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Premature Deaths and Life-Years Lost From Lack of Amivantamab in Brazil's Unified Health System. 巴西统一卫生系统中阿米万他抗缺乏导致的过早死亡和寿命损失。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-19 DOI: 10.1200/GO-25-00302
Gabriel Lenz, Rafael Alvim Pereira, Wallace Klein Schwengber, Milena Tumelero, Nicolas Peruzzo, Leonardo Stone Lago, Gilberto Lopes

Purpose: Lung cancer remains a leading cause of cancer mortality in Brazil, with non-small cell lung cancer (NSCLC) accounting for 85% of cases, with 1.6% carrying epidermal growth factor receptor (EGFR) exon 20 mutations. In the phase I CHRYSALIS trial (ClinicalTrials.gov identifier: NCT02609776), amivantamab demonstrated a median overall survival (OS) of 22.8 months versus 8.3 months with docetaxel, the standard second-line Brazil's Unified Health System (SUS) therapy. Although the Brazilian Health Regulatory Agency approved amivantamab, the National Commission for the Incorporation of Technologies' cost-effectiveness reviews result in an average 10-year delay before SUS incorporation. We aimed to estimate premature deaths and life-years lost attributable to this access gap.

Methods: Using National Institute of Cancer (INCA) data, we estimated SUS-eligible patients, NSCLC prevalence, and EGFR exon 20 frequency. Stage distribution and 5-year recurrence rates identify candidates for amivantamab. A hazard ratio (HR) was derived from the inverse exponential method (ln(2)/OS ratio). Preventable deaths were calculated as: eligible patients × (1 - HR). Life-years gained per patient were estimated as OS difference.

Results: Of the 26,548 new patients with lung cancer, 18,973 are SUS-eligible, 16,127 have NSCLC, and 258 have EGFR exon 20 mutations. Metastatic disease accounts for 114, whereas recurrences occur in 60 (stage III), eight (II), and four (I), totaling 186 candidates annually. With an HR of 0.364, the annual preventable death in the base-case scenario is equal to 186 × (1 - 0.364) × 95% = 112 patients. Over 10 years, 1,120 premature deaths and 1,353 life-years could be avoided.

Conclusion: Delayed SUS incorporation of amivantamab may result in over a 1,000 preventable deaths and life-years lost among Brazilian EGFR exon 20-mutated NSCLC. Urgent real-world studies and cost-effectiveness analyses are needed.

目的:肺癌仍然是巴西癌症死亡的主要原因,非小细胞肺癌(NSCLC)占85%的病例,其中1.6%携带表皮生长因子受体(EGFR)外显子20突变。在CHRYSALIS I期试验(ClinicalTrials.gov标识号:NCT02609776)中,阿米万他单抗的中位总生存期(OS)为22.8个月,而多西他赛(docetaxel)为8.3个月,多西他赛是巴西统一卫生系统(SUS)的标准二线治疗。尽管巴西卫生监管机构批准了amivantamab,但国家技术整合委员会的成本效益审查导致在纳入SUS之前平均延迟10年。我们的目的是估计由于这一获取差距导致的过早死亡和生命年损失。方法:使用美国国家癌症研究所(INCA)的数据,我们估计了符合sus条件的患者、NSCLC患病率和EGFR外显子20的频率。分期分布和5年复发率确定了阿米伐他单抗的候选药物。风险比(HR)采用逆指数法(ln(2)/OS比)计算。可预防死亡计算为:符合条件的患者× (1 - HR)。每位患者获得的生命年以OS差异估计。结果:在26548例新发肺癌患者中,18973例符合sus标准,16127例为NSCLC, 258例为EGFR外显子20突变。转移性疾病占114例,而复发发生在60例(III期),8例(II期)和4例(I期),每年共计186例候选人。HR为0.364,在基本情况下,每年可预防的死亡人数等于186 × (1 - 0.364) × 95% = 112例患者。在10年内,可以避免1 120例过早死亡和1 353个生命年。结论:在巴西EGFR外显子20突变的NSCLC中,延迟SUS合并阿米万他单可能导致超过1000例可预防的死亡和生命年损失。迫切需要现实世界的研究和成本效益分析。
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引用次数: 0
Pharmacogenomic Impact on Breast Cancer Survival for Black Zimbabwean Patients on Tamoxifen. 药物基因组学对服用他莫昔芬的津巴布韦黑人乳腺癌患者生存率的影响。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-19 DOI: 10.1200/GO-25-00367
Tinashe A Mazhindu, E Duke Chase, Matthew Joel, Ntokozo Ndlovu, Margaret Z Borok, Collen Masimirembwa, Audrey E Hendricks

Purpose: About one in three Black Africans carry the African-predominant allele variants CYP2D6*17 and/or CYP2D6*29, which confer a reduced enzymatic activity. CYP2D6 intermediate metabolizers (IM) have a reduced biotransformation rate of tamoxifen compared with its more active metabolite endoxifen.

Methods: A prospective cohort study of Black Zimbabwean patients with hormone receptor-positive breast cancer on tamoxifen therapy was conducted. Patients were genotyped for CYP2D6 and followed up for event-free survival (EFS) on tamoxifen.

Results: In total, 18 CYP2D6 IM and 33 normal metabolizers (NM) were enrolled. At 2 years, the estimated EFS was 40.1% (95% CI, 20.3 to 79.4) for the IM group and 84.0% (95% CI, 72.1 to 97.9) for the NM group (log-rank P = .0021). A Cox proportional hazards model, after adjusting for BMI, stage at diagnosis, and previous breast cancer surgery, estimated about a 5.5-fold higher hazard of recurrence, progression, or death in IM compared with NM.

Conclusion: Individuals with hormone receptor-positive breast cancer who are CYP2D6 NM had better disease recurrence and progression-free survival outcomes compared with IM.

