Stephanie O Dudzinski, Maria E Cabanillas, Sarah Hamidi, Vicente R Marczyk, Naifa L Busaidy, Ramona Dadu, James Welsh, Mimi I Hu, G Brandon Gunn, Chenyang Wang, Steven G Waguespack, Jack Phan, Thomas H Beckham, Joe Y Chang, Steven I Sherman, Jay P Reddy, Anita K Ying, Michael S O'Reilly, Aileen Chen, Anna Lee, Saumil J Gandhi, Zhongxing Liao, Ethan B Ludmir, Quynh-Nhu Nguyen, Steven H Lin, Mark E Zafereo, Matthew S Ning
{"title":"Definitive Radiotherapy for Oligometastatic and Oligoprogressive Thyroid Cancer: A Potential Strategy for Systemic Therapy Deferral.","authors":"Stephanie O Dudzinski, Maria E Cabanillas, Sarah Hamidi, Vicente R Marczyk, Naifa L Busaidy, Ramona Dadu, James Welsh, Mimi I Hu, G Brandon Gunn, Chenyang Wang, Steven G Waguespack, Jack Phan, Thomas H Beckham, Joe Y Chang, Steven I Sherman, Jay P Reddy, Anita K Ying, Michael S O'Reilly, Aileen Chen, Anna Lee, Saumil J Gandhi, Zhongxing Liao, Ethan B Ludmir, Quynh-Nhu Nguyen, Steven H Lin, Mark E Zafereo, Matthew S Ning","doi":"10.6004/jnccn.2024.7072","DOIUrl":"https://doi.org/10.6004/jnccn.2024.7072","url":null,"abstract":"<p><strong>Background: </strong>Definitive radiotherapy (dRT) has been shown to be an effective option for patients with oligometastatic and oligoprogressive cancers; however, this approach has not been well-studied in metastatic thyroid cancer.</p><p><strong>Methods: </strong>This retrospective cohort included 119 patients with oligometastatic (34%) and oligoprogressive (66%) metastatic thyroid cancer treated from 2005 to 2024 with 207 dRT courses for 344 sites (50% thoracic, 37% bone, 7.5% brain, 4% abdominopelvic, and 1.5% neck/skull base). Histologies included 61% papillary, 15% poorly differentiated, 13% follicular, and 10% oncocytic, and 114 (96%) patients had radioiodine-refractory disease prior to dRT. Each course involved 1 to 5 sites, with prescriptions intended for definitive control (median BED10, 72 Gy), and palliative RT was excluded. Somatic mutation testing for oncologic drivers was performed in 103 (87%) patients.</p><p><strong>Results: </strong>Each patient had an average of 3 sites (range, 1-23) treated over 2 courses (range, 1-9). Follow-up from first dRT was a median 2.5 years, with overall survival at 3 and 5 years of 81.5% and 70%, respectively. Actuarial local control per site was 91% at 3 years. Median progression-free survival (PFS) after first course was 17 months (95% CI, 10-24 months), with poorly differentiated histology associated with worse outcomes (hazard ratio [HR], 2.20; 95% CI, 1.24-3.90; P=.007), BRAF mutation with improved PFS (HR, 0.59; 95% CI, 0.37-0.95; P=.029), and no significant findings with respect to systemic therapy. At initial dRT, 92 (77%) patients were not on systemic therapy; and after first dRT, freedom from systemic therapy escalation was a median 4.1 years (95% CI, 1.7-6.5 years), with 2- and 5-year continued deferral rates of 73% and 46%, respectively. Grade 3 toxicities were noted for 1.5% of courses, with no grade 4-5 events observed.</p><p><strong>Conclusions: </strong>This study underscores the potential of dRT as a feasible strategy for deferring systemic therapy escalation in patients with oligometastatic and oligoprogressive metastatic thyroid cancer, demonstrating that sequential dRT courses impart excellent local control and are safe to deliver repeatedly for multiple distant sites. Further studies are warranted to validate these findings and elucidate the full benefit of dRT as part of a multidisciplinary approach for metastatic thyroid cancer.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"1-7"},"PeriodicalIF":14.8,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813660","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}
Valentin H Meissner, Kolja Imhof, Matthias Jahnen, Lukas Lunger, Andreas Dinkel, Stefan Schiele, Donna P Ankerst, Jürgen E Gschwend, Kathleen Herkommer
