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Corrigendum to "Impact of EDP-M on survival of patients with metastatic adrenocortical carcinoma: A population-based study" [Eur J Cancer 196 (2024) 113424]. EDP-M 对转移性肾上腺皮质癌患者生存期的影响:一项基于人群的研究》[Eur J Cancer 196 (2024) 113424]的更正。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-15 DOI: 10.1016/j.ejca.2024.115123
Pien Debets, Koen M A Dreijerink, Anton F Engelsman, Max Dahele, Harm R Haak, Rebecca V Steenaard, Ellen Kapiteijn, Eleonora Corssmit, C Willemien Menke-van der Houven van Oordt
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引用次数: 0
Impact of the timing of immunotherapy administration on overall survival for resectable non-small cell lung cancer (iACORN study): A systematic review and meta-analysis of randomised trials 免疫疗法给药时机对可切除非小细胞肺癌总生存期的影响(iACORN 研究):随机试验的系统回顾和荟萃分析。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.ejca.2024.115118
Akshay J. Patel , Hanan Hemead , Jacie Law , Anuj Wali , Paulo De Sousa , Eric Lim

Background

We sought to investigate the relative impact of the timing of the administration of immunotherapy on survival in patients with resectable lung cancer.

Methods

We conducted a systematic review and meta-analysis of randomised controlled trials in this setting. We searched MEDLINE, EMBASE, LILACS and Cochrane Library databases from 1st January 1980 onwards. We excluded case reports; non-randomised studies; studies without an immunotherapy arm and if there was incomplete reporting on outcome data including conference abstracts. A standardised, pre-piloted form was used to extract data from the included studies for the assessment of study quality and for evidence synthesis. The primary outcome measure was overall survival which was assessed using random-effects meta-analyses (DerSimonian and Laird). The study was registered with PROSPERO (CRD42023407825).

Findings

We screened 865 studies and assessed 58 full text articles after removing non-human, non-surgical studies. These studies collectively enrolled 4982 participants and 4425 were included in the respective analyses. Hazard ratios (HRs) for death by timing of administration of immunotherapy, i.e., Neoadjuvant (pre-operative), peri-operative and post-operative were 0.57 (95 % CI 0.302–1.08), 0.67 (95 % CI 0.39–1.13) and 0.94 (95 % CI 0.29–3.06) respectively. The timing of administration accounted for 100 % of the difference in true effect size (test of moderators (QM p = 0.127), residual I2 0 %, p = 0.561). OR for adverse events was higher in the neoadjuvant setting compared to the peri-operative setting; 1.49 (0.64–3.47) and 1.34 (1.08–1.66) respectively. Bias assessment found the majority of studies to be low risk with respect to random sequencing, incomplete outcomes, and selective reporting.

Interpretation

In resectable non-small cell lung cancer, administration of adjuvant chemo-immunotherapy regimens in clinical trials did not lead to statistically significant survival benefits. Overall survival outcomes of neoadjuvant and peri-operative chemo-immunotherapy were comparable, but given the shorter duration and lower costs, neoadjuvant chemo-immunotherapy can be considered the current multimodality combination of choice.
背景我们试图研究免疫疗法的施用时机对可切除肺癌患者生存期的相对影响:我们对这种情况下的随机对照试验进行了系统回顾和荟萃分析。我们检索了自 1980 年 1 月 1 日起的 MEDLINE、EMBASE、LILACS 和 Cochrane Library 数据库。我们排除了病例报告、非随机研究、没有免疫疗法部分的研究,以及包括会议摘要在内的结果数据报告不完整的研究。我们采用了预先试行的标准化表格,从纳入的研究中提取数据,用于评估研究质量和证据综合。主要结果指标是总生存率,采用随机效应荟萃分析法(DerSimonian 和 Laird)进行评估。该研究已在 PROSPERO 注册(CRD42023407825):我们筛选了 865 项研究,并在删除非人类、非手术研究后评估了 58 篇全文文章。这些研究共招募了 4982 名参与者,其中 4425 人被纳入相关分析。根据免疫疗法的施用时机,即新辅助治疗(术前)、围手术期和术后,死亡的危险比(HRs)分别为 0.57(95 % CI 0.302-1.08)、0.67(95 % CI 0.39-1.13)和 0.94(95 % CI 0.29-3.06)。给药时间占真实效应大小差异的 100%(调节因子检验 (QM p = 0.127),残差 I2 0 %,p = 0.561)。与围手术期相比,新辅助治疗的不良反应发生率更高,分别为1.49(0.64-3.47)和1.34(1.08-1.66)。偏倚评估发现,大多数研究在随机排序、结果不完整和选择性报告方面风险较低:对于可切除的非小细胞肺癌,在临床试验中采用辅助化疗-免疫治疗方案并不能带来统计学意义上的生存获益。新辅助化疗免疫疗法和围手术期化疗免疫疗法的总生存率不相上下,但鉴于新辅助化疗免疫疗法疗程短、费用低,因此可将其视为目前多模式联合疗法的首选。
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引用次数: 0
Radiomic features of primary retroperitoneal sarcomas: a prognostic study 原发性腹膜后肉瘤的放射学特征:预后研究。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.ejca.2024.115120
Sandro Pasquali , Sara Iadecola , Andrea Vanzulli , Gabriele Infante , Marco Bologna , Valentina Corino , Gabriella Greco , Raffaella Vigorito , Carlo Morosi , Alessia Beretta , Stefano Percio , Viviana Vallacchi , Paola Collini , Roberta Sanfilippo , Chiara Fabbroni , Silvia Stacchiotti , Marco Fiore , Paul Huang , Matteo Benelli , Luca Mainardi , Dario Callegaro