目的:大约三分之一的非洲黑人携带非洲显性等位基因变异CYP2D6*17和/或CYP2D6*29,这导致酶活性降低。CYP2D6中间代谢物(IM)与他莫昔芬更活跃的代谢物endoxifen相比,其生物转化速率降低。方法:对津巴布韦黑人激素受体阳性乳腺癌患者进行他莫昔芬治疗的前瞻性队列研究。对患者进行CYP2D6基因分型,并随访他莫昔芬治疗后的无事件生存期(EFS)。结果:共纳入18例CYP2D6 IM和33例正常代谢物(NM)。在2年时,IM组的估计EFS为40.1% (95% CI, 20.3至79.4),NM组的估计EFS为84.0% (95% CI, 72.1至97.9)(log-rank P = 0.0021)。在调整BMI、诊断阶段和既往乳腺癌手术后,Cox比例风险模型估计IM的复发、进展或死亡风险比NM高5.5倍。结论:CYP2D6 NM的激素受体阳性乳腺癌患者与IM相比具有更好的疾病复发和无进展生存结果。
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引用次数: 0
Geriatric Assessment: ASCO Global Guideline Clinical Insights. 老年评估:ASCO全球指南临床见解。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-05 DOI: 10.1200/GO-25-00309
Haydee C Verduzco-Aguirre, Sarah Temin, Cristiane Decat Bergerot, Enrique Soto-Perez-de-Celis
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引用次数: 0
Late Presentation and Treatment Outcomes of Gastric Carcinoma in Jordanian Population. 约旦人群胃癌的晚期表现和治疗结果。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-05 DOI: 10.1200/GO-25-00266
Hikmat Abdel-Razeq, Maha Barbar, Rashid Abdel-Razeq, Issa Mohamad, Fawzi Abuhijla, Adel Muhanna, Razan Mansour, Ayat Taqash, Kholoud Alqasem, Asem Mansour

Purpose: Majority of the patients with gastric cancer in resource-restricted country, like Jordan, are diagnosed with advanced-stage disease with poor treatment outcomes. This study explores the state of gastric cancer in Jordan and outlines strategies for disease control.

Materials and methods: Data on disease stage at presentation and treatment outcomes were obtained from the King Hussein Cancer Center registry. Patients were staged according to the US SEER staging system, which classifies gastric cancer into localized, regional and distant. Overall survival (OS) was reported for the whole group and stratified by age at diagnosis, stage, sex, and year of diagnosis, and compared with published data from the United States and Asia.

Results: During the study period, a total of 888 patients were treated and followed up at our institution. The majority (n = 503, 56.6%) were diagnosed with distant metastases); 315 (35.5%) had regional disease and only a minority (n = 70, 7.9%) had localized disease. After a median follow-up of 5.7 (1.3-18.7) years, the 5-year OS for the entire cohort was 18.1% (95% CI, 15.5% to 20.8%), varying by stage; 62.9% (95% CI, 50.7% to 74.3%) for localized disease, 34.1% (95% CI, 28.7% to 39.8%) for regional disease, and only 1.86% (95% CI, 0.80% to 3.36%) for distant metastasis, P < .0001. Patients' age at diagnosis (<40 v ≥40 years), sex, or year at diagnosis (recent years v >10 years ago) had no significant impact on 5-year OS.

Conclusion: Although gastric cancer is relatively uncommon in Jordan, fewer than 10% of patients are diagnosed at an early, localized disease, contributing to persistently poor treatment outcomes with little improvement over time. National initiatives and strategies to improve treatment outcome are urgently needed.

目的:在约旦等资源受限的国家,胃癌患者多为晚期,治疗效果较差。本研究探讨了约旦胃癌的状况,并概述了疾病控制的策略。材料和方法:疾病出现时的分期和治疗结果的数据来自侯赛因国王癌症中心登记处。患者按照美国SEER分期系统进行分期,将胃癌分为局部、局部和远处。报告了整个组的总生存期(OS),并按诊断时的年龄、分期、性别和诊断年份进行了分层,并与美国和亚洲发表的数据进行了比较。结果:研究期间,共有888例患者在我院接受了治疗和随访。大多数(n = 503, 56.6%)被诊断为远处转移;315例(35.5%)有区域性疾病,只有少数(70例,7.9%)有局限性疾病。中位随访5.7年(1.3-18.7年)后,整个队列的5年OS为18.1% (95% CI, 15.5% - 20.8%),随分期而变化;局部病变62.9% (95% CI, 50.7% ~ 74.3%),局部病变34.1% (95% CI, 28.7% ~ 39.8%),远处转移仅1.86% (95% CI, 0.80% ~ 3.36%), P < 0.0001。患者的诊断年龄(≥40岁)、性别、诊断年份(最近几年至10年前)对5年OS无显著影响。结论:虽然胃癌在约旦相对罕见,但只有不到10%的患者在早期被诊断为局部疾病,导致治疗结果持续不佳,随着时间的推移几乎没有改善。迫切需要采取国家行动和战略来改善治疗结果。
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引用次数: 0
Perceptions of Value in Cancer Care Across Distinct Health Systems: A Comparison of Providers in High- and Low- and Middle-Income Countries. 不同卫生系统对癌症治疗价值的认知:高、中、低收入国家提供者的比较
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-05 DOI: 10.1200/GO-25-00280
Edward A Joseph, Muhammad Anees, Bibek Aryal, Shreya Acharya, Merina Pandey, Saqib K Bakhshi, David L Bartlett, Adil Haider, Casey J Allen

Purpose: Value in health care is a multifaceted concept encompassing patient outcomes, treatment effectiveness, and costs. However, the definition of value can vary between distinct health systems. We compared the perceptions of value in cancer care between providers in high-income countries (HICs) and low- and middle-income countries (LMICs).

Materials and methods: A novel survey assessed the relative importance of health care priorities, including longevity, experience, functional and emotional well-being, costs to patients, and costs to the health system between providers in HICs and LMICs. Kendall's coefficient of concordance assessed agreement between groups.

