Rebecca Dent, Javier Cortés, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Michael Untch, Peter A Fasching, Fatima Cardoso, Amin Haiderali, Liyi Jia, Allison Martin Nguyen, Wilbur Pan, Joyce O'Shaughnessy, Peter Schmid
{"title":"Neoadjuvant pembrolizumab plus chemotherapy/adjuvant pembrolizumab for early-stage triple-negative breast cancer: quality-of-life results from the randomized KEYNOTE-522 study.","authors":"Rebecca Dent, Javier Cortés, Lajos Pusztai, Heather McArthur, Sherko Kümmel, Jonas Bergh, Carsten Denkert, Yeon Hee Park, Rina Hui, Nadia Harbeck, Masato Takahashi, Michael Untch, Peter A Fasching, Fatima Cardoso, Amin Haiderali, Liyi Jia, Allison Martin Nguyen, Wilbur Pan, Joyce O'Shaughnessy, Peter Schmid","doi":"10.1093/jnci/djae129","DOIUrl":"10.1093/jnci/djae129","url":null,"abstract":"<p><strong>Background: </strong>In KEYNOTE-522 (NCT03036488), neoadjuvant pembrolizumab plus chemotherapy and then adjuvant pembrolizumab significantly improved pathological complete response and event-free survival vs neoadjuvant chemotherapy in early-stage triple-negative breast cancer (TNBC). We report patient-reported outcomes (PROs) from KEYNOTE-522.</p><p><strong>Methods: </strong>Patients were randomized 2:1 to neoadjuvant pembrolizumab 200 mg or placebo every 3 weeks, plus 4 cycles of paclitaxel plus carboplatin and then 4 cycles of doxorubicin (or epirubicin) plus cyclophosphamide. After surgery, patients received adjuvant pembrolizumab or placebo for up to 9 cycles. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and EORTC Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23) were prespecified secondary objectives. Between-group differences in least squares (LS) mean change from baseline (day 1 of cycle 1 in both neoadjuvant and adjuvant phases) to the prespecified latest time point with at least 60% completion and at least 80% compliance were assessed using a longitudinal model (no alpha error assigned).</p><p><strong>Results: </strong>Week 21 (neoadjuvant phase) and week 24 (adjuvant phase) were the latest time points at which completion/compliance rates were ≥60%/80%. In the neoadjuvant phase, between-group differences (pembrolizumab plus chemotherapy [n = 762] vs placebo plus chemotherapy [n = 383]) in LS mean change from baseline to week 21 in QLQ-C30 global health status/quality of life (GHS/QoL), emotional functioning, and physical functioning were -1.04 (95% confidence interval = -3.46 to 1.38), -0.69 (95% CI = -3.13 to 1.75), and -2.85 (95% CI = -5.11 to -0.60), respectively. In the adjuvant phase, between-group differences (pembrolizumab [n = 539] vs placebo [n = 308]) in LS mean change from baseline to week 24 were -0.41 (95% CI = -2.60 to 1.77), -0.60 (95% CI = -2.99 to 1.79), and -1.57 (95% CI = -3.36 to 0.21).</p><p><strong>Conclusions: </strong>No substantial differences in PRO assessments were observed between neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab vs neoadjuvant placebo plus chemotherapy in early-stage TNBC.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT03036488.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1654-1663"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11461162/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446205","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}
{"title":"Retraction and Replacement of: Increasing power in screening trials by testing control-arm specimens: application to multicancer detection screening.","authors":"","doi":"10.1093/jnci/djae217","DOIUrl":"10.1093/jnci/djae217","url":null,"abstract":"","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1706"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142287740","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}
