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Olaparib as treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency: Phase 2 LIGHT study final overall survival analysis. 奥拉帕尼治疗BRCA突变和同源重组缺陷的铂敏感复发卵巢癌:2期LIGHT研究最终总生存分析
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 DOI: 10.1002/cncr.35707
Ying L Liu, Cara A Mathews, Fiona Simpkins, Karen A Cadoo, Diane Provencher, Colleen C McCormick, Adam C ElNaggar, Alon D Altman, Lucy Gilbert, Destin Black, Nashwa Kabil, Rosie N Taylor, Alan Barnicle, Jiefen Y Munley, Carol Aghajanian
{"title":"Olaparib as treatment for platinum-sensitive relapsed ovarian cancer by BRCA mutation and homologous recombination deficiency: Phase 2 LIGHT study final overall survival analysis.","authors":"Ying L Liu, Cara A Mathews, Fiona Simpkins, Karen A Cadoo, Diane Provencher, Colleen C McCormick, Adam C ElNaggar, Alon D Altman, Lucy Gilbert, Destin Black, Nashwa Kabil, Rosie N Taylor, Alan Barnicle, Jiefen Y Munley, Carol Aghajanian","doi":"10.1002/cncr.35707","DOIUrl":"https://doi.org/10.1002/cncr.35707","url":null,"abstract":"<p><strong>Background: </strong>LIGHT (oLaparib In HRD-Grouped Tumor types; NCT02983799) prospectively evaluated olaparib treatment in patients with platinum-sensitive relapsed ovarian cancer (PSROC) assigned to cohorts by known BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: germline BRCAm (gBRCAm), somatic BRCAm (sBRCAm), HRD-positive non-BRCAm, and HRD-negative. At the primary analysis, olaparib treatment demonstrated activity across all cohorts, with greatest efficacy in terms of objective response rate and progression-free survival observed in the g/sBRCAm cohorts. The authors report final overall survival (OS).</p><p><strong>Methods: </strong>In this phase 2, open-label, noncomparative study, patients with PSROC and one or more prior line of platinum-based chemotherapy were assigned to cohorts by BRCAm and HRD status. OS was a secondary end point. Tumors were analyzed using Myriad BRACAnalysis CDx and MyChoice CDx assays; HRD-positive tumors were defined using a genomic instability score of ≥42.</p><p><strong>Results: </strong>Of 272 enrolled patients, 271 received olaparib and 270 met the inclusion criteria for the efficacy analysis. At data cutoff, 18-month OS rates in the gBRCAm, sBRCAm, HRD-positive non-BRCAm, and HRD-negative cohorts were 86.4%, 88.0%, 78.6%, and 59.6%, respectively. No new safety signals were observed. In a post hoc analysis, patients on treatment for >18 months were most frequently present in g/sBRCAm cohorts (31.0%).</p><p><strong>Conclusions: </strong>Olaparib treatment continued to demonstrate benefit across all cohorts. Consistent with the primary analysis, the highest OS rates were observed in the BRCAm cohorts, regardless of g/sBRCAm. In patients without a BRCAm, a higher OS rate was observed in the HRD-positive non-BRCAm than the HRD-negative cohorts. These results highlight the importance of biomarker testing in this treatment setting.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":"e35707"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11736996/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142996820","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
Decision in Braidwood v. Becerra increases uncertainty in coverage for cancer screenings. Braidwood 诉 Becerra 案的判决增加了癌症筛查覆盖范围的不确定性。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 Epub Date: 2024-12-12 DOI: 10.1002/cncr.35689
David G Hill, Ernest Hawk
{"title":"Decision in Braidwood v. Becerra increases uncertainty in coverage for cancer screenings.","authors":"David G Hill, Ernest Hawk","doi":"10.1002/cncr.35689","DOIUrl":"10.1002/cncr.35689","url":null,"abstract":"","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35689"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142816751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The role of surgery and deescalation for HPV-related oropharyngeal cancer. HPV相关口咽癌的手术和降级治疗作用。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 Epub Date: 2024-03-18 DOI: 10.1002/cncr.35287
Kevin J Contrera, Mihir R Patel, Barbara Burtness, Ranee Mehra, Robert L Ferris