Results: We received 365 responses: 216 (59.2%) from HICs and 149 (40.8%) from LMICs. HIC providers more frequently rated treatment experience (82.9% v 65.1%) and patient functional independence (72.7% v 59.7%) as extremely important, while fewer rated emotional well-being (65.3% v 78.5%) and costs to the health system (26.4% v 51.7%) as such (all P < .050). With consensus (HIC: W = 35%; P < .001; LMIC: W = 19%; P < .001), both cohorts ranked patient emotional well-being (2.56 ± 1.30 HIC v 2.74 ± 1.58 LMIC; P = .254) as the most important priority. HICs placed higher priority on treatment experience (3.02 ± 1.55 v 3.59 ± 1.47; P < .001) and less on costs to the health system (5.56 ± 1.15 v 4.97 ± 1.44; P < .001), when compared with LMICs.

Conclusion: Although there is consensus on the importance of patient-centered outcomes, the prioritization of treatment experience and costs of care to the health system differ between HICs and LMICs. These findings underscore the importance of developing adaptable value frameworks that are relevant and effective across diverse health care settings.

目的:医疗保健中的价值是一个多方面的概念,包括患者结果、治疗效果和成本。然而,价值的定义在不同的卫生系统之间可能有所不同。我们比较了高收入国家(HICs)和低收入和中等收入国家(LMICs)提供者对癌症护理价值的看法。材料和方法:一项新的调查评估了卫生保健优先事项的相对重要性,包括寿命、经验、功能和情感健康、患者成本以及高收入国家和中低收入国家提供者之间卫生系统的成本。肯德尔一致性系数评估组间的一致性。结果:共收到365份回复,其中高收入国家216份(59.2%),低收入国家149份(40.8%)。HIC提供者更频繁地认为治疗经验(82.9% vs 65.1%)和患者功能独立性(72.7% vs 59.7%)极其重要,而较少地认为情绪健康(65.3% vs 78.5%)和卫生系统成本(26.4% vs 51.7%)是如此(均P < .050)。结果一致(HIC: W = 35%; P < .001; LMIC: W = 19%; P < .001),两个队列都将患者情绪健康(2.56±1.30 HIC vs 2.74±1.58 LMIC; P = .254)列为最重要的优先事项。与中低收入国家相比,高收入国家更重视治疗经验(3.02±1.55 v 3.59±1.47;P < .001),而对卫生系统成本的重视程度较低(5.56±1.15 v 4.97±1.44;P < .001)。结论:尽管人们对以患者为中心的结果的重要性达成共识,但在高收入国家和中低收入国家之间,治疗经验的优先级和卫生系统的护理成本有所不同。这些发现强调了在不同的卫生保健环境中制定相关和有效的适应性价值框架的重要性。
{"title":"Perceptions of Value in Cancer Care Across Distinct Health Systems: A Comparison of Providers in High- and Low- and Middle-Income Countries.","authors":"Edward A Joseph, Muhammad Anees, Bibek Aryal, Shreya Acharya, Merina Pandey, Saqib K Bakhshi, David L Bartlett, Adil Haider, Casey J Allen","doi":"10.1200/GO-25-00280","DOIUrl":"https://doi.org/10.1200/GO-25-00280","url":null,"abstract":"<p><strong>Purpose: </strong>Value in health care is a multifaceted concept encompassing patient outcomes, treatment effectiveness, and costs. However, the definition of value can vary between distinct health systems. We compared the perceptions of value in cancer care between providers in high-income countries (HICs) and low- and middle-income countries (LMICs).</p><p><strong>Materials and methods: </strong>A novel survey assessed the relative importance of health care priorities, including longevity, experience, functional and emotional well-being, costs to patients, and costs to the health system between providers in HICs and LMICs. Kendall's coefficient of concordance assessed agreement between groups.</p><p><strong>Results: </strong>We received 365 responses: 216 (59.2%) from HICs and 149 (40.8%) from LMICs. HIC providers more frequently rated treatment experience (82.9% <i>v</i> 65.1%) and patient functional independence (72.7% <i>v</i> 59.7%) as extremely important, while fewer rated emotional well-being (65.3% <i>v</i> 78.5%) and costs to the health system (26.4% <i>v</i> 51.7%) as such (all <i>P</i> < .050). With consensus (HIC: W = 35%; <i>P</i> < .001; LMIC: W = 19%; <i>P</i> < .001), both cohorts ranked patient emotional well-being (2.56 ± 1.30 HIC <i>v</i> 2.74 ± 1.58 LMIC; <i>P</i> = .254) as the most important priority. HICs placed higher priority on treatment experience (3.02 ± 1.55 <i>v</i> 3.59 ± 1.47; <i>P</i> < .001) and less on costs to the health system (5.56 ± 1.15 <i>v</i> 4.97 ± 1.44; <i>P</i> < .001), when compared with LMICs.</p><p><strong>Conclusion: </strong>Although there is consensus on the importance of patient-centered outcomes, the prioritization of treatment experience and costs of care to the health system differ between HICs and LMICs. These findings underscore the importance of developing adaptable value frameworks that are relevant and effective across diverse health care settings.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500280"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145451936","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Empowering Global Hematology-Oncology Education: Assessing the Impact of a Virtual Platform in Combating Educational Inequity. 授权全球血液肿瘤学教育:评估虚拟平台在打击教育不平等方面的影响。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-26 DOI: 10.1200/GO-25-00190
Yan Leyfman, Viviana Cortiana, Maduri Balasubramanian, Gayathri Pramil Menon, Muskan Joshi, Alexandra Van de Kieft, Harshal Chorya, Jenna Ghazal, Helena S Coloma, Ghena Khasawneh, Jade Gambill, Chandler H Park, Arturo Loaiza-Bonilla

Purpose: Social media informs 77% of patients with cancer, yet one third of posts contain misinformation. MedNews Week (MNW) is a volunteer virtual platform that delivers expert hematology-oncology content while intentionally pursuing gender balance.

Methods: We analyzed program metrics (January 2022-June 2023) for 36 biweekly keynotes by oncology leaders (mean H-index 50.1). Aggregated audience demographics and engagement data were exported from X (Twitter), LinkedIn, YouTube, and Clubhouse. Unique reach, geographic distribution, and growth were calculated after deduplicating cross-platform IDs. Attendance and engagement were compared by speaker gender with χ2 tests and linear regression.

