每8周4个周期）或奥曲肽60mg（每4周），根据原发肿瘤部位（胰腺与非胰腺），病理肿瘤分级（1与2）和既往生长抑素类似物治疗持续时间（≤6个月与bbb6个月）分层。主要终点是一个盲法独立审查委员会的无进展生存期（PFS）。主要次要终点包括总缓解率（ORR）；总生存期（OS）；生活质量，使用欧洲癌症研究和治疗组织生活质量问卷QLQ-C30和QLQ-GI.NET21进行评估；安全;药物动力学;和剂量测定法。结果：患者（N = 196）随机分为XTR008组（N = 99）和对照组（N = 97）。原发肿瘤部位：胰腺（59%），直肠（28%），中肠（7%）。中位随访：11.1个月[四分位数间距（IQR） 8.5-11.5, XTR008] vs . 10.2个月（IQR 8.5-11.9个月，对照组）。78例PFS事件，中位PFS未达到[95%置信区间（CI） 16.13个月至未估计]，而5.8个月（95% CI 5.65-8.41个月）；分层风险比（HR） 0.06 （P < 0.0001）。ORR: 43.4% (95% CI 33.50% ~ 53.77%) vs . 1.0% （95% CI 0.03% ~ 5.61%）。两组的OS数据均不成熟，XTR008表现出更长的生存趋势（HR 0.24, P = 0.0550）。治疗相关不良事件：98%对89%；严重不良事件：16.3%对12.5%（6.1%对3.1%与药物相关）。XTR008组中1%的患者出现骨髓增生异常综合征和≥3级肾毒性；未发生急性髓性白血病或药物相关死亡。结论：在所有来源的晚期GEP-NET肿瘤的后期治疗中，XTR008单药治疗与高剂量长效可重复（LAR）奥曲肽单药治疗相比，疗效更佳，安全性可控，支持其作为一种新的治疗选择。

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引用次数: 0

Corrigendum to “Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3” 《Abemaciclib联合非甾体芳香酶抑制剂作为HR+、HER2-晚期乳腺癌的初始治疗：MONARCH 3的最终总生存期结果》的勘误：[Ann Oncol 2024；35: 718 - 727)。

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.07.002

M.P. Goetz , M. Toi , J. Huober , J. Sohn , O. Trédan , I.H. Park , M. Campone , S.-C. Chen , L.M. Manso , S. Paluch-Shimon , O.C. Freedman , J. O’Shaughnessy , X. Pivot , S.M. Tolaney , S.A. Hurvitz , A. Llombart-Cussac , V. André , A. Saha , G. van Hal , A. Shahir , S.R.D. Johnston

引用次数: 0

LBA1 Analysis of Asian patients (pts) with HR+/HER2− early breast cancer (EBC) treated with ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI): 5-year outcomes from NATALEE 亚洲HR+/HER2−早期乳腺癌（EBC）患者（pts）接受核糖环尼(RIB) +非甾体芳香化酶抑制剂（NSAI）治疗的5年结果分析

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.834

Y-S. Lu , D.L. Stroyakovskiy , J. Sohn , Y.H. Park , C-S. Huang , S-A. Im , K.H. Jung , A. Chan , J. Zhang , J. Lee , J.H. Kim , C-F. Chung , D. Slamon , V. Sakalosh , M. Gao , K. Amin , N. Harun , B. Xu

引用次数: 0

3MO Axillary management strategies in breast cancer patients with ypN0 after neoadjuvant therapy 乳腺癌ypN0患者新辅助治疗后腋窝的3MO管理策略

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.837

Q. Shang , Y. Zhuang , S. Luo , X. Wang

引用次数: 0

87MO Capivasertib (C) + paclitaxel (P) as first-line treatment of metastatic triple-negative breast cancer: The CAPItello-290 phase III trial extended China cohort Capivasertib (C) +紫杉醇(P)作为转移性三阴性乳腺癌的一线治疗：CAPItello-290 III期试验延长了中国队列

IF 65.4 1区医学 Q1 ONCOLOGY

Annals of Oncology

Pub Date : 2025-12-01 DOI: 10.1016/j.annonc.2025.10.922

W. Xia , S. Wang , J. Yang , T. Luo , H. Wang , X. Wang , Y. Wang , Y. Yin , J. Ou , H. Wang , W. Li , O. Wang , S. Wang , J. Luo , H. Xiong , W. Zhao , L. Jiang , K. Laskowska-Macios , P. Schmid , B. Xu

引用次数: 0

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