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AML-119 The Impact of Post-Remission Granulocyte Colony-Stimulating Factor (G-CSF) Use (G-CSFu) in the Phase 3 Studies of Venetoclax (Ven) Combination Treatments in Patients (Pts) With Newly Diagnosed Acute Myeloid Leukemia (AML)
DC Field | Value | Language |
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dc.contributor.author | DiNardo, Courtney | - |
dc.contributor.author | Pratz, Keith | - |
dc.contributor.author | Panayiotidis, Panayiotis | - |
dc.contributor.author | Wei, Xudong | - |
dc.contributor.author | Vorobyev, Vladimir | - |
dc.contributor.author | Illés, Àrpád | - |
dc.contributor.author | Kim, Inho | - |
dc.contributor.author | Ivanov, Vladