Rachel T Kurtzman, Lisa Mikesell, Benjamin F Crabtree
Background: Individuals with a history of cancer increasingly seek health information from online resources, including NCI-designated Cancer Center websites. Centers receive NCI designation because they provide excellent care and engage in cutting-edge research. However, the information presented on these webpages and their accessibility is unknown. An evaluation of the survivorship-focused webpages from NCI-designated Cancer Centers is needed to assess survivorship information and accessibility of these webpages.
Methods: We conducted an evaluation of the survivorship-focused webpages from 64 NCI-designated Cancer Centers. We evaluated where survivorship-focused webpages were housed, if there was a survivorship clinic or program, target audience of the webpage, how cancer survivor was defined, contact methods, and available resources. Accessibility outcomes included readability, font type, font size, color scheme, and alternative text (alt text) descriptors. An artificial intelligence (AI) audit was conducted to assess if the webpage was compliant with national accessibility guidelines.
Results: Most cancer centers had a survivorship-focused webpage, with 72% located on the cancer center's website and 28% on a health system website. Survivorship information available varied considerably and was often lacking in detail. Although three-quarters of webpages targeted patients only, variable definitions of cancer survivor were observed. Accessibility issues identified included inconsistent use of alt text descriptors, font size smaller than 15 points, and color schemes without adequate contrast. The average reading-level of information presented was above 12th grade. Only 9% of webpages were compliant with online accessibility guidelines; 72% semicompliant and 21% were noncompliant.
Conclusions: Information presented on NCI-designated Cancer Center survivorship-focused webpages was inconsistent, often lacking, and inaccessible. NCI-designated Cancer Centers are role models for cancer research in the United States and have an obligation to provide survivorship information. Changes to content and website design are needed to provide better information for individuals seeking resources and health information relative to their cancer and care.
{"title":"Evaluation of NCI-Designated Cancer Center and Comprehensive Cancer Center Survivorship-Focused Websites: Information Provided and Accessibility.","authors":"Rachel T Kurtzman, Lisa Mikesell, Benjamin F Crabtree","doi":"10.6004/jnccn.2024.7017","DOIUrl":"10.6004/jnccn.2024.7017","url":null,"abstract":"<p><strong>Background: </strong>Individuals with a history of cancer increasingly seek health information from online resources, including NCI-designated Cancer Center websites. Centers receive NCI designation because they provide excellent care and engage in cutting-edge research. However, the information presented on these webpages and their accessibility is unknown. An evaluation of the survivorship-focused webpages from NCI-designated Cancer Centers is needed to assess survivorship information and accessibility of these webpages.</p><p><strong>Methods: </strong>We conducted an evaluation of the survivorship-focused webpages from 64 NCI-designated Cancer Centers. We evaluated where survivorship-focused webpages were housed, if there was a survivorship clinic or program, target audience of the webpage, how cancer survivor was defined, contact methods, and available resources. Accessibility outcomes included readability, font type, font size, color scheme, and alternative text (alt text) descriptors. An artificial intelligence (AI) audit was conducted to assess if the webpage was compliant with national accessibility guidelines.</p><p><strong>Results: </strong>Most cancer centers had a survivorship-focused webpage, with 72% located on the cancer center's website and 28% on a health system website. Survivorship information available varied considerably and was often lacking in detail. Although three-quarters of webpages targeted patients only, variable definitions of cancer survivor were observed. Accessibility issues identified included inconsistent use of alt text descriptors, font size smaller than 15 points, and color schemes without adequate contrast. The average reading-level of information presented was above 12th grade. Only 9% of webpages were compliant with online accessibility guidelines; 72% semicompliant and 21% were noncompliant.</p><p><strong>Conclusions: </strong>Information presented on NCI-designated Cancer Center survivorship-focused webpages was inconsistent, often lacking, and inaccessible. NCI-designated Cancer Centers are role models for cancer research in the United States and have an obligation to provide survivorship information. Changes to content and website design are needed to provide better information for individuals seeking resources and health information relative to their cancer and care.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"475-481"},"PeriodicalIF":14.8,"publicationDate":"2024-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995994","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}
Keita Miura, Takehito Shukuya, Ray Greenstein, Ben Kaplan, Heather Wakelee, Kana Kurokawa, Kazuyuki Furuta, Shunsuke Kato, Junghee Suh, Smruthy Sivakumar, Ethan S Sokol, David P Carbone, Kazuhisa Takahashi
Background: Some genomic alterations in non-small cell lung cancer (NSCLC) are known to differ according to race, sex, or age. These studies have been limited in sample size and thus they cannot detect the differences precisely and comprehensively.
Methods: Tissue-based comprehensive genomic profiling was performed on 75,362 patients with NSCLC from the United States during routine clinical care. Additionally, we examined data of a Japanese NSCLC cohort with 1,019 patients. In the US cohort, 296 genes were examined for pathogenic alterations. Predominant genetic ancestry was inferred using a SNP-based approach, and patients were categorized into European (EUR), African (AFR), East Asian (EAS), Admixed American (AMR), and South Asian (SAS) ancestry groups. Patients were additionally stratified by histologic type, age (<40/≥40 years, <75/≥75 years), and sex. The prevalence of high tumor mutational burden (TMB-High) and microsatellite instability status was also calculated.
Results: Stratified by ancestry, EGFR alterations were significantly enriched in EAS versus other ancestry groups. The prevalence of ALK was significantly higher in the AMR, EAS, and SAS patients than in AFR and EUR patients. KRAS and STK11 were enriched in EUR and AFR patients versus other groups. TMB-High was significantly enriched in AFR patients versus all other groups. An analysis based on sex revealed differences in prevalence of alterations in 80 genes and TMB-High status. For example, EGFR, ALK, BRAF, and KRAS alterations were significantly enriched in females, whereas TP53, STK11, KEAP1, and TMB-High were significantly enriched in males. With respect to age, the prevalence of alterations in 41 genes, including ALK, RET, MET, EGFR, STK11, KEAP1, BRAF, and KRAS, as well as TMB-High, were significantly different between patients aged <40 years and those aged ≥40 years.
Conclusions: Comprehensive analysis from a large real-world dataset revealed ancestry-associated differences in genomic alterations in NSCLC. Age- and sex-related differences in prevalence of genomic alterations and TMB-High status were also observed.
{"title":"Ancestry-, Sex-, and Age-Based Differences of Gene Alterations in NSCLC: From the Real-World Data of Cancer Genomic Profiling Tests.","authors":"Keita Miura, Takehito Shukuya, Ray Greenstein, Ben Kaplan, Heather Wakelee, Kana Kurokawa, Kazuyuki Furuta, Shunsuke Kato, Junghee Suh, Smruthy Sivakumar, Ethan S Sokol, David P Carbone, Kazuhisa Takahashi","doi":"10.6004/jnccn.2024.7021","DOIUrl":"10.6004/jnccn.2024.7021","url":null,"abstract":"<p><strong>Background: </strong>Some genomic alterations in non-small cell lung cancer (NSCLC) are known to differ according to race, sex, or age. These studies have been limited in sample size and thus they cannot detect the differences precisely and comprehensively.</p><p><strong>Methods: </strong>Tissue-based comprehensive genomic profiling was performed on 75,362 patients with NSCLC from the United States during routine clinical care. Additionally, we examined data of a Japanese NSCLC cohort with 1,019 patients. In the US cohort, 296 genes were examined for pathogenic alterations. Predominant genetic ancestry was inferred using a SNP-based approach, and patients were categorized into European (EUR), African (AFR), East Asian (EAS), Admixed American (AMR), and South Asian (SAS) ancestry groups. Patients were additionally stratified by histologic type, age (<40/≥40 years, <75/≥75 years), and sex. The prevalence of high tumor mutational burden (TMB-High) and microsatellite instability status was also calculated.</p><p><strong>Results: </strong>Stratified by ancestry, EGFR alterations were significantly enriched in EAS versus other ancestry groups. The prevalence of ALK was significantly higher in the AMR, EAS, and SAS patients than in AFR and EUR patients. KRAS and STK11 were enriched in EUR and AFR patients versus other groups. TMB-High was significantly enriched in AFR patients versus all other groups. An analysis based on sex revealed differences in prevalence of alterations in 80 genes and TMB-High status. For example, EGFR, ALK, BRAF, and KRAS alterations were significantly enriched in females, whereas TP53, STK11, KEAP1, and TMB-High were significantly enriched in males. With respect to age, the prevalence of alterations in 41 genes, including ALK, RET, MET, EGFR, STK11, KEAP1, BRAF, and KRAS, as well as TMB-High, were significantly different between patients aged <40 years and those aged ≥40 years.</p><p><strong>Conclusions: </strong>Comprehensive analysis from a large real-world dataset revealed ancestry-associated differences in genomic alterations in NSCLC. Age- and sex-related differences in prevalence of genomic alterations and TMB-High status were also observed.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906998","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}
{"title":"Accelerated Approval Program Versus NCCN Guidelines as Mechanisms for Early Drug Access.","authors":"Austin Wesevich, Mark J Ratain","doi":"10.6004/jnccn.2024.7056","DOIUrl":"10.6004/jnccn.2024.7056","url":null,"abstract":"","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"435-436"},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995995","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}
Al B Benson, Alan P Venook, Mohamed Adam, George Chang, Yi-Jen Chen, Kristen K Ciombor, Stacey A Cohen, Harry S Cooper, Dustin Deming, Ignacio Garrido-Laguna, Jean L Grem, Paul Haste, J Randolph Hecht, Sarah Hoffe, Steven Hunt, Hisham Hussan, Kimberly L Johung, Nora Joseph, Natalie Kirilcuk, Smitha Krishnamurthi, Midhun Malla, Jennifer K Maratt, Wells A Messersmith, Jeffrey Meyerhardt, Eric D Miller, Mary F Mulcahy, Steven Nurkin, Aparna Parikh, Hitendra Patel, Katrina Pedersen, Leonard Saltz, Charles Schneider, David Shibata, Benjamin Shogan, John M Skibber, Constantinos T Sofocleous, Anna Tavakkoli, Christopher G Willett, Christina Wu, Frankie Jones, Lisa Gurski
The determination of an optimal treatment plan for an individual patient with rectal cancer is a complex process. In addition to decisions relating to the intent of rectal cancer surgery (ie, curative or palliative), consideration must also be given to the likely functional results of treatment, including the probability of maintaining or restoring normal bowel function/anal continence and preserving genitourinary functions. Particularly for patients with distal rectal cancer, finding a balance between curative-intent therapy while having minimal impact on quality of life can be challenging. Furthermore, the risk of pelvic recurrence is higher in patients with rectal cancer compared with those with colon cancer, and locally recurrent rectal cancer is associated with a poor prognosis. Careful patient selection and the use of sequenced multimodality therapy following a multidisciplinary approach is recommended. These NCCN Guidelines Insights detail recent updates to the NCCN Guidelines for Rectal Cancer, including the addition of endoscopic submucosal dissection as an option for early-stage rectal cancer, updates to the total neoadjuvant therapy approach based on the results of recent clinical trials, and the addition of a "watch-and-wait" nonoperative management approach for clinical complete responders to neoadjuvant therapy.
{"title":"NCCN Guidelines® Insights: Rectal Cancer, Version 3.2024.","authors":"Al B Benson, Alan P Venook, Mohamed Adam, George Chang, Yi-Jen Chen, Kristen K Ciombor, Stacey A Cohen, Harry S Cooper, Dustin Deming, Ignacio Garrido-Laguna, Jean L Grem, Paul Haste, J Randolph Hecht, Sarah Hoffe, Steven Hunt, Hisham Hussan, Kimberly L Johung, Nora Joseph, Natalie Kirilcuk, Smitha Krishnamurthi, Midhun Malla, Jennifer K Maratt, Wells A Messersmith, Jeffrey Meyerhardt, Eric D Miller, Mary F Mulcahy, Steven Nurkin, Aparna Parikh, Hitendra Patel, Katrina Pedersen, Leonard Saltz, Charles Schneider, David Shibata, Benjamin Shogan, John M Skibber, Constantinos T Sofocleous, Anna Tavakkoli, Christopher G Willett, Christina Wu, Frankie Jones, Lisa Gurski","doi":"10.6004/jnccn.2024.0041","DOIUrl":"10.6004/jnccn.2024.0041","url":null,"abstract":"<p><p>The determination of an optimal treatment plan for an individual patient with rectal cancer is a complex process. In addition to decisions relating to the intent of rectal cancer surgery (ie, curative or palliative), consideration must also be given to the likely functional results of treatment, including the probability of maintaining or restoring normal bowel function/anal continence and preserving genitourinary functions. Particularly for patients with distal rectal cancer, finding a balance between curative-intent therapy while having minimal impact on quality of life can be challenging. Furthermore, the risk of pelvic recurrence is higher in patients with rectal cancer compared with those with colon cancer, and locally recurrent rectal cancer is associated with a poor prognosis. Careful patient selection and the use of sequenced multimodality therapy following a multidisciplinary approach is recommended. These NCCN Guidelines Insights detail recent updates to the NCCN Guidelines for Rectal Cancer, including the addition of endoscopic submucosal dissection as an option for early-stage rectal cancer, updates to the total neoadjuvant therapy approach based on the results of recent clinical trials, and the addition of a \"watch-and-wait\" nonoperative management approach for clinical complete responders to neoadjuvant therapy.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"366-375"},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995976","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}
Rochelle Bagatell, Julie R Park, Sahaja Acharya, Jennifer Aldrink, Jenna Allison, Elizabeth Alva, Carola Arndt, Daniel Benedetti, Erin Brown, Steve Cho, Alanna Church, Andrew Davidoff, Ami V Desai, Steven DuBois, Douglas Fair, Joaquim Farinhas, Douglas Harrison, Frederick Huang, Paul Iskander, Susan Kreissman, Margaret Macy, Brian Na, Farzana Pashankar, Praveen Pendyala, Navin Pinto, Stephanie Polites, Raja Rabah, Hiroyuki Shimada, Leonora Slatnick, Elizabeth Sokol, Clare Twist, Kieuhoa Vo, Tanya Watt, Suzanne Wolden, Peter Zage, Ryan Schonfeld, Lisa Hang
Neuroblastoma is the most common extracranial solid tumor diagnosed in children. This inaugural version of the NCCN Guidelines for Neuroblastoma provides recommendations for the diagnosis, risk classification, and treatment of neuroblastoma. The information in these guidelines was developed by the NCCN Neuroblastoma Panel, a multidisciplinary group of representatives with expertise in neuroblastoma, consisting of pediatric oncologists, radiologists, pathologists, surgeons, and radiation oncologists from NCCN Member Institutions. The evidence-based and consensus recommendations contained in the NCCN Guidelines are intended to guide clinicians in selecting the most appropriate treatments for their patients with this clinically heterogeneous disease.