{"title":"The role of surgery and deescalation for HPV-related oropharyngeal cancer.","authors":"Kevin J Contrera, Mihir R Patel, Barbara Burtness, Ranee Mehra, Robert L Ferris","doi":"10.1002/cncr.35287","DOIUrl":"10.1002/cncr.35287","url":null,"abstract":"<p><p>Recently published and ongoing trials are helping to define the role of transoral robotic surgery for oropharyngeal cancer. Evidence to date supports the use of surgery as a valuable tool in the multidisciplinary deescalation of low-risk human papillomavirus-related oropharyngeal squamous cell carcinoma.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35287"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11736833/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140142414","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
De-escalation of axillary surgery in patients with sentinel lymph node micrometastases after neoadjuvant systemic therapy. 新辅助系统疗法后前哨淋巴结微转移患者的腋窝手术升级。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 DOI: 10.1002/cncr.35698
Mariam Rizk, Kefah Mokbel
{"title":"De-escalation of axillary surgery in patients with sentinel lymph node micrometastases after neoadjuvant systemic therapy.","authors":"Mariam Rizk, Kefah Mokbel","doi":"10.1002/cncr.35698","DOIUrl":"https://doi.org/10.1002/cncr.35698","url":null,"abstract":"","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":"e35698"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
First person profile: Julie Brahmer, MD: Dr Brahmer's research paved the way for the first immunotherapy agent to receive US Food and Drug Administration approval for the treatment of lung cancer. 第一人称简介:Julie Brahmer,医学博士:Brahmer博士的研究为首个获得美国食品和药物管理局批准用于治疗肺癌的免疫疗法铺平了道路。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 DOI: 10.1002/cncr.35686
Mary Beth Nierengarten
{"title":"First person profile: Julie Brahmer, MD: Dr Brahmer's research paved the way for the first immunotherapy agent to receive US Food and Drug Administration approval for the treatment of lung cancer.","authors":"Mary Beth Nierengarten","doi":"10.1002/cncr.35686","DOIUrl":"https://doi.org/10.1002/cncr.35686","url":null,"abstract":"","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":"e35686"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142996846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treatment of focal anaplastic Wilms tumor: A report from the Children's Oncology Group AREN0321 and AREN03B2 studies. 局灶性无细胞 Wilms 肿瘤的治疗:儿童肿瘤组织 AREN0321 和 AREN03B2 研究报告。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-15 DOI: 10.1002/cncr.35713
Amy E Armstrong, Najat C Daw, Lindsay A Renfro, James I Geller, John A Kalapurakal, Geetika Khanna, Arnold C Paulino, Elizabeth J Perlman, Peter F Ehrlich, Kenneth W Gow, Anne B Warwick, Paul E Grundy, Conrad V Fernandez, Elizabeth A Mullen, Jeffrey S Dome
{"title":"Treatment of focal anaplastic Wilms tumor: A report from the Children's Oncology Group AREN0321 and AREN03B2 studies.","authors":"Amy E Armstrong, Najat C Daw, Lindsay A Renfro, James I Geller, John A Kalapurakal, Geetika Khanna, Arnold C Paulino, Elizabeth J Perlman, Peter F Ehrlich, Kenneth W Gow, Anne B Warwick, Paul E Grundy, Conrad V Fernandez, Elizabeth A Mullen, Jeffrey S Dome","doi":"10.1002/cncr.35713","DOIUrl":"https://doi.org/10.1002/cncr.35713","url":null,"abstract":"<p><strong>Background: </strong>In the fifth National Wilms Tumor Study, patients received vincristine and dactinomycin (VA) without radiation for stage I focal anaplastic Wilms tumor (FAWT) and VA plus doxorubicin (DD4A) and radiation for stage II-IV FAWT. Four-year event-free survival (EFS) and overall survival (OS) for stage I FAWT were 67.5% and 88.9% and for stage IV FAWT were 61.4% and 71.6%, respectively. Therapy intensification for stage I and IV FAWT was evaluated as secondary objectives in AREN0321.</p><p><strong>Methods: </strong>Central review in the AREN03B2 Renal Tumors Classification, Biology, and Banking Study confirmed patient stage and tumor histology. Patients were then enrolled in AREN0321 and received DD4A with radiation for stage I-III FAWT and vincristine, doxorubicin, cyclophosphamide, carboplatin, and etoposide (UH-1/revised UH-1) with radiation for stage IV FAWT. Outcomes of patients with FAWT who were treated in AREN0321 (n = 25) and in AREN03B2 (n = 20) treated as per AREN0321 were analyzed.</p><p><strong>Results: </strong>In the pooled data analysis from AREN0321 and AREN03B2, 4-year EFS and OS were both 100% for stage I-II FAWT (n = 21), 82.4% (95% CI, 66.1%-100%) and 87.8% (95% CI, 73.4%-100%) for stage III FAWT (n = 17), respectively, and both 85.7% (95% CI, 63.3%-100%) for stage IV FAWT (n = 7). Four patients enrolled in AREN0321 had events: treatment failure occurred in three patients with stage III FAWT, and one treatment-related death was observed in a patient with stage IV FAWT following revised UH-1. No EFS or OS events occurred in patients with FAWT enrolled in AREN03B2 only.