{"title":"Vitamin D receptor gene polymorphisms, bioavailable 25-hydroxyvitamin D, and hepatocellular carcinoma survival.","authors":"Jing Shu, Mingjie Zhang, Xiaocong Dong, Jingan Long, Yunshan Li, Peishan Tan, Tongtong He, Edward L Giovannucci, Xuehong Zhang, Zhongguo Zhou, Yanjun Xu, Xiaojun Xu, Tianyou Peng, Jialin Lu, Minshan Chen, Huilian Zhu, Yaojun Zhang, Aiping Fang","doi":"10.1093/jnci/djae116","DOIUrl":"10.1093/jnci/djae116","url":null,"abstract":"<p><strong>Background: </strong>Little is known about the role of vitamin D receptor polymorphisms and their interaction with vitamin D status in hepatocellular carcinoma (HCC) prognosis.</p><p><strong>Methods: </strong>We evaluated the association of TaqI, BsmI, Cdx-2, and ApaI polymorphisms, individually and in combination, with liver cancer-specific (LCSS) and overall survival (OS) among 967 patients with newly diagnosed HCC. Subsequently, we examined whether these polymorphisms modified the association between serum bioavailable 25-hydroxyvitamin D (25OHD) concentrations and survival. Cox proportional hazard models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>During a median follow-up of 1017 days, 393 deaths occurred, with 360 attributed to HCC. Having TaqI G allele (HRper allele = 1.30, 95% CI = 1.08 to 1.57) or BsmI T allele (HRper allele = 1.41, 95% CI = 1.01 to 1.99) was associated with worse LCSS. Carrying increasing numbers of protective alleles was associated with superior LCSS (HR6-8 vs 0-3 = 0.52, 95% CI = 0.34 to 0.80). The inverse association of bioavailable 25OHD with LCSS was statistically significant only in patients with TaqI AA (HRQuartile 4 vs Quartile 1 = 0.63, 95% CI = 0.44 to 0.92), BsmI CC (HRQuartile 4 vs Quartile 1 = 0.62, 95% CI = 0.44 to 0.88), and 6 to 8 protective alleles (HRQuartile 4 vs Quartile 1 = 0.45, 95% CI = 0.23 to 0.87). Similar associations were observed for OS.</p><p><strong>Conclusions: </strong>Patients carrying wild-type TaqI, BsmI, or more protective alleles had improved survival and might benefit from optimizing bioavailable 25OHD status.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1687-1696"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141237100","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}
Chien-Kuang C Ding, Zhuo Tony Su, Erik Erak, Lia De Paula Oliveira, Daniela C Salles, Yuezhou Jing, Pranab Samanta, Saikiran Bonthu, Uttara Joshi, Chaith Kondragunta, Nitin Singhal, Angelo M De Marzo, Bruce J Trock, Christian P Pavlovich, Claire M de la Calle, Tamara L Lotan
{"title":"Predicting prostate cancer grade reclassification on active surveillance using a deep learning-based grading algorithm.","authors":"Chien-Kuang C Ding, Zhuo Tony Su, Erik Erak, Lia De Paula Oliveira, Daniela C Salles, Yuezhou Jing, Pranab Samanta, Saikiran Bonthu, Uttara Joshi, Chaith Kondragunta, Nitin Singhal, Angelo M De Marzo, Bruce J Trock, Christian P Pavlovich, Claire M de la Calle, Tamara L Lotan","doi":"10.1093/jnci/djae139","DOIUrl":"10.1093/jnci/djae139","url":null,"abstract":"<p><p>Deep learning (DL)-based algorithms to determine prostate cancer (PCa) Grade Group (GG) on biopsy slides have not been validated by comparison to clinical outcomes. We used a DL-based algorithm, AIRAProstate, to regrade initial prostate biopsies in 2 independent PCa active surveillance (AS) cohorts. In a cohort initially diagnosed with GG1 PCa using only systematic biopsies (n = 138), upgrading of the initial biopsy to ≥GG2 by AIRAProstate was associated with rapid or extreme grade reclassification on AS (odds ratio = 3.3, P = .04), whereas upgrading of the initial biopsy by contemporary uropathologist reviews was not associated with this outcome. In a contemporary validation cohort that underwent prostate magnetic resonance imaging before initial biopsy (n = 169), upgrading of the initial biopsy (all contemporary GG1 by uropathologist grading) by AIRAProstate was associated with grade reclassification on AS (hazard ratio = 1.7, P = .03). These results demonstrate the utility of a DL-based grading algorithm in PCa risk stratification for AS.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1683-1686"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141419202","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}
Dipesh Uprety, Randell Seaton, Tarik Hadid, Hirva Mamdani, Ammar Sukari, Julie J Ruterbusch, Ann G Schwartz
