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Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies
DC Field | Value | Language |
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dc.contributor.author | 김건민 | - |
dc.date.accessioned | 2024-03-22T05:55:17Z | - |
dc.date.available | 2024-03-22T05:55:17Z | - |
dc.date.issued | 2023-07 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198289 | - |
dc.description.abstract | Purpose We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English, Korean | - |
dc.publisher | Official journal of Korean Cancer Association | - |
dc.relation.isPartOf | CANCER RESEARCH AND TREATMENT | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Agents* / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Breast Neoplasms* / drug therapy | - |
dc.subject.MESH | East Asian People | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Filgrastim* / therapeutic use | - |
dc.subject.MESH | Granulocyte Colony-Stimulating Factor* / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Neutropenia* / chemically induced | - |
dc.subject.MESH | Neutropenia* / drug therapy | - |
dc.subject.MESH | Polyethylene Glycols | - |
dc.subject.MESH | Republic of Korea | - |
dc.title | Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Yong Wha Moon | - |
dc.contributor.googleauthor | Seung Ki Kim | - |
dc.contributor.googleauthor | Keun Seok Lee | - |
dc.contributor.googleauthor | Moon Hee Lee | - |
dc.contributor.googleauthor | Yeon Hee Park | - |
dc.contributor.googleauthor | Kyong Hwa Park | - |
dc.contributor.googleauthor | Gun Min Kim | - |
dc.contributor.googleauthor | Seungtaek Lim | - |
dc.contributor.googleauthor | Seung Ah Lee | - |
dc.contributor.googleauthor | Jae Duk Choi | - |
dc.contributor.googleauthor | Eunhye Baek | - |
dc.contributor.googleauthor | Hyesun Han | - |
dc.contributor.googleauthor | Seungjae Baek | - |
dc.contributor.googleauthor | Seock-Ah Im | - |
dc.identifier.doi | 10.4143/crt.2022.987 | - |
dc.contributor.localId | A00287 | - |
dc.relation.journalcode | J00453 | - |
dc.identifier.eissn | 2005-9256 | - |
dc.identifier.pmid | 36701846 | - |
dc.subject.keyword | Asians | - |
dc.subject.keyword | Breast neoplasms | - |
dc.subject.keyword | Koreans | - |
dc.subject.keyword | Long-acting granulocyte-colony stimulating factor | - |
dc.subject.keyword | Neutropenia | - |
dc.contributor.alternativeName | Kim, Gun Min | - |
dc.contributor.affiliatedAuthor | 김건민 | - |
dc.citation.volume | 55 | - |
dc.citation.number | 3 | - |
dc.citation.startPage | 766 | - |
dc.citation.endPage | 777 | - |
dc.identifier.bibliographicCitation | CANCER RESEARCH AND TREATMENT, Vol.55(3) : 766-777, 2023-07 | - |
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