{"title":"Neuroblastoma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology.","authors":"Rochelle Bagatell, Julie R Park, Sahaja Acharya, Jennifer Aldrink, Jenna Allison, Elizabeth Alva, Carola Arndt, Daniel Benedetti, Erin Brown, Steve Cho, Alanna Church, Andrew Davidoff, Ami V Desai, Steven DuBois, Douglas Fair, Joaquim Farinhas, Douglas Harrison, Frederick Huang, Paul Iskander, Susan Kreissman, Margaret Macy, Brian Na, Farzana Pashankar, Praveen Pendyala, Navin Pinto, Stephanie Polites, Raja Rabah, Hiroyuki Shimada, Leonora Slatnick, Elizabeth Sokol, Clare Twist, Kieuhoa Vo, Tanya Watt, Suzanne Wolden, Peter Zage, Ryan Schonfeld, Lisa Hang","doi":"10.6004/jnccn.2024.0040","DOIUrl":"10.6004/jnccn.2024.0040","url":null,"abstract":"<p><p>Neuroblastoma is the most common extracranial solid tumor diagnosed in children. This inaugural version of the NCCN Guidelines for Neuroblastoma provides recommendations for the diagnosis, risk classification, and treatment of neuroblastoma. The information in these guidelines was developed by the NCCN Neuroblastoma Panel, a multidisciplinary group of representatives with expertise in neuroblastoma, consisting of pediatric oncologists, radiologists, pathologists, surgeons, and radiation oncologists from NCCN Member Institutions. The evidence-based and consensus recommendations contained in the NCCN Guidelines are intended to guide clinicians in selecting the most appropriate treatments for their patients with this clinically heterogeneous disease.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"413-433"},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995977","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}
{"title":"Cancer Health Disparities.","authors":"Daniel M Geynisman","doi":"10.6004/jnccn.2024.0042","DOIUrl":"10.6004/jnccn.2024.0042","url":null,"abstract":"","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"363-364"},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995996","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}
Alexander T Cohen, Amol D Dhamane, Xuejun Liu, Risho Singh, Stella Han, Robert Stellhorn, Jane Wang, Xuemei Luo
Background: Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months.
Methods: A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB).
Results: A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34-0.53), MB (HR, 0.50; 95% CI, 0.41-0.61), and CRNMB (HR, 0.76; 95% CI, 0.68-0.85) versus LMWH.
Conclusions: Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.
背景:阿哌沙班和低分子量肝素(LMWH)在预防长期接受抗凝治疗的活动性癌症患者复发性静脉血栓栓塞症(VTE)方面的安全性和有效性比较的实际证据有限。本研究评估了接受阿哌沙班或 LMWH 治疗≥3 个月的癌症相关 VTE 患者的出血和复发性 VTE 风险:方法:利用美国商业索赔数据库来识别首次 VTE 诊断后 30 天开始使用阿哌沙班或 LMWH 的 VTE 和活动性癌症成年患者,这些患者的连续入组时间≥3 个月,且接受了 3 个月的主要抗凝治疗。患者的随访时间从基础抗凝治疗结束的次日开始,直至下列最早出现的日期:退出研究、停用指标抗凝剂、换用另一种抗凝剂或研究期结束。采用反概率治疗加权(IPTW)来平衡治疗队列。结果的发病率(IR)按每 100 人-年(PY)计算。采用 Cox 比例危险模型评估复发性 VTE、大出血(MB)和临床相关非大出血(CRNMB)的调整风险:共分析了13564名接受阿哌沙班治疗的患者和2808名接受LMWH治疗的患者。IPTW后,两组患者的治疗效果均衡。与 LMWH 相比,接受阿哌沙班治疗的患者复发性 VTE(4.1 vs 9.6 per 100 PY)、MB(6.3 vs 12.6)和 CRNMB(26.1 vs 36.0)的调整后 IR 值较低:在癌症相关 VTE 成人患者中,与 LMWH 相比,阿哌沙班延长抗凝治疗时间≥3 个月可降低复发性 VTE、MB 和 CRNMB 的发生率。
{"title":"Effectiveness and Safety of Extended Treatment Apixaban Versus Low-Molecular-Weight Heparin in Cancer-Associated Venous Thromboembolism.","authors":"Alexander T Cohen, Amol D Dhamane, Xuejun Liu, Risho Singh, Stella Han, Robert Stellhorn, Jane Wang, Xuemei Luo","doi":"10.6004/jnccn.2024.7016","DOIUrl":"10.6004/jnccn.2024.7016","url":null,"abstract":"<p><strong>Background: </strong>Limited real-world evidence is available comparing the safety and effectiveness of apixaban and low-molecular-weight heparins (LMWHs) for preventing recurrent venous thromboembolism (VTE) in patients with active cancer receiving anticoagulation in an extended treatment setting. This study evaluated the risk of bleeding and recurrent VTE in patients with cancer-associated VTE who were prescribed apixaban or LMWH for ≥3 months.