Results: MNW reached 743,991 unique viewers across 95 countries, including 23 low- and middle-income nations, and rose 10.5-fold in attendance over 18 months. Speakers achieved gender parity (18 women, 18 men); female-led sessions drew similar live attendance and video views (P = .41). MNW ranks in the top 0.07 percentile for health care influence on X. Participants included clinicians (40%), patients/advocates (22%), students (18%), and nonmedical stakeholders (20%).

Conclusion: A no-cost, volunteer, gender-balanced platform can rapidly scale credible oncology education worldwide, counter misinformation, and engage under-resourced audiences. Sustained partnerships and outcome assessments are warranted.

目的:社交媒体告知77%的癌症患者,但三分之一的帖子包含错误信息。MedNews Week (MNW)是一个志愿者虚拟平台,提供专业的血液肿瘤学内容,同时有意追求性别平衡。方法:我们分析了36位肿瘤学领导者(平均h指数50.1)每两周做一次主题演讲的项目指标(2022年1月至2023年6月)。聚合的用户统计数据和用户粘性数据是从X (Twitter)、LinkedIn、YouTube和Clubhouse导出的。在删除跨平台id后计算出独特的覆盖范围、地理分布和增长情况。采用χ2检验和线性回归比较讲话者性别的出席率和参与度。结果:MNW在95个国家拥有743,991名独立观众,其中包括23个低收入和中等收入国家,在18个月的时间里,观众人数增长了10.5倍。发言者实现性别平等(18名妇女,18名男子);女性主导的会议吸引了类似的现场出席率和视频浏览量(P = 0.41)。MNW在医疗保健对x的影响方面排名前0.07个百分位数。参与者包括临床医生(40%)、患者/倡导者(22%)、学生(18%)和非医疗利益相关者(20%)。结论:一个免费的、自愿的、性别平衡的平台可以在全球范围内迅速扩大可信的肿瘤学教育,反击错误信息,并吸引资源不足的受众。持续的伙伴关系和成果评估是必要的。
{"title":"Empowering Global Hematology-Oncology Education: Assessing the Impact of a Virtual Platform in Combating Educational Inequity.","authors":"Yan Leyfman, Viviana Cortiana, Maduri Balasubramanian, Gayathri Pramil Menon, Muskan Joshi, Alexandra Van de Kieft, Harshal Chorya, Jenna Ghazal, Helena S Coloma, Ghena Khasawneh, Jade Gambill, Chandler H Park, Arturo Loaiza-Bonilla","doi":"10.1200/GO-25-00190","DOIUrl":"https://doi.org/10.1200/GO-25-00190","url":null,"abstract":"<p><strong>Purpose: </strong>Social media informs 77% of patients with cancer, yet one third of posts contain misinformation. MedNews Week (MNW) is a volunteer virtual platform that delivers expert hematology-oncology content while intentionally pursuing gender balance.</p><p><strong>Methods: </strong>We analyzed program metrics (January 2022-June 2023) for 36 biweekly keynotes by oncology leaders (mean H-index 50.1). Aggregated audience demographics and engagement data were exported from X (Twitter), LinkedIn, YouTube, and Clubhouse. Unique reach, geographic distribution, and growth were calculated after deduplicating cross-platform IDs. Attendance and engagement were compared by speaker gender with χ<sup>2</sup> tests and linear regression.</p><p><strong>Results: </strong>MNW reached 743,991 unique viewers across 95 countries, including 23 low- and middle-income nations, and rose 10.5-fold in attendance over 18 months. Speakers achieved gender parity (18 women, 18 men); female-led sessions drew similar live attendance and video views (<i>P</i> = .41). MNW ranks in the top 0.07 percentile for health care influence on X. Participants included clinicians (40%), patients/advocates (22%), students (18%), and nonmedical stakeholders (20%).</p><p><strong>Conclusion: </strong>A no-cost, volunteer, gender-balanced platform can rapidly scale credible oncology education worldwide, counter misinformation, and engage under-resourced audiences. Sustained partnerships and outcome assessments are warranted.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500190"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145633852","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biomarker Concordance of Invasive Breast Carcinoma on Re-Evaluation: A Comprehensive Retrospective Real-World Analysis of Paired Samples. 重新评估浸润性乳腺癌的生物标志物一致性:对配对样本的全面回顾性现实世界分析。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-13 DOI: 10.1200/GO-25-00358
Pooja Padwale, Ayushi Sahay, Archita Juneja, Asawari J Patil, Shalaka Joshi, Tabassum Wadasadawala, Palak Popat Thakkar, Tanuja M Shet, Sudeep Gupta, Sangeeta B Desai

Purpose: Biomarkers estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) may undergo alteration on reassessment, with significant impact on management. There is a paucity of large-scale paired data on biomarker changes from low- and middle-income countries (LMICs).

Materials and methods: We performed a retrospective audit on 1,107 paired samples, wherein biomarkers were performed at least twice between: core needle biopsy (CNB) and upfront resection (category 1, n = 277); CNB and postchemotherapy resection (category 2, n = 104); primary (CNB/resection) and recurrence (local/metastatic; category 3, n = 702); and initial and subsequent distant metastasis (category 4, n = 24). Concordance was noted for individual receptors and surrogate molecular classification (hormone receptor+HER2-, hormonal receptor+HER2+, hormonal receptor-HER2+, triple-negative).

Results: Overall concordance for ER, PR, and HER2 was 85.4% (k value = 0.693), 77.1% (k value = 0.541), and 93.8% (k value = 0.827), respectively. For HRs, higher concordance was in category 1 > 3 > 2 > 4 (ER k value = 0.764 > 0.684 > 0.591 > 0.515, respectively; PR k value = 0.68 > 0.495 > 0.482 > 0.329, respectively), while HER2 was relatively constant across categories (k value range, 0.808-0.882). Molecular classification showed overall 79.5% concordance (k value = 0.688). Discordance was 27.1% in triple-positive (highest) and 17.7% in HER2+/hormonal receptor- (lowest). Univariate and multivariate analyses showed poorer concordance for therapy (v no therapy; odds ratio [OR], 0.437 [95% CI, 0.255 to 0.749]; P = .003) and specific/targeted therapy (v CT alone; OR, 0.126 [95% CI, 0.073 to 0.217]; P = .001). Shorter time interval (<6 months), both specimens breast, CNB, and optimum fixation showed better concordance on univariate (P = .004, .002, .01, and .009, respectively) but not multivariate analysis.

