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Real-world implementation of a decision aid for treatment decisions in metastatic pancreatic cancer: a prospective multicenter study across expert centers. 转移性胰腺癌治疗决策的决策辅助在现实世界的实施:一项跨专家中心的前瞻性多中心研究。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag373
Merlijn U J E Graus, Thijmen H T Broekman, Sietske van Nassau, Nicol Pepels-Aarts, Geert A Cirkel, Marcel den Dulk, Brigitte C M Haberkorn, Irene E G van Hellemond, Karlijn E P E Hermans, Marjolein Y V Homs, Maartje Los, Saskia A C Luelmo, Sasja F Mulder, Mirte M Streppel, Miriam L Wumkes, Johanna W Wilmink, Ignace H J T de Hingh, Liselot B J Valkenburg-van Iersel, Judith de Vos-Geelen
{"title":"Real-world implementation of a decision aid for treatment decisions in metastatic pancreatic cancer: a prospective multicenter study across expert centers.","authors":"Merlijn U J E Graus, Thijmen H T Broekman, Sietske van Nassau, Nicol Pepels-Aarts, Geert A Cirkel, Marcel den Dulk, Brigitte C M Haberkorn, Irene E G van Hellemond, Karlijn E P E Hermans, Marjolein Y V Homs, Maartje Los, Saskia A C Luelmo, Sasja F Mulder, Mirte M Streppel, Miriam L Wumkes, Johanna W Wilmink, Ignace H J T de Hingh, Liselot B J Valkenburg-van Iersel, Judith de Vos-Geelen","doi":"10.1093/oncolo/oyag373","DOIUrl":"10.1093/oncolo/oyag373","url":null,"abstract":"<p><strong>Background: </strong>Treatment decisions in metastatic pancreatic adenocarcinoma (mPAC) involve complex tradeoffs between survival benefits and treatment burden. Shared decision-making (SDM) is crucial but challenging in emotionally charged and time-pressured consultations. This study evaluated the real-world implementation of a decision aid to support SDM in treatment decisions in mPAC care.</p><p><strong>Materials and methods: </strong>In this prospective, multicenter study across 10 Dutch expert centers, patients with mPAC and their clinicians used a newly-developed decision aid during consultations for treatment decisions. Data were collected on preferences, decision aid use, and final treatment choices, supplemented by surveys and interviews assessing feasibility and experiences. Outcomes included decision aid use, user experience, and concordance of final treatment decision with physician and patient preferences.</p><p><strong>Results: </strong>A total of 68 clinicians participated and 227 patients were counseled using the decision aid, of whom 181 patients consented to participate in the implementation study, and 135 patients used the online decision aid. Patients who received consideration time were more likely to use the decision aid (P < 0.01). Both patients and clinicians rated the decision aid positively (median score 8/10). Discordance between physician and patient preferences regarding treatment decisions was observed in 37%.</p><p><strong>Conclusion: </strong>A structured decision aid can be successfully implemented in real-world mPAC care and was highly valued by both patients and clinicians. Differences between clinician preference, patient preference, and ultimate treatment decision were frequently observed, highlighting the need to consider treatment decision-making as an ongoing process that allows time for reflection and dialogue.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13652022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149082851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
New prognosis indexes specific to Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma combining functional hepatic reserve and tumor burden. 结合肝功能储备和肿瘤负荷的巴塞罗那临床B期肝癌特异性预后指标
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag392
Koji Fujita, Rie Yano, Mai Nakahara, Kyoko Oura, Hironobu Suto, Asahiro Morishita, Takashi Himoto, Keiichi Okano, Hideki Kobara
{"title":"New prognosis indexes specific to Barcelona Clinic Liver Cancer stage B hepatocellular carcinoma combining functional hepatic reserve and tumor burden.","authors":"Koji Fujita, Rie Yano, Mai Nakahara, Kyoko Oura, Hironobu Suto, Asahiro Morishita, Takashi Himoto, Keiichi Okano, Hideki Kobara","doi":"10.1093/oncolo/oyag392","DOIUrl":"10.1093/oncolo/oyag392","url":null,"abstract":"<p><strong>Background: </strong>Patients with Barcelona Clinic Liver Cancer stage B (BCLC-B) hepatocellular carcinoma (HCC) are characterized by heterogeneity in functional hepatic reserve and tumor burden. Conventional prognosis indexes are not specific to this stage. This study aimed to establish novel prognosis indexes that integrated functional hepatic reserve and tumor burden in patients with BCLC-B HCC.</p><p><strong>Methods: </strong>A total of 1843 patients with BCLC-B HCC were retrospectively enrolled from 4 hospitals. The primary endpoint was overall survival. Tumor burden was quantified as the biproduct or sum of the maximum diameter and the number of tumor nodules that is referred to as mMDN and mUS. Functional hepatic reserve was described using the albumin-bilirubin (ALBI) score.</p><p><strong>Results: </strong>Multivariate analysis demonstrated that functional hepatic reserve and tumor burden were significantly associated with overall survival. Novel prognosis indexes, termed mMDN/ALBI and mUS/ALBI, were generated by dividing mMDN and mUS by the absolute value of the ALBI score. The mMDN/ALBI and mUS/ALBI models demonstrated superior prognostic stratification of overall survival compared with the ALBI and Tokyo scores, as reflected by higher log-rank trend chi-square statistics and C-index values. Time-dependent ROC and decision curve analyses further supported their superior predictive performance and clinical utility. mMDN/ALBI ≥ 8.2 indicated poor overall survival with a median survival time of 12 to 14 months whether functional hepatic reserve was preserved or not. mUS/ALBI ≥ 5.6 also suggested the median survival time of 9 to 12 months.</p><p><strong>Conclusion: </strong>The novel prognosis indexes stratified overall survival more clearly compared to the ALBI score and Tokyo score. These indexes enable more accurate prognosis prediction for patients with BCLC-B HCC.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13693367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149118669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Is there a role for immune checkpoint inhibitors in high-risk medulloblastoma beyond the salvage setting? 免疫检查点抑制剂在高危髓母细胞瘤中是否有救助性作用?
