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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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引用次数: 0
Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial 中药(健皮布散)与 II 期和 III 期结肠癌患者辅助化疗的完成率:随机临床试验
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115109
Lingyun Sun , Yun Xu , Nan Chen , Chunze Zhang , Aiwen Wu , Huaqing Wang , Yutong Fei , Peng Shu , Dechang Diao , Jianping Cheng , Yuping Chu , Tianshu Liu , Wei Wang , Ye Yuan , Baozhu Zeng , Yang Cao , Shundong Cang , Huijuan Cao , Tong Zhang , Yang Zheng , Yufei Yang

Purpose

Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients.

Patients and methods

This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III).

Results

A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients.

Conclusion

JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.
目的许多癌症患者表示有兴趣在化疗期间使用中药,但对中药的益处和风险却知之甚少。这项多中心、III 期、随机、安慰剂对照试验纳入了术后计划接受 CAPOX(卡培他滨和奥沙利铂)化疗的 II 期(高复发风险)和 III 期结肠癌患者。患者按 1:1 随机分配接受 JPBS 或安慰剂治疗。主要结果是计划化疗周期的完成率。次要结果包括相对剂量强度(RDI)、化疗引起的毒性反应、生活质量(通过埃德蒙顿症状评估系统ESAS测量)、不良事件(AEs)和严重不良事件(SAEs)。按照年龄(65/≤65岁)和TNM分期(II/III期)进行了预定义的亚组分析。JPBS 组的化疗完成率明显高于安慰剂组(63.0% 对 47.6%,P = 0.003)。JPBS 组的奥沙利铂 RDI 也更高(P = 0.049)。亚组分析显示,JPBS 显著提高了 II 期患者(73.0% 对 42.4%,P = 0.001)和年轻患者(66.9% 对 48.8%,P = 0.004)的手术完成率。JPBS减少了≥2级呕吐(3.8% vs. 6.4%,P = 0.007),但增加了≥2级血小板减少(16.2% vs. 12.4%,P = 0.012)。结论JPBS提高了II期和年轻结肠癌患者的化疗完成率,同时不影响耐受性。需要进一步研究其机制和长期效果。
{"title":"Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial","authors":"Lingyun Sun ,&nbsp;Yun Xu ,&nbsp;Nan Chen ,&nbsp;Chunze Zhang ,&nbsp;Aiwen Wu ,&nbsp;Huaqing Wang ,&nbsp;Yutong Fei ,&nbsp;Peng Shu ,&nbsp;Dechang Diao ,&nbsp;Jianping Cheng ,&nbsp;Yuping Chu ,&nbsp;Tianshu Liu ,&nbsp;Wei Wang ,&nbsp;Ye Yuan ,&nbsp;Baozhu Zeng ,&nbsp;Yang Cao ,&nbsp;Shundong Cang ,&nbsp;Huijuan Cao ,&nbsp;Tong Zhang ,&nbsp;Yang Zheng ,&nbsp;Yufei Yang","doi":"10.1016/j.ejca.2024.115109","DOIUrl":"10.1016/j.ejca.2024.115109","url":null,"abstract":"<div><h3>Purpose</h3><div>Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients.</div></div><div><h3>Patients and methods</h3><div>This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (&gt;65/≤65) and TNM stage (II/III).</div></div><div><h3>Results</h3><div>A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients.</div></div><div><h3>Conclusion</h3><div>JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115109"},"PeriodicalIF":7.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Updated survival outcome of regorafenib, ipilimumab, and nivolumab in refractory microsatellite stable non-liver metastatic colorectal cancer: A phase I nonrandomized clinical trial regorafenib、ipilimumab和nivolumab治疗难治性微卫星稳定型非肝转移性结直肠癌的最新生存结果:一期非随机临床试验
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115111
Annie Xiao , Xiaochen Li , Chongkai Wang , Jian Ye , Marwan Fakih

Background

Combination regorafenib, ipilimumab, and nivolumab (RIN) was evaluated in a phase 1 nonrandomized study (NCT04362839) of refractory microsatellite stable (MSS) metastatic colorectal cancer. Promising antitumor activity was previously reported in the non-liver metastatic (NLM) population. This updated analysis describes long-term survival outcomes in the NLM cohort and highlights durable remissions with potential cure following completion of RIN therapy.