{"title":"Racial and socioeconomic disparities in survival among patients with metastatic non-small cell lung cancer.","authors":"Dipesh Uprety, Randell Seaton, Tarik Hadid, Hirva Mamdani, Ammar Sukari, Julie J Ruterbusch, Ann G Schwartz","doi":"10.1093/jnci/djae118","DOIUrl":"10.1093/jnci/djae118","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors have profoundly impacted survival among patients with metastatic non-small cell lung cancer. However, population-based studies evaluating this impact on survival by race and socioeconomic factors are lacking.</p><p><strong>Methods: </strong>We used the Surveillance, Epidemiology, and End Results Program-Medicare database to identify patients with metastatic non-small cell lung cancer diagnosed between 2015 and 2019. The primary study outcomes were the receipt of an immune checkpoint inhibitor and overall survival. χ2 tests and logistic regression were used to identify demographic factors associated with receipt of immune checkpoint inhibitors. The Kaplan-Meier method was used to calculate 2-year overall survival rates, and log-rank tests were used to compare survival by race and ethnicity.</p><p><strong>Results: </strong>Of 17 134 patients, approximately 39% received an immune checkpoint inhibitor. Those diagnosed with cancer recently (in 2019); who are relatively younger (aged younger than 85 years); non-Hispanic White, non-Hispanic Asian, or Hispanic; living in high socioeconomic status or metropolitan areas; not Medicaid eligible; and with adenocarcinoma histology were more likely to receive immune checkpoint inhibitors. The 2-year overall survival rate from diagnosis was 21% for the overall population. The 2-year overall survival rate from immune checkpoint inhibitor initiation was 30%, among those who received at least 1 cycle and 11% among those who did not receive immune checkpoint inhibitors. The 2-year overall survival rates were higher among non-Hispanic White (22%) and non-Hispanic Asian (23%) patients compared with non-Hispanic Black (15%) and Hispanic (17%) patients. There was no statistically significant racial differences in survival for those who received immune checkpoint inhibitors.</p><p><strong>Conclusion: </strong>Immune checkpoint inhibitor utilization rates and the resulting outcomes were inferior for certain vulnerable groups, mandating the need for strategies to improve access to care.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1697-1704"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11461161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141237070","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}
Sen Liu, Seleste L Rivero, Bing Zhang, Keyi Shen, Zixuan Li, Tianhua Niu, Brian G Rowan, S Michal Jazwinski, Asim B Abdel-Mageed, Chad Steele, Alun R Wang, Oliver Sartor, Qiuyang Zhang
{"title":"BATF-dependent Th17 cells act through the IL-23R pathway to promote prostate adenocarcinoma initiation and progression.","authors":"Sen Liu, Seleste L Rivero, Bing Zhang, Keyi Shen, Zixuan Li, Tianhua Niu, Brian G Rowan, S Michal Jazwinski, Asim B Abdel-Mageed, Chad Steele, Alun R Wang, Oliver Sartor, Qiuyang Zhang","doi":"10.1093/jnci/djae120","DOIUrl":"10.1093/jnci/djae120","url":null,"abstract":"<p><strong>Background: </strong>The role of Th17 cells in prostate cancer is not fully understood. The transcription factor BATF controls the differentiation of Th17 cells. Mice deficient in Batf do not produce Th17 cells.</p><p><strong>Methods: </strong>In this study, we aimed to characterize the role of Batf-dependent Th17 cells in prostate cancer by crossbreeding Batf knockout mice with mice conditionally mutant for Pten.</p><p><strong>Results: </strong>We found that Batf knockout mice had changes in the morphology of prostate epithelial cells compared with normal mice, and Batf knockout mice deficient in Pten (called Batf-) had smaller prostate size and developed fewer invasive prostate adenocarcinomas than Pten-deficient mice with Batf expression (called Batf+). The prostate tumors in Batf- mice showed reduced proliferation, increased apoptosis, decreased angiogenesis and inflammatory cell infiltration, and activation of nuclear factor-κB signaling. Moreover, Batf- mice showed significantly reduced interleukin 23 (IL-23)-IL-23R signaling. In the prostate stroma of Batf- mice, IL-23R-positive cells were decreased considerably compared with Batf+ mice. Splenocytes and prostate tissues from Batf- mice cultured under Th17 differentiation conditions expressed reduced IL-23/IL-23R than cultured cells from Batf+ mice. Anti-IL-23p19 antibody treatment of Pten-deficient mice reduced prostate tumors and angiogenesis compared with control immunoglobulin G-treated mice. In human prostate tumors, BATF messenger RNA level was positively correlated with IL-23A and IL-23R but not RORC.</p><p><strong>Conclusion: </strong>Our novel findings underscore the crucial role of IL-23-IL-23R signaling in mediating the function of Batf-dependent Th17 cells, thereby promoting prostate cancer initiation and progression. This finding highlights the BATF-IL-23R axis as a promising target for the development of innovative strategies for prostate cancer prevention and treatment.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1598-1611"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11461145/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141248095","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}