{"title":"Frailty in Long-Term Prostate Cancer Survivors and Its Association With Quality of Life and Emotional Health.","authors":"Valentin H Meissner, Kolja Imhof, Matthias Jahnen, Lukas Lunger, Andreas Dinkel, Stefan Schiele, Donna P Ankerst, Jürgen E Gschwend, Kathleen Herkommer","doi":"10.6004/jnccn.2024.7066","DOIUrl":"https://doi.org/10.6004/jnccn.2024.7066","url":null,"abstract":"<p><strong>Background: </strong>Frailty is emerging as an important determinant for quality of life (QoL) and emotional health in older patients with cancer, and specifically in long-term prostate cancer survivors, but quantitative studies are lacking. The current study assesses the prevalence of frailty and its association with QoL and emotional health in long-term prostate cancer survivors after radical prostatectomy.</p><p><strong>Patients and methods: </strong>A total of 2,979 prostate cancer survivors from the multicenter German Familial Prostate Cancer cohort completed questionnaires on frailty (Groningen Frailty Indicator [GFI]), QoL (EORTC QoL Questionnaire-Core 30), and emotional health (anxiety/depression symptoms via the Patient Health Questionnaire-4). Modified Poisson regression analysis was used to assess factors associated with frailty.</p><p><strong>Results: </strong>Average patient age was 79.4 years [SD, 6.4 years] and average time since radical prostatectomy was 17.4 years [SD, 3.8 years]. Among the cohort, 33.1% (n=985) of patients were classified as frail (GFI ≥4). Frail patients reported worse emotional health than nonfrail patients (depression symptoms: 24.0% vs 4.0%; anxiety symptoms: 20.6% vs 2.0%; both P<.001) and lower QoL (mean [SD], 53.4 [19.2] vs 72.7 [16.0]); P<.001). Higher age (relative risk [RR], 1.02; 95% CI, 1.01-1.03) and worse depressive (RR, 1.18; 95% CI, 1.12-1.24) and anxiety symptoms (RR, 1.17; 95% CI, 1.11-1.23) were associated with frailty. Living in a partnership (RR, 0.76; 95% CI, 0.67-0.86) and a higher QoL (RR, 0.86 for a 10-point increase; 95% CI, 0.84-0.89) were associated with nonfrailty.</p><p><strong>Conclusions: </strong>In a large German cohort, every third long-term prostate cancer survivor after radical prostatectomy was frail. The association of frailty with lower QoL and poorer mental health indicates the need for an integrated care approach including further geriatric assessment and possible interventions to improve health outcomes targeted to frail patients.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"1-6"},"PeriodicalIF":14.8,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142813662","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":"The Oncologist Outside the Exam Room.","authors":"Daniel M Geynisman","doi":"10.6004/jnccn.2024.0063","DOIUrl":"10.6004/jnccn.2024.0063","url":null,"abstract":"","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":"645-646"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846799","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}
Brandon Anderson, Liisa Lyon, Michael Lee, Deepika Kumar, Elad Neeman, Ali Duffens, Dinesh Kotak, Hongxin Sun, Mary Reed, Raymond Liu
{"title":"Empowering Care Teams: Redefining Message Management to Enhance Care Delivery and Alleviate Oncologist Burnout.","authors":"Brandon Anderson, Liisa Lyon, Michael Lee, Deepika Kumar, Elad Neeman, Ali Duffens, Dinesh Kotak, Hongxin Sun, Mary Reed, Raymond Liu","doi":"10.6004/jnccn.2024.7055","DOIUrl":"10.6004/jnccn.2024.7055","url":null,"abstract":"<p><strong>Background: </strong>Widespread adoption of secure messaging (SM) provides patients with cancer with unprecedented access to medical providers at the expense of increased workload for oncologists. Herein, we analyze oncology SM clinical content and acuity and translate these to estimated cost savings from reduced appointments.</p><p><strong>Methods: </strong>This population-based retrospective cohort study examined the content of patient-initiated SM threads exchanged through the patient portal website or app over 1 year (June 1, 2021-May 31, 2022) at 21 Kaiser Permanente Northern California oncology practices, which typically do not have patient copayments associated with SM. A random sample of 500 SM threads were reviewed and categorized by message content, acuity, and appropriate level of service. Cost and time estimates were used to compare the cost of SM management by oncologists alone versus assisted by medical assistants and nurses.</p><p><strong>Results: </strong>During the study, 41,272 patients initiated 334,053 unique SM threads to 132 oncologists. Of the SM threads reviewed, only 26.8% required oncologist expertise. Based on thread content, the remaining 73.2% may have been better managed by a nurse (38.2%), medical assistant (28.4%), primary care physician (5.4%), or another subspecialty provider (1.2%). Emergency care was recommended in 2.4% of the threads reviewed. Significant medical care was provided to patients in 24.4% of the reviewed threads that would typically require an appointment. We estimate that the SM exchanges provided $11.2 million in care, including $3.6 million in avoided out-of-pocket copayment costs to patients and $7.6 million in missed billing codes.