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Primary endpoints in randomized controlled trials for older adults with cancer: A scoping review 老年癌症患者随机对照试验的主要终点:范围综述
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-29 DOI: 10.1016/j.jgo.2026.102895
Tomonori Mizutani , Funato Sato , Kohei Uemura , Yukari Shimizu , Tsuguo Iwatani , Satoshi Kobayashi , Masataka Sawaki , Shimon Tashiro , Tetsuya Tsuji , Hiroshi Yamamoto , Asao Ogawa , Tetsuya Hamaguchi , on behalf of the Geriatric Study Committee of the Japan Clinical Oncology Group, Japan

Introduction

Older adults represent a growing proportion of patients with cancer. However, confirmatory randomized controlled trials (RCTs) continue to rely primarily on tumor-based endpoints such as overall survival (OS), which may overlook outcomes particularly important to older adults, including quality of life (QOL), functional status, and treatment tolerance. This review aimed to systematically characterize the primary endpoints used in confirmatory RCTs enrolling adults aged ≥65 years and to evaluate how novel endpoints reflecting patient priorities were defined and analyzed.

Materials and methods

PubMed, CINAHL, and the Cochrane Library were searched for English-language confirmatory RCTs exclusively enrolling adults aged ≥65 years with cancer and reporting a primary endpoint (up to January 19, 2024). Endpoints were classified as conventional (tumor-based) or novel (non-tumor-based). Data were extracted on endpoint definitions, measurement tools, and statistical approaches.

Results

Of 822 records identified, 66 RCTs met the eligibility criteria, yielding 71 primary endpoints. Conventional outcomes predominated (n = 53; 74.6%), with OS being the most frequent, followed by progression-free survival and disease-free survival. Novel endpoints (n = 18; 25.3%) included health-related QOL (HR-QOL), toxicity, geriatric assessment–based measures, composite endpoints, and patient satisfaction. HR-QOL was most commonly assessed using the European Organization for Research and Treatment of Cancer QLQ-C30. Definitions of toxicity and functional decline varied across studies. Variance assumptions were rarely reported, and minimal clinically important differences were inconsistently applied. Additional endpoints, such as quality-adjusted survival, overall treatment utility, and disability-free survival, were infrequently reported.