</p><p><strong>Conclusions: </strong>Patients with stage I and II FAWT have outstanding survival when treated with DD4A and radiation. Intensification of therapy may have improved survival for stage IV FAWT, albeit with an increased toxicity risk.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"131 2","pages":"e35713"},"PeriodicalIF":6.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142968892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A systematic review and meta-analysis of patient-relevant outcomes in comprehensive cancer centers versus noncomprehensive cancer centers. 综合癌症中心与非综合癌症中心患者相关结果的系统回顾和荟萃分析。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-01 Epub Date: 2024-11-20 DOI: 10.1002/cncr.35646
Carla Thamm, Elise Button, Jolyn Johal, Reegan Knowles, Aarti Gulyani, Catherine Paterson, Michael T Halpern, Andreas Charalambous, Alexandre Chan, Sanchia Aranda, Carolyn Taylor, Raymond J Chan
{"title":"A systematic review and meta-analysis of patient-relevant outcomes in comprehensive cancer centers versus noncomprehensive cancer centers.","authors":"Carla Thamm, Elise Button, Jolyn Johal, Reegan Knowles, Aarti Gulyani, Catherine Paterson, Michael T Halpern, Andreas Charalambous, Alexandre Chan, Sanchia Aranda, Carolyn Taylor, Raymond J Chan","doi":"10.1002/cncr.35646","DOIUrl":"10.1002/cncr.35646","url":null,"abstract":"<p><p>This systematic review describes difference in patient-relevant outcomes between comprehensive cancers (CCCs) versus non-CCCs. Studies were identified in PubMed, Cochrane CENTRAL, Epistemonikos, and gray literature from January 2002 to May 2024. Data were extracted and appraised by two authors. Results were narratively synthesized, and meta-analyzed where appropriate. Of 2272 records screened, 36 observational studies were included, predominantly from the United States, and focused on adults with solid cancers. Compared to non-CCCs, studies consistently or predominantly reported superior outcomes at CCCs relating to mortality and survival, quality of peri- and postoperative care, rates of cancer recurrence or progression, and impact on symptoms and health-related quality of life. Meta-analysis showed a significantly lower overall mortality risk of 23% in CCCs compared to non-CCCs (hazard ratio, 0.77; 95% confidence interval, 0.74-0.81, p < .001), with medium heterogeneity (I<sup>2</sup> = 64.61%; Q-test = 36.29, p < .01) observed between the studies. Studies reporting on health equity and costs outcomes consistently or predominantly favored non-CCCs over CCCs. Mixed results were reported for outcomes relating to time to care, palliative and end-of-life care, and health care utilization. The literature reports CCCs are associated with superior outcomes in many areas, especially around mortality and survival. Greater focus is needed to explore outcomes that are important to people with cancer including health-related quality of life, symptoms, and treatment experience, and economic evaluation. Rather than aiming for superior outcomes, CCCs should be striving to enable equitable, high value, patient-centered outcomes for all people affected by cancer.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35646"},"PeriodicalIF":6.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142674630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Survival trends among patients with metastatic non-small cell lung cancer before and after the approval of immunotherapy in the United States: A Surveillance, Epidemiology, and End Results database-based study. 免疫疗法在美国获批前后转移性非小细胞肺癌患者的生存趋势:基于监测、流行病学和最终结果数据库的研究。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-01 Epub Date: 2024-07-10 DOI: 10.1002/cncr.35476
Yating Wang, Kyle Kondrat, Janak Adhikari, Quynh Nguyen, Qian Yu, Dipesh Uprety