</p><p><strong>Conclusions: </strong>High utilization of SM generates additional workload for oncologists that could mostly be appropriately managed by alternate providers. The magnitude of unreimbursed medical care provided via SM and the use of SM for emergent medical situations creates an urgent need for new practice models. An alternative architecture for triaging, managing, and billing SM could reduce costs and oncologist burnout.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"664-669"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739920","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":"Optimizing Electronic Secure Messaging to Mitigate Oncologist Burnout.","authors":"Sayeh Lavasani","doi":"10.6004/jnccn.2024.7087","DOIUrl":"https://doi.org/10.6004/jnccn.2024.7087","url":null,"abstract":"","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":"713-714"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846794","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":"ctDNA/MRD Testing for Colon Cancer: A Work in Progress or Ready for Prime-Time Standard of Care?","authors":"Bennett A Caughey, Aparna R Parikh","doi":"10.6004/jnccn.2024.7049","DOIUrl":"10.6004/jnccn.2024.7049","url":null,"abstract":"<p><p>In patients with surgically resectable colon cancer (CC), clinicopathologic characteristics translate into cancer staging and predict recurrence risk. Adjuvant chemotherapy reduces the risk of recurrence and is offered to high-risk patients. However, some patients are inevitably overtreated or undertreated; better risk stratification is necessary to improve outcomes after surgery. Circulating tumor DNA (ctDNA)-based minimum residual disease (MRD) assays sequence plasma cell-free DNA for tumor DNA to predict the presence of otherwise subclinical malignancy. Studies have demonstrated that detectable ctDNA after surgery for CC predicts a high rate of recurrence and improves prognostication. Recent clinical trials show promise for using ctDNA to guide therapy, in particular standard-risk stage II CC. Large, randomized studies evaluating ctDNA-guided adjuvant chemotherapy versus standard of care in stage III CC are ongoing. Current data are insufficient to recommend routine use of ctDNA to guide adjuvant chemotherapy in resectable stage III CC.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142837304","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}
Julie M L Sijmons, Jan Willem T Dekker, Jurriaan B Tuynman, Femke J Amelung, Esther C J Consten, Henderik L van Westreenen, Johannes H W de Wilt, Rob A E M Tollenaar, Pieter J Tanis
{"title":"Evolution in the Management of Left-Sided Obstructive Colon Cancer in the Netherlands During a 9-Year Period.","authors":"Julie M L Sijmons, Jan Willem T Dekker, Jurriaan B Tuynman, Femke J Amelung, Esther C J Consten, Henderik L van Westreenen, Johannes H W de Wilt, Rob A E M Tollenaar, Pieter J Tanis","doi":"10.6004/jnccn.2024.7057","DOIUrl":"10.6004/jnccn.2024.7057","url":null,"abstract":"<p><strong>Background: </strong>There is growing evidence that bridge to surgery with stent or decompressing stoma for left-sided obstructive colon cancer (LSOCC) is better than emergency resection (ER), especially in elderly patients (age ≥70 years). This was already incorporated in Dutch guideline recommendations in 2014. The aim of this study was to evaluate time trends and interhospital variability in treatment approaches for LSOCC, and to compare short-term outcomes between approaches.</p><p><strong>Patients and methods: </strong>Data of patients undergoing resection for LSOCC between 2012 and 2020 were extracted from the Dutch ColoRectal Audit.