Discussion

Survival remains the predominant endpoint in confirmatory RCTs involving older adults with cancer, while patient-relevant outcomes are inconsistently incorporated. Addressing these gaps may facilitate more patient-centered trial designs and improve the real-world applicability of research findings for the aging cancer population.
老年人在癌症患者中所占的比例越来越大。然而,验证性随机对照试验(rct)仍然主要依赖于基于肿瘤的终点,如总生存期(OS),这可能忽略了对老年人特别重要的结果,包括生活质量(QOL)、功能状态和治疗耐受性。本综述旨在系统地描述入组年龄≥65岁成人的验证性随机对照试验中使用的主要终点,并评估如何定义和分析反映患者优先级的新终点。材料和方法检索了spubmed、CINAHL和Cochrane图书馆的英语验证性随机对照试验,这些随机对照试验专门纳入年龄≥65岁的癌症患者,并报告了一个主要终点(截至2024年1月19日)。终点分为常规(基于肿瘤)和新型(非基于肿瘤)。根据终点定义、测量工具和统计方法提取数据。结果在822条记录中,66项rct符合入选标准,产生71个主要终点。常规结果占主导地位(n = 53; 74.6%),其中OS最常见,其次是无进展生存期和无病生存期。新的终点(n = 18; 25.3%)包括与健康相关的生活质量(HR-QOL)、毒性、基于老年评估的措施、复合终点和患者满意度。HR-QOL最常用的评估方法是欧洲癌症研究和治疗组织的QLQ-C30。毒性和功能衰退的定义在不同研究中有所不同。方差假设很少被报道,最小的临床重要差异被不一致地应用。其他终点,如质量调整生存期、总体治疗效用和无残疾生存期,很少被报道。在涉及老年癌症患者的验证性随机对照试验中,生存仍然是主要的终点,而患者相关的结局并不一致。解决这些差距可能会促进更多以患者为中心的试验设计,并提高研究结果对老年癌症人群的现实适用性。
{"title":"Primary endpoints in randomized controlled trials for older adults with cancer: A scoping review","authors":"Tomonori Mizutani ,&nbsp;Funato Sato ,&nbsp;Kohei Uemura ,&nbsp;Yukari Shimizu ,&nbsp;Tsuguo Iwatani ,&nbsp;Satoshi Kobayashi ,&nbsp;Masataka Sawaki ,&nbsp;Shimon Tashiro ,&nbsp;Tetsuya Tsuji ,&nbsp;Hiroshi Yamamoto ,&nbsp;Asao Ogawa ,&nbsp;Tetsuya Hamaguchi ,&nbsp;on behalf of the Geriatric Study Committee of the Japan Clinical Oncology Group, Japan","doi":"10.1016/j.jgo.2026.102895","DOIUrl":"10.1016/j.jgo.2026.102895","url":null,"abstract":"<div><h3>Introduction</h3><div>Older adults represent a growing proportion of patients with cancer. However, confirmatory randomized controlled trials (RCTs) continue to rely primarily on tumor-based endpoints such as overall survival (OS), which may overlook outcomes particularly important to older adults, including quality of life (QOL), functional status, and treatment tolerance. This review aimed to systematically characterize the primary endpoints used in confirmatory RCTs enrolling adults aged ≥65 years and to evaluate how novel endpoints reflecting patient priorities were defined and analyzed.</div></div><div><h3>Materials and methods</h3><div>PubMed, CINAHL, and the Cochrane Library were searched for English-language confirmatory RCTs exclusively enrolling adults aged ≥65 years with cancer and reporting a primary endpoint (up to January 19, 2024). Endpoints were classified as conventional (tumor-based) or novel (non-tumor-based). Data were extracted on endpoint definitions, measurement tools, and statistical approaches.</div></div><div><h3>Results</h3><div>Of 822 records identified, 66 RCTs met the eligibility criteria, yielding 71 primary endpoints. Conventional outcomes predominated (<em>n</em> = 53; 74.6%), with OS being the most frequent, followed by progression-free survival and disease-free survival. Novel endpoints (<em>n</em> = 18; 25.3%) included health-related QOL (HR-QOL), toxicity, geriatric assessment–based measures, composite endpoints, and patient satisfaction. HR-QOL was most commonly assessed using the European Organization for Research and Treatment of Cancer QLQ-C30. Definitions of toxicity and functional decline varied across studies. Variance assumptions were rarely reported, and minimal clinically important differences were inconsistently applied. Additional endpoints, such as quality-adjusted survival, overall treatment utility, and disability-free survival, were infrequently reported.</div></div><div><h3>Discussion</h3><div>Survival remains the predominant endpoint in confirmatory RCTs involving older adults with cancer, while patient-relevant outcomes are inconsistently incorporated. Addressing these gaps may facilitate more patient-centered trial designs and improve the real-world applicability of research findings for the aging cancer population.</div></div>","PeriodicalId":15943,"journal":{"name":"Journal of geriatric oncology","volume":"17 2","pages":"Article 102895"},"PeriodicalIF":2.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146078059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Systematic review of frailty, functional status & comorbidities in older adults with multiple myeloma undergoing high dose therapy & autologous stem cell transplant 接受高剂量治疗和自体干细胞移植的老年多发性骨髓瘤患者的虚弱、功能状态和合并症的系统评价
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-26 DOI: 10.1016/j.jgo.2025.102846
Nadine Abdallah , Ashlyn O’Leary , Cynthia M. Schmidt , Sikander Ailawadhi , Hira Mian , Ashley Rosko , Tanya M. Wildes