Conclusion: Biomarker re-evaluation is not mandatory between CNB and upfront resection or evaluating HER2 status alone, but one in five patients may show discordance at metastasis/recurrence. We recommend re-evaluation in recurrent/metastatic settings, post-treatment, >6 months' time interval, or poorly fixed material, which is of particular relevance in LMICs.

目的:生物标志物雌激素受体(ER)、孕激素受体(PR)和人表皮生长因子受体2 (HER2)在重新评估时可能发生改变,对治疗有重要影响。关于中低收入国家(LMICs)生物标志物变化的大规模配对数据缺乏。材料和方法:我们对1107个配对样本进行了回顾性审核,其中生物标志物在核心针活检(CNB)和前期切除(1类,n = 277)之间至少进行了两次检查;CNB和化疗后切除(2类,n = 104);原发(CNB/切除)和复发(局部/转移;3类,n = 702);以及最初和随后的远处转移(第4类,n = 24)。个体受体和替代分子分类(激素受体+HER2-、激素受体+HER2+、激素受体-HER2+、三阴性)一致。结果:ER、PR、HER2的总体一致性分别为85.4% (k值= 0.693)、77.1% (k值= 0.541)、93.8% (k值= 0.827)。在hr方面,1 > > 2 >类别的一致性较高(ER k值分别为0.764 > 0.684 > 0.591 > 0.515;PR k值分别为0.68 > 0.495 > 0.482 > 0.329),而HER2在各类别之间相对稳定(k值范围为0.808-0.882)。分子分类总体一致性为79.5% (k值= 0.688)。三阳性患者的不一致性为27.1%(最高),HER2+/激素受体-的不一致性为17.7%(最低)。单因素和多因素分析显示,治疗(v不治疗;优势比[OR], 0.437 [95% CI, 0.255至0.749];P = 0.003)和特异性/靶向治疗(v单独CT; OR, 0.126 [95% CI, 0.073至0.217];P = 0.001)的一致性较差。时间间隔较短(P = 0.004,。002年,。01,和。009),但不是多变量分析。结论:在CNB和前期切除或单独评估HER2状态之间,生物标志物重新评估不是强制性的,但五分之一的患者在转移/复发时可能出现不一致。我们建议在复发/转移情况下,治疗后,bbb6个月的时间间隔,或固定不良的材料重新评估,这与中低收入国家特别相关。
{"title":"Biomarker Concordance of Invasive Breast Carcinoma on Re-Evaluation: A Comprehensive Retrospective Real-World Analysis of Paired Samples.","authors":"Pooja Padwale, Ayushi Sahay, Archita Juneja, Asawari J Patil, Shalaka Joshi, Tabassum Wadasadawala, Palak Popat Thakkar, Tanuja M Shet, Sudeep Gupta, Sangeeta B Desai","doi":"10.1200/GO-25-00358","DOIUrl":"https://doi.org/10.1200/GO-25-00358","url":null,"abstract":"<p><strong>Purpose: </strong>Biomarkers estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) may undergo alteration on reassessment, with significant impact on management. There is a paucity of large-scale paired data on biomarker changes from low- and middle-income countries (LMICs).</p><p><strong>Materials and methods: </strong>We performed a retrospective audit on 1,107 paired samples, wherein biomarkers were performed at least twice between: core needle biopsy (CNB) and upfront resection (category 1, n = 277); CNB and postchemotherapy resection (category 2, n = 104); primary (CNB/resection) and recurrence (local/metastatic; category 3, n = 702); and initial and subsequent distant metastasis (category 4, n = 24). Concordance was noted for individual receptors and surrogate molecular classification (hormone receptor+HER2-, hormonal receptor+HER2+, hormonal receptor-HER2+, triple-negative).</p><p><strong>Results: </strong>Overall concordance for ER, PR, and HER2 was 85.4% (<i>k</i> value = 0.693), 77.1% (<i>k</i> value = 0.541), and 93.8% (<i>k</i> value = 0.827), respectively. For HRs, higher concordance was in category 1 > 3 > 2 > 4 (ER <i>k</i> value = 0.764 > 0.684 > 0.591 > 0.515, respectively; PR <i>k</i> value = 0.68 > 0.495 > 0.482 > 0.329, respectively), while HER2 was relatively constant across categories (<i>k</i> value range, 0.808-0.882). Molecular classification showed overall 79.5% concordance (<i>k</i> value = 0.688). Discordance was 27.1% in triple-positive (highest) and 17.7% in HER2+/hormonal receptor- (lowest). Univariate and multivariate analyses showed poorer concordance for therapy (<i>v</i> no therapy; odds ratio [OR], 0.437 [95% CI, 0.255 to 0.749]; <i>P</i> = .003) and specific/targeted therapy (<i>v</i> CT alone; OR, 0.126 [95% CI, 0.073 to 0.217]; <i>P</i> = .001). Shorter time interval (<6 months), both specimens breast, CNB, and optimum fixation showed better concordance on univariate (<i>P</i> = .004, .002, .01, and .009, respectively) but not multivariate analysis.</p><p><strong>Conclusion: </strong>Biomarker re-evaluation is not mandatory between CNB and upfront resection or evaluating HER2 status alone, but one in five patients may show discordance at metastasis/recurrence. We recommend re-evaluation in recurrent/metastatic settings, post-treatment, >6 months' time interval, or poorly fixed material, which is of particular relevance in LMICs.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500358"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512767","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Barriers to Cancer Research in Low- and Middle-Income Countries: Findings From the Arab Region and Beyond. 低收入和中等收入国家癌症研究的障碍:来自阿拉伯地区及其他地区的调查结果。
IF 3 Q2 ONCOLOGY Pub Date : 2025-11-01 Epub Date: 2025-11-13 DOI: 10.1200/GO-25-00412
Amal Al Omari, Bayan Altalla', Osama Alayyan, Hikmat Abdel-Razeq, Asem H Mansour

Purpose: Low- and middle-income countries (LMICs) account for nearly 70% of global cancer mortality, yet remain under-represented in oncology research. In the Middle East and North Africa, deficits in training, funding, infrastructure, regulation, and human capital restrict regionally led studies. This survey examined barriers through the experiences of cancer research professionals in Jordan and neighboring LMICs.

