JNCI Journal of the National Cancer Institute最新文献

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An international multi-institutional validation of T1 sub-staging of intraductal papillary mucinous neoplasm-derived pancreatic cancer. 导管内乳头状粘液瘤源性胰腺癌T1亚分期的国际多机构验证。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae166
Joseph R Habib, Ingmar F Rompen, Brady A Campbell, Paul C M Andel, Benedict Kinny-Köster, Ryte Damaseviciute, D Brock Hewitt, Greg D Sacks, Ammar A Javed, Marc G Besselink, Hjalmar C van Santvoort, Lois A Daamen, Martin Loos, Jin He, I Quintus Molenaar, Markus W Büchler, Christopher L Wolfgang
{"title":"An international multi-institutional validation of T1 sub-staging of intraductal papillary mucinous neoplasm-derived pancreatic cancer.","authors":"Joseph R Habib, Ingmar F Rompen, Brady A Campbell, Paul C M Andel, Benedict Kinny-Köster, Ryte Damaseviciute, D Brock Hewitt, Greg D Sacks, Ammar A Javed, Marc G Besselink, Hjalmar C van Santvoort, Lois A Daamen, Martin Loos, Jin He, I Quintus Molenaar, Markus W Büchler, Christopher L Wolfgang","doi":"10.1093/jnci/djae166","DOIUrl":"10.1093/jnci/djae166","url":null,"abstract":"<p><strong>Background: </strong>Intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic ductal adenocarcinoma (PDAC) is resected at smaller sizes compared with its biologically distinct counterpart, pancreatic intraepithelial neoplasia (PanIN)-derived PDAC. Thus, experts proposed T1 sub-staging for IPMN-derived PDAC. However, this has never been validated.</p><p><strong>Methods: </strong>Consecutive upfront surgery patients with IPMN-derived PDAC from 5 international high-volume centers were classified by the proposed T1 sub-staging classification (T1a ≤0.5, T1b >0.5 and ≤1.0, and T1c >1.0 and ≤2.0 cm) using the invasive component size. Kaplan-Meier and log-rank tests were used to compare overall survival (OS). A multivariable Cox regression was used to determine hazard ratios (HRs) with confidence intervals (95% CIs).</p><p><strong>Results: </strong>Among 747 patients, 69 (9.2%), 50 (6.7%), 99 (13.0%), and 531 patients (71.1%), comprised the T1a, T1b, T1c, and T2-4 subgroups, respectively. Increasing T-stage was associated with elevated CA19-9, poorer grade, nodal positivity, R1 margin, and tubular subtype. Median OS for T1a, T1b, T1c, and T2-4 were 159.0 (95% CI = 126.0 to NR), 128.8 (98.3 to NR), 77.6 (48.3 to 108.2), and 31.4 (27.5 to 37.7) months, respectively (P < .001). OS decreased with increasing T-stage for all pairwise comparisons (all P < .05). After risk adjustment, older than age 65, elevated CA19-9, T1b [HR = 2.55 (1.22 to 5.32)], T1c [HR = 3.04 (1.60 to 5.76)], and T2-4 [HR = 3.41 (1.89 to 6.17)] compared with T1a, nodal positivity, R1 margin, and no adjuvant chemotherapy were associated with worse OS. Disease recurrence was more common in T2-4 tumors (56.4%) compared with T1a (18.2%), T1b (23.9%), and T1c (36.1%, P < .001).</p><p><strong>Conclusion: </strong>T1 sub-staging of IPMN-derived PDAC is valid and has significant prognostic value. Advancing T1 sub-stage is associated with worse histopathology, survival, and recurrence. T1 sub-staging is recommended for future guidelines.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542988/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141727126","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}
引用次数: 0
Ovarian cancer risk factors in relation to family history. 卵巢癌风险因素与家族史的关系。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae164
Guoqiao Zheng, Louise Baandrup, Jiangrong Wang, Rasmus Hertzum-Larsen, Charlotte Gerd Hannibal, Mette Tuxen Faber, Karin Sundström, Susanne K Kjær