Background

Risk-stratification of patients with retroperitoneal sarcomas (RPS) relies on validated nomograms, such as Sarculator. This retrospective study investigated whether radiomic features extracted from computed tomography (CT) imaging could i) enhance the performance of Sarculator and ii) identify G3 dedifferentiated liposarcoma (DDLPS) or leiomyosarcoma (LMS), which are currently consider in a randomized clinical trial testing neoadjuvant chemotherapy.

Methods

Patients with primary localized RPS treated with curative-intent surgery (2011–2015) and available pre-operative CT imaging were included. Regions of interest (ROIs) were manually annotated on both unenhanced and portal venous phase acquisitions. Top performing radiomic features were selected with outcome-specific random forest models, through generation of replicative experiments (contexts) where patients were split into training and testing sets. Endpoints were overall and disease-free survival (OS, DFS).
Prognostic models for DFS and OS included the top five selected radiomic features and the Sarculator nomogram score.
Models accuracy was assessed with Harrell’s Concordance (C-)index.

Results

The study included 112 patients, with a median follow-up of 77 months (IQR 65–92 months).
Sarculator alone achieved a C-index of 0.622 and 0.686 for DFS and OS, respectively. Radiomic features only marginally enhanced the prediction accuracy of Sarculator for OS (C-index=0.726, C-index gain: 0.04) or DFS (C-index=0.639, C-index gain: 0.017). Finally, radiomic features identified patients with G3 DDLPS or LMS with an accuracy of 0.806.

Conclusion

Radiomic features marginally improved the performance of Sarculator in RPS.
However, they accurately identified G3 DDLPS or LMS at diagnosis, potentially improving patients selection for neoadjuvant treatments.
背景:腹膜后肉瘤(RPS)患者的风险分级依赖于经过验证的提名图,如 Sarculator。这项回顾性研究探讨了从计算机断层扫描(CT)成像中提取的放射学特征是否能:i)提高 Sarculator 的性能;ii)识别 G3 级低分化脂肪肉瘤(DDLPS)或leiomyosarcoma(LMS):纳入接受治愈性手术治疗的原发性局部RPS患者(2011-2015年),并提供术前CT成像。人工标注未增强和门静脉相采集的感兴趣区(ROI)。通过生成复制实验(上下文),将患者分成训练集和测试集,利用结果特异性随机森林模型选出表现最佳的放射学特征。终点是总生存期和无病生存期(OS、DFS)。DFS和OS的预后模型包括前五个选定的放射学特征和Sarculator提名图评分。模型的准确性通过哈雷尔一致性(C-)指数进行评估:研究共纳入 112 名患者,中位随访时间为 77 个月(IQR 65-92 个月)。单用 Sarculator 计算的 DFS 和 OS 的 C 指数分别为 0.622 和 0.686。放射学特征仅略微提高了 Sarculator 对 OS(C-index=0.726,C-index gain:0.04)或 DFS(C-index=0.639,C-index gain:0.017)的预测准确性。最后,放射学特征识别 G3 DDLPS 或 LMS 患者的准确率为 0.806:结论:放射学特征略微提高了 Sarculator 在 RPS 中的性能。然而,它们能在诊断时准确识别出 G3 DDLPS 或 LMS,从而有可能改善患者对新辅助治疗的选择。
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引用次数: 0
PCCA variant rs16957301 is a novel AKI risk genotype-specific for patients who receive ICI treatment: Real-world evidence from all of us cohort PCCA 变异 rs16957301 是一种新型 AKI 风险基因型,对接受 ICI 治疗的患者具有特异性:来自我们所有人队列的真实世界证据。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-09 DOI: 10.1016/j.ejca.2024.115114
Yanfei Wang , Chenxi Xiong , Weifeng Yu , Minghao Zhou , Tyler Shugg , Fang-Chi Hsu , Michael T. Eadon , Jing Su , Qianqian Song