{"title":"Correction to: Effect of the p53 P72R Polymorphism on Mutant TP53 Allele Selection in Human Cancer.","authors":"","doi":"10.1093/jnci/djae206","DOIUrl":"10.1093/jnci/djae206","url":null,"abstract":"","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1705"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11461160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142107612","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}
{"title":"Efficacy and safety of personalized optimal PD-(L)1 combinations in advanced NSCLC: a network meta-analysis.","authors":"Xianjing Chu, Wentao Tian, Jiaoyang Ning, Rongrong Zhou","doi":"10.1093/jnci/djae137","DOIUrl":"10.1093/jnci/djae137","url":null,"abstract":"<p><strong>Introduction: </strong>Programmed death 1 (PD-1)/programmed death 1 ligand 1 (PD-L1)-directed immunotherapy has revolutionized the treatments for advanced non-small cell lung cancer (NSCLC), whereas the optimal therapeutic combinations remain uncertain.</p><p><strong>Methods: </strong>Our study encompassed phase II/III randomized controlled trials (RCTs) that involved anti-PD-(L)1-based therapies for stage-IV NSCLC. The primary outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and incidences of adverse events. Subgroup analyses were conducted by treatment lines, PD-L1 expression levels, histological types, and metastatic sites.</p><p><strong>Results: </strong>Our analysis incorporated 38 publications, covering 14 therapeutic combinations and involving 18 048 participants. PD-(L)1+chemotherapy (CT), PD-(L)1+ cytotoxic T lymphocyte-associated antigen-4 (CTLA4) +CT, and PD-(L)1+ T-cell immunoglobulin and ITIM domain were notably effective in prolonging OS. Overall, PD-(L)1+CT and PD-(L)1+CT+ vascular endothelial growth factor (VEGF) were significantly beneficial for PFS and ORR. As for the subsequent-line treatments, incorporating radiotherapy can enhance PFS and ORR (ranked fourth among enrolled treatments). For patients with PD-L1 <1%, PD-(L)1+CT+VEGF and PD-(L)1+CTLA4+CT were favorable approaches. Conversely, in patients with PD-L1 ≥50%, PD-(L)1+CT represented an effective treatment. Patients with nonsquamous cell carcinoma or liver metastases might benefit from the addition of VEGF. In cases of squamous cell carcinoma or brain metastases, the combination of PD-(L)1+CTLA4+CT yielded superior benefits.</p><p><strong>Conclusions: </strong>This study underscores the enhanced efficacy of combination immunotherapies over monotherapy. It highlights the necessity for personalized treatment, considering individual factors. These insights are vital for clinical decision making in the management of advanced NSCLC.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1571-1586"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141419200","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}
Hayley S Thompson, Kimlin Tam Ashing, Nadine J Barrett, Monica L Baskin, Lisa Carter-Bawa, Timiya S Nolan, Folakemi T Odedina, Kim F Rhoads, Vanessa B Sheppard, Charnita Zeigler-Johnson
{"title":"The state of cancer-focused community outreach and engagement (COE): reflections of Black COE directors.","authors":"Hayley S Thompson, Kimlin Tam Ashing, Nadine J Barrett, Monica L Baskin, Lisa Carter-Bawa, Timiya S Nolan, Folakemi T Odedina, Kim F Rhoads, Vanessa B Sheppard, Charnita Zeigler-Johnson","doi":"10.1093/jnci/djae138","DOIUrl":"10.1093/jnci/djae138","url":null,"abstract":"<p><p>The requirement of community outreach and engagement (COE) as a major component of the National Cancer Institute (NCI) Cancer Center Support Grant has had an enormous impact on the way NCI-designated cancer centers identify, investigate, and address the needs of their catchment area (CA) communities. Given the wide-ranging diversity of our