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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 | Moon, Yong Wha | - |
dc.contributor.author | Kim, Seung Ki | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.contributor.author | Lee, Moon Hee | - |
dc.contributor.author | Park, Yeon Hee | - |
dc.contributor.author | Park, Kyong Hwa | - |
dc.contributor.author | Kim, Gun Min | - |
dc.contributor.author | Lim, Seungtaek | - |
dc.contributor.author | Lee, Seung Ah | - |
dc.contributor.author | Choi, Jae Duk | - |
dc.contributor.author | Baek, Eunhye | - |
dc.contributor.author | Han, Hyesun | - |
dc.contributor.author | Baek, Seungjae | - |
dc.contributor.author | Im, Seock-Ah | - |
dc.date.accessioned | 2023-10-30T01:45:19Z | - |
dc.date.available | 2023-10-30T01:45:19Z | - |
dc.date.created | 2023-08-24 | - |
dc.date.created | 2023-08-24 | - |
dc.date.created | 2023-08-24 | - |
dc.date.issued | 2023-07 | - |
dc.identifier.citation | Cancer Research and Treatment, Vol.55 No.3, pp.766-777 | - |
dc.identifier.issn | 1598-2998 | - |
dc.identifier.uri | https://hdl.handle.net/10371/195849 | - |
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.language | 영어 | - |
dc.publisher | 대한암학회 | - |
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.identifier.doi | 10.4143/crt.2022.987 | - |
dc.citation.journaltitle | Cancer Research and Treatment | - |
dc.identifier.wosid | 001040944900006 | - |
dc.identifier.scopusid | 2-s2.0-85164626003 | - |
dc.citation.endpage | 777 | - |
dc.citation.number | 3 | - |
dc.citation.startpage | 766 | - |
dc.citation.volume | 55 | - |
dc.identifier.kciid | ART002979538 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Im, Seock-Ah | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | COLONY-STIMULATING FACTOR | - |
dc.subject.keywordPlus | FEBRILE NEUTROPENIA | - |
dc.subject.keywordPlus | MORTALITY | - |
dc.subject.keywordPlus | REGIONS | - |
dc.subject.keywordAuthor | Asians | - |
dc.subject.keywordAuthor | Breast neoplasms | - |
dc.subject.keywordAuthor | Koreans | - |
dc.subject.keywordAuthor | Long-acting granulocyte-colony stimulating factor | - |
dc.subject.keywordAuthor | Neutropenia | - |
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