{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,12,7]],"date-time":"2023-12-07T10:22:01Z","timestamp":1701944521786},"reference-count":112,"publisher":"Harborside Press, LLC","issue":"13","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> Chemotherapy-induced febrile neutropenia (FN) is prevented or minimized with granulocyte colony-stimulating factors (G-CSFs). Several G-CSF biosimilars are approved in the United States. The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) is a nonprofit initiative whose objective is to provide scientific evidence on real-world use and comparative safety and effectiveness of biologics and biosimilars using the BBCIC distributed research network (DRN). <jats:bold>Patients and Methods:<\/jats:bold> We describe real-world G-CSF use in patients with breast or lung cancer receiving first-cycle chemotherapy associated with high FN risk. We assessed hospitalizations for FN, availability of absolute neutrophil counts, and G-CSF\u2013induced adverse events to inform future observational comparative effectiveness studies of G-CSF reference products and their biosimilars. A descriptive analysis of 5 participating national health insurance plans was conducted within the BBCIC DRN. <jats:bold>Results:<\/jats:bold> A total of 57,725 patients who received at least one G-CSF dose were included. Most (92.5%) patients received pegfilgrastim. FN hospitalization rates were evaluated by narrow (&lt;0.5%), intermediate (1.91%), and broad (2.99%) definitions. Anaphylaxis and hyperleukocytosis were identified in 1.15% and 2.28% of patients, respectively. This analysis provides real-world evidence extracted from a large, readily available database of diverse patients, characterizing G-CSF reference product use to inform the feasibility of future observational comparative safety and effectiveness analyses of G-CSF biosimilars. We showed that the rates of FN and adverse events in our research network are consistent with those reported by previous small studies. <jats:bold>Conclusions:<\/jats:bold> Readily available BBCIC DRN data can be used to assess G-CSF use with the incidence of FN hospitalizations. Insufficient laboratory result data were available to report absolute neutrophil counts; however, other safety data are available for assessment that provide valuable baseline data regarding the effectiveness and safety of G-CSFs in preparation for comparative effectiveness studies of reference G-CSFs and their biosimilars.<\/jats:p>","DOI":"10.6004\/jnccn.2021.7027","type":"journal-article","created":{"date-parts":[[2021,10,22]],"date-time":"2021-10-22T12:59:57Z","timestamp":1634907597000},"page":"141-148","source":"Crossref","is-referenced-by-count":1,"title":["BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High\u2013Neutropenia Risk Chemotherapy"],"prefix":"10.6004","volume":"19","author":[{"given":"Pamala A.","family":"Pawloski","sequence":"first","affiliation":[{"name":"1HealthPartners Institute, Bloomington, Minnesota;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cara L.","family":"McDermott","sequence":"additional","affiliation":[{"name":"2Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, Virginia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James H.","family":"Marshall","sequence":"additional","affiliation":[{"name":"3Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanita","family":"Pindolia","sequence":"additional","affiliation":[{"name":"4Henry Ford Health System, Detroit, Michigan."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine M.","family":"Lockhart","sequence":"additional","affiliation":[{"name":"2Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, Virginia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine A.","family":"Panozzo","sequence":"additional","affiliation":[{"name":"3Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey S.","family":"Brown","sequence":"additional","affiliation":[{"name":"3Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts; and"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernadette","family":"Eichelberger","sequence":"additional","affiliation":[{"name":"2Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, Virginia;"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"4047","reference":[{"key":"ref901","doi-asserted-by":"crossref","first-page":"911","DOI":"10.1007\/s00520-015-2861-z","article-title":"Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study)","volume":"24","author":"Gasc\u00f3n","year":"2016","journal-title":"Support Care Cancer"},{"key":"ref1051","doi-asserted-by":"crossref","first-page":"37","DOI":"10.2217\/cer.14.62","article-title":"Comparative