{"title":"Ovarian cancer risk factors in relation to family history.","authors":"Guoqiao Zheng, Louise Baandrup, Jiangrong Wang, Rasmus Hertzum-Larsen, Charlotte Gerd Hannibal, Mette Tuxen Faber, Karin Sundström, Susanne K Kjær","doi":"10.1093/jnci/djae164","DOIUrl":"10.1093/jnci/djae164","url":null,"abstract":"<p><strong>Background: </strong>Women with a family history of breast and/or ovarian cancer have an increased ovarian cancer risk. Yet it remains uncertain if common ovarian cancer risk factors-especially those that are modifiable-affect this high-risk population similarly to the general population.</p><p><strong>Methods: </strong>Using the Danish and Swedish nationwide registers, we established 2 nested case-control study populations in women with a family history of breast and/or ovarian cancer (2138 ovarian cancers, 85 240 controls) and women without (10 730 ovarian cancers, 429 200 controls). The overall and histology-specific associations were assessed with conditional logistic regression. The country-specific estimates were combined based on a fixed-effect assumption.</p><p><strong>Results: </strong>Multiparity, hysterectomy, tubal ligation, salpingectomy, and oral contraceptive (OC) use were associated with a reduced risk of ovarian cancer in women with and without a family history, while endometriosis and menopausal hormone therapy were associated with increased risk. Multiparity and OC use presented protective effects across all histologic subtypes except mucinous ovarian cancer, which was not associated with OC use. Menopausal hormone treatment increased the risk of serous ovarian cancer but decreased the risk of the mucinous and clear cell cancers. Endometriosis was especially related to an increased risk of endometrioid and clear cell ovarian cancer.</p><p><strong>Conclusion: </strong>Factors associated with a decreased ovarian cancer risk were similar between women with and without a family history of breast and/or ovarian cancer. Given the higher baseline risk for women with a family history, special attention should be paid to risk factors like endometriosis and nulliparity in this high-risk population.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534473","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}
引用次数: 0
Adverse events in men with advanced prostate cancer treated with androgen biosynthesis inhibitors and androgen receptor inhibitors. 使用雄激素生物合成抑制剂和雄激素受体抑制剂治疗晚期前列腺癌男性患者的不良事件。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae155
Kassem S Faraj, Mary Oerline, Samuel R Kaufman, Christopher Dall, Arnav Srivastava, Megan E V Caram, Vahakn B Shahinian, Brent K Hollenbeck
{"title":"Adverse events in men with advanced prostate cancer treated with androgen biosynthesis inhibitors and androgen receptor inhibitors.","authors":"Kassem S Faraj, Mary Oerline, Samuel R Kaufman, Christopher Dall, Arnav Srivastava, Megan E V Caram, Vahakn B Shahinian, Brent K Hollenbeck","doi":"10.1093/jnci/djae155","DOIUrl":"10.1093/jnci/djae155","url":null,"abstract":"<p><strong>Background: </strong>The use of androgen biosynthesis and second-generation androgen receptor inhibitors for advanced prostate cancer is increasing. Because these therapies alter the androgen pathway, they have been associated with cardiometabolic and neurocognitive toxicities. Although their safety profiles have been assessed in clinical trials, real-world data are limited.</p><p><strong>Methods: </strong>A 20% sample of national Medicare claims was used to perform a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer treated with androgen biosynthesis (ie, abiraterone) and second-generation androgen receptor inhibitors between 2012 and 2019. Outcomes were assessed after the first fill of either class of drug for the 12-month period after starting therapy. The primary outcome was a hospital admission or emergency department visit for a cardiometabolic event. Secondary outcomes included neurocognitive events and fractures. Multivariable regression was used to assess the association between the class of drug and occurrence of an adverse event.</p><p><strong>Results: </strong>There were 3488 (60%) men started on an androgen biosynthesis inhibitor and 2361 (40%) started on an androgen receptor inhibitor for the first time. Cardiometabolic adverse events were more common in men managed with androgen biosynthesis inhibitor (9.2% vs 7.5%, P = .027). No difference between androgen biosynthesis and androgen receptor inhibitors was observed for neurocognitive events (3.3% vs 3.4%, respectively; P = .71) or fractures (4.2% vs 3.6%, respectively; P = .26).</p><p><strong>Conclusions: </strong>Men with advanced prostate cancer initiating an androgen biosynthesis inhibitor for the first time more commonly had cardiometabolic events than those started on androgen receptor inhibitors. Neurocognitive events and fractures did not differ by drug class.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141758739","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}