Methods

Between May 2020 and January 2022, 39 patients with refractory MSS metastatic colorectal cancer were enrolled. Patients received RIN until progression, unacceptable toxicity, or completion at two years. The primary endpoint was recommended phase 2 dose (RP2D) selection. Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) at the RP2D level.

Results

22 patients with refractory non-liver metastatic MSS colorectal cancer were treated at the RP2D of RIN. ORR was 36.4 % (8/22 patients), and median PFS was 5.0 months (95 % CI: 3–9). After a median follow-up of 42 months, the 1-, 2-, and 3-year PFS rates were 24.1 %, 24.1 %, and 19.3 % by RECIST. The median OS was 27.5 months (95 % CI: 14.0 to NE). At data cutoff, 6 patients had ongoing clinical benefit, including 3 responders who remain disease-free > 18 months after treatment completion.

Conclusion

With extended follow-up, RIN combination therapy demonstrated durable clinical benefit in a subset of patients with NLM MSS metastatic colorectal cancer, including potential cure in 3 responders who remain disease-free > 18 months after treatment completion.
背景在一项针对难治性微卫星稳定(MSS)转移性结直肠癌的1期非随机研究(NCT04362839)中,对瑞戈非尼、伊匹单抗和尼伐单抗(RIN)的组合进行了评估。此前曾有报道称,该药在非肝转移(NLM)人群中具有良好的抗肿瘤活性。本更新分析描述了 NLM 组群的长期生存结果,并强调了完成 RIN 治疗后可能治愈的持久缓解。方法在 2020 年 5 月至 2022 年 1 月期间,39 例难治性 MSS 转移性结直肠癌患者入组。患者接受 RIN 治疗,直到病情进展、出现不可接受的毒性或两年后治疗结束。主要终点是推荐的二期剂量(RP2D)选择。结果22名难治性非肝转移MSS结直肠癌患者接受了RIN的RP2D治疗。ORR为36.4%(8/22例患者),中位PFS为5.0个月(95% CI:3-9个月)。中位随访 42 个月后,根据 RECIST 标准,1 年、2 年和 3 年的 PFS 分别为 24.1%、24.1% 和 19.3%。中位 OS 为 27.5 个月(95 % CI:14.0 至 NE)。结论随着随访时间的延长,RIN联合疗法在NLM MSS转移性结直肠癌患者中显示出持久的临床疗效,包括3名在治疗结束后18个月仍无疾病的应答者。
{"title":"Updated survival outcome of regorafenib, ipilimumab, and nivolumab in refractory microsatellite stable non-liver metastatic colorectal cancer: A phase I nonrandomized clinical trial","authors":"Annie Xiao ,&nbsp;Xiaochen Li ,&nbsp;Chongkai Wang ,&nbsp;Jian Ye ,&nbsp;Marwan Fakih","doi":"10.1016/j.ejca.2024.115111","DOIUrl":"10.1016/j.ejca.2024.115111","url":null,"abstract":"<div><h3>Background</h3><div>Combination regorafenib, ipilimumab, and nivolumab (RIN) was evaluated in a phase 1 nonrandomized study (NCT04362839) of refractory microsatellite stable (MSS) metastatic colorectal cancer. Promising antitumor activity was previously reported in the non-liver metastatic (NLM) population. This updated analysis describes long-term survival outcomes in the NLM cohort and highlights durable remissions with potential cure following completion of RIN therapy.</div></div><div><h3>Methods</h3><div>Between May 2020 and January 2022, 39 patients with refractory MSS metastatic colorectal cancer were enrolled. Patients received RIN until progression, unacceptable toxicity, or completion at two years. The primary endpoint was recommended phase 2 dose (RP2D) selection. Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) at the RP2D level.</div></div><div><h3>Results</h3><div>22 patients with refractory non-liver metastatic MSS colorectal cancer were treated at the RP2D of RIN. ORR was 36.4 % (8/22 patients), and median PFS was 5.0 months (95 % CI: 3–9). After a median follow-up of 42 months, the 1-, 2-, and 3-year PFS rates were 24.1 %, 24.1 %, and 19.3 % by RECIST. The median OS was 27.5 months (95 % CI: 14.0 to NE). At data cutoff, 6 patients had ongoing clinical benefit, including 3 responders who remain disease-free &gt; 18 months after treatment completion.</div></div><div><h3>Conclusion</h3><div>With extended follow-up, RIN combination therapy demonstrated durable clinical benefit in a subset of patients with NLM MSS metastatic colorectal cancer, including potential cure in 3 responders who remain disease-free &gt; 18 months after treatment completion.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115111"},"PeriodicalIF":7.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Epidemiology of men with synchronous metastatic prostate cancer diagnosis – A nationwide 26-year temporal analysis 同步转移性前列腺癌男性患者的流行病学--26 年全国时间分析
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-11-01 DOI: 10.1016/j.ejca.2024.115110
Hein V. Stroomberg , J. Thomas Helgstrand , Klaus Brasso , Signe Benzon Larsen , Andreas Røder