effectiveness of colony-stimulating factors in febrile neutropenia prophylaxis: how results are affected by research design","volume":"4","author":"Henk","year":"2015","journal-title":"J Comp Eff Res"},{"key":"ref961","article-title":"Guidelines in Non Version Accessed To view the most recent version visit org","author":"EttingerDS","year":"2020","journal-title":"Clinical Practice Oncology Small Cell Lung Cancer"},{"key":"ref371","article-title":"Guidelines in Non Version Accessed To view the most recent version visit org","author":"EttingerDS","year":"2020","journal-title":"Clinical Practice Oncology Small Cell Lung Cancer"},{"key":"ref821","doi-asserted-by":"crossref","first-page":"1260","DOI":"10.1200\/JCO.2017.77.4893","article-title":"American Society of Clinical Oncology statement: biosimilars in oncology","volume":"36","author":"Lyman","year":"2018","journal-title":"J Clin Oncol"},{"key":"ref921","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1186\/1471-2407-13-547","article-title":"Study design: two long-term observational studies of the biosimilar filgrastim Nivestim\u2122 (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia","volume":"13","author":"Kamioner","year":"2013","journal-title":"BMC Cancer"},{"key":"ref231","doi-asserted-by":"crossref","first-page":"1260","DOI":"10.1200\/JCO.2017.77.4893","article-title":"American Society of Clinical Oncology statement: biosimilars in oncology","volume":"36","author":"Lyman","year":"2018","journal-title":"J Clin Oncol"},{"key":"ref301","first-page":"1221","article-title":"A comparison of brand and biosimilar granulocyte-colony stimulating factors for prophylaxis of chemotherapy-induced febrile neutropenia","volume":"23","author":"Douglas","year":"2017","journal-title":"J Manag Care Spec Pharm"},{"key":"ref721","doi-asserted-by":"crossref","first-page":"934","DOI":"10.6004\/jnccn.2011.0076","article-title":"Biosimilars: are they ready for primetime in the United States?","volume":"9","author":"Hirsch","year":"2011","journal-title":"J Natl Compr Canc Netw"},{"key":"ref781","doi-asserted-by":"crossref","first-page":"e000141","DOI":"10.1136\/rmdopen-2015-000141","article-title":"Biosimilars: what do patients need to consider?","volume":"1","author":"Skingle","year":"2015","journal-title":"RMD Open"},{"key":"ref391","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1186\/1472-6963-13-60","article-title":"Technical evaluation of methods for identifying chemotherapy-induced febrile neutropenia in healthcare claims databases","volume":"13","author":"Weycker","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"ref741","doi-asserted-by":"crossref","first-page":"1460","DOI":"10.6004\/jnccn.2017.7049","article-title":"Ensuring patient safety and access in cancer care","volume":"15","author":"Winckworth-Prejsnar","year":"2017","journal-title":"J Natl Compr Canc Netw"},{"key":"ref41","doi-asserted-by":"crossref","first-page":"3158","DOI":"10.1200\/JCO.2006.08.8823","article-title":"Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review","volume":"25","author":"Kuderer","year":"2007","journal-title":"J Clin Oncol"},{"key":"ref851","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1007\/s40259-019-00343-8","article-title":"PF-06881893 (Nivestym\u2122), a filgrastim biosimilar, versus US-licensed filgrastim reference product (US-Neupogen\u00ae): pharmacokinetics, pharmacodynamics, immunogenicity, and safety of single or multiple subcutaneous doses in healthy volunteers","volume":"33","author":"Yao","year":"2019","journal-title":"BioDrugs"},{"key":"ref1081","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1634\/theoncologist.10-6-427","article-title":"Risk models for predicting chemotherapy-induced neutropenia","volume":"10","author":"Lyman","year":"2005","journal-title":"Oncologist"},{"key":"ref861","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1007\/s00277-019-03639-5","article-title":"Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia","volume":"98","author":"Waller","year":"2019","journal-title":"Ann Hematol"},{"key":"ref281","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.ejca.2017.10.034","article-title":"Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: a meta-analysis of randomised clinical trials in breast cancer patients","volume":"89","author":"Botteri","year":"2018","journal-title":"Eur J Cancer"},{"key":"ref541","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1002\/pds.3674","article-title":"Measuring frailty using claims data for pharmacoepidemiologic studies of mortality in older adults: evidence and recommendations","volume":"23","author":"Kim","year":"2014","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"ref931","article-title":"Collective Consortium Accessed Available at https www bbcic org","author":"Biologics","year":"2020","journal-title":"Intelligence"},{"key":"ref701","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1089\/blr.2013.9884","article-title":"Biosimilarity and interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA\u2019s 2012 Draft Guidance for Industry","volume":"32","author":"Koyfman","year":"2013","journal-title":"Biotechnol Law Rep"},{"key":"ref01","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1093\/annonc\/mdg019","article-title":"A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy","volume":"14","author":"Green","year":"2003","journal-title":"Ann Oncol"},{"key":"ref1091","doi-asserted-by":"crossref","first-page":"2069","DOI":"10.1080\/1042819031000119262","article-title":"Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin\u2019s lymphoma receiving CHOP chemotherapy","volume":"44","author":"Lyman","year":"2003","journal-title":"Leuk Lymphoma"},{"key":"ref171","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.6004\/jnccn.2011.0136","article-title":"NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives","volume":"9","author":"Zelenetz","year":"2011","journal-title":"J Natl Compr Canc Netw"},{"key":"ref1141","doi-asserted-by":"crossref","first-page":"980","DOI":"10.1093\/gerona\/glx229","article-title":"Measuring frailty in Medicare data: development and validation of a claims-based frailty index","volume":"73","author":"Kim","year":"2018","journal-title":"J Gerontol A Biol Sci Med Sci"},{"key":"ref401","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1016\/j.jclinepi.2010.10.004","article-title":"A combined comorbidity score predicted mortality in elderly patients better than existing scores","volume":"64","author":"Gagne","year":"2011","journal-title":"J Clin Epidemiol"},{"key":"ref311","doi-asserted-by":"crossref","first-page":"911","DOI":"10.1007\/s00520-015-2861-z","article-title":"Treatment patterns and outcomes in the prophylaxis of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim (the MONITOR-GCSF study)","volume":"24","author":"Gasc\u00f3n","year":"2016","journal-title":"Support Care Cancer"},{"key":"ref791","first-page":"102","article-title":"Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review","volume":"25","author":"Leonard","year":"2019","journal-title":"J Manag Care Spec Pharm"},{"key":"ref191","doi-asserted-by":"crossref","first-page":"e000141","DOI":"10.1136\/rmdopen-2015-000141","article-title":"Biosimilars: what do patients need to consider?","volume":"1","author":"Skingle","year":"2015","journal-title":"RMD Open"},{"key":"ref881","first-page":"976","article-title":"Clinical outcomes of treatment with filgrastim versus a filgrastim biosimilar and febrile neutropenia-associated costs among patients with nonmyeloid cancer undergoing chemotherapy","volume":"24","author":"Schwartzberg","year":"2018","journal-title":"J Manag Care Spec Pharm"},{"key":"ref1071","doi-asserted-by":"crossref","first-page":"1576","DOI":"10.1177\/1078155218799859","article-title":"Appropriateness of granulocyte colony-stimulating factor use in patients receiving chemotherapy by febrile neutropenia risk level","volume":"25","author":"Baig","year":"2019","journal-title":"J Oncol Pharm Pract"},{"key":"ref131","doi-asserted-by":"crossref","first-page":"934","DOI":"10.6004\/jnccn.2011.0076","article-title":"Biosimilars: are they ready for primetime in the United States?","volume":"9","author":"Hirsch","year":"2011","journal-title":"J Natl Compr Canc Netw"},{"key":"ref1101","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1007\/s10549-006-9254-4","article-title":"Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy","volume":"100","author":"Shayne","year":"2006","journal-title":"Breast Cancer Res Treat"},{"key":"ref941","doi-asserted-by":"crossref","first-page":"2091","DOI":"10.1056\/NEJMp1809643","article-title":"The FDA Sentinel Initiative\u2014an evolving national resource","volume":"379","author":"Platt","year":"2018","journal-title":"N Engl J Med"},{"key":"ref1171","doi-asserted-by":"crossref","first-page":"1120","DOI":"10.1093\/gerona\/glz224","article-title":"Measuring frailty in administrative claims data: comparative performance of four claims-based frailty measures in the U.S. Medicare data","volume":"75","author":"Kim","year":"2020","journal-title":"J Gerontol A Biol Sci Med Sci"},{"key":"ref141","doi-asserted-by":"crossref","first-page":"1291","DOI":"10.6004\/jnccn.2013.0149","article-title":"Will