Introduction

Immune checkpoint inhibitors (ICIs) enhance the immune system's ability to target and destroy cancer cells, but can also trigger immune-related adverse events (irAEs), such as acute kidney injury (ICI-AKI), complicating patient management. Limited knowledge of genetic predispositions to ICI-AKI highlights the need for genomic studies to improve therapeutic strategies.

Objective

To identify genetic predispositions for ICI-AKI using large-scale real-world data.

Methods

A systematic literature search led to 14 candidate variants related to irAEs. We performed a candidate variant association study with these variants using the All of Us cohort. An ICI-treated cohort and a general cohort were established to evaluate ICI-AKI risk. Logistic regression, adjusted for sex, evaluated the impact of each candidate genotype, separately for self-reported and ancestry-estimated race. Kaplan-Meier survival analysis assessed genetic effects on AKI-free survival.

Results

The ICI cohort (n = 414) showed a one-year AKI incidence rate of 23.2 %, significantly higher than the general cohort (6.5 %, n = 213,282). The rs16957301 variant (chr13:100324308, T > C) in the PCCA gene was a significant risk genotype for ICI-AKI among self-reported White (Beta=0.93, CI: 0.32 – 1.54, ORs= 2.53, Bonferroni-corrected P-value=0.047) and ancestry estimated Europeans (Beta = 0.94, CI: 0.31 – 1.57, ORs= 2.56, Bonferroni-corrected P-value=0.044). Self-reported White with the rs16957301 risk genotypes (TC/CC) developed AKI significantly earlier (3.6 months) compared to the reference genotype (TT, 7.0 months, log-rank P = 0.04). Consistent results were found in ancestry-estimated Europeans. This variant did not present significant AKI risks in the general cohort (Beta: −0.008–0.035, FDR: 0.75–0.99).