</p><p><strong>Results: </strong>A total of 4,535 patients were included (3,155 ER, 573 semielective resection [SER], 807 resection after stent or stoma [RSS]). A decrease in ER over time was observed (79.7% in 2012-2014, 68.8% in 2015-2017, and 54.7% in 2018-2020) in favor of RSS (9.2%, 17.9%, and 31.2%, respectively). Compared with SER and RSS, ER was associated with higher 30-day mortality (6.2% ER, 2.8% SER, and 1.0% RSS; P<.001) and complication rates (45.4%, 31.2%, 31.5%, respectively; P<.001). There were still 19 hospitals with >75% ER in 2018-2020. For hospitals with >75% ER, mortality was significantly higher compared with hospitals mainly performing SER and RSS (5.6% vs 4.2%; P=.038). The proportion of ER in patients (age ≥70 years) decreased from 80.7% in 2012-2014 to 54.3% in 2018-2020 (P<.001). Mortality in patients aged ≥70 years was significantly lower after RSS than after ER (1.6% vs 9.5%; P<.001).</p><p><strong>Conclusions: </strong>A significant decrease in ER for LSOCC at a national level was observed, although with a variable degree of adherence to revised guidelines among hospitals. The high risk of mortality after ER, especially in elderly patients, strongly supports the guideline recommendations to perform bridge to surgery in these patients.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":""},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142837305","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}
Rachel Hodan, Samir Gupta, Jennifer M Weiss, Lisen Axell, Carol A Burke, Lee-May Chen, Daniel C Chung, Katherine M Clayback, Seth Felder, Zachariah Foda, Francis M Giardiello, William Grady, Susan Gustafson, Andrea Hagemann, Michael J Hall, Heather Hampel, Gregory Idos, Nora Joseph, Nawal Kassem, Bryson Katona, Kaitlyn Kelly, AnnMarie Kieber-Emmons, Sonia Kupfer, Katie Lang, Xavier Llor, Arnold J Markowitz, Mariana Moreno Prats, Mariana Niell-Swiller, Darryl Outlaw, Sara Pirzadeh-Miller, Niloy Jewel Samadder, David Shibata, Peter P Stanich, Benjamin J Swanson, Brittany M Szymaniak, Jeanna Welborn, Georgia L Wiesner, Matthew B Yurgelun, Mary Dwyer, Susan Darlow, Zeenat Diwan
{"title":"Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric, Version 3.2024, NCCN Clinical Practice Guidelines In Oncology.","authors":"Rachel Hodan, Samir Gupta, Jennifer M Weiss, Lisen Axell, Carol A Burke, Lee-May Chen, Daniel C Chung, Katherine M Clayback, Seth Felder, Zachariah Foda, Francis M Giardiello, William Grady, Susan Gustafson, Andrea Hagemann, Michael J Hall, Heather Hampel, Gregory Idos, Nora Joseph, Nawal Kassem, Bryson Katona, Kaitlyn Kelly, AnnMarie Kieber-Emmons, Sonia Kupfer, Katie Lang, Xavier Llor, Arnold J Markowitz, Mariana Moreno Prats, Mariana Niell-Swiller, Darryl Outlaw, Sara Pirzadeh-Miller, Niloy Jewel Samadder, David Shibata, Peter P Stanich, Benjamin J Swanson, Brittany M Szymaniak, Jeanna Welborn, Georgia L Wiesner, Matthew B Yurgelun, Mary Dwyer, Susan Darlow, Zeenat Diwan","doi":"10.6004/jnccn.2024.0061","DOIUrl":"https://doi.org/10.6004/jnccn.2024.0061","url":null,"abstract":"<p><p>Multigene panel testing has allowed for the detection of a growing number of inherited pathogenic/likely pathogenic variants in people at high risk of cancer, including endometrial cancer (EC). Hereditary syndromes associated with EC include Lynch syndrome, PTEN hamartoma tumor syndrome, and Peutz-Jeghers syndrome. This manuscript provides the latest recommendations from the NCCN Guidelines for Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric on the screening and management of EC in patients at high risk for these syndromes, as well as the advantages and limitations of multigene panel testing. This manuscript also describes recent updates to these guidelines regarding de-implementation of colon cancer screening in individuals with CHEK2 pathogenic/likely pathogenic variants, based on the most up-to-date evidence regarding the association between CHEK2 pathogenic/likely pathogenic variants and colon cancer risk.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":"695-711"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846707","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}
Tara Sanft, Andrew T Day, Mindy Goldman, Shannon Ansbaugh, Saro Armenian, K Scott Baker, Tarah J Ballinger, Wendy Demark-Wahnefried, Nathan Paul Fairman, Josephine Feliciano, Tessa Faye Flores, Debra L Friedman, Nicolette Gabel, Christine Hill-Kayser, Divya Koura, Kimberley Lee, Nita Lee, Allison L McDonough, Michelle Melisko, Kathi Mooney, Halle C F Moore, Natalie Moryl, Heather Neuman, Linda Overholser, Chirayu Patel, Lindsay Peterson, William Pirl, Andrea Porpiglia, Lidia Schapira, Anna Schwartz, Sophia Smith, Amye Tevaarwerk, Diane Von Ah, Robert Wake, Eric Yang, Phyllis Zee, Nicole McMillian, Deborah Freedman-Cass