</p><p><strong>Methods: </strong>A US commercial claims database was used to identify adult patients with VTE and active cancer who initiated apixaban or LMWH 30 days following the first VTE diagnosis and had ≥3 months of continuous enrollment and 3 months of primary anticoagulation treatment. Patients were followed from the day after the end of primary anticoagulation treatment until the earliest of: date of disenrollment, discontinuation of index anticoagulant, switch to another anticoagulant, or end of the study period. Inverse-probability treatment weighting (IPTW) was used to balance treatment cohorts. Incidence rates (IRs) for the outcomes were calculated per 100 person-years (PY). Cox proportional hazard models were used to evaluate the adjusted risk of recurrent VTE, major bleeding (MB), and clinically relevant nonmajor bleeding (CRNMB).</p><p><strong>Results: </strong>A total of 13,564 apixaban- and 2,808 LMWH-treated patients were analyzed. Post-IPTW, the treatment cohorts were balanced. Patients receiving apixaban had lower adjusted IRs for recurrent VTE (4.1 vs 9.6 per 100 PY), MB (6.3 vs 12.6), and CRNMB (26.1 vs 36.0) versus LMWH (P<.0001 for all comparisons) during the follow-up period. Patients on apixaban had a lower adjusted risk of recurrent VTE (hazard ratio [HR], 0.42; 95% CI, 0.34-0.53), MB (HR, 0.50; 95% CI, 0.41-0.61), and CRNMB (HR, 0.76; 95% CI, 0.68-0.85) versus LMWH.</p><p><strong>Conclusions: </strong>Extended anticoagulation treatment of ≥3 months with apixaban was associated with lower rates of recurrent VTE, MB, and CRNMB compared with LMWH in adults with cancer-associated VTE.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":"397-403"},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995975","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}
Neuroblastoma has heterogenous clinical presentations that are reflected by several well-defined clinical factors and biomarkers. Combinations of these clinical and biologic prognostic factors have been used for decades to generate classifiers to stratify patients into risk groups (low, intermediate, and high), which in turn are used to inform and tailor treatment as reported in the new NCCN Clinical Practice Guidelines in Oncology for Neuroblastoma. Risk classification uses clinical features, such as age and tumor stage, along with the most significant prognostic tumor biomarkers, including histologic features (differentiation and mitosis-karyorrhexis index), MYCN amplification status, chromosomal copy number alterations (segmental or numerical), and ploidy (DNA content). Recent next-generation sequencing approaches have identified additional tumor-specific genetic factors that have potential roles as prognostic and predictive biomarkers. These emerging biomarkers include telomerase maintenance mechanisms, such as telomerase reverse transcription (TERT) expression and alternative lengthening of telomeres (ALT) status. Somatic alterations of genes, including mutations in the anaplastic lymphoma kinase gene ALK, detected in >10% of patients with newly diagnosed disease, have both prognostic and predictive roles in determining eligibility for targeted therapies (eg, ALK tyrosine kinase inhibitors). In addition to diagnostic tumor-derived biomarkers, significant effort is being directed toward identification of markers to predict response to chemotherapy and immunotherapies. With the increasing use of GD2-containing immunotherapy regimens, efforts are aimed at identifying host or tumor microenvironment immune correlatives that can serve as predictive biomarkers. Understanding the potential role of liquid biopsies as biomarkers during and following treatment, including sequential circulating tumor DNA or tumor-specific mRNA transcripts, is expected to enhance the ability to predict recurrences and also inform understanding of tumor evolution and therapy resistance. These and other emerging biomarkers will lead to refinement and optimization of future neuroblastoma risk classification systems.