Conclusion

Our findings suggest that rs16957301 in PCCA may serve as an ICI-AKI risk marker in Caucasians. Further studies are needed to validate this association and explore risks in other populations.
简介:免疫检查点抑制剂(ICIs)可增强免疫系统靶向和消灭癌细胞的能力,但也可能引发免疫相关不良事件(irAEs),如急性肾损伤(ICI-AKI),从而使患者管理复杂化。由于对 ICI-AKI 遗传倾向的了解有限,因此需要进行基因组研究以改进治疗策略:利用大规模真实世界数据确定 ICI-AKI 的遗传倾向:通过系统性文献检索,我们发现了 14 个与 ICI-AKI 相关的候选变体。我们利用 "我们所有人 "队列对这些变异进行了候选变异关联研究。为了评估 ICI-AKI 风险,我们建立了一个 ICI 治疗队列和一个普通队列。经性别调整的逻辑回归评估了每个候选基因型对自我报告种族和祖先估计种族的影响。Kaplan-Meier 生存分析评估了遗传对无 AKI 生存的影响:结果:ICI队列(n = 414)显示一年的AKI发病率为23.2%,明显高于普通队列(6.5%,n = 213 282)。PCCA基因中的rs16957301变体(chr13:100324308,T > C)是自述为白人(Beta=0.93,CI:0.32 - 1.54,ORs= 2.53,Bonferroni校正后的P-值=0.047)和祖先估计为欧洲人(Beta=0.94,CI:0.31 - 1.57,ORs= 2.56,Bonferroni校正后的P-值=0.044)的人群中ICI-AKI的重要风险基因型。与参考基因型(TT,7.0 个月,对数秩 P = 0.04)相比,具有 rs16957301 风险基因型(TC/CC)的自我报告白种人发生 AKI 的时间显著提前(3.6 个月)。在祖先估计的欧洲人中也发现了一致的结果。在一般队列中,该变异不存在显著的 AKI 风险(Beta:-0.008-0.035,FDR:0.75-0.99):我们的研究结果表明,PCCA 中的 rs16957301 可作为白种人的 ICI-AKI 风险标记。还需要进一步的研究来验证这种关联,并探索其他人群的风险。
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引用次数: 0
Chemoradiotherapy plus induction or consolidation chemotherapy as total neoadjuvant therapy for rectal cancer: Pooled analysis of the CAO/ARO/AIO-12 and the OPRA randomized phase 2 trials. 化放疗加诱导或巩固化疗作为直肠癌的整体新辅助治疗:CAO/ARO/AIO-12 和 OPRA 随机 2 期试验的汇总分析。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-06 DOI: 10.1016/j.ejca.2024.115112
Steven Sorscher, Caio Max Sao Padro Rocha Lima
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引用次数: 0
Comparison of immune checkpoint inhibitor plus chemotherapy or ipilimumab plus nivolumab-based therapy for NSCLC patients with PD-L1 TPS (1–49 %): TOPGAN2023-01 比较免疫检查点抑制剂加化疗或伊匹单抗加尼伐单抗治疗PD-L1 TPS(1-49 %)的NSCLC患者:TOPGAN2023-01。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-05 DOI: 10.1016/j.ejca.2024.115117
Hisashi Tanaka , Tomonori Makiguchi , Takehiro Tozuka , Yosuke Kawashima , Tomohiro Oba , Ryosuke Tsugitomi , Junji Koyama , Yuichi Tambo , Shinsuke Ogusu , Masafumi Saiki , Hiroshi Gyotoku , Tsukasa Hasegawa , Eisaku Miyauchi , Tomoaki Sonoda , Ryota Saito , Katsumi Nakatomi , Toshio Sakatani , Keita Kudo , Yuko Tsuchiya-Kawano , Makoto Nishio

Introduction

Immune checkpoint inhibitors (ICIs) plus chemotherapy is now a standard treatment for non-small cell lung cancer (NSCLC). Whether ICI plus chemotherapy (ICI-chemo) or ipilimumab plus nivolumab (I-N)-based therapy is superior for patients with NSCLC with a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) of 1–49 % has not been evaluated.

Methods

This multicenter retrospective study included NSCLC patients with a TPS score of 1–49 %, who began first-line chemotherapy. Propensity score matching analysis was used to adjust for various confounders and evaluate treatment efficacy.

Results

A total of 401 patients were enrolled, of whom 308 received ICI-chemo and 93 received I-N-based therapy. The median OS was 21.0 months in the ICI-chemo group and 20.0 months in the I-N-based therapy group. After propensity score matching, there was no difference in OS or PFS between the ICI-chemo group and the I-N-based therapy group (OS: hazard ratios (HR), 0.83; 95 % confidence interval [CI], 0.54–1.26, PFS: HR, 0.72; 95 % CI, 0.52–1.00). Among PD-L1 TPS 25–49 %, there was a tendency for OS to be favorable for the ICI-chemo group (OS: HR, 0.30; 95 % CI, 0.09–0.85). Treatment discontinuation occurred for 26.2 % of the patients in the ICI-chemo group and 41.9 % in the I-N-based therapy group.