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag386
Yi-Lun Wang, Chieh-Tsai Wu, Wei-Heng Kao, Tsung-Yen Chang, Tang-Her Jaing
{"title":"Is there a role for immune checkpoint inhibitors in high-risk medulloblastoma beyond the salvage setting?","authors":"Yi-Lun Wang, Chieh-Tsai Wu, Wei-Heng Kao, Tsung-Yen Chang, Tang-Her Jaing","doi":"10.1093/oncolo/oyag386","DOIUrl":"10.1093/oncolo/oyag386","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13691377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149118550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cerebrospinal fluid tumor-derived DNA analysis aids in the diagnosis of postpartum diffuse midline glioma. 脑脊液肿瘤来源DNA分析有助于产后弥漫性中线胶质瘤的诊断。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag417
Andrew Rodriguez, DeElegant Robinson, David Akhavan, Danielle Cunningham, Alexandra Larson, Vindhya Udhane, Kala F Schilter, Qian Nie, Honey V Reddi
{"title":"Cerebrospinal fluid tumor-derived DNA analysis aids in the diagnosis of postpartum diffuse midline glioma.","authors":"Andrew Rodriguez, DeElegant Robinson, David Akhavan, Danielle Cunningham, Alexandra Larson, Vindhya Udhane, Kala F Schilter, Qian Nie, Honey V Reddi","doi":"10.1093/oncolo/oyag417","DOIUrl":"10.1093/oncolo/oyag417","url":null,"abstract":"<p><strong>Background: </strong>Gliomas diagnosed during pregnancy or postpartum pose diagnostic and management challenges. Neurologic symptoms may be attributed to physiological changes of pregnancy or the postpartum state, possibly delaying evaluation. When lesions arise in high-risk locations, such as the brainstem, tissue biopsy is frequently infeasible, further complicating the diagnostic process.</p><p><strong>Patient presentation: </strong>A 28-year-old woman developed dysphagia during pregnancy, which persisted and gradually worsened after delivery. Postpartum evaluation identified a right thyroid nodule, subsequently diagnosed as papillary thyroid carcinoma following hemithyroidectomy. Eight months postpartum, the patient experienced progressive dysphagia, headaches, and dizziness. Magnetic resonance imaging revealed an expansile medullary lesion concerning for a high-grade primary brainstem tumor. Due to the brainstem location, biopsy was infeasible, and empiric chemoradiation was initiated for presumed high-grade glioma.</p><p><strong>Molecular findings: </strong>Cerebrospinal fluid (CSF) tumor-derived nucleic acid analysis using Summit 2.0 identified an H3-3A K28M alteration, along with co-occurring pathogenic alterations in NF1 and TP53. In conjunction with the clinical and radiographic findings, these molecular results supported classification of the tumor as diffuse midline glioma, H3 K27-altered.</p><p><strong>Management and outcome: </strong>Following completion of chemoradiation, dordaviprone therapy was initiated. At the most recent documented follow-up in January 2026, brain MRI demonstrated decreased size and enhancement of the medullary lesion, accompanied by improvement in dysphagia, headaches, dystonic movements, balance, and overall performance status.</p><p><strong>Conclusions: </strong>This case demonstrates that cerebrospinal fluid-based genomic profiling can provide clinically meaningful molecular information when tissue diagnosis is contraindicated and can inform treatment planning for patients with anatomically inaccessible central nervous system tumors. It also highlights the significance of ongoing evaluation of persistent neurologic symptoms during pregnancy and the postpartum period.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13713193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149197819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Target trial emulation studies in oncology: a comprehensive analysis. 肿瘤学靶标试验模拟研究:综合分析。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag258
Chenfeng Tan, Zelei Dai, Renjie Zhao, Kefan Li, Bingran Zhang, Ying Wang, Yonggang Zhang, Lei Liu, Nian Li