引用次数: 0
Celebrating the 1945 JNCI pioneering contribution to antiangiogenic therapy for cancer. 庆祝 1945 年 JNCI 为癌症抗血管生成疗法做出的开创性贡献。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae181
Giovanna Tosato, Yuyi Wang
{"title":"Celebrating the 1945 JNCI pioneering contribution to antiangiogenic therapy for cancer.","authors":"Giovanna Tosato, Yuyi Wang","doi":"10.1093/jnci/djae181","DOIUrl":"10.1093/jnci/djae181","url":null,"abstract":"","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142043916","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}
引用次数: 0
Comparing characteristics of individuals screened for lung cancer with 2021 vs 2013 US Preventive Services Task Force recommendations. 比较 2021 年与 2013 年 USPSTF 建议肺癌筛查者的特征。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae141
Louise M Henderson, Danielle D Durham, James Gruden, Michael Pritchard, Lindsay Lane, Jason Long, Christina Bellinger, M Patricia Rivera
{"title":"Comparing characteristics of individuals screened for lung cancer with 2021 vs 2013 US Preventive Services Task Force recommendations.","authors":"Louise M Henderson, Danielle D Durham, James Gruden, Michael Pritchard, Lindsay Lane, Jason Long, Christina Bellinger, M Patricia Rivera","doi":"10.1093/jnci/djae141","DOIUrl":"10.1093/jnci/djae141","url":null,"abstract":"<p><p>We conducted a cross-sectional, multicenter study to compare the demographics, clinical characteristics, and lung cancer screening results among individuals eligible for lung cancer screening per 2013 vs 2021 US Preventive Services Task Force recommendations. Statistical tests are 2 sided, with P less than  .05 considered statistically significant. Among 17 702 screened individuals (85.2% 2013 eligible, 14.8% 2021 newly eligible), a higher proportion of individuals screened per 2021 vs 2013 criteria were female (56.1% vs 48.1%, P < .001) and non-Hispanic Black (19.3% vs 13.4%, P < .001). The risk of developing and dying from lung cancer per 1000 people was statistically significantly higher among individuals eligible per 2013 vs 2021 criteria. A higher proportion of lung cancer screening exams had an increased suspicion of lung cancer in the 2013 vs 2021 criteria groups. Our data suggest that, as intended, updated 2021 US Preventive Services Task Force recommendations are leading to a higher proportion of lung cancer screening exams among non-Hispanic Black individuals and women.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542990/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446203","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}
引用次数: 0
Fecal, duodenal, and tumor microbiota composition of esophageal carcinoma patients, a longitudinal prospective cohort. 食管癌患者的粪便、十二指肠和肿瘤微生物群组成,一项纵向前瞻性队列研究
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae153
Tom van den Ende, Nicolien C de Clercq, Mark Davids, Ruben Goedegebuure, Benthe H Doeve, Gati Ebrahimi, Jeroen Buijsen, Ronald Hoekstra, Nadia Haj Mohammad, Maarten F Bijlsma, Max Nieuwdorp, Hanneke W M van Laarhoven
{"title":"Fecal, duodenal, and tumor microbiota composition of esophageal carcinoma patients, a longitudinal prospective cohort.","authors":"Tom van den Ende, Nicolien C de Clercq, Mark Davids, Ruben Goedegebuure, Benthe H Doeve, Gati Ebrahimi, Jeroen Buijsen, Ronald Hoekstra, Nadia Haj Mohammad, Maarten F Bijlsma, Max Nieuwdorp, Hanneke W M van Laarhoven","doi":"10.1093/jnci/djae153","DOIUrl":"10.1093/jnci/djae153","url":null,"abstract":"<p><strong>Background: </strong>The microbiome has been associated with chemotherapy and immune checkpoint inhibitor efficacy. How this pertains to resectable esophageal carcinoma is unknown. Our aim was to identify microbial signatures in resectable esophageal carcinoma associated with response to neoadjuvant chemoradiotherapy with or without an immune checkpoint inhibitor.