神经母细胞瘤的临床表现多种多样,有几种明确的临床因素和生物标志物。几十年来,这些临床和生物预后因素的组合被用于生成分类器,将患者分为低、中和高风险组,进而用于指导和调整治疗,正如新的《NCCN 神经母细胞瘤肿瘤学临床实践指南》所报告的那样。风险分类使用年龄和肿瘤分期等临床特征以及最重要的预后肿瘤生物标志物,包括组织学特征(分化和有丝分裂-核分裂指数)、MYCN扩增状态、染色体拷贝数改变(节段性或数字性)和倍性(DNA含量)。最近的新一代测序方法发现了更多肿瘤特异性遗传因素,这些因素有可能成为预后和预测生物标志物。这些新出现的生物标志物包括端粒酶维持机制,如端粒酶逆转录(TERT)表达和端粒替代性延长(ALT)状态。在超过10%的新确诊患者中检测到的基因体细胞改变,包括无性淋巴瘤激酶基因ALK的突变,在确定靶向治疗(如ALK酪氨酸激酶抑制剂)的资格方面具有预后和预测作用。除了诊断性肿瘤衍生生物标记物外,人们还在努力确定预测化疗和免疫疗法反应的标记物。随着含有 GD2 的免疫疗法方案的使用越来越多,人们正致力于鉴定可作为预测性生物标记物的宿主或肿瘤微环境免疫相关因子。了解液体活检作为生物标记物在治疗过程中和治疗后的潜在作用,包括连续循环肿瘤 DNA 或肿瘤特异性 mRNA 转录物,有望提高预测复发的能力,并为了解肿瘤演变和治疗耐药性提供信息。这些和其他新出现的生物标志物将有助于完善和优化未来的神经母细胞瘤风险分类系统。
{"title":"Current and Emerging Biomarkers: Impact on Risk Stratification for Neuroblastoma.","authors":"Meredith S Irwin, Kelly C Goldsmith","doi":"10.6004/jnccn.2024.7051","DOIUrl":"10.6004/jnccn.2024.7051","url":null,"abstract":"<p><p>Neuroblastoma has heterogenous clinical presentations that are reflected by several well-defined clinical factors and biomarkers. Combinations of these clinical and biologic prognostic factors have been used for decades to generate classifiers to stratify patients into risk groups (low, intermediate, and high), which in turn are used to inform and tailor treatment as reported in the new NCCN Clinical Practice Guidelines in Oncology for Neuroblastoma. Risk classification uses clinical features, such as age and tumor stage, along with the most significant prognostic tumor biomarkers, including histologic features (differentiation and mitosis-karyorrhexis index), MYCN amplification status, chromosomal copy number alterations (segmental or numerical), and ploidy (DNA content). Recent next-generation sequencing approaches have identified additional tumor-specific genetic factors that have potential roles as prognostic and predictive biomarkers. These emerging biomarkers include telomerase maintenance mechanisms, such as telomerase reverse transcription (TERT) expression and alternative lengthening of telomeres (ALT) status. Somatic alterations of genes, including mutations in the anaplastic lymphoma kinase gene ALK, detected in >10% of patients with newly diagnosed disease, have both prognostic and predictive roles in determining eligibility for targeted therapies (eg, ALK tyrosine kinase inhibitors). In addition to diagnostic tumor-derived biomarkers, significant effort is being directed toward identification of markers to predict response to chemotherapy and immunotherapies. With the increasing use of GD2-containing immunotherapy regimens, efforts are aimed at identifying host or tumor microenvironment immune correlatives that can serve as predictive biomarkers. Understanding the potential role of liquid biopsies as biomarkers during and following treatment, including sequential circulating tumor DNA or tumor-specific mRNA transcripts, is expected to enhance the ability to predict recurrences and also inform understanding of tumor evolution and therapy resistance. These and other emerging biomarkers will lead to refinement and optimization of future neuroblastoma risk classification systems.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 6","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995974","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}
Anna B Halpern, Jessica M Sugalski, Lindsey Bandini, Megan Othus, F Marc Stewart, Roland B Walter
Background: Prolonged hospitalization following intensive (re)induction chemotherapy for acute myeloid leukemia (AML), while standard, is costly and resource intense, limits inpatient bed capacity, and negatively impacts quality of life. Early hospital discharge (EHD) following completion of chemotherapy has proven safe as an alternative at select institutions, but is not widely implemented.
Patients and methods: From February 2023 through May 2023, the NCCN Best Practices Committee conducted a survey evaluating AML hospitalization patterns, care models, and barriers to EHD at its 33 member institutions.
Results: A total of 30 (91%) institutions completed the survey; two-thirds treat >100 patients with AML annually and 45% treat more than half of these with intensive chemotherapy. In the (re)induction setting, 80% of institutions keep patients hospitalized until blood count recovery, whereas 20% aim to discharge patients after completion of chemotherapy if medically stable and logistically feasible. The predominant reasons for the perceived need for ongoing hospitalization were high risk of infection, treatment toxicities, and lack of nearby/accessible housing. There was no significant association between ability to practice EHD and annual AML volume or treatment intensity patterns (P=.60 and P=.11, respectively). In contrast, in the postremission setting, 87% of centers support patients following chemotherapy in the outpatient setting unless toxicities arise requiring readmission. Survey responses showed that 80% of centers were interested in exploring EHD after (re)induction but noted significant barriers, including accessible housing (71%), transportation (50%), high toxicity/infection rate (50%), high transfusion burden (50%), and limited bed availability for rehospitalization (50%).