Introduction

Improvements in supportive care strategies and growing evidence for benefit have led to increased use of autologous stem cell transplant (ASCT) in older patients with multiple myeloma (MM). However, the lack of standardized criteria for transplant eligibility often leaves the decision to the physician's clinical judgment. The roles of frailty/geriatric assessment tools, functional status, and comorbidity in selecting candidates and predicting transplant outcomes in older patients with MM remain uncertain. The purpose of this systematic review was to examine the measures of frailty, functional status, and comorbidity reported for older patients with MM who underwent ASCT and to evaluate their association with outcomes.

Materials and methods

On April 11, 2024, MEDLINE, EMBASE, and the Cochrane Library were searched for articles that included older adults (>60 years) with MM addressing the use of ASCT or ASCT eligibility/ineligibility. We included retrospective and prospective studies that included (1) at least one measure of functional status and/or comorbidities and (2) at least one transplant-related outcome (response rate, transplant-related mortality).

Results

Twenty-five studies were included, four prospective and 21 retrospective. Of these, four studies utilized the International Myeloma Working Group (IMWG) frailty index, with some including frail patients. In one study utilizing a comprehensive geriatric assessment, >50 % of older adults who were considered transplant-eligible reported dependence on ≥1 Instrumental Activities of Daily Living (IADL), severe limitations in vigorous activities, and/or self-reported weight loss. Eighteen studies reported a measure of functional status, most commonly Eastern Cooperative Oncology Group Performance Status; 19 studies reported a comorbidity measure, most commonly Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI). The comorbidity scores were generally low in patients who underwent ASCT (<3). The 100-day treatment-related mortality ranged from 0 % to 6 %, with overall response rates were generally high across studies.