{"title":"Survival trends among patients with metastatic non-small cell lung cancer before and after the approval of immunotherapy in the United States: A Surveillance, Epidemiology, and End Results database-based study.","authors":"Yating Wang, Kyle Kondrat, Janak Adhikari, Quynh Nguyen, Qian Yu, Dipesh Uprety","doi":"10.1002/cncr.35476","DOIUrl":"10.1002/cncr.35476","url":null,"abstract":"<p><strong>Background: </strong>In 2015, the US Food and Drug Administration approved nivolumab as the first immunotherapy for patients with advanced non-small cell lung cancer (NSCLC). However, population-based survival benefit studies after the introduction of immunotherapy in lung cancer are lacking. This study examined overall survival (OS) and cancer-specific survival in patients with NSCLC in the pre immunotherapy and immunotherapy eras.</p><p><strong>Methods: </strong>This study used the Surveillance, Epidemiology, and End Results database, which spanned 17 registries from 2000 to 2020. Two cohorts were delineated: preimmunotherapy (2010-2014) and immunotherapy (2015-2020), which coincided with nivolumab's approval.</p><p><strong>Results: </strong>This study included 191,802 patients, 90,807 in the preimmunotherapy era and 100,995 in the immunotherapy era. OS was significantly higher in the immunotherapy era, as shown by Kaplan-Meier curves (1-year OS, 40.1% vs. 33.5%; 3-year OS, 17.8% vs. 11.7%; 5-year OS, 10.7% vs. 6.8%; median OS, 8 vs. 7 months; p < .001 by log-rank test). Similarly, cancer-specific survival improved in the immunotherapy era (1-year survival, 44.0% vs. 36.8%; 3-year survival, 21.7% vs. 14.4%; 5-year survival, 14.3% vs. 9.0%; median OS, 10 vs. 8 months; p < .001 by log-rank test). Survival rates were significantly better in the immunotherapy era, as confirmed by multivariate analysis with a Cox proportional hazards model after adjusting for age, sex, race, income, and geographical area (adjusted hazard ratio, 0.830; 95% CI, 0.821-0.840; p < .001).</p><p><strong>Conclusions: </strong>In summary, the survival rate of patients with metastatic NSCLC has improved since the introduction of immunotherapy.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35476"},"PeriodicalIF":6.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141578408","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of three-dimensional-printing technology guidance on surgical outcomes for retroperitoneal sarcoma: A propensity score-matched study. 三维打印技术对腹膜后肉瘤手术效果的影响:倾向评分匹配研究。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-01 Epub Date: 2024-07-03 DOI: 10.1002/cncr.35452
Jiaxin Lin, Yingru Li, Xiaochuang Feng, Yu Zhang, Jiahao Wang, Weilin Liao, Hongming Li, Xiaojiang Yi, Wenchang Gan, Zhilong Yuan, Fuheng Liu, Lishuo Shi, Bing Zeng, Dechang Diao
{"title":"Impact of three-dimensional-printing technology guidance on surgical outcomes for retroperitoneal sarcoma: A propensity score-matched study.","authors":"Jiaxin Lin, Yingru Li, Xiaochuang Feng, Yu Zhang, Jiahao Wang, Weilin Liao, Hongming Li, Xiaojiang Yi, Wenchang Gan, Zhilong Yuan, Fuheng Liu, Lishuo Shi, Bing Zeng, Dechang Diao","doi":"10.1002/cncr.35452","DOIUrl":"10.1002/cncr.35452","url":null,"abstract":"<p><strong>Background: </strong>The surgical treatment of retroperitoneal sarcoma (RPS) is highly challenging because of its complex anatomy. In this study, the authors compared the surgical outcomes of patients with RPS who underwent surgical resection guided by three-dimensional (3D) printing technology versus traditional imaging.</p><p><strong>Methods: </strong>This retrospective study included 251 patients who underwent RPS resection guided by 3D-printing technology or traditional imaging from January 2019 to December 2022. The main outcome measures were operative time, intraoperative blood loss, postoperative complications, and hospital stay.</p><p><strong>Results: </strong>In total, 251 patients were enrolled in the study: 46 received 3D-printed navigation, and 205 underwent traditional surgical methods. Propensity score matching yielded 44 patients in the 3D group and 82 patients in the control group. The patients' demographics and tumor characteristics were comparable in the matched cohorts. The 3D group had significantly shorter operative time (median, 186.5 minutes [interquartile range (IQR), 130.0-251.3 minutes] vs. 210.0 minutes [IQR, 150.8-277.3 minutes]; p = .04), less intraoperative blood loss (median, 300.0 mL [IQR, 100.0-575.0 mL] vs. 375.0 mL [IQR, 200.0-925.0 mL]; p = .02), shorter postoperative hospital stays (median, 11.0 days [IQR, 9.0-13.0 days] vs. 14.0 days [IQR, 10.8-18.3 days]; p = .02), and lower incidence rate of overall postoperative complications than the control group (18.1% vs. 36.6%; p = .03). There were no differences with regard to the intraoperative blood transfusion rate, the R0/R1 resection rate, 30-day mortality, or overall survival.