Conclusions: Hospitalization and care patterns following intensive AML therapy vary widely across major US cancer institutions. Although only 20% of surveyed centers practice EHD following intensive (re)induction chemotherapy, 87% do so following postremission therapy. Given the interest in exploring the EHD approach given potential advantages of EHD for both patients and health care systems, strategies to address identified medical and logistical barriers should be explored.
{"title":"Care Patterns and Barriers to Outpatient Care for Adults With AML Following Intensive Chemotherapy at NCCN Member Institutions.","authors":"Anna B Halpern, Jessica M Sugalski, Lindsey Bandini, Megan Othus, F Marc Stewart, Roland B Walter","doi":"10.6004/jnccn.2024.7026","DOIUrl":"10.6004/jnccn.2024.7026","url":null,"abstract":"<p><strong>Background: </strong>Prolonged hospitalization following intensive (re)induction chemotherapy for acute myeloid leukemia (AML), while standard, is costly and resource intense, limits inpatient bed capacity, and negatively impacts quality of life. Early hospital discharge (EHD) following completion of chemotherapy has proven safe as an alternative at select institutions, but is not widely implemented.</p><p><strong>Patients and methods: </strong>From February 2023 through May 2023, the NCCN Best Practices Committee conducted a survey evaluating AML hospitalization patterns, care models, and barriers to EHD at its 33 member institutions.</p><p><strong>Results: </strong>A total of 30 (91%) institutions completed the survey; two-thirds treat >100 patients with AML annually and 45% treat more than half of these with intensive chemotherapy. In the (re)induction setting, 80% of institutions keep patients hospitalized until blood count recovery, whereas 20% aim to discharge patients after completion of chemotherapy if medically stable and logistically feasible. The predominant reasons for the perceived need for ongoing hospitalization were high risk of infection, treatment toxicities, and lack of nearby/accessible housing. There was no significant association between ability to practice EHD and annual AML volume or treatment intensity patterns (P=.60 and P=.11, respectively). In contrast, in the postremission setting, 87% of centers support patients following chemotherapy in the outpatient setting unless toxicities arise requiring readmission. Survey responses showed that 80% of centers were interested in exploring EHD after (re)induction but noted significant barriers, including accessible housing (71%), transportation (50%), high toxicity/infection rate (50%), high transfusion burden (50%), and limited bed availability for rehospitalization (50%).</p><p><strong>Conclusions: </strong>Hospitalization and care patterns following intensive AML therapy vary widely across major US cancer institutions. Although only 20% of surveyed centers practice EHD following intensive (re)induction chemotherapy, 87% do so following postremission therapy. Given the interest in exploring the EHD approach given potential advantages of EHD for both patients and health care systems, strategies to address identified medical and logistical barriers should be explored.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"469-474"},"PeriodicalIF":14.8,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855884","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}
Kristen K Curtis, Nathan J Fakult, Jennifer L Strunck, Sumaira Z Aasi, Christine S Ahn, Murad Alam, Anna A Bar, Ramona Behshad, Christopher K Bichakjian, Diana Bolotin, Susan L Boone, Jeremy S Bordeaux, Jerry D Brewer, David R Carr, John A Carucci, Jason R Castillo, Sean R Christensen, Melanie A Clark, Lindsey K Collins, Addison M Demer, Daniel B Eisen, Hao Feng, Bahar F Firoz, Roy C Grekin, Jason M Hirshburg, Todd E Holmes, Conway C Huang, Thomas A Jennings, Shang I Brian Jiang, Sailesh Konda, Justin J Leitenberger, Jesse M Lewin, Ian A Maher, Elise Ng, Ida F Orengo, Faramarz H Samie, Drew K Saylor, Victoria Rose Sharon, Teo Soleymani, Susan M Swetter, Jesalyn A Tate, Marta J Van Beek, Nahid Y Vidal, Alok Vij, Ashley Wysong, Yaohui Gloria Xu, Bryan T Carroll, Wesley Y Yu
Background: Mohs micrographic surgery (MMS) is a promising treatment modality for melanoma in situ (MIS). However, variations in surgical technique limit the generalizability of existing data and may impede future study of MMS in clinical trials.
Methods: A modified Delphi method was selected to establish consensus on optimal MMS techniques for treating MIS in future clinical trials. The Delphi method was selected due to the limited current data, the wide range of techniques used in the field, and the intention to establish a standardized technique for future clinical trials. A literature review and interviews with experienced MMS surgeons were performed to identify dimensions of the MMS technique for MIS that (1) likely impacted costs or outcomes of the procedure, and (2) showed significant variability between surgeons. A total of 8 dimensions of technical variation were selected. The Delphi process consisted of 2 rounds of voting and commentary, during which 44 expert Mohs surgeons across the United States rated their agreement with specific recommendations using a Likert scale.
Results: Five of eight recommendations achieved consensus in Round 1. All 3 of the remaining recommendations achieved consensus in Round 2. Techniques achieving consensus in Round 1 included the use of a starting peripheral margin of ≤5 mm, application of immunohistochemistry, frozen tissue processing, and resecting to the depth of subcutaneous fat. Consensus on the use of Wood's lamp, dermatoscope, and negative tissue controls was established in Round 2.