Background

Evolving imaging modalities, increased awareness, and prostate-specific antigen testing in men with synchronous metastatic prostate cancer (mHSPC) are expected to have prolonged survival. Here we analyze trends in survival among men diagnosed with synchronous metastatic prostate cancer in Denmark.

Methods

Here, we included all men diagnosed with mHSPC (N = 12,017) in Denmark between January 1st, 1995, and December 31st, 2021. Men were followed until December 31st, 2022. Median time to death was calculated by the Kaplan Meier method and the 3-year risk of prostate cancer death per calendar year was estimated by the Aalen-Johansen estimator from time of diagnosis.

Findings

Median follow-up was 9 years (IQR: 4–15), from 2015 59 % of the men with mHSPC had treatment beyond androgen depletion therapy. Median survival increased from 1.7 years (IQR: 1·3–2·0) to 3.8 years (IQR: 3·3–4·2) in men diagnosed in 1995 and 2018, respectively (p < 0·001), after which median survival was not reached. The prostate cancer-specific mortality three years after diagnosis decreased from 66 % (95 %CI: 60–72) in 1995 to 28 % (95 %CI: 25–32) in 2019 (p < 0·001). From the period 1995–1999 to 2015–2021 median overall survival increased from 1·7 years (IQR: 0·8–3·7) to 4·5 years (IQR: 2·4-not reached; p < 0·001) in men age < 65 years and from 1·5 years (IQR: 0·7–2·9) to 3·1 years (IQR: 1·6–5·7; p < 0.001) in men older than 74 years at diagnosis.