{"title":"NCCN Guidelines® Insights: Survivorship, Version 2.2024.","authors":"Tara Sanft, Andrew T Day, Mindy Goldman, Shannon Ansbaugh, Saro Armenian, K Scott Baker, Tarah J Ballinger, Wendy Demark-Wahnefried, Nathan Paul Fairman, Josephine Feliciano, Tessa Faye Flores, Debra L Friedman, Nicolette Gabel, Christine Hill-Kayser, Divya Koura, Kimberley Lee, Nita Lee, Allison L McDonough, Michelle Melisko, Kathi Mooney, Halle C F Moore, Natalie Moryl, Heather Neuman, Linda Overholser, Chirayu Patel, Lindsay Peterson, William Pirl, Andrea Porpiglia, Lidia Schapira, Anna Schwartz, Sophia Smith, Amye Tevaarwerk, Diane Von Ah, Robert Wake, Eric Yang, Phyllis Zee, Nicole McMillian, Deborah Freedman-Cass","doi":"10.6004/jnccn.2024.0062","DOIUrl":"https://doi.org/10.6004/jnccn.2024.0062","url":null,"abstract":"<p><p>The NCCN Guidelines for Survivorship include recommendations for screening, evaluation, and treatment of psychosocial and physical problems resulting from adult-onset cancer and its treatment. They also include recommendations to promote healthy behaviors and immunizations in survivors and provide a framework for care coordination. These NCCN Guidelines Insights summarize the panel's current recommendations regarding sexual health and fertility.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":"22 10","pages":"648-658"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846715","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}
Caroline Muñoz, Jaclyn M Beca, Erind Dvorani, Rebecca E Mercer, Jessica Arias, Andrea Adamic, Scott Gavura, Kelvin K W Chan
{"title":"Comparative Safety and Effectiveness of Bevacizumab Biosimilars to Originator for the Treatment of Metastatic Colorectal Cancer.","authors":"Caroline Muñoz, Jaclyn M Beca, Erind Dvorani, Rebecca E Mercer, Jessica Arias, Andrea Adamic, Scott Gavura, Kelvin K W Chan","doi":"10.6004/jnccn.2024.7053","DOIUrl":"10.6004/jnccn.2024.7053","url":null,"abstract":"<p><strong>Background: </strong>Ontario has publicly funded biosimilar bevacizumab for first-line metastatic colorectal cancer (mCRC) since 2019. Clinical trials demonstrate comparable efficacy and safety of bevacizumab biosimilars to originator bevacizumab. The objective of this study was to assess real-world safety and effectiveness of the implementation of bevacizumab biosimilars compared with originator bevacizumab in patients with mCRC.</p><p><strong>Methods: </strong>This was a population-based, retrospective study comparing Ontario patients starting treatment with bevacizumab biosimilars between August 12, 2019, and March 31, 2021, and starting treatment with originator bevacizumab between July 2, 2008, and August 11, 2019. Safety outcomes included death within 30 days of the last dose received, any hospitalization, direct hospitalization, and hospitalization resulting from bevacizumab-related toxicity, chemotherapy-related toxicity, and febrile neutropenia. Event rates were assessed using negative binomial and logistic regression. The effectiveness outcome was overall survival, calculated using Kaplan-Meier and Cox proportional hazards regression. A subgroup analysis compared safety and effectiveness outcomes between patients on bevacizumab biosimilar products and matched comparators.</p><p><strong>Results: </strong>We identified 8,996 patients who initiated first-line treatment of bevacizumab for mCRC. Accounting for duration of follow-up, no significant differences were observed in the rate of hospitalization between treatment groups. No differences in overall survival (log-rank P>.05) or hazard ratios (propensity score-matched hazard ratio, 1.03; 95% CI, 0.92-1.16) were observed in the crude and propensity score-matched cohorts. Subgroup analysis demonstrated similar safety and effectiveness patterns.</p><p><strong>Conclusions: </strong>The demonstrated similarity in safety and effectiveness between bevacizumab biosimilars and originator bevacizumab provides further support for the use of and confidence in biosimilar products.</p>","PeriodicalId":17483,"journal":{"name":"Journal of the National Comprehensive Cancer Network","volume":" ","pages":"677-684"},"PeriodicalIF":14.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142739919","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}