Conclusions: This study generated 8 consensus recommendations intended to offer guidance for Mohs surgeons treating MIS. The adoption of these recommendations will promote standardization to facilitate comparisons of aggregate data in multicenter clinical trials.
背景:莫氏显微放射手术(MMS)是治疗原位黑色素瘤(MIS)的一种很有前景的方法。然而,手术技术的差异限制了现有数据的可推广性,并可能妨碍今后在临床试验中对 MMS 进行研究:方法:我们选择了一种改良德尔菲法,以便在未来的临床试验中就治疗 MIS 的最佳 MMS 技术达成共识。之所以选择德尔菲法,是因为目前的数据有限,该领域使用的技术种类繁多,而且有意为未来的临床试验建立标准化技术。通过文献综述和对经验丰富的 MMS 外科医生的访谈,我们确定了 MIS 的 MMS 技术的以下方面:(1)可能影响手术成本或疗效;(2)外科医生之间存在显著差异。总共选出了 8 个技术差异维度。德尔菲过程包括两轮投票和评议,在此期间,全美 44 名莫氏外科专家使用李克特量表对他们是否同意具体建议进行评分:结果:8 项建议中有 5 项在第一轮达成共识,其余 3 项在第二轮达成共识。在第一轮中达成共识的技术包括使用≤5 mm的起始周边边缘、应用免疫组化、冷冻组织处理和切除至皮下脂肪深度。在第二轮中,就伍德灯、皮肤镜和阴性组织对照的使用达成了共识:本研究提出了 8 项共识建议,旨在为莫氏外科医生治疗 MIS 提供指导。采用这些建议将促进标准化,以便于在多中心临床试验中对综合数据进行比较。
{"title":"Establishing Consensus for Mohs Micrographic Surgical Techniques in the Treatment of Melanoma in Situ for Future Clinical Trials: A Modified Delphi Study.","authors":"Kristen K Curtis, Nathan J Fakult, Jennifer L Strunck, Sumaira Z Aasi, Christine S Ahn, Murad Alam, Anna A Bar, Ramona Behshad, Christopher K Bichakjian, Diana Bolotin, Susan L Boone, Jeremy S Bordeaux, Jerry D Brewer, David R Carr, John A Carucci, Jason R Castillo, Sean R Christensen, Melanie A Clark, Lindsey K Collins, Addison M Demer, Daniel B Eisen, Hao Feng, Bahar F Firoz, Roy C Grekin, Jason M Hirshburg, Todd E Holmes, Conway C Huang, Thomas A Jennings, Shang I Brian Jiang, Sailesh Konda, Justin J Leitenberger, Jesse M Lewin, Ian A Maher, Elise Ng, Ida F Orengo, Faramarz H Samie, Drew K Saylor, Victoria Rose Sharon, Teo Soleymani, Susan M Swetter, Jesalyn A Tate, Marta J Van Beek, Nahid Y Vidal, Alok Vij, Ashley Wysong, Yaohui Gloria Xu, Bryan T Carroll, Wesley Y Yu","doi":"10.6004/jnccn.2024.7036","DOIUrl":"10.6004/jnccn.2024.7036","url":null,"abstract":"<p><strong>Background: </strong>Mohs micrographic surgery (MMS) is a promising treatment modality for melanoma in situ (MIS). However, variations in surgical technique limit the generalizability of existing data and may impede future study of MMS in clinical trials.</p><p><strong>Methods: </strong>A modified Delphi method was selected to establish consensus on optimal MMS techniques for treating MIS in future clinical trials. The Delphi method was selected due to the limited current data, the wide range of techniques used in the field, and the intention to establish a standardized technique for future clinical trials. A literature review and interviews with experienced MMS surgeons were performed to identify dimensions of the MMS technique for MIS that (1) likely impacted costs or outcomes of the procedure, and (2) showed significant variability between surgeons. A total of 8 dimensions of technical variation were selected. The Delphi process consisted of 2 rounds of voting and commentary, during which 44 expert Mohs surgeons across the United States rated their agreement with specific recommendations using a Likert scale.</p><p><strong>Results: </strong>Five of eight recommendations achieved consensus in Round 1. All 3 of the remaining recommendations achieved consensus in Round 2. Techniques achieving consensus in Round 1 included the use of a starting peripheral margin of ≤5 mm, application of immunohistochemistry, frozen tissue processing, and resecting to the depth of subcutaneous fat. Consensus on the use of Wood's lamp, dermatoscope, and negative tissue controls was established in Round 2.</p><p><strong>Conclusions: </strong>This study generated 8 consensus recommendations intended to offer guidance for Mohs surgeons treating MIS. The adoption of these recommendations will promote standardization to facilitate comparisons of aggregate data in multicenter clinical trials.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855885","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}