Methods: We conducted a cross-sectional, web-based survey of clinicians, scientists, and allied professionals with ≥1 year of cancer research experience. Recruitment used institutional e-mails, social media, and snowball sampling. The 10- to 12-minute REDCap questionnaire covered demographics, training, funding, infrastructure, ethics/regulation, data access, collaboration, workforce, and government support. Quantitative data were summarized descriptively; open-text responses underwent thematic coding.

Results: Among 206 respondents (70.7% Jordan; 61% < 40 years; 66.3% female), 53.2% received research training at university but only 28.8% during residency; 77.9% judged programs inadequate. One third consistently struggled to obtain grants, and just 7.8% reported no difficulty. Infrastructure was limited: 38.3% had full laboratory access and 56.0% had full journal access. Only 48.7% rated national cancer data as good/excellent. International collaboration was reported by 57.0% but often impeded by bureaucracy. Human capital shortages were noted by 84.5%; 69.6% observed brain drain, and 68.2% lacked protected time. Government support was rated poor/very poor by 35.6% and excellent by 9.6%. Thematic analysis highlighted resource scarcity, bureaucratic inertia, and the absence of a national strategy.

Conclusion: Cancer research in Jordan and LMICs is constrained by linked weaknesses in training, funding, infrastructure, regulation, data, and workforce. Reforms should embed experiential training and mentorship, diversify funding, expand shared facilities and data systems, streamline ethics processes, and strengthen career pathways with protected time and incentives, underpinned by coordinated policy commitment.

目的:低收入和中等收入国家(LMICs)占全球癌症死亡率的近70%,但在肿瘤研究中的代表性仍然不足。在中东和北非,培训、资金、基础设施、监管和人力资本方面的不足限制了以区域为主导的研究。这项调查通过约旦和邻近中低收入国家癌症研究专业人员的经历考察了障碍。方法:我们对具有1年以上癌症研究经验的临床医生、科学家和相关专业人员进行了一项基于网络的横断面调查。招聘使用了机构电子邮件、社交媒体和滚雪球抽样。REDCap调查问卷时长10- 12分钟,涵盖人口统计、培训、资金、基础设施、道德/法规、数据访问、协作、劳动力和政府支持。定量数据进行描述性总结;开放文本响应进行主题编码。结果:206名调查对象(约旦人占70.7%,年龄< 40岁的占61%,女性占66.3%)中,53.2%的人在大学接受过研究培训,而在住院期间接受过研究培训的比例仅为28.8%;77.9%的人认为项目不足。三分之一的人一直难以获得资助,只有7.8%的人表示没有困难。基础设施有限:38.3%的人有完整的实验室访问权限,56.0%的人有完整的期刊访问权限。只有48.7%的人认为国家癌症数据是好的/优秀的。据报道,国际合作的比例为57.0%,但往往受到官僚主义的阻碍。84.5%的人认为人力资本短缺;69.6%出现人才流失,68.2%缺乏保护时间。35.6%的人认为政府支持差/很差,9.6%的人认为很好。专题分析强调了资源短缺、官僚惰性和缺乏国家战略。结论:约旦和中低收入国家的癌症研究受到培训、资金、基础设施、监管、数据和劳动力方面相关弱点的制约。改革应包括体验式培训和指导,使资金多样化,扩大共享设施和数据系统,简化道德流程,并在协调一致的政策承诺的基础上,通过保护时间和激励措施加强职业道路。
{"title":"Barriers to Cancer Research in Low- and Middle-Income Countries: Findings From the Arab Region and Beyond.","authors":"Amal Al Omari, Bayan Altalla', Osama Alayyan, Hikmat Abdel-Razeq, Asem H Mansour","doi":"10.1200/GO-25-00412","DOIUrl":"https://doi.org/10.1200/GO-25-00412","url":null,"abstract":"<p><strong>Purpose: </strong>Low- and middle-income countries (LMICs) account for nearly 70% of global cancer mortality, yet remain under-represented in oncology research. In the Middle East and North Africa, deficits in training, funding, infrastructure, regulation, and human capital restrict regionally led studies. This survey examined barriers through the experiences of cancer research professionals in Jordan and neighboring LMICs.</p><p><strong>Methods: </strong>We conducted a cross-sectional, web-based survey of clinicians, scientists, and allied professionals with ≥1 year of cancer research experience. Recruitment used institutional e-mails, social media, and snowball sampling. The 10- to 12-minute REDCap questionnaire covered demographics, training, funding, infrastructure, ethics/regulation, data access, collaboration, workforce, and government support. Quantitative data were summarized descriptively; open-text responses underwent thematic coding.</p><p><strong>Results: </strong>Among 206 respondents (70.7% Jordan; 61% < 40 years; 66.3% female), 53.2% received research training at university but only 28.8% during residency; 77.9% judged programs inadequate. One third consistently struggled to obtain grants, and just 7.8% reported no difficulty. Infrastructure was limited: 38.3% had full laboratory access and 56.0% had full journal access. Only 48.7% rated national cancer data as good/excellent. International collaboration was reported by 57.0% but often impeded by bureaucracy. Human capital shortages were noted by 84.5%; 69.6% observed brain drain, and 68.2% lacked protected time. Government support was rated poor/very poor by 35.6% and excellent by 9.6%. Thematic analysis highlighted resource scarcity, bureaucratic inertia, and the absence of a national strategy.</p><p><strong>Conclusion: </strong>Cancer research in Jordan and LMICs is constrained by linked weaknesses in training, funding, infrastructure, regulation, data, and workforce. Reforms should embed experiential training and mentorship, diversify funding, expand shared facilities and data systems, streamline ethics processes, and strengthen career pathways with protected time and incentives, underpinned by coordinated policy commitment.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500412"},"PeriodicalIF":3.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145512799","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Budget Impact of the Oncotype DX Test in Early-Stage Breast Cancer for the Brazilian Private Health Care System. 早期乳腺癌Oncotype DX检测对巴西私人医疗保健系统的预算影响
IF 3 Q2 ONCOLOGY Pub Date : 2025-10-01 Epub Date: 2025-10-22 DOI: 10.1200/GO-25-00245
Carlos Alberto da Silva Magliano, Ivan R Zimmermann, Leandro Jonata de Carvalho Oliveira, Marcia Gisele Santos da Costa, Tomás Reinert, Carlos Henrique Dos Anjos, Daniela D Rosa, Julio A P Araújo, Andrea K Shimada, Daniele Assad-Suzuki, Max S Mano, Gustavo Póvoa Dos Santos, Sergio Cordeiro de Oliveira, Virginia Areal, Steve Millen