Conclusions

Among PD-L1 TPS 1–49 %, there was no significant difference in survival outcomes between the ICI-chemo group and the I-N-based therapy group. Based on the results of a subgroup analysis, ICI-chemo may be superior for treating NSCLC with a TPS of 25–49 %.
简介免疫检查点抑制剂(ICIs)加化疗现已成为治疗非小细胞肺癌(NSCLC)的标准疗法。对于程序性死亡配体1(PD-L1)肿瘤比例评分(TPS)为1-49%的NSCLC患者,ICI加化疗(ICI-chemo)或伊匹单抗加尼伐单抗(I-N)疗法是否更优,尚未进行评估:这项多中心回顾性研究纳入了TPS评分为1-49%、开始一线化疗的NSCLC患者。采用倾向评分匹配分析法调整各种混杂因素并评估疗效:共有401名患者入选,其中308人接受了ICI-化疗,93人接受了基于I-N的治疗。ICI-化疗组的中位OS为21.0个月,I-N疗法组为20.0个月。经过倾向评分匹配后,ICI-化疗组和基于I-N疗法组的OS或PFS没有差异(OS:危险比(HR),0.83;95%置信区间[CI],0.54-1.26;PFS:HR,0.72;95% CI,0.52-1.00)。在 PD-L1 TPS 为 25-49% 的患者中,ICI-化疗组的 OS 有上升趋势(OS:HR,0.30;95% CI,0.09-0.85)。ICI-化疗组中有26.2%的患者中断了治疗,I-N疗法组中有41.9%的患者中断了治疗:结论:在PD-L1 TPS 1-49%的患者中,ICI-化疗组和I-N疗法组的生存率没有显著差异。根据亚组分析结果,ICI-chemo治疗TPS为25-49%的NSCLC可能更具优势。
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引用次数: 0
Prevalence of invasive lung cancer in pure ground glass nodules less than 30 mm: A systematic review 小于 30 毫米的纯磨碎玻璃结节中浸润性肺癌的发病率:系统综述。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-05 DOI: 10.1016/j.ejca.2024.115116
Abdullah AlShammari , Akshay Patel , Mark Boyle , Chiara Proli , Jose Alvarez Gallesio , Anuj Wali , Paulo De Sousa , Eric Lim

Background

The IASLC TNM proposal suggests that pure ground glass nodules less than 30 mm should be classified as cTis corresponding to pathologic adenocarcinoma in situ implying no invasive malignancy potential. We sought to ascertain the proportion of pure ground glass nodules that harbour tissue confirmed minimally invasive or invasive adenocarcinoma.

Methods

We analyzed data from 3874 individuals with pure ground glass nodules less than 30 mm, reported in 28 observational studies identified through a systematic search of electronic databases. The primary outcome was the prevalence of invasive malignancy by random effects meta-analysis, and we used meta-regression to determine the impact of baseline risk, size, and country of investigation on overall effect size. The study was registered with PROSPERO (CRD42021286261).

Results

All published studies were retrospective (n = 28) and the majority conducted in Asia (n = 25). Baseline patient cohorts were mainly from published surgical series (n = 22) or lung cancer screening programs (n = 6). The proportion of minimally invasive and invasive cancer ranged from 0.9 % to 100 % with a pooled prevalence of 42.4 % [95 % CI: 0.28, 0.57].
Considerable heterogeneity was observed (I2 =99 %) and patient selection was the most significant contribution, accounting for 73 % of the observed heterogeneity (p < 0.0001). Meta-regression based on size selection and country of investigation revealed no significant contribution to effect size effect or heterogeneity.