biosimilars gain momentum?","volume":"11","author":"Hirsch","year":"2013","journal-title":"J Natl Compr Canc Netw"},{"key":"ref1161","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1097\/MLR.0000000000001359","article-title":"Claims-based frailty indices: a systematic review","volume":"58","author":"Shashikumar","year":"2020","journal-title":"Med Care"},{"key":"ref261","doi-asserted-by":"crossref","first-page":"207","DOI":"10.1007\/s40259-019-00343-8","article-title":"PF-06881893 (Nivestym\u2122), a filgrastim biosimilar, versus US-licensed filgrastim reference product (US-Neupogen\u00ae): pharmacokinetics, pharmacodynamics, immunogenicity, and safety of single or multiple subcutaneous doses in healthy volunteers","volume":"33","author":"Yao","year":"2019","journal-title":"BioDrugs"},{"key":"ref671","doi-asserted-by":"crossref","first-page":"4097","DOI":"10.1007\/s00520-018-4280-4","article-title":"Febrile neutropenia in adjuvant and neoadjuvant chemotherapy for breast cancer: a retrospective study in routine clinical practice from a single institution","volume":"26","author":"Bacrie","year":"2018","journal-title":"Support Care Cancer"},{"key":"ref551","doi-asserted-by":"crossref","first-page":"980","DOI":"10.1093\/gerona\/glx229","article-title":"Measuring frailty in Medicare data: development and validation of a claims-based frailty index","volume":"73","author":"Kim","year":"2018","journal-title":"J Gerontol A Biol Sci Med Sci"},{"key":"ref211","author":"Greener","journal-title":"Biosimilars: ensuring safety in the search for savings."},{"key":"ref181","doi-asserted-by":"crossref","first-page":"188","DOI":"10.18773\/austprescr.2016.084","article-title":"Safety considerations of biosimilars","volume":"39","author":"McKinnon","year":"2016","journal-title":"Aust Prescr"},{"key":"ref591","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1093\/annonc\/mdg019","article-title":"A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy","volume":"14","author":"Green","year":"2003","journal-title":"Ann Oncol"},{"key":"ref681","doi-asserted-by":"crossref","first-page":"e129","DOI":"10.1093\/jamia\/ocw131","article-title":"Predicting neutropenia risk in patients with cancer using electronic data","volume":"24","author":"Pawloski","year":"2017","journal-title":"J Am Med Inform Assoc"},{"key":"ref481","doi-asserted-by":"crossref","first-page":"1576","DOI":"10.1177\/1078155218799859","article-title":"Appropriateness of granulocyte colony-stimulating factor use in patients receiving chemotherapy by febrile neutropenia risk level","volume":"25","author":"Baig","year":"2019","journal-title":"J Oncol Pharm Pract"},{"key":"ref621","first-page":"CD007913","article-title":"Primary prophylactic colony-stimulating factors for the prevention of chemotherapy-induced febrile neutropenia in breast cancer patients","volume":"10","author":"Renner","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"ref51","doi-asserted-by":"crossref","first-page":"3199","DOI":"10.1200\/JCO.2015.62.3488","article-title":"Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update","volume":"33","author":"Smith","year":"2015","journal-title":"J Clin Oncol"},{"key":"ref801","author":"Greener","journal-title":"Biosimilars: ensuring safety in the search for savings."},{"key":"ref1061","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1007\/s12325-010-0093-7","article-title":"Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis","volume":"28","author":"Tan","year":"2011","journal-title":"Adv Ther"},{"key":"ref531","doi-asserted-by":"crossref","first-page":"1038","DOI":"10.1002\/cncr.25677","article-title":"Using claims-based measures to predict performance status score in patients with lung cancer","volume":"117","author":"Salloum","year":"2011","journal-title":"Cancer"},{"key":"ref1151","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1097\/EDE.0000000000000833","article-title":"Controlling for frailty in pharmacoepidemiologic studies of older adults: validation of an existing Medicare claims-based algorithm","volume":"29","author":"Cuthbertson","year":"2018","journal-title":"Epidemiology"},{"key":"ref491","doi-asserted-by":"crossref","first-page":"427","DOI":"10.1634\/theoncologist.10-6-427","article-title":"Risk models for predicting chemotherapy-induced neutropenia","volume":"10","author":"Lyman","year":"2005","journal-title":"Oncologist"},{"key":"ref1031","article-title":"Sentinel Initiative Sentinel data quality assurance practices Accessed Available at https www sentinelinitiative org sentinel data distributed database