Purpose: Adjuvant chemotherapy decisions for early-stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer remain challenging, requiring a balance between treatment efficacy and avoiding overtreatment. Gene expression signatures, such as the Oncotype DX assay, are valuable tools to predict recurrence risk and guide chemotherapy use. This study estimates the budget impact of incorporating the Oncotype DX test into clinical practice for patients with HR+/HER2- early-stage breast cancer in Brazil's private health care system.

Methods: A budget impact analysis was performed using a hybrid decision tree-Markov model with transitions between recurrence-free survival, distant recurrence, acute myeloid leukemia, and death. The eligible population was derived from epidemiologic data. Subgroup analyses included node-negative (N0) patients stratified by age and clinical risk and node-positive (N1) patients stratified by menopausal status. The model assessed direct medical costs over 5 years without applying a discount rate. Two scenarios were analyzed: scenario 1, with progressive market uptake (40%-80% over 5 years), and scenario 2, with universal testing.

Results: The introduction of the Oncotype DX test was associated with 5-year cost savings of approximately $19.3 million US dollars (USD; scenario 1) to $26.7 million USD (scenario 2). Incremental costs were observed only in N0 low-risk patients 50 years and younger ($9.5-$16.9 million USD) and premenopausal N1 patients ($2.2-$4.4 million USD).

Conclusion: Incorporating the Oncotype DX test is expected to optimize chemotherapy recommendations, reduce overtreatment, and generate cost savings in most subgroups. In Brazil's private health care system, the reduction in chemotherapy-related costs is anticipated to fully or partially offset the cost of testing.

目的:早期激素受体阳性(HR+)、人表皮生长因子受体2阴性(HER2-)乳腺癌的辅助化疗决策仍然具有挑战性,需要在治疗效果和避免过度治疗之间取得平衡。基因表达特征,如Oncotype DX测定,是预测复发风险和指导化疗使用的有价值的工具。本研究估计了将Oncotype DX检测纳入巴西私人医疗系统中HR+/HER2-早期乳腺癌患者临床实践的预算影响。方法:使用混合决策树-马尔可夫模型进行预算影响分析,该模型包含无复发生存、远处复发、急性髓性白血病和死亡之间的过渡。符合条件的人群来源于流行病学资料。亚组分析包括按年龄和临床风险分层的淋巴结阴性(N0)患者和按绝经状况分层的淋巴结阳性(N1)患者。该模型在不采用贴现率的情况下评估了5年的直接医疗费用。我们分析了两种情景:情景1,逐步市场吸收(5年内40%-80%),情景2,普遍测试。结果:引入Oncotype DX检测后,5年的成本节约约为1930万美元(情景1)至2670万美元(情景2)。仅在50岁及以下的N0低风险患者($ 950 -$ 1690万美元)和绝经前N1患者($ 220 -$ 440万美元)中观察到增量成本。结论:结合Oncotype DX检测有望优化化疗建议,减少过度治疗,并在大多数亚组中节省成本。在巴西的私人卫生保健系统中,化疗相关费用的减少预计将完全或部分抵消检测费用。
{"title":"Budget Impact of the Oncotype DX Test in Early-Stage Breast Cancer for the Brazilian Private Health Care System.","authors":"Carlos Alberto da Silva Magliano, Ivan R Zimmermann, Leandro Jonata de Carvalho Oliveira, Marcia Gisele Santos da Costa, Tomás Reinert, Carlos Henrique Dos Anjos, Daniela D Rosa, Julio A P Araújo, Andrea K Shimada, Daniele Assad-Suzuki, Max S Mano, Gustavo Póvoa Dos Santos, Sergio Cordeiro de Oliveira, Virginia Areal, Steve Millen","doi":"10.1200/GO-25-00245","DOIUrl":"https://doi.org/10.1200/GO-25-00245","url":null,"abstract":"<p><strong>Purpose: </strong>Adjuvant chemotherapy decisions for early-stage hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer remain challenging, requiring a balance between treatment efficacy and avoiding overtreatment. Gene expression signatures, such as the Oncotype DX assay, are valuable tools to predict recurrence risk and guide chemotherapy use. This study estimates the budget impact of incorporating the Oncotype DX test into clinical practice for patients with HR+/HER2- early-stage breast cancer in Brazil's private health care system.</p><p><strong>Methods: </strong>A budget impact analysis was performed using a hybrid decision tree-Markov model with transitions between recurrence-free survival, distant recurrence, acute myeloid leukemia, and death. The eligible population was derived from epidemiologic data. Subgroup analyses included node-negative (N0) patients stratified by age and clinical risk and node-positive (N1) patients stratified by menopausal status. The model assessed direct medical costs over 5 years without applying a discount rate. Two scenarios were analyzed: scenario 1, with progressive market uptake (40%-80% over 5 years), and scenario 2, with universal testing.</p><p><strong>Results: </strong>The introduction of the Oncotype DX test was associated with 5-year cost savings of approximately $19.3 million US dollars (USD; scenario 1) to $26.7 million USD (scenario 2). Incremental costs were observed only in N0 low-risk patients 50 years and younger ($9.5-$16.9 million USD) and premenopausal N1 patients ($2.2-$4.4 million USD).</p><p><strong>Conclusion: </strong>Incorporating the Oncotype DX test is expected to optimize chemotherapy recommendations, reduce overtreatment, and generate cost savings in most subgroups. In Brazil's private health care system, the reduction in chemotherapy-related costs is anticipated to fully or partially offset the cost of testing.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500245"},"PeriodicalIF":3.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145345328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Barriers and Facilitators to Cancer Clinical Trial Participation: Perspectives of Patients in the ICON-3 Practice-Based Research Network, Nigeria. 癌症临床试验参与的障碍和促进因素:尼日利亚ICON-3基于实践的研究网络中患者的观点
IF 3 Q2 ONCOLOGY Pub Date : 2025-10-01 Epub Date: 2025-10-08 DOI: 10.1200/GO-25-00181
Ngozi Idemili-Aronu, Babayemi O Olakunde, Tara M Friebel-Klingner, Adaeze Chike-Okoli, Ijeoma U Itanyi, Tonia C Onyeka, Anne F Rositch, Richard B S Roden, Tzyy-Choou Wu, Echezona E Ezeanolue, Kimberly Levinson