Discussion

There is wide variability in the tools used to assess characteristics of older adults who underwent ASCT across studies. The optimal tool for selecting older ASCT candidates remains undefined, but it is likely that no single measure can adequately capture overall health status. Prospective studies incorporating a multidimensional assessment are necessary to better define transplant eligibility in this population.
导论:支持治疗策略的改进和越来越多的获益证据导致自体干细胞移植(ASCT)在老年多发性骨髓瘤(MM)患者中的应用增加。然而,缺乏移植资格的标准化标准往往使决定留给医生的临床判断。衰弱/老年评估工具、功能状态和合并症在选择候选者和预测老年MM患者移植结果中的作用仍然不确定。本系统综述的目的是检查接受ASCT治疗的老年MM患者的虚弱、功能状态和合并症,并评估其与预后的关系。材料和方法:2024年4月11日,检索MEDLINE、EMBASE和Cochrane图书馆,检索老年人(60 - 60岁)MM的文章,讨论ASCT的使用或ASCT是否合格。我们纳入了回顾性和前瞻性研究,这些研究包括:(1)至少一项功能状态和/或合并症的测量;(2)至少一项移植相关的结果(反应率、移植相关死亡率)。结果:纳入25项研究,4项前瞻性研究,21项回顾性研究。其中,四项研究使用了国际骨髓瘤工作组(IMWG)的虚弱指数,其中一些研究包括虚弱的患者。在一项利用综合老年病学评估的研究中,bb50 %被认为适合移植的老年人报告依赖≥1种日常生活工具活动(IADL),剧烈活动严重受限,和/或自我报告体重减轻。18项研究报告了功能状态的测量,最常见的是东部肿瘤合作小组的表现状态;19项研究报告了合并症测量,最常见的是造血细胞移植合并症指数(HCT-CI)。接受ASCT的患者的合并症评分通常较低(讨论:在不同研究中,用于评估接受ASCT的老年人特征的工具存在很大的差异。选择老年ASCT候选人的最佳工具仍不明确,但可能没有单一的措施可以充分捕捉整体健康状况。纳入多维评估的前瞻性研究对于更好地确定该人群的移植资格是必要的。
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引用次数: 0
Pre-existing autoimmune disease and risk of immune checkpoint inhibitor (ICI) discontinuation in older adults with melanoma 先前存在的自身免疫性疾病和老年黑色素瘤患者停止使用免疫检查点抑制剂(ICI)的风险
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-03-13 DOI: 10.1016/j.jgo.2026.102870
S. Sharma , H. Yao , K. Gandhi , A.L. Shaver , S.W. Keith , R.S. Seedor , N. Nikita
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引用次数: 0
Real-world outcomes of frontline polatuzumab and impact of frailty in older adults with newly diagnosed diffuse large B-cell lymphoma (DLBCL), a multicenter study 一项多中心研究:新诊断弥漫性大b细胞淋巴瘤(DLBCL)的老年人,前线polatuzumab的真实结局和虚弱的影响
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-03-13 DOI: 10.1016/j.jgo.2026.102880
P. Torka , J. Meeko Manzano , L. Chen , V. Iyengar , J. Chicola , D. Russler-Germain , V. Pizzuti , A. Major , Y. Sawalha , D. Wallace , N. Birrer , A. Bock , Y. Wang , J. Rhodes , J. Crombie , J. Alderuccio , P. Reidell , B. Heyman , C. Ujjani , H.-J. Cherng , S. Kambhampati Thiruvengadam
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引用次数: 0
Quality of life and grade 3+ toxicities in older men with advanced prostate cancer receiving geriatric assessment and/or remote symptom monitoring in a randomized trial 在一项随机试验中接受老年评估和/或远程症状监测的晚期前列腺癌老年男性患者的生活质量和3级以上毒性
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-03-13 DOI: 10.1016/j.jgo.2026.102859
S. Abdallah , A. Bukhari , S. Sabesan , W. Faiaz , U. Emmenegger , R. Jin , D. Khalaf , R. Lee , D. Ly , N. Jebanesan , C. Hernandez Favela , N. Segal , M. Krzyzanowska , E. Soto-Perez-de-Celis , S.K. Sridhar , L. Moody , E. Papadopoulos , R. Glicksman , J. Bender , A. Matthew , S.M.H. Alibhai
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引用次数: 0
Survival benefit from evidence-based treatment for rectal cancer among older people – Analysis of SEER-medicare 老年人直肠癌循证治疗的生存获益——seer医疗保险分析。
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-19 DOI: 10.1016/j.jgo.2026.102851
Uma R. Phatak , Yong Shan , Yong-Fang Kuo

Introduction

The treatment of stage III rectal cancer (RC) is complex and requires a multidisciplinary approach. Evidence-based guidelines (EBG) exist for the treatment of RC. We aimed to determine adherence to EBG in the treatment of stage III RC and the impact on survival in older adults.

Materials and methods

This is a retrospective study of patients within the Surveillance, Epidemiology, and End Results program (SEER). We included adults with stage III RC between 2007 and 2018 with one pathologically confirmed primary tumor. We defined guideline-based care as receipt of: chemoradiation within 6 months of date of diagnosis; surgery within 6 months of completion of chemoradiation; and chemotherapy after surgery. Overall survival (OS) and cancer-specific survival (CSS) were analyzed using the Kaplan-Meier method. Multivariable Cox regression was performed to determine factors associated with survival.

Results

We identified 3962 patients, and 1945 (49.1%) were female. There were 1707 (43.1%) with a Charlson Comorbidity Index of zero. Of the total, 994 (25.1%) received all guideline-based treatments. Factors associated with lack of guideline-based care included age, comorbidities, income, and geographic location. Guideline-based care was associated with increased OS (HR: 0.55, 95% CI: 0.49–0.60) and CSS (HR: 0.59, 95% CI: 0.48–0.73).