</p><p><strong>Methods: </strong>From 2 prospectively collected esophageal carcinoma cohorts (n = 172 in total) treated with neoadjuvant chemoradiotherapy alone (n = 132) or a combination of neoadjuvant chemoradiotherapy and an immune checkpoint inhibitor (n = 40), fecal samples were available at baseline, during treatment, and presurgery. Additionally, in the immune checkpoint inhibitor-treated patients, tumor and duodenal snap frozen biopsies were collected over time. Fecal, tumor, and duodenal DNA were extracted for 16S ribosomal RNA sequencing. Associations were investigated between microbiome composition pathological complete response and progression-free survival (PFS).</p><p><strong>Results: </strong>There was a statistically significant shift in the microbiota profile of the fecal, tumor, and duodenal microbiota over time. In the total cohort, patients with a pathological complete response had a stable fecal alpha diversity, while the diversity of poor responders decreased during treatment (P = .036). Presurgery, lower alpha diversity (<4.12) was related to worse PFS (log-rank P = .025). Baseline tumor biopsies of patients with short PFS had more Fusobacterium. A low baseline duodenal alpha diversity (<3.96) was associated with worse PFS (log-rank P = .012).</p><p><strong>Conclusions: </strong>Lower intestinal alpha diversity was associated with worse response and survival of esophageal carcinoma patients. In tumor biopsies, Fusobacterium was more abundant in patients with poor PFS. After further mechanistic validation, these findings may aid in response prediction and the design of novel microbiome modulating treatments for esophageal carcinoma patients.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542985/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141456939","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}
引用次数: 0
What happens in the community? Broadening research on the impacts of mass incarceration. 社区会发生什么?扩大对大规模监禁影响的研究。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae235
Andrea Knittel, Hazel B Nichols
{"title":"What happens in the community? Broadening research on the impacts of mass incarceration.","authors":"Andrea Knittel, Hazel B Nichols","doi":"10.1093/jnci/djae235","DOIUrl":"https://doi.org/10.1093/jnci/djae235","url":null,"abstract":"","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142557875","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}
引用次数: 0
Effect of smoking on melanoma incidence: a systematic review with meta-analysis. 吸烟对黑色素瘤发病率的影响:系统回顾与荟萃分析。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae142
Erica B Friedman, Gabrielle J Williams, Serigne N Lo, John F Thompson
{"title":"Effect of smoking on melanoma incidence: a systematic review with meta-analysis.","authors":"Erica B Friedman, Gabrielle J Williams, Serigne N Lo, John F Thompson","doi":"10.1093/jnci/djae142","DOIUrl":"10.1093/jnci/djae142","url":null,"abstract":"<p><strong>Background: </strong>There is a strong correlation between cigarette smoking and the development of many cancer types. It is therefore paradoxical that multiple reports have suggested a reduced incidence of melanoma in smokers. This study aimed to analyze all existing studies of melanoma incidence in smokers relative to nonsmokers.</p><p><strong>Methods: </strong>Searches of MEDLINE and Embase were conducted for studies reporting data on melanoma in smokers and never-smokers. No study design limitations or language restrictions were applied. The outcome examined was the association between smoking status and melanoma. Analyses focused on risk of melanoma in smokers and never-smokers generated from multivariable analyses, and these analyses were pooled using a fixed-effects model. Risk of bias was assessed using the Newcastle-Ottawa tool.</p><p><strong>Results: </strong>Forty-nine studies that included 59 429 patients with melanoma were identified. Pooled analyses showed statistically significant reduced risks of melanoma in male smokers (risk ratio [RR] = 0.60, 95% confidence interval [CI] = 0.56 to 0.65, P < .001) and female smokers (RR = 0.79, 95% CI = 0.73 to 0.86, P < .001). Male former smokers had a 16% reduction in melanoma risk compared with male never-smokers (RR = 0.84, 95% CI = 0.77 to 0.93, P < .001), but no risk reduction was observed in female former smokers (RR = 1.0, 95% CI = 0.92 to 1.08).</p><p><strong>Conclusions: </strong>Current smokers have a statistically significant reduced risk of developing melanoma compared with never-smokers, with a reduction in melanoma risk of 40% in men and 21% in women.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141446204","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}