common data model sentinel data quality assurance practices","author":"May","year":"2020"},{"key":"ref431","article-title":"Sentinel Initiative Sentinel Initiative data quality characterization Accessed Available at https www sentinelinitiative org sentinel data quality review and characterization","author":"May","year":"2020","journal-title":"review"},{"key":"ref81","doi-asserted-by":"crossref","first-page":"4097","DOI":"10.1007\/s00520-018-4280-4","article-title":"Febrile neutropenia in adjuvant and neoadjuvant chemotherapy for breast cancer: a retrospective study in routine clinical practice from a single institution","volume":"26","author":"Bacrie","year":"2018","journal-title":"Support Care Cancer"},{"key":"ref981","doi-asserted-by":"crossref","first-page":"60","DOI":"10.1186\/1472-6963-13-60","article-title":"Technical evaluation of methods for identifying chemotherapy-induced febrile neutropenia in healthcare claims databases","volume":"13","author":"Weycker","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"ref771","doi-asserted-by":"crossref","first-page":"188","DOI":"10.18773\/austprescr.2016.084","article-title":"Safety considerations of biosimilars","volume":"39","author":"McKinnon","year":"2016","journal-title":"Aust Prescr"},{"key":"ref951","article-title":"Guidelines in Version Accessed To view the most recent version visit org","author":"GantiAKP","year":"2020","journal-title":"Clinical Practice Oncology Small Cell Lung Cancer"},{"key":"ref1011","first-page":"019","article-title":"Sentinel Initiative The Sentinel routine querying system modification history Accessed Available at https dev sentinelsystem org projects SENTINEL repos sentinel routine querying tool documentation browse files file typeall modification md","author":"May","year":"2020"},{"key":"ref561","doi-asserted-by":"crossref","first-page":"556","DOI":"10.1097\/EDE.0000000000000833","article-title":"Controlling for frailty in pharmacoepidemiologic studies of older adults: validation of an existing Medicare claims-based algorithm","volume":"29","author":"Cuthbertson","year":"2018","journal-title":"Epidemiology"},{"key":"ref341","article-title":"Collective Consortium Accessed Available at https www bbcic org","author":"Biologics","year":"2020","journal-title":"Intelligence"},{"key":"ref991","doi-asserted-by":"crossref","first-page":"749","DOI":"10.1016\/j.jclinepi.2010.10.004","article-title":"A combined comorbidity score predicted mortality in elderly patients better than existing scores","volume":"64","author":"Gagne","year":"2011","journal-title":"J Clin Epidemiol"},{"key":"ref271","doi-asserted-by":"crossref","first-page":"1217","DOI":"10.1007\/s00277-019-03639-5","article-title":"Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia","volume":"98","author":"Waller","year":"2019","journal-title":"Ann Hematol"},{"key":"ref751","first-page":"405","article-title":"Biosimilars: opportunity or cause for concern?","volume":"10","author":"Roger","year":"2007","journal-title":"J Pharm Pharm Sci"},{"key":"ref571","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1097\/MLR.0000000000001359","article-title":"Claims-based frailty indices: a systematic review","volume":"58","author":"Shashikumar","year":"2020","journal-title":"Med Care"},{"key":"ref811","doi-asserted-by":"crossref","first-page":"e000142","DOI":"10.1136\/esmoopen-2016-000142","article-title":"Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers","volume":"1","author":"Tabernero","year":"2016","journal-title":"ESMO Open"},{"key":"ref581","doi-asserted-by":"crossref","first-page":"1120","DOI":"10.1093\/gerona\/glz224","article-title":"Measuring frailty in administrative claims data: comparative performance of four claims-based frailty measures in the U.S. Medicare data","volume":"75","author":"Kim","year":"2020","journal-title":"J Gerontol A Biol Sci Med Sci"},{"key":"ref21","doi-asserted-by":"crossref","first-page":"2695","DOI":"10.1007\/s00520-016-3079-4","article-title":"Granulocyte growth factor use in elderly patients with non-Hodgkin\u2019s lymphoma in the United States: adherence to guidelines and comparative effectiveness","volume":"24","author":"Elting","year":"2016","journal-title":"Support Care Cancer"},{"key":"ref601","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1007\/s00520-010-0843-8","article-title":"Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy","volume":"19","author":"Chan","year":"2011","journal-title":"Support Care Cancer"},{"key":"ref161","first-page":"405","article-title":"Biosimilars: opportunity or cause for concern?","volume":"10","author":"Roger","year":"2007","journal-title":"J