Discussion

Although 43.1% of the cohort had a comorbidity index of zero, only 25.1% received all guideline-based treatments. Deviation from guideline-based care had a significant impact on OS. Our data show that more efforts can be made to recommend multimodal RC treatment among older adults.
III期直肠癌(RC)的治疗是复杂的,需要多学科的方法。针对RC的治疗存在循证指南(EBG)。我们的目的是确定EBG治疗III期RC的依从性及其对老年人生存的影响。材料和方法:这是一项对监测、流行病学和最终结果项目(SEER)患者的回顾性研究。我们纳入了2007年至2018年间患有III期RC的成年人,其中有一个病理证实的原发肿瘤。我们将基于指南的治疗定义为:诊断后6个月内接受放化疗;放化疗完成后6个月内手术;还有手术后的化疗。采用Kaplan-Meier法分析总生存期(OS)和肿瘤特异性生存期(CSS)。采用多变量Cox回归确定与生存率相关的因素。结果:3962例患者中女性1945例(49.1%)。Charlson合并症指数为零的1707例(43.1%)。其中,994例(25.1%)接受了所有基于指南的治疗。与缺乏基于指南的护理相关的因素包括年龄、合并症、收入和地理位置。基于指南的护理与OS (HR: 0.55, 95% CI: 0.49-0.60)和CSS (HR: 0.59, 95% CI: 0.48-0.73)的增加相关。讨论:尽管43.1%的队列患者的合并症指数为零,但只有25.1%的患者接受了所有基于指南的治疗。偏离基于指南的护理对OS有显著影响。我们的数据表明,在老年人中推荐多模式RC治疗可以做更多的努力。
{"title":"Survival benefit from evidence-based treatment for rectal cancer among older people – Analysis of SEER-medicare","authors":"Uma R. Phatak ,&nbsp;Yong Shan ,&nbsp;Yong-Fang Kuo","doi":"10.1016/j.jgo.2026.102851","DOIUrl":"10.1016/j.jgo.2026.102851","url":null,"abstract":"<div><h3>Introduction</h3><div>The treatment of stage III rectal cancer (RC) is complex and requires a multidisciplinary approach. Evidence-based guidelines (EBG) exist for the treatment of RC. We aimed to determine adherence to EBG in the treatment of stage III RC and the impact on survival in older adults.</div></div><div><h3>Materials and methods</h3><div>This is a retrospective study of patients within the Surveillance, Epidemiology, and End Results program (SEER). We included adults with stage III RC between 2007 and 2018 with one pathologically confirmed primary tumor. We defined guideline-based care as receipt of: chemoradiation within 6 months of date of diagnosis; surgery within 6 months of completion of chemoradiation; and chemotherapy after surgery. Overall survival (OS) and cancer-specific survival (CSS) were analyzed using the Kaplan-Meier method. Multivariable Cox regression was performed to determine factors associated with survival.</div></div><div><h3>Results</h3><div>We identified 3962 patients, and 1945 (49.1%) were female. There were 1707 (43.1%) with a Charlson Comorbidity Index of zero. Of the total, 994 (25.1%) received all guideline-based treatments. Factors associated with lack of guideline-based care included age, comorbidities, income, and geographic location. Guideline-based care was associated with increased OS (HR: 0.55, 95% CI: 0.49–0.60) and CSS (HR: 0.59, 95% CI: 0.48–0.73).</div></div><div><h3>Discussion</h3><div>Although 43.1% of the cohort had a comorbidity index of zero, only 25.1% received all guideline-based treatments. Deviation from guideline-based care had a significant impact on OS. Our data show that more efforts can be made to recommend multimodal RC treatment among older adults.</div></div>","PeriodicalId":15943,"journal":{"name":"Journal of geriatric oncology","volume":"17 2","pages":"Article 102851"},"PeriodicalIF":2.7,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146010334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"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
Safety of CDK4/6 inhibitors in older patients: A FAERS-based analysis of serious and fatal adverse events CDK4/6抑制剂在老年患者中的安全性:基于faers的严重和致命不良事件分析
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2025-12-11 DOI: 10.1016/j.jgo.2025.102820
Fausto Petrelli , Alessandro Iaculli , Maria Chiara Parati , Karen Borgonovo , Mara Ghilardi , Veronica Lonati , Irene Angeli , Lorenzo Dottorini