Conclusions

Pure ground glass nodules less than 30 mm harbour a high proportion of invasive malignancy, contrary to the IASLC staging proposals and opinions from numerous guidelines across the world.
背景:IASLC TNM 建议将小于 30 毫米的纯磨玻璃结节归类为 cTis,与病理原位腺癌相对应,这意味着没有侵袭性恶性肿瘤的可能性。我们试图确定纯磨碎玻璃结节中藏有组织证实的微侵袭性或侵袭性腺癌的比例:我们分析了通过系统搜索电子数据库发现的 28 项观察性研究中报告的 3874 例纯磨玻璃结节患者的数据,这些结节小于 30 毫米。主要结果是通过随机效应荟萃分析得出的侵袭性恶性肿瘤发病率,我们使用荟萃回归法确定了基线风险、大小和调查国家对总体效应大小的影响。该研究已在 PROSPERO(CRD42021286261)注册:所有已发表的研究均为回顾性研究(28 项),大部分研究在亚洲进行(25 项)。基线患者队列主要来自已发表的手术系列(22 人)或肺癌筛查项目(6 人)。微创和浸润性癌症的比例从0.9%到100%不等,总患病率为42.4% [95 % CI: 0.28, 0.57]。观察到了相当大的异质性(I2 = 99 %),而患者选择是最重要的原因,占观察到的异质性的 73 %(P 结论:患者选择是最重要的原因,占观察到的异质性的 73 %):小于 30 毫米的纯磨碎玻璃结节具有很高比例的浸润性恶性肿瘤,这与 IASLC 分期建议和全球众多指南的意见相悖。
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引用次数: 0
FIGO 2023 staging for endometrial cancer, when, if it is not now? FIGO 2023 子宫内膜癌分期,如果不是现在,是何时?
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-05 DOI: 10.1016/j.ejca.2024.115115
Xavier Matias-Guiu , Sigurd Lax , Maria Rosaria Raspollini , Jose Palacios , Wenxin Zheng , Congrong Liu , Louise de Brot , Leonardo Lordello , David Hardisson , David Gaffney , David Mutch , Giovanni Scambia , Carien L. Creutzberg , Christina Fotopoulou , Jonathan S. Berek , Nicole Concin
Incorporation of pathological and (not mandatory) molecular features into the new FIGO 2023 staging system has generated some controversy. Several validations have been published recently that demonstrated the higher prognostic precision of FIGO 2023 compared to the previous FIGO 2009 scheme. In the present article, the authors want to respond to some concerns that were raised by some pathologists and clinicians.
在新的 FIGO 2023 分期系统中纳入病理特征和(非强制性的)分子特征引起了一些争议。最近发表的一些验证结果表明,与之前的 FIGO 2009 方案相比,FIGO 2023 的预后精确度更高。在本文中,作者希望对一些病理学家和临床医生提出的疑虑做出回应。
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引用次数: 0
The journey of patients affected by metastatic hormone receptor-positive/HER2-negative breast cancer from CDK 4/6 inhibitors to second-line treatment: A real-world analysis of 701 patients enrolled in the GIM14/BIOMETA study 转移性激素受体阳性/HER2 阴性乳腺癌患者从 CDK 4/6 抑制剂到二线治疗的历程:对参加 GIM14/BIOMETA 研究的 701 例患者的实际情况分析。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-04 DOI: 10.1016/j.ejca.2024.115113
Chiara Molinelli , Marco Bruzzone , Eva Blondeaux , Tommaso Ruelle , Chiara Lanzavecchia , Michelino De Laurentiis , Stefania Russo , Ferdinando Riccardi , Valentina Sini , Francesco Cognetti , Grazia Arpino , Alessandra Fabi , Palma Pugliese , Elena Collovà , Andrea Fontana , Fabio Puglisi , Claudia Bighin , Matteo Lambertini , Lucia Del Mastro

Purpose

The aim of this study was to evaluate the effectiveness of CDK 4/6 inhibitors (CDK 4–6i) according to HER2 status (low/zero), and endocrine resistance/sensitivity, as well as the efficacy of second-line treatments, in a large real-world cohort.

Methods

The GIM14/BIOMETA study (NCT02284581) is a retrospective/prospective study of the Gruppo Italiano Mammella evaluating treatment patterns and survival outcomes in patients with metastatic breast cancer (MBC). We retrieved data on patients with hormone receptor-positive/HER2-negative MBC receiving first-line CDK 4/6i.

Results

Among 3832 patients enrolled in the GIM14-BIOMETA study, 701 were eligible. At a median follow-up of 24.80 months, no significant differences were found between HER2-zero and HER2-low subgroups in terms of first-line time to treatment discontinuation (TTD) (26.16 months [IQR 12.84-NR] vs. 27.60 months [IQR 12.12–64.44], p = 0.972) or overall survival (OS) (mOS>60 months for both groups, p = 0.398). Median TTD was 33.24 months (IQR 16.32-NR) for the endocrine sensitive subgroup, 19.92 months (IQR 8.88–51.24) for the secondary endocrine resistant subgroup and 17.40 months (IQR 7.44–24.72) for the primary endocrine resistant subset, respectively (p < 0.001). Among 239 patients receiving second-line treatment, no significant difference (p = 0.188) was found in terms of second-line TTD between those treated with capecitabine (6.11 months, IQR 2.96–11.47), taxane-based chemotherapy (5.06 months, IQR 2.99–9.99), everolimus plus exemestane (5.39 months, IQR 2.53–9.03) or fulvestrant (6.44 months, IQR 3.38-NR).