引用次数: 0
RE: Prevalence of cancer survivors in the United States. 关于:"美国癌症幸存者的患病率"。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae205
Jason Domogauer, Marina Stasenko, Gwendolyn P Quinn, Matthew B Schabath
{"title":"RE: Prevalence of cancer survivors in the United States.","authors":"Jason Domogauer, Marina Stasenko, Gwendolyn P Quinn, Matthew B Schabath","doi":"10.1093/jnci/djae205","DOIUrl":"10.1093/jnci/djae205","url":null,"abstract":"","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142046697","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}
引用次数: 0
Optimizing early phase clinical trial washout periods: a report from the Therapeutic Advances in Childhood Leukemia and Lymphoma consortium. 优化早期临床试验冲洗期:儿童白血病和淋巴瘤治疗进展(TACL)联盟报告。
IF 9.9 1区 医学
JNCI Journal of the National Cancer Institute Pub Date : 2024-11-01 DOI: 10.1093/jnci/djae165
Eric S Schafer, Teresa Rushing, Kristine R Crews, Colleen Annesley, Susan I Colace, Nicole Kaiser, Lauren Pommert, Laura B Ramsey, Himalee S Sabnis, Kenneth Wong, Bill H Chang, Todd M Cooper, Nirali N Shah, Susan R Rheingold, Andrew E Place, Yueh-Yun Chi, Deepa Bhojwani, Alan S Wayne, M Brooke Bernhardt
{"title":"Optimizing early phase clinical trial washout periods: a report from the Therapeutic Advances in Childhood Leukemia and Lymphoma consortium.","authors":"Eric S Schafer, Teresa Rushing, Kristine R Crews, Colleen Annesley, Susan I Colace, Nicole Kaiser, Lauren Pommert, Laura B Ramsey, Himalee S Sabnis, Kenneth Wong, Bill H Chang, Todd M Cooper, Nirali N Shah, Susan R Rheingold, Andrew E Place, Yueh-Yun Chi, Deepa Bhojwani, Alan S Wayne, M Brooke Bernhardt","doi":"10.1093/jnci/djae165","DOIUrl":"10.1093/jnci/djae165","url":null,"abstract":"<p><strong>Background: </strong>The National Cancer Institute (NCI) issued a 2021 memorandum adopting the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research (Friends) task force recommendations to broaden clinical study eligibility criteria. They recommended that washout periods be eliminated for most prior cancer therapy and when required to utilize evidence- and/or rationale-based criteria. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) consortium responded to this guidance.</p><p><strong>Methods: </strong>A TACL task force reviewed the consortium's research portfolio, the relevant literature and guidance documents from ASCO-Friends, NCI, and US Food and Drug Administration to make expert consensus and evidence-based recommendations for modernizing, broadening, and codifying TACL-study washout periods while ensuring consistency with pediatric ethics, and federal regulations. TACL's screening log was reviewed to estimate the impact that updated washout periods would have on patient inclusivity and recruitment.</p><p><strong>Results: </strong>Over a 19-year period, 42 (14.6% of all screened ineligible patients [n = 287]) patients were identified as excluded from TACL early phase studies exclusively because of not meeting washout criteria. An additional 6 (2.1%) did not meet washout and at least 1 other exclusion criterion. A new TACL washout guidance document was developed and then adopted for use. Where washout criteria were not eliminated, rationale- and/or evidenced-based criteria were established with citation.</p><p><strong>Conclusion: </strong>In an effort to reduce unnecessary exclusion from clinical trials, TACL created rationale- and/or evidenced-based washout period standards largely following guidance from the NCI and ASCO-Friends recommendations. These new, expanded eligibility criteria are expected to increase access to TACL clinical trials while maintaining safety and scientific excellence.</p>","PeriodicalId":14809,"journal":{"name":"JNCI Journal of the National Cancer Institute","volume":null,"pages":null},"PeriodicalIF":9.9,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11542989/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534472","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}
引用次数: 0
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