Introduction

CDK4/6 inhibitors—abemaciclib, palbociclib, and ribociclib—are standard treatments for hormone receptor–positive, ERBB2 (HER2)-negative metastatic breast cancer. However, older adults are underrepresented in clinical trials, and age-related safety data remain limited in real-world settings.

Materials and Methods

We conducted a pharmacovigilance analysis using 44,100 individual case safety reports (ICSRs) from the FDA Adverse Event Reporting System (FAERS) involving patients aged ≥65 years treated with CDK4/6 inhibitors. Primary endpoints included serious adverse events (SAEs) and fatal outcomes. A secondary analysis compared adverse events between patients aged <65 and 65–85 years, calculating odds ratios (ORs) for selected toxicities, including death, disease progression, diarrhea, and myelosuppression.

Results

Among older patients, 71.2 % of reports involved SAEs and 5.3 % were fatal. Abemaciclib was linked to higher risk of death in those aged 65–85 compared to younger adults (OR 1.53; 95 % CI 1.18–1.99), but lower odds of myelosuppression (OR 0.37; 95 % CI 0.26–0.53). Palbociclib showed similar death risk across age groups (OR 0.98; 95 % CI 0.92–1.05) and reduced risk of disease progression in older adults (OR 0.72; 95 % CI 0.61–0.84). Ribociclib showed no significant age-related difference in fatality (OR 1.01; 95 % CI 0.87–1.17) but had the highest overall death risk (OR 9.14 vs palbociclib; 95 % CI 7.70–10.84).

Discussion

Real-world data reveal drug- and age-specific toxicity differences. Ribociclib and abemaciclib pose higher risks in older adults compared to palbociclib, supporting the need for personalized treatment and careful monitoring in older patients.
cdk4 /6抑制剂abemaciclib、palbociclib和ribociclib是激素受体阳性、ERBB2 (HER2)阴性转移性乳腺癌的标准治疗药物。然而,老年人在临床试验中的代表性不足,与年龄相关的安全性数据在现实环境中仍然有限。材料和方法我们对来自FDA不良事件报告系统(FAERS)的44,100例个体安全报告(ICSRs)进行了药物警戒分析,涉及年龄≥65岁的CDK4/6抑制剂治疗患者。主要终点包括严重不良事件(SAEs)和致命结局。第二项分析比较了65岁和65 - 85岁患者的不良事件,计算了所选毒性的优势比(or),包括死亡、疾病进展、腹泻和骨髓抑制。结果在老年患者中,71.2%的报告涉及SAEs, 5.3%的报告死亡。与年轻人相比,Abemaciclib与65-85岁患者的死亡风险相关(OR 1.53; 95% CI 1.18-1.99),但骨髓抑制的风险较低(OR 0.37; 95% CI 0.26-0.53)。帕博西尼在各年龄组显示相似的死亡风险(OR 0.98; 95% CI 0.92-1.05),老年人疾病进展风险降低(OR 0.72; 95% CI 0.61-0.84)。Ribociclib在病死率方面没有显着的年龄相关差异(OR 1.01; 95% CI 0.87-1.17),但总体死亡风险最高(OR 9.14 vs palbociclib; 95% CI 7.70-10.84)。真实世界的数据揭示了药物和年龄特异性的毒性差异。与帕博西尼相比,Ribociclib和abemaciclib在老年人中具有更高的风险,这支持了老年患者个性化治疗和仔细监测的必要性。
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引用次数: 0
Adding comprehensive geriatric assessment to standard of care in older patients with frailty and hematological cancer: A pilot and feasibility study 在老年虚弱和血液病患者的标准护理中加入综合老年评估:一项试点和可行性研究
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2025-12-13 DOI: 10.1016/j.jgo.2025.102835
Nina Andersen , Ann Kristine Weber Giger , Dana Audrey Lawrie , Wee Kheng Soo , Cecilia Margareta Lund , Jesper Ryg , Henrik Frederiksen
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引用次数: 0
Geriatric prehabilitation prior to surgery for kidney tumors: Study protocol for Pre-KiT - A randomized controlled trial 肾脏肿瘤手术前的老年康复:Pre-KiT的研究方案-一项随机对照试验。
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-26 DOI: 10.1016/j.jgo.2026.102893
Marie Juul-Haslund , Cecilia M. Lund , Troels G. Dolin , Katrine Schou-Jensen , Peter B. Østergren , Anders Vinther , Frederik F. Thomsen , Mikkel Fode