{"title":"Target trial emulation studies in oncology: a comprehensive analysis.","authors":"Chenfeng Tan, Zelei Dai, Renjie Zhao, Kefan Li, Bingran Zhang, Ying Wang, Yonggang Zhang, Lei Liu, Nian Li","doi":"10.1093/oncolo/oyag258","DOIUrl":"10.1093/oncolo/oyag258","url":null,"abstract":"<p><strong>Background: </strong>Target trial emulation (TTE) has emerged as an important framework for generating comparative effectiveness real-world evidence. However, the methodological characteristics and clinical utility of this framework in oncology remain insufficiently characterized. This study systematically evaluated the characteristics of oncological emulation studies.</p><p><strong>Materials and methods: </strong>We systematically searched PubMed, Embase, and Web of Science Core Collection databases from inception to December 22, 2023, to identify oncology-focused TTE studies. Study characteristics, TTE components, and consistency with corresponding randomized controlled trials (RCTs) were analyzed. Categorical variables were summarized as frequencies and percentages and compared using Chi-square tests in SPSS (version 27.0), with P-values <0 .05 considered statistically significant.</p><p><strong>Results: </strong>A total of 54 TTEs were included. Most were conducted in the United States (22, 40.7%), and publications peaked in 2023 (17, 31.5%). Colorectal cancer (13, 24.1%) was the most frequently investigated cancer type. Studies predominantly used data from national databases (18, 33.3%). While all studies prospectively specified the target trial protocol and emulation procedures, only 1 (1.9%) study was prospectively registered, and most emulation studies (48, 88.9%) did not reference a reporting guideline. Among the 10 RCT-TTE pairs available for comparison, 6 (60.0%) pairs achieved agreement in both statistical significance and effect estimates.</p><p><strong>Conclusion: </strong>This study provides a comprehensive analysis of TTE studies in oncology, highlighting their value for generating higher-quality real-world evidence. Future efforts should prioritize prospective protocol registration and standardize reporting to enhance the credibility and reproducibility of emulation studies.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13645428/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148399939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Resilience in symptom response as a descriptive label or an explanatory construct? Comments on Zhang et al. 症状反应中的弹性是描述性标签还是解释性构念?对Zhang等人的评论。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag407
Joran Geeraerts, Lara Pivodic
{"title":"Resilience in symptom response as a descriptive label or an explanatory construct? Comments on Zhang et al.","authors":"Joran Geeraerts, Lara Pivodic","doi":"10.1093/oncolo/oyag407","DOIUrl":"10.1093/oncolo/oyag407","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13691372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149186131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Advanced cancer treatment decisions and their patient-facing financial burdens: a thematic analysis. 更正:晚期癌症治疗决定及其患者面临的经济负担:专题分析。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-10-07 DOI: 10.1093/oncolo/oyag422
{"title":"Correction to: Advanced cancer treatment decisions and their patient-facing financial burdens: a thematic analysis.","authors":"","doi":"10.1093/oncolo/oyag422","DOIUrl":"10.1093/oncolo/oyag422","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"31 11","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13711317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149277243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Redefining the mCRPC frontline: lessons from PEACE-3 and BRCAaway in the post-ARPI era. 重新定义mCRPC前线:PEACE-3和BRCAaway在后arpi时代的经验教训。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag238
Giuseppe Luigi Banna, Giuseppe Neola, Fabrizio Di Costanzo, Pasquale Rescigno
{"title":"Redefining the mCRPC frontline: lessons from PEACE-3 and BRCAaway in the post-ARPI era.","authors":"Giuseppe Luigi Banna, Giuseppe Neola, Fabrizio Di Costanzo, Pasquale Rescigno","doi":"10.1093/oncolo/oyag238","DOIUrl":"10.1093/oncolo/oyag238","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13614713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148426574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Global management of drug-drug interaction in patients with prostate cancer: international survey by Meet-URO group and ONCOassist. 前列腺癌患者药物-药物相互作用的全球管理:met - uro小组和ONCOassist的国际调查。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag360
Anna Amela Valsecchi, Michele Maffezzoli, Maria Concetta Cursano, Mattia Di Civita, Fiorenza Santamaria, Stefania Kingspergher, Elisa Zanardi, Giuseppe Procopio, Suleka Ashok, Lakshmi Ramachandran, Renita George, Kevin Bambury, Richard Bambury, Eoin O'Carroll, Giuseppe Luigi Banna, Massimo Di Maio, Daniele Santini