Purpose: Africa faces a growing burden of cancer yet remains under-represented in global cancer clinical trials. This disparity limits the generation of population-specific evidence needed to improve cancer outcomes. Recruitment and retention in cancer clinical trials are particularly challenging because of various systemic and individual barriers in Nigeria. This study explores patients' perspectives on barriers and facilitators to recruitment and retention in cancer clinical trials.

Methods: A convergent parallel mixed-methods design was used, which comprised a cross-sectional survey and a descriptive qualitative approach. Participants were recruited from multiple oncology centers and secondary facilities within Nigeria's ICON-3 Practice-Based Research Network. Quantitative data were collected through interviewer-administered questionnaires, whereas qualitative data were gathered via semistructured interviews and analyzed thematically.

Results: A total of 317 patients participated in the quantitative survey, 18 of whom participated in interviews. Barriers included limited understanding of clinical trials, logistical challenges such as transportation and visit frequency, distrust in researchers and the health care system, and lack of family support. Facilitators included effective communication, incentives, flexible research visits, and culturally tailored interventions.

Conclusion: To optimize cancer clinical trial participation in low-resource settings, interventions must be tailored to local contexts, addressing structural and cultural barriers. Enhanced communication, community involvement, and supportive policies can significantly improve trial participation and outcomes.

目的:非洲面临着日益沉重的癌症负担,但在全球癌症临床试验中代表性仍然不足。这种差异限制了改善癌症预后所需的人群特异性证据的产生。由于尼日利亚存在各种系统和个人障碍,癌症临床试验人员的招募和保留尤其具有挑战性。本研究探讨了患者对癌症临床试验招募和保留的障碍和促进因素的看法。方法:采用收敛平行混合方法设计,包括横断面调查和描述性定性方法。参与者是从尼日利亚ICON-3基于实践的研究网络内的多个肿瘤中心和二级机构招募的。定量数据通过访谈者管理的问卷收集,而定性数据通过半结构化访谈收集并进行主题分析。结果:共有317例患者参与了定量调查,其中18例患者参与了访谈。障碍包括对临床试验的了解有限、运输和就诊频率等后勤挑战、对研究人员和卫生保健系统的不信任以及缺乏家庭支持。促进因素包括有效的沟通、激励、灵活的研究访问和有文化针对性的干预。结论:为了优化低资源环境下的癌症临床试验参与,干预措施必须根据当地情况量身定制,解决结构和文化障碍。加强沟通、社区参与和支持性政策可以显著改善试验参与和结果。
{"title":"Barriers and Facilitators to Cancer Clinical Trial Participation: Perspectives of Patients in the ICON-3 Practice-Based Research Network, Nigeria.","authors":"Ngozi Idemili-Aronu, Babayemi O Olakunde, Tara M Friebel-Klingner, Adaeze Chike-Okoli, Ijeoma U Itanyi, Tonia C Onyeka, Anne F Rositch, Richard B S Roden, Tzyy-Choou Wu, Echezona E Ezeanolue, Kimberly Levinson","doi":"10.1200/GO-25-00181","DOIUrl":"10.1200/GO-25-00181","url":null,"abstract":"<p><strong>Purpose: </strong>Africa faces a growing burden of cancer yet remains under-represented in global cancer clinical trials. This disparity limits the generation of population-specific evidence needed to improve cancer outcomes. Recruitment and retention in cancer clinical trials are particularly challenging because of various systemic and individual barriers in Nigeria. This study explores patients' perspectives on barriers and facilitators to recruitment and retention in cancer clinical trials.</p><p><strong>Methods: </strong>A convergent parallel mixed-methods design was used, which comprised a cross-sectional survey and a descriptive qualitative approach. Participants were recruited from multiple oncology centers and secondary facilities within Nigeria's ICON-3 Practice-Based Research Network. Quantitative data were collected through interviewer-administered questionnaires, whereas qualitative data were gathered via semistructured interviews and analyzed thematically.</p><p><strong>Results: </strong>A total of 317 patients participated in the quantitative survey, 18 of whom participated in interviews. Barriers included limited understanding of clinical trials, logistical challenges such as transportation and visit frequency, distrust in researchers and the health care system, and lack of family support. Facilitators included effective communication, incentives, flexible research visits, and culturally tailored interventions.</p><p><strong>Conclusion: </strong>To optimize cancer clinical trial participation in low-resource settings, interventions must be tailored to local contexts, addressing structural and cultural barriers. Enhanced communication, community involvement, and supportive policies can significantly improve trial participation and outcomes.</p>","PeriodicalId":14806,"journal":{"name":"JCO Global Oncology","volume":"11 ","pages":"e2500181"},"PeriodicalIF":3.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12679331/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145251031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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JCO Global Oncology
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