Introduction

Renal cell carcinoma (RCC) primarily affects older adults who often present with frailty, increasing their risk of surgical complications and delayed recovery. Prehabilitation, incorporating exercise, nutrition, and psychological support, may improve postoperative outcomes. However, no studies have investigated prehabilitation prior to surgery for RCC. The aim is to assess whether a one-month multimodal prehabilitation program including geriatric interventions improves recovery in patients with frailty undergoing surgery for localized RCC ≤ 7 cm.

Materials and methods

60 patients, aged ≥65, with a Clinical Frailty Scale (CFS) score of 3–6 are randomized 1:1 to standard care or prehabilitation involving home-based exercise, geriatric assessment with tailored interventions, and smoking cessation support. The primary outcome is change in Quality of Recovery-15 (QoR-15) 21 days postoperatively. Secondary outcomes include changes in QoR-15, health-related quality of life (EQ-5D-5L) and physical performance (30-s chair-stand test, handgrip strength) assessed preoperatively, 1, 21 and 90 days postoperatively. Postoperative complications will be evaluated using the Clavien-Dindo classification, alongside a cost-effectiveness analysis. Long-term outcomes include 1- and 5-year recurrence-free, cancer-specific, and overall survival.

Discussion

Pre-KiT explores if a pragmatic geriatric prehabilitation strategy is effective and feasible for older frail patients with RCC. The intervention is designed for easy implementation in clinical practice: administered by a single healthcare professional, requiring only one additional hospital visit, and consists of home-based exercises. This low-resource approach also aims to minimize financial costs, which is of importance for implementation possibilities. If successful, it could improve standard care and outcomes after surgery.
Trial registration: ClinicalTrials.gov ID: NCT06745609. Prospectively registered December 12th, 2024.
肾细胞癌(RCC)主要影响老年人,他们经常表现出虚弱,增加了手术并发症和延迟恢复的风险。康复训练,包括运动、营养和心理支持,可以改善术后预后。然而,没有研究调查RCC手术前的康复。目的是评估包括老年干预在内的为期一个月的多模式康复计划是否能改善因局限性RCC≤7 cm而接受手术的虚弱患者的康复。材料和方法:60例年龄≥65岁,临床虚弱量表(CFS)评分为3-6分的患者,以1:1的比例随机分为标准治疗或康复治疗,包括基于家庭的锻炼、定制干预的老年评估和戒烟支持。主要观察指标为术后21天恢复质量-15 (QoR-15)的变化。次要结局包括术前、术后1、21和90天评估的QoR-15、健康相关生活质量(EQ-5D-5L)和身体表现(30秒椅架测试、握力)的变化。术后并发症将使用Clavien-Dindo分类进行评估,并进行成本-效果分析。长期预后包括1年和5年无复发、癌症特异性和总生存期。讨论:Pre-KiT探讨了一种实用的老年康复策略对患有肾细胞癌的老年体弱患者是否有效和可行。该干预措施旨在便于在临床实践中实施:由一名保健专业人员管理,只需要一次额外的医院就诊,并包括以家庭为基础的练习。这种低资源方法还旨在尽量减少财政成本,这对执行的可能性很重要。如果成功,它可以改善手术后的标准护理和结果。试验注册:ClinicalTrials.gov ID: NCT06745609。预计于2024年12月12日注册。
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引用次数: 0