Pharm Pharm Sci"},{"key":"ref841","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1634\/theoncologist.2017-0348","article-title":"Safety profile of biosimilar filgrastim (Zarzio\/Zarxio): a combined analysis of phase III studies","volume":"23","author":"Harbeck","year":"2018","journal-title":"Oncologist"},{"key":"ref411","article-title":"Sentinel Initiative The Sentinel routine querying system Accessed Available at https www sentinelinitiative org methods data tools routine querying tools routine querying system","author":"May","year":"2020"},{"key":"ref61","doi-asserted-by":"crossref","first-page":"v248","DOI":"10.1093\/annonc\/mdq195","article-title":"Hematopoietic growth factors: ESMO clinical practice guidelines for the applications","volume":"21","author":"Crawford","year":"2010","journal-title":"Ann Oncol"},{"key":"ref241","doi-asserted-by":"crossref","first-page":"1948","DOI":"10.1093\/annonc\/mdv281","article-title":"Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy","volume":"26","author":"Blackwell","year":"2015","journal-title":"Ann Oncol"},{"key":"ref761","doi-asserted-by":"crossref","first-page":"S1","DOI":"10.6004\/jnccn.2011.0136","article-title":"NCCN Biosimilars White Paper: regulatory, scientific, and patient safety perspectives","volume":"9","author":"Zelenetz","year":"2011","journal-title":"J Natl Compr Canc Netw"},{"key":"ref381","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/1471-2407-13-11","article-title":"Pegfilgrastim prophylaxis is associated with a lower risk of hospitalization of cancer patients than filgrastim prophylaxis: a retrospective United States claims analysis of granulocyte colony-stimulating factors (G-CSF)","volume":"13","author":"Naeim","year":"2013","journal-title":"BMC Cancer"},{"key":"ref631","doi-asserted-by":"crossref","first-page":"3158","DOI":"10.1200\/JCO.2006.08.8823","article-title":"Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review","volume":"25","author":"Kuderer","year":"2007","journal-title":"J Clin Oncol"},{"key":"ref31","first-page":"CD007913","article-title":"Primary prophylactic colony-stimulating factors for the prevention of chemotherapy-induced febrile neutropenia in breast cancer patients","volume":"10","author":"Renner","year":"2012","journal-title":"Cochrane Database Syst Rev"},{"key":"ref611","doi-asserted-by":"crossref","first-page":"2695","DOI":"10.1007\/s00520-016-3079-4","article-title":"Granulocyte growth factor use in elderly patients with non-Hodgkin\u2019s lymphoma in the United States: adherence to guidelines and comparative effectiveness","volume":"24","author":"Elting","year":"2016","journal-title":"Support Care Cancer"},{"key":"ref1131","doi-asserted-by":"crossref","first-page":"891","DOI":"10.1002\/pds.3674","article-title":"Measuring frailty using claims data for pharmacoepidemiologic studies of mortality in older adults: evidence and recommendations","volume":"23","author":"Kim","year":"2014","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1007\/s00520-010-0843-8","article-title":"Impact of colony-stimulating factors to reduce febrile neutropenic events in breast cancer patients receiving docetaxel plus cyclophosphamide chemotherapy","volume":"19","author":"Chan","year":"2011","journal-title":"Support Care Cancer"},{"key":"ref1111","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1016\/j.jgo.2018.06.007","article-title":"Frailty assessment predicts toxicity during first cycle chemotherapy for advanced lung cancer regardless of chronologic age","volume":"10","author":"Ruiz","year":"2019","journal-title":"J Geriatr Oncol"},{"key":"ref501","doi-asserted-by":"crossref","first-page":"2069","DOI":"10.1080\/1042819031000119262","article-title":"Risk of febrile neutropenia among patients with intermediate-grade non-Hodgkin\u2019s lymphoma receiving CHOP chemotherapy","volume":"44","author":"Lyman","year":"2003","journal-title":"Leuk Lymphoma"},{"key":"ref331","doi-asserted-by":"crossref","first-page":"547","DOI":"10.1186\/1471-2407-13-547","article-title":"Study design: two long-term observational studies of the biosimilar filgrastim Nivestim\u2122 (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia","volume":"13","author":"Kamioner","year":"2013","journal-title":"BMC Cancer"},{"key":"ref651","doi-asserted-by":"crossref","first-page":"v248","DOI":"10.1093\/annonc\/mdq195","article-title":"Hematopoietic growth factors: ESMO clinical practice guidelines for the applications","volume":"21","author":"Crawford","year":"2010","journal-title":"Ann