nation, COE's scope of work (SOW) is extremely demanding and complex. Yet, COE is often marginalized and viewed as void of scientific methods when, in fact, it requires specialized scientific knowledge and a broad range of proficiencies. Black COE scientific directors may be particularly attuned to this marginalization as they have often confronted workplace inequities that resemble the health inequities observed within their cancer center's CA. Thus, Black COE leaders are uniquely positioned to offer insight on the past, present, and future of COE. Key areas discussed include the low involvement of minoritized group members and those with appropriate expertise in national COE leadership; the lack of established, consistent criteria for evaluation of COE components and qualifications of evaluators; the need for substantial financial investment in COE; potential misalignment of community priorities and cancer center objectives; professional development and growth of COE staff and leaders; the expanding scope of COE across their respective cancer centers and CAs; and the need for center-wide involvement in COE and an \"all-hands-on-deck\" approach. These areas warrant thoughtful dialogue as COE evolves, for the benefit and success of all COE leaders. However, this dialogue must include diverse voices representing similarly diverse stakeholders at every level.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1549-1554"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141320889","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}
Pedro Nascimento de Lima, Rosita van den Puttelaar, Amy B Knudsen, Anne I Hahn, Karen M Kuntz, Jonathan Ozik, Nicholson Collier, Fernando Alarid-Escudero, Ann G Zauber, John M Inadomi, Iris Lansdorp-Vogelaar, Carolyn M Rutter
{"title":"Characteristics of a cost-effective blood test for colorectal cancer screening.","authors":"Pedro Nascimento de Lima, Rosita van den Puttelaar, Amy B Knudsen, Anne I Hahn, Karen M Kuntz, Jonathan Ozik, Nicholson Collier, Fernando Alarid-Escudero, Ann G Zauber, John M Inadomi, Iris Lansdorp-Vogelaar, Carolyn M Rutter","doi":"10.1093/jnci/djae124","DOIUrl":"10.1093/jnci/djae124","url":null,"abstract":"<p><strong>Background: </strong>Blood-based biomarker tests can potentially change the landscape of colorectal cancer (CRC) screening. We characterize the conditions under which blood test screening would be as effective and cost-effective as annual fecal immunochemical testing or decennial colonoscopy.</p><p><strong>Methods: </strong>We used the 3 Cancer Information and Surveillance Modeling Network-Colon models to compare scenarios of no screening, annual fecal immunochemical testing, decennial colonoscopy, and a blood test meeting Centers for Medicare & Medicaid (CMS) coverage criteria (74% CRC sensitivity and 90% specificity). We varied the sensitivity to detect CRC (74%-92%), advanced adenomas (10%-50%), screening interval (1-3 years), and test cost ($25-$500). Primary outcomes included quality-adjusted life-years (QALY) gained from screening and costs for a US average-risk cohort of individuals aged 45 years.</p><p><strong>Results: </strong>Annual fecal immunochemical testing yielded 125-163 QALY gained per 1000 at a cost of $3811-$5384 per person, whereas colonoscopy yielded 132-177 QALY gained at a cost of $5375-$7031 per person. A blood test with 92% CRC sensitivity and 50% advanced adenoma sensitivity yielded 117-162 QALY gained if used every 3 years and 133-173 QALY gained if used every year but would not be cost-effective if priced above $125 per test. If used every 3 years, a $500 blood test only meeting CMS coverage criteria yielded 83-116 QALY gained at a cost of $8559-$9413 per person.</p><p><strong>Conclusion: </strong>Blood tests that only meet CMS coverage requirements should not be recommended to patients who would otherwise undergo screening by colonoscopy or fecal immunochemical testing because of lower benefit. Blood tests need higher advanced adenoma sensitivity (above 40%) and lower costs (below $125) to be cost-effective.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":" ","pages":"1612-1620"},"PeriodicalIF":9.9,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11461157/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141283767","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}