{"title":"Global management of drug-drug interaction in patients with prostate cancer: international survey by Meet-URO group and ONCOassist.","authors":"Anna Amela Valsecchi, Michele Maffezzoli, Maria Concetta Cursano, Mattia Di Civita, Fiorenza Santamaria, Stefania Kingspergher, Elisa Zanardi, Giuseppe Procopio, Suleka Ashok, Lakshmi Ramachandran, Renita George, Kevin Bambury, Richard Bambury, Eoin O'Carroll, Giuseppe Luigi Banna, Massimo Di Maio, Daniele Santini","doi":"10.1093/oncolo/oyag360","DOIUrl":"10.1093/oncolo/oyag360","url":null,"abstract":"<p><strong>Background: </strong>Patients with prostate cancer (PC) frequently receive multiple medications for comorbidities, increasing the risk of drug-drug interactions (DDIs). Despite guidelines highlighting DDI relevance, data on real-world management are limited. This international survey aimed to characterize current practices, barriers, and needs in this setting.</p><p><strong>Materials and methods: </strong>A self-administered, multiple-choice online survey was sent to 3342 Italian oncologists (AIOM/Meet-URO members) and 19 139 global healthcare professionals via the ONCOassist app. A part of the survey included optional case studios completed only by Italian respondents.</p><p><strong>Results: </strong>Responses were received by 69 healthcare professionals in Italy and 1064 worldwide. Overall, DDIs were widely recognized as clinically relevant in PC care. Digital tools (online databases and smartphone applications) were the most frequently used resources for DDI assessment in both cohorts, whereas AI-based tools were limited. Italian oncologists reported limited on-site pharmacologist access (29%), while global respondents reported more frequent pharmacologist support (76%). Common barriers included time constraints, uncertain reliability of sources, and lack of training. When DDI checkers conflicted, Italian and global respondents favored pharmacologist consultation, although global users relied also on literature (31%) and clinical judgment (26%). Proposed solutions differed between cohorts: Italian clinicians emphasized the need for greater access to pharmacologists' support, whereas the global cohort highlighted institutional training and educational initiatives. Clinical scenarios demonstrated awareness of specific DDI risks, with cautious selection of ARTAs and co-medications in line with current recommendations.</p><p><strong>Conclusion: </strong>Although limited by potential selection bias and restricted generalizability, these findings suggest that strengthening multidisciplinary collaboration could enhance patient safety and optimize therapy outcomes.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13596776/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148978758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Overall survival in oncology phase III trials: an individual patient level meta-analysis (OPTIMA). 肿瘤学III期试验的总生存率:个体患者水平荟萃分析(OPTIMA)。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag157
Alexander D Sherry, Noah Meimoun, Avital M Miller, Jessica Liu, Kimi Chauhan, Ramez Kouzy, Timothy A Lin, Pavlos Msaouel, Ethan B Ludmir
{"title":"Overall survival in oncology phase III trials: an individual patient level meta-analysis (OPTIMA).","authors":"Alexander D Sherry, Noah Meimoun, Avital M Miller, Jessica Liu, Kimi Chauhan, Ramez Kouzy, Timothy A Lin, Pavlos Msaouel, Ethan B Ludmir","doi":"10.1093/oncolo/oyag157","DOIUrl":"10.1093/oncolo/oyag157","url":null,"abstract":"<p><p>Designing phase III oncology trials to demonstrate overall survival (OS) superiority may be challenging due to sample size, follow-up time, resources, and costs as compared to trials evaluating intermediate endpoints, which may or may not be reliable surrogates of OS. In this study, we investigate at scale the relative gains in OS achieved in modern phase III oncology trials using OS primary endpoints in OPTIMA, a prospectively registered, pre-specified meta-analysis leveraging a large assembly of reconstructed individual patient-level data (PROSPERO: CRD420251162778). After screening 1184 trials and excluding 937 without an OS primary endpoint, 159 trials enrolling 104 740 patients met the inclusion criteria. In the two-stage Cox model, randomization to the experimental arm was associated with improvement in OS (random effects HR, 0.87; 95% CI, 0.85-0.89; P < .0001). In the one-stage Cox model stratified by trial identity, OS was also longer with the experimental arm (HR, 0.88; 95% CI, 0.85-0.90; P < .0001). Taken together, the data from OPTIMA should encourage renewed enthusiasm among trialists, funders, regulatory agencies, and policymakers for prioritizing phase III oncology trials evaluating OS primary endpoints.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"31 10","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13614714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149065878","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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