Oncol"},{"key":"ref911","doi-asserted-by":"crossref","first-page":"2301","DOI":"10.1007\/s00520-018-4513-6","article-title":"Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio\u00ae) initiated \u201csame-day\u201d (<\u200924 h), \u201cper-guidelines\u201d (24-72 h), and \u201clate\u201d (>\u200972 h): findings from the MONITOR-GCSF study","volume":"27","author":"Ludwig","year":"2019","journal-title":"Support Care Cancer"},{"key":"ref471","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1007\/s12325-010-0093-7","article-title":"Impact of adherence to disease-modifying therapies on clinical and economic outcomes among patients with multiple sclerosis","volume":"28","author":"Tan","year":"2011","journal-title":"Adv Ther"},{"key":"ref521","doi-asserted-by":"crossref","first-page":"48","DOI":"10.1016\/j.jgo.2018.06.007","article-title":"Frailty assessment predicts toxicity during first cycle chemotherapy for advanced lung cancer regardless of chronologic age","volume":"10","author":"Ruiz","year":"2019","journal-title":"J Geriatr Oncol"},{"key":"ref971","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1186\/1471-2407-13-11","article-title":"Pegfilgrastim prophylaxis is associated with a lower risk of hospitalization of cancer patients than filgrastim prophylaxis: a retrospective United States claims analysis of granulocyte colony-stimulating factors (G-CSF)","volume":"13","author":"Naeim","year":"2013","journal-title":"BMC Cancer"},{"key":"ref351","doi-asserted-by":"crossref","first-page":"2091","DOI":"10.1056\/NEJMp1809643","article-title":"The FDA Sentinel Initiative\u2014an evolving national resource","volume":"379","author":"Platt","year":"2018","journal-title":"N Engl J Med"},{"key":"ref871","doi-asserted-by":"crossref","first-page":"49","DOI":"10.1016\/j.ejca.2017.10.034","article-title":"Comparing granulocyte colony-stimulating factor filgrastim and pegfilgrastim to its biosimilars in terms of efficacy and safety: a meta-analysis of randomised clinical trials in breast cancer patients","volume":"89","author":"Botteri","year":"2018","journal-title":"Eur J Cancer"},{"key":"ref151","doi-asserted-by":"crossref","first-page":"1460","DOI":"10.6004\/jnccn.2017.7049","article-title":"Ensuring patient safety and access in cancer care","volume":"15","author":"Winckworth-Prejsnar","year":"2017","journal-title":"J Natl Compr Canc Netw"},{"key":"ref891","first-page":"1221","article-title":"A comparison of brand and biosimilar granulocyte-colony stimulating factors for prophylaxis of chemotherapy-induced febrile neutropenia","volume":"23","author":"Douglas","year":"2017","journal-title":"J Manag Care Spec Pharm"},{"key":"ref251","doi-asserted-by":"crossref","first-page":"403","DOI":"10.1634\/theoncologist.2017-0348","article-title":"Safety profile of biosimilar filgrastim (Zarzio\/Zarxio): a combined analysis of phase III studies","volume":"23","author":"Harbeck","year":"2018","journal-title":"Oncologist"},{"key":"ref221","doi-asserted-by":"crossref","first-page":"e000142","DOI":"10.1136\/esmoopen-2016-000142","article-title":"Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers","volume":"1","author":"Tabernero","year":"2016","journal-title":"ESMO Open"},{"key":"ref731","doi-asserted-by":"crossref","first-page":"1291","DOI":"10.6004\/jnccn.2013.0149","article-title":"Will biosimilars gain momentum?","volume":"11","author":"Hirsch","year":"2013","journal-title":"J Natl Compr Canc Netw"},{"key":"ref421","first-page":"019","article-title":"Sentinel Initiative The Sentinel routine querying system modification history Accessed Available at https dev sentinelsystem org projects SENTINEL repos sentinel routine querying tool documentation browse files file typeall modification md","author":"May","year":"2020"},{"key":"ref641","doi-asserted-by":"crossref","first-page":"3199","DOI":"10.1200\/JCO.2015.62.3488","article-title":"Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update","volume":"33","author":"Smith","year":"2015","journal-title":"J Clin Oncol"},{"key":"ref831","doi-asserted-by":"crossref","first-page":"1948","DOI":"10.1093\/annonc\/mdv281","article-title":"Comparison of EP2006, a filgrastim biosimilar, to the reference: a phase III, randomized, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy","volume":"26","author":"Blackwell","year":"2015","journal-title":"Ann Oncol"},{"key":"ref321","doi-asserted-by":"crossref","first-page":"2301","DOI":"10.1007\/s00520-018-4513-6","article-title":"Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio\u00ae) initiated \u201csame-day\u201d (<\u200924 h), \u201cper-guidelines\u201d (24-72 h), and \u201clate\u201d (>\u200972 h): findings from the MONITOR-GCSF