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Eflapegrastim-xnst, a long-acting G-CSF, has shown favorable safety and efficacy when given 24 h after chemotherapy, but same-day benefit has lacked randomized evaluation. This phase 1, multicenter, open-label trial assessed outcomes after administering eflapegrastim-xnst 0.5 h post-TC across four cycles. Outcomes included time to ANC recovery, severe neutropenia duration, FN incidence, and adverse events.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/safety-and-efficacy-of-same-day-administration-of-eflapegrastim-in-patients-with-early-stage-breast-cancer-receiving-chemotherapy/449838/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/safety-and-efficacy-of-same-day-administration-of-eflapegrastim-in-patients-with-early-stage-breast-cancer-receiving-chemotherapy/449838.png","ImageObject",300,407,{"name":92,"@type":93},"acoobca","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-07","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":81},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What complication does the study focus on in early-stage breast cancer patients receiving TC chemotherapy?","Question",{"text":112,"@type":113},"The study focuses on febrile neutropenia (FN), a common and serious complication associated with myelosuppressive chemotherapy.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was eflapegrastim-xnst administered in this phase 1 trial?",{"text":117,"@type":113},"Eflapegrastim-xnst was administered 0.5 hours after TC chemotherapy for four cycles in early-stage breast cancer patients.",{"name":119,"@type":110,"acceptedAnswer":120},"What were the key efficacy and safety findings?",{"text":121,"@type":113},"The primary endpoint, time to ANC recovery from nadir to ≥1.5×10^9/L in cycle 1, averaged 1.8 days. FN occurred in 1 patient (2%) in cycle 1, and the treatment was generally well tolerated with adverse events such as fatigue, nausea, alopecia, and bone pain.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},449838,1791307066,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":81,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":34,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},3985747870733,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","Safety and efficacy of same-day administration of eflapegrastim in patients with early-stage breast cancer receiving chemotherapy  \nManuel Modiano, MD1, Shanta Chawla, MD2, Jeffrey L. Vacirca, MD3, Kenneth Crist, PharmD4, Howard Franklin, MD4, Lee Schwartzberg, MD5, *,  \n1Arizona Clinical Research Center, Tucson, AZ 85715, United States 2Spectrum Pharmaceuticals, Inc., Irvine, CA 92618, United States 3 New York Cancer Specialists, East Setauket, NY 11733, United States 4Assertio Holdings, Inc., Lake Forest, IL 60045, United States  \n5Renown Health-Pennington Cancer Institute, Reno, NV 89502, United States  \n*Corresponding author: Lee Schwartzberg, MD, Chief of Medical Oncology, Renown Health, 75 Pringle Way, Reno, NV 89502, USA ([lee.schwartzberg@renown.org](lee.schwartzberg@renown.org)) .  \nAbstract  \nBackground: Febrile neutropenia (FN) is a common complication with myelosuppressive chemotherapy regimens, significantly affecting patients with breast cancer (BC) receiving docetaxel and cyclophosphamide (TC) . Treatment with granulocyte colony-stimulating factor (G-CSF) is established for prophylactic and therapeutic use to reduce risk of FN. Eflapegrastim-xnst, a novel long-acting G-CSF, has a favorable safety profile and is effective in reducing neutropenia risk in patients with early-stage BC receiving TC, when administered 24 h after chemotherapy. The benefits of eflapegrastim-xnst given same day as TC have not been evaluated in a randomized controlled trial.  \nPatients and Methods: This phase 1, multicenter, open-label trial evaluated efficacy and safety of eflapegrastim-xnst administered 0.5 h post-TC chemotherapy for four cycles in patients with early-stage BC. The primary end point was time to recovery of absolute neutrophil count (ANC) from nadir to ≥1.5 × 109/L in cycle 1. Secondary end points included safety, duration of severe neutropenia, incidence of FN, and neutropenic complications.  \nResults: Of 53 patients enrolled, 49 completed the study. Mean time to ANC recovery in cycle 1, the primary end point, was 1.8 days. Only 1 patient (2%) experienced an FN episode in cycle 1 (1 episode/228 cycles received [0 .4%]) . Incidence of severe neutropenia decreased from 42.9%(cycle 1) to 27.3%(cycle 4) . Eflapegrastim-xnst was well tolerated; common treatment-emergent adverse events included fatigue, nausea, alopecia, and bone pain.  \nConclusions: Eflapegrastim-xnst, administered same day as TC chemotherapy was effective and well tolerated evidenced by short time to neutrophil recovery and low incidence of FN, with an adverse event profile similar to that of next-day dosing.  \nKey words: granulocyte colony-stimulating factor; eflapegrastim; chemotherapy-induced neutropenia; febrile neutropenia; breast cancer.  \nIntroduction  \nEflapegrastim-xnst (herein referred to as eflapegrastim) is a novel, long-acting human granulocyte colony-stimulating factor (G-CSF) used for the prevention of febrile neutropenia (FN), a common and serious complication in patients with cancer receiving myelosuppressive anticancer drugs.1–3 Eflapegrastim consists of a recombinant human G-CSF analog covalently linked to recombinant human IgG Fc fragment via a polyethylene glycol linker.3 Evidence from the ADVANCE and RECOVER phase 3 trials demonstrated the safety and efficacy of eflapegrastim for reducing the risk of chemotherapy-induced neutropenia in patients with early-stage breast cancer (BC) .4,5 Both studies met their primary end point of noninferiority of eflapegrastim compared to pegfilgrastim for the duration of severe neutropeni∼a in cycle 1. In both studies, eflapegrastim  \nwas administered 24 h after docetaxel and cyclophosphamide (TC) . G-CSF treatment 24 h after chemotherapy presents  \nseveral challenges, including the need for additional clinic visits per cycle of treatment or the need to wear an on-body device to deliver G-CSF in a delayed form, with the potential for device failure.  \nChemotherapy-induced FN may predispose patients to ","cbCaifNvpVqeoDmj","https://ap.wps.com/l/cbCaifNvpVqeoDmj","pdf",552403,"English","# Abstract\n## Background\n## Patients and Methods\n## Results\n## Conclusions\n# Introduction\n## Eflapegrastim and rationale for timing\n## Clinical impact of febrile neutropenia\n## Standard of care and study context\n# Implications for Practice","[{\"question\":\"What complication does the study focus on in early-stage breast cancer patients receiving TC chemotherapy?\",\"answer\":\"The study focuses on febrile neutropenia (FN), a common and serious complication associated with myelosuppressive chemotherapy.\"},{\"question\":\"How was eflapegrastim-xnst administered in this phase 1 trial?\",\"answer\":\"Eflapegrastim-xnst was administered 0.5 hours after TC chemotherapy for four cycles in early-stage breast cancer patients.\"},{\"question\":\"What were the key efficacy and safety findings?\",\"answer\":\"The primary endpoint, time to ANC recovery from nadir to ≥1.5×10^9/L in cycle 1, averaged 1.8 days. FN occurred in 1 patient (2%) in cycle 1, and the treatment was generally well tolerated with adverse events such as fatigue, nausea, alopecia, and bone pain.\"}]","Safety and efficacy of same-day administration of eflapegrastim in patients with early-stage breast cancer receiving chemotherapy | PDF",1790731200,18]