</p><p><strong>Conclusions: </strong>Patients in the 3D group had favorable surgical outcomes compared with those in the control group. These results suggest that 3D-printing technology might overcome challenges in RPS surgical treatment.</p><p><strong>Plain language summary: </strong>The surgical treatment of retroperitoneal sarcoma (RPS) is highly challenging because of its complex anatomy. The purpose of this study was to investigate whether three-dimensional (3D) printing technology offers advantages over traditional two-dimensional imaging (such as computed tomography and magnetic resonance imaging) for guiding the surgical treatment of RPS. In a group of patients who had RPS, surgery guided by 3D-printing technology was associated with better surgical outcomes, including shorter operative time, decreased blood loss, shorter hospital stays, and fewer postoperative complications. These findings suggested that 3D-printing technology could help surgeons overcome challenges in the surgical treatment of RPS. 3D-printing technology has important prospects in the surgical treatment of RPS.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35452"},"PeriodicalIF":6.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141496474","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study: Lessons learned about management and patient enrollment in a large, pragmatic, patient-centered trial. 膀胱癌膀胱内治疗与手术治疗方案比较(CISTO)研究:在一项以患者为中心的大型务实试验中,从管理和患者入组方面汲取的经验教训。
IF 6.1 2区 医学
Cancer Pub Date : 2025-01-01 Epub Date: 2024-10-14 DOI: 10.1002/cncr.35600
Krupa K Nathan, Kristin M Follmer, Michael G Nash, Erika M Wolff, Jenney R Lee, Solange Mecham, Marielle Yano, Sung Min Kim, Bryan A Comstock, John L Gore, Angela B Smith
{"title":"The Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study: Lessons learned about management and patient enrollment in a large, pragmatic, patient-centered trial.","authors":"Krupa K Nathan, Kristin M Follmer, Michael G Nash, Erika M Wolff, Jenney R Lee, Solange Mecham, Marielle Yano, Sung Min Kim, Bryan A Comstock, John L Gore, Angela B Smith","doi":"10.1002/cncr.35600","DOIUrl":"10.1002/cncr.35600","url":null,"abstract":"<p><strong>Background: </strong>The growth of patient and public involvement in clinical research highlights the paucity of literature on operational practices that ensure the success of large, patient-centered outcomes trials. The authors' objective was to identify tools launched by the Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (CISTO) study team to determine their effectiveness in maximizing patient enrollment in this observational, pragmatic trial.</p><p><strong>Methods: </strong>The primary outcomes for this study were patient screening and enrollment across 36 CISTO study sites. The operational strategies included CISTOquestion email correspondence and All Sites Meetings, specifically poll performance data from meetings, and a nonanonymized feedback survey about the CISTO study's management practices. Effectiveness was measured using correlation analysis with patient cohort data, including screenings, enrollments, post-hoc exclusions, and the post-hoc exclusion rate.</p><p><strong>Results: </strong>Average screenings and enrollment rose after the implementation of CISTOquestion in April 2021, with the average number of screenings rising from 7.42 to 26.8 patients per month and enrollment rising from 3.76 to 16 patients per month. Use of CISTOquestion was correlated strongly with increased patient screenings and enrollment across all study sites. Eighty-three percent of sites with above-average post-hoc exclusion rates (≥0.092) sent below the average number of CISTOquestion inquiries. Poll performance and survey data revealed that all survey respondents who used CISTOquestion found that it was a valuable and accessible resource.</p><p><strong>Conclusions: </strong>Of the several operational tools implemented within the CISTO study that aimed to improve patient enrollment, CISTOquestion, a centralized email for addressing eligibility questions, was most beneficial to overall patient accrual.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":" ","pages":"e35600"},"PeriodicalIF":6.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142454014","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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