study","volume":"27","author":"Ludwig","year":"2019","journal-title":"Support Care Cancer"},{"key":"ref461","doi-asserted-by":"crossref","first-page":"37","DOI":"10.2217\/cer.14.62","article-title":"Comparative effectiveness of colony-stimulating factors in febrile neutropenia prophylaxis: how results are affected by research design","volume":"4","author":"Henk","year":"2015","journal-title":"J Comp Eff Res"},{"key":"ref291","first-page":"976","article-title":"Clinical outcomes of treatment with filgrastim versus a filgrastim biosimilar and febrile neutropenia-associated costs among patients with nonmyeloid cancer undergoing chemotherapy","volume":"24","author":"Schwartzberg","year":"2018","journal-title":"J Manag Care Spec Pharm"},{"key":"ref361","article-title":"Guidelines in Version Accessed To view the most recent version visit org","author":"GantiAKP","year":"2020","journal-title":"Clinical Practice Oncology Small Cell Lung Cancer"},{"key":"ref201","first-page":"102","article-title":"Factors affecting health care provider knowledge and acceptance of biosimilar medicines: a systematic review","volume":"25","author":"Leonard","year":"2019","journal-title":"J Manag Care Spec Pharm"},{"key":"ref441","article-title":"Sentinel Initiative Sentinel data quality assurance practices Accessed Available at https www sentinelinitiative org sentinel data distributed database common data model sentinel data quality assurance practices","author":"May","year":"2020"},{"key":"ref511","doi-asserted-by":"crossref","first-page":"255","DOI":"10.1007\/s10549-006-9254-4","article-title":"Predictors of reduced dose intensity in patients with early-stage breast cancer receiving adjuvant chemotherapy","volume":"100","author":"Shayne","year":"2006","journal-title":"Breast Cancer Res Treat"},{"key":"ref1121","doi-asserted-by":"crossref","first-page":"1038","DOI":"10.1002\/cncr.25677","article-title":"Using claims-based measures to predict performance status score in patients with lung cancer","volume":"117","author":"Salloum","year":"2011","journal-title":"Cancer"},{"key":"ref111","doi-asserted-by":"crossref","first-page":"238","DOI":"10.1089\/blr.2013.9884","article-title":"Biosimilarity and interchangeability in the Biologics Price Competition and Innovation Act of 2009 and FDA\u2019s 2012 Draft Guidance for Industry","volume":"32","author":"Koyfman","year":"2013","journal-title":"Biotechnol Law Rep"},{"key":"ref1021","article-title":"Sentinel Initiative Sentinel Initiative data quality characterization Accessed Available at https www sentinelinitiative org sentinel data quality review and characterization","author":"May","year":"2020","journal-title":"review"},{"key":"ref1041","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1177\/1078155215585188","article-title":"Pegfilgrastim use and bone pain: a cohort study of community-based cancer patients","volume":"22","author":"Pawloski","year":"2016","journal-title":"J Oncol Pharm Pract"},{"key":"ref91","doi-asserted-by":"crossref","first-page":"e129","DOI":"10.1093\/jamia\/ocw131","article-title":"Predicting neutropenia risk in patients with cancer using electronic data","volume":"24","author":"Pawloski","year":"2017","journal-title":"J Am Med Inform Assoc"},{"key":"ref451","doi-asserted-by":"crossref","first-page":"423","DOI":"10.1177\/1078155215585188","article-title":"Pegfilgrastim use and bone pain: a cohort study of community-based cancer patients","volume":"22","author":"Pawloski","year":"2016","journal-title":"J Oncol Pharm Pract"},{"key":"ref1001","article-title":"Sentinel Initiative The Sentinel routine querying system Accessed Available at https www sentinelinitiative org methods data tools routine querying tools routine querying system","author":"May","year":"2020"}],"container-title":["Journal of the National Comprehensive Cancer Network"],"original-title":[],"link":[{"URL":"https:\/\/jnccn.org\/view\/journals\/jnccn\/19\/13\/article-p141.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/jnccn.org\/downloadpdf\/journals\/jnccn\/19\/13\/article-p141.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,16]],"date-time":"2022-09-16T18:31:43Z","timestamp":1663353103000},"score":1,"resource":{"primary":{"URL":"https:\/\/jnccn.org\/view\/journals\/jnccn\/19\/13\/article-p141.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3]]},"references-count":112,"journal-issue":{"issue":"13"},"URL":"https:\/\/doi.org\/10.6004\/jnccn.2021.7027","relation":{},"ISSN":["1540-1405","1540-1413"],"issn-type":[{"value":"1540-1405","type":"print"},{"value":"1540-1413","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3]]}}}