Interpretation

The improved survival suggests that, among other contributing factors, implementing novel therapies has likely been efficacious outside the clinical trial setting. Still, most men diagnosed with synchronous metastatic prostate cancer will die of prostate cancer. As such the need for life-prolonging and age-tailored treatment trials remains evident.
背景同步转移性前列腺癌(mHSPC)男性患者的成像模式不断发展、认知度提高以及前列腺特异性抗原检测有望延长患者的生存期。在此,我们分析了丹麦确诊为同步转移性前列腺癌的男性患者的生存趋势。方法我们纳入了1995年1月1日至2021年12月31日期间丹麦确诊为mHSPC的所有男性患者(N = 12,017)。随访至 2022 年 12 月 31 日。中位死亡时间用卡普兰-梅耶尔法计算,前列腺癌每日历年的3年死亡风险用Aalen-Johansen估算器估算,从诊断时间算起。1995年和2018年确诊的男性中位生存期分别从1.7年(IQR:1-3-2-0)增至3.8年(IQR:3-3-4-2)(p <0-001),之后未达到中位生存期。确诊三年后的前列腺癌特异性死亡率从 1995 年的 66 %(95 %CI:60-72)降至 2019 年的 28 %(95 %CI:25-32)(p < 0-001)。从1995-1999年到2015-2021年,65岁男性的中位总生存期从1-7年(IQR:0-8-3-7)延长至4-5年(IQR:2-4-未达到;p< 0-001),74岁以上男性的中位总生存期从1-5年(IQR:0-7-2-9)延长至3-1年(IQR:1-6-5-7;p< 0.001)。释义生存期的延长表明,除其他因素外,新型疗法的实施很可能在临床试验环境之外具有疗效。不过,大多数确诊为同步转移性前列腺癌的男性将死于前列腺癌。因此,延长生命和针对不同年龄段进行治疗试验的必要性仍然是显而易见的。
{"title":"Epidemiology of men with synchronous metastatic prostate cancer diagnosis – A nationwide 26-year temporal analysis","authors":"Hein V. Stroomberg ,&nbsp;J. Thomas Helgstrand ,&nbsp;Klaus Brasso ,&nbsp;Signe Benzon Larsen ,&nbsp;Andreas Røder","doi":"10.1016/j.ejca.2024.115110","DOIUrl":"10.1016/j.ejca.2024.115110","url":null,"abstract":"<div><h3>Background</h3><div>Evolving imaging modalities, increased awareness, and prostate-specific antigen testing in men with synchronous metastatic prostate cancer (mHSPC) are expected to have prolonged survival. Here we analyze trends in survival among men diagnosed with synchronous metastatic prostate cancer in Denmark.</div></div><div><h3>Methods</h3><div>Here, we included all men diagnosed with mHSPC (N = 12,017) in Denmark between January 1st, 1995, and December 31st, 2021. Men were followed until December 31st, 2022. Median time to death was calculated by the Kaplan Meier method and the 3-year risk of prostate cancer death per calendar year was estimated by the Aalen-Johansen estimator from time of diagnosis.</div></div><div><h3>Findings</h3><div>Median follow-up was 9 years (IQR: 4–15), from 2015 59 % of the men with mHSPC had treatment beyond androgen depletion therapy. Median survival increased from 1.7 years (IQR: 1·3–2·0) to 3.8 years (IQR: 3·3–4·2) in men diagnosed in 1995 and 2018, respectively (p &lt; 0·001), after which median survival was not reached. The prostate cancer-specific mortality three years after diagnosis decreased from 66 % (95 %CI: 60–72) in 1995 to 28 % (95 %CI: 25–32) in 2019 (p &lt; 0·001). From the period 1995–1999 to 2015–2021 median overall survival increased from 1·7 years (IQR: 0·8–3·7) to 4·5 years (IQR: 2·4-not reached; p &lt; 0·001) in men age &lt; 65 years and from 1·5 years (IQR: 0·7–2·9) to 3·1 years (IQR: 1·6–5·7; p &lt; 0.001) in men older than 74 years at diagnosis.</div></div><div><h3>Interpretation</h3><div>The improved survival suggests that, among other contributing factors, implementing novel therapies has likely been efficacious outside the clinical trial setting. Still, most men diagnosed with synchronous metastatic prostate cancer will die of prostate cancer. As such the need for life-prolonging and age-tailored treatment trials remains evident.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":"213 ","pages":"Article 115110"},"PeriodicalIF":7.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prospective study on Oncotype DX® assay to assess recurrence risk in early ER-positive HER2-negative breast cancer patients with uncertain biological behavior by standard parameters and its impact on treatment recommendation: The POST trial 通过标准参数评估生物学行为不确定的早期ER阳性HER2阴性乳腺癌患者复发风险的Oncotype DX®测定及其对治疗建议的影响的前瞻性研究:POST试验。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-31 DOI: 10.1016/j.ejca.2024.115108
Luca Livraghi , Francesca Martella , Matteo Ghilli , Catia Angiolini , Simonetta Magnanini , Erica Moretti , Carmelo Bengala , Emanuela Risi , Elena Molinara , Ilaria Pazzagli , Luca Malorni , Sara Donati , Stefano Gabellini , Angelo Martignetti , Piergiorgio Giannessi , Giuseppina Sanna , Leonardo Barellini , Chiara Biagioni , Luca Boni , Simonetta Bianchi , Laura Biganzoli

Background

Data published in 2015 showed that patients with early breast cancer (EBC) and a low-risk (LR) Recurrence Score® (RS) result by the 21-gene Oncotype DX® assay (“the test”) did not derive benefit from adding chemotherapy (CT) to endocrine therapy (HT), while those with a high-risk (HR) RS result did. However, the role of CT remained uncertain in patients with intermediate-risk (IR) cancers. We designed a study to assess the test’s ability to categorize patients with EBC with uncertain biological behavior into the groups (LR and HR) for which the value of additional chemotherapy was defined.

Methods

The POST trial was a multicenter, prospective cohort study conducted in 14 Breast Centers of the Tuscany region of Italy. Consecutive patients with pT1–2 pN0-N1mi hormone receptor-positive/HER2-negative EBC and uncertain biological behavior based on standard parameters were enrolled. Patients were categorized based on RS results into LR, IR, and HR groups if RS result was < 11, 11–25, and > 25, respectively. Treatment recommendations by multidisciplinary meeting assessed before and after RS results were available.