Conclusions

Endocrine therapy plus CDK 4/6i represents an effective treatment, regardless of HER2 status (low/zero). Second-line agents did not differ significantly in terms of TTD. Endocrine resistant cancers exhibit poor response to CDK 4/6i.
目的:本研究旨在评估CDK 4/6抑制剂(CDK 4-6i)在大型真实世界队列中根据HER2状态(低/零)、内分泌耐药/敏感性以及二线治疗疗效的有效性:GIM14/BIOMETA研究(NCT02284581)是意大利玛梅拉集团(Gruppo Italiano Mammella)的一项回顾性/前瞻性研究,旨在评估转移性乳腺癌(MBC)患者的治疗模式和生存结果。我们检索了接受一线 CDK 4/6i 治疗的激素受体阳性/HER2 阴性 MBC 患者的数据:在参加 GIM14-BIOMETA 研究的 3832 例患者中,有 701 例符合条件。在24.80个月的中位随访中,HER2-0亚组和HER2-低亚组在一线治疗终止时间(TTD)(26.16个月[IQR 12.84-NR] vs. 27.60个月[IQR 12.12-64.44],p = 0.972)或总生存期(OS)(两组mOS均>60个月,p = 0.398)方面无明显差异。内分泌敏感亚组的中位TTD分别为33.24个月(IQR 16.32-NR),继发性内分泌耐药亚组的中位TTD分别为19.92个月(IQR 8.88-51.24),原发性内分泌耐药亚组的中位TTD分别为17.40个月(IQR 7.44-24.72)(P 结论:内分泌治疗加CDK 4.0的疗效更佳:无论HER2状态如何(低/零),内分泌治疗加CDK 4/6i都是一种有效的治疗方法。二线药物在TTD方面没有明显差异。内分泌耐药癌症对CDK 4/6i的反应较差。
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引用次数: 0
Shared decision-making supported by outcome information regarding surveillance after curative treatment for breast cancer: Results of the SHOUT-BC study 乳腺癌根治性治疗后监测结果信息支持的共同决策:SHOUT-BC研究的结果
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115107
J.W. Ankersmid , C.H.C. Drossaert , L.J.A. Strobbe , M.Q.N. Hackert , N. Engels , J.C.M. Prick , S. Teerenstra , Y.E.A. van Riet , R. The , C.F. van Uden-Kraan , S. Siesling , on behalf of the Santeon VBHC Breast Cancer Group

Background

Integrating outcome information into the process of shared decision-making (SDM) about post-treatment surveillance can enhance its effectiveness. The Breast Cancer Surveillance Decision Aid (BCS-PtDA) integrates risk estimations of patients’ risks for recurrences as well as outcome information on fear of cancer recurrence (FCR). The SHOUT-BC study aimed to evaluate the effectiveness of the implementation of the BCS-PtDA. Patients’ satisfaction with the BCS-PtDA was also evaluated.

Methods

As described in a previously published protocol paper, the study employed a Prospective multiple interrupted time series (ITS) design in which the BCS-PtDA was implemented stepwise into the care pathways of eight Dutch hospitals.

Results

A total of 507 participants completed a questionnaire after their first surveillance consultation which usually takes place approximately one year after surgery. ITS analysis per hospital and subsequent meta-analysis over hospital effects indicated a significant increase in patient-reported SDM from pre- to post-implementation (overall estimated effect: 27.14, 95 % CI: 22.71 to 31.87, p < .0001). Moreover, post-implementation participants (n = 225) reported a more active role in decision-making, decreased decisional conflict, and increased knowledge on the aim and methods of surveillance. Furthermore, a decrease in FCR was seen post-implementation. The self-reported intensity of surveillance schedules decreased slightly and the BCS-PtDA received highly positive evaluations.

Discussion

The implementation of the BCS-PtDA, which integrates outcome information, led to increased patient-reported SDM and an improved quality of decision-making. The BCS-PtDA was evaluated highly positively by participants. Further research should address optimisation of the implementation.
背景将结果信息纳入有关治疗后监测的共同决策(SDM)过程可提高其有效性。乳腺癌监测决策辅助工具(BCS-PtDA)整合了对患者复发风险的估计以及对癌症复发恐惧(FCR)的结果信息。SHOUT-BC研究旨在评估BCS-PtDA的实施效果。结果 共有 507 名参与者在首次监测咨询(通常在术后一年左右)后填写了调查问卷。每家医院的 ITS 分析和随后的医院效应荟萃分析表明,从实施前到实施后,患者报告的 SDM 显著增加(总体估计效应:27.14,95 % CI:22.71 至 31.87,p < .0001)。此外,实施后的参与者(n = 225)表示在决策中扮演了更积极的角色,减少了决策冲突,增加了对监测目的和方法的了解。此外,FCR 在实施后也有所下降。讨论整合了结果信息的 BCS-PtDA 的实施增加了患者报告的 SDM,提高了决策质量。参与者对 BCS-PtDA 的评价非常积极。进一步的研究应解决实施过程中的优化问题。
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期刊
European Journal of Cancer
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