A literature review on hypothalamic–pituitary–adrenal (HPA) axis dysregulation in older adults with cancer: A missing link in predicting treatment toxicity? 关于老年癌症患者下丘脑-垂体-肾上腺(HPA)轴失调的文献综述:预测治疗毒性的缺失环节?
IF 2.7 3区 医学 Q3 GERIATRICS & GERONTOLOGY Pub Date : 2026-03-01 Epub Date: 2026-01-24 DOI: 10.1016/j.jgo.2026.102854
Len De Nys
Older adults with cancer face disproportionately high rates of severe treatment-related toxicities, yet current prediction tools rarely incorporate biomarkers that capture physiological resilience. The hypothalamic–pituitary–adrenal (HPA) axis—central to stress adaptation, immune regulation, and tissue repair—undergoes pronounced age-related alterations, including elevated basal cortisol, reduced dehydroepiandrosterone (DHEA) and its sulphate form DHEAS, and an increased cortisol:DHEA(S) ratio. These changes may impair immune function, delay recovery, and exacerbate vulnerability to treatment toxicity. This narrative review synthesizes mechanistic and clinical evidence linking HPA-axis dysregulation to treatment tolerance in geriatric oncology. Common patterns include blunted diurnal cortisol slopes, elevated evening cortisol, and low DHEA(S), which are associated with fatigue, functional decline, and reduced survival across cancer types. However, their predictive value for acute treatment toxicities remains underexplored due to methodological heterogeneity, lack of age-specific reference ranges, and absence from existing geriatric toxicity models. This review proposes a translational roadmap that prioritizes (1) standardization of salivary cortisol/DHEA(S) protocols; (2) prospective, age-stratified validation studies using standardized toxicity endpoints; (3) interventional testing of behavioral or pharmacological strategies to modulate HPA function; and (4) integration into oncology workflows and electronic decision-support tools. Incorporating endocrine biomarkers into risk prediction could refine treatment stratification, enable targeted supportive care, and ultimately improve outcomes for older patients with cancer.
患有癌症的老年人面临着不成比例的高比例的严重治疗相关毒性,但目前的预测工具很少纳入捕捉生理弹性的生物标志物。下丘脑-垂体-肾上腺(HPA)轴-应激适应、免疫调节和组织修复的中心-经历明显的年龄相关改变,包括基础皮质醇升高,脱氢表雄酮(DHEA)及其硫酸盐形式DHEAS减少,皮质醇:DHEA(S)比率增加。这些变化可能损害免疫功能,延缓恢复,并加剧对治疗毒性的易感性。这篇叙述性综述综合了hpa轴失调与老年肿瘤治疗耐受性之间的机制和临床证据。常见的模式包括昼夜皮质醇斜率变钝、夜间皮质醇升高和低脱氢表雄酮(S),这与疲劳、功能下降和癌症类型的生存率降低有关。然而,由于方法学的异质性,缺乏年龄特异性参考范围,以及缺乏现有的老年毒性模型,它们对急性治疗毒性的预测价值仍未得到充分探讨。本综述提出了一个翻译路线图,优先考虑(1)唾液皮质醇/脱氢表雄酮(S)协议的标准化;(2)使用标准化毒性终点的前瞻性年龄分层验证研究;(3)干预测试调节HPA功能的行为或药物策略;(4)整合肿瘤学工作流程和电子决策支持工具。将内分泌生物标志物纳入风险预测可以细化治疗分层,实现有针对性的支持性护理,并最终改善老年癌症患者的预后。
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引用次数: 0
期刊
Journal of geriatric oncology
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