Results

Of 246 tested samples, 78 were classified as LR or HR, with most of the patients (65.4 %) being at IR. Following test results, the recommendation changed in 15.9 % of cases. Among patients initially recommended for CT or for discussion about the role of CT, respectively 64.3 % and 75.9 % ultimately received recommendation for HT alone.

Conclusions

Our study suggests that RS results can refine treatment decisions for patients with EBC exhibiting uncertain biological behavior initially recommended or considered for CT.
(250/250)
背景:2015年公布的数据显示,早期乳腺癌(EBC)患者和21基因Oncotype DX®检测("检测")结果为低风险(LR)复发评分®(RS)的患者在内分泌治疗(HT)的基础上加用化疗(CT)并不能获益,而结果为高风险(HR)RS的患者则能获益。然而,CT在中危(IR)癌症患者中的作用仍不确定。我们设计了一项研究,以评估该检验将生物学行为不确定的EBC患者分为LR和HR两组的能力,从而确定额外化疗的价值:POST试验是一项多中心、前瞻性队列研究,在意大利托斯卡纳地区的14家乳腺中心进行。根据标准参数,pT1-2 pN0-N1mi 激素受体阳性/HER2 阴性 EBC 患者的生物学行为不确定。如果RS结果为25,则根据RS结果将患者分别分为LR组、IR组和HR组。在RS结果出来之前和之后,由多学科会议评估治疗建议:结果:在 246 份检测样本中,78 人被分为 LR 或 HR 组,其中大部分患者(65.4%)为 IR 组。检测结果出来后,15.9%的病例改变了建议。在最初被建议进行 CT 或讨论 CT 作用的患者中,分别有 64.3% 和 75.9% 最终被建议仅进行 HT:我们的研究表明,对于最初被建议或考虑进行 CT 检查的生物学行为不确定的 EBC 患者,RS 结果可以完善他们的治疗决策。(250/250).
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引用次数: 0
Why effect sizes are systematically larger for progression-free survival than overall survival in cancer drug trials: Prognostic scores as a way forward 为什么在癌症药物试验中,无进展生存期的效应大小系统性地大于总生存期?预后评分是前进的方向。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-30 DOI: 10.1016/j.ejca.2024.115106
Luca Locher , Miquel Serra-Burriel , Dario Trapani , Emanuel Nussli , Kerstin N. Vokinger
Cancer drugs have accumulated the most approvals over the past years. Overall survival (OS) is considered the gold standard for cancer trial outcomes. However, its use has declined over the past years, in favor of surrogate endpoints, such as progression-free survival (PFS). PFS allows to assess outcomes earlier and, thus, accelerates approval of cancer drugs. Previous studies have demonstrated a poor correlation between PFS and OS. Using simulation models, we examined why PFS usually overestimates survival benefit. We created a publicly accessible web application that allows users to run the simulations with different parameter settings. Based on the findings, we propose that assessment of preliminary evidence should be based on a combination of OS result and prognostic scores that reflect the health status of surviving patients.
在过去几年中,癌症药物累计获批数量最多。总生存期(OS)被认为是癌症试验结果的黄金标准。然而,在过去几年中,它的使用率有所下降,取而代之的是无进展生存期(PFS)等替代终点。无进展生存期可以更早地评估结果,从而加速癌症药物的审批。以往的研究表明,无进展生存期与手术生存期之间的相关性较差。我们利用模拟模型研究了 PFS 通常会高估生存获益的原因。我们创建了一个可公开访问的网络应用程序,用户可以使用不同的参数设置运行模拟。根据研究结果,我们建议应结合 OS 结果和反映存活患者健康状况的预后评分来评估初步证据。
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引用次数: 0
Corrigendum to “Letter re: High serum sodium predicts immunotherapy response in metastatic renal cell and urothelial carcinoma” [Eur J Cancer, 207, August 2024, 114173] 更正:"关于高血清钠可预测转移性肾细胞癌和尿路上皮癌的免疫疗法反应的信函"[《欧洲癌症杂志》,207 年 8 月 2024 日,114173]。
IF 7.6 1区 医学 Q1 ONCOLOGY Pub Date : 2024-10-30 DOI: 10.1016/j.ejca.2024.115101
Hujian Hong , Yanli Qu
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引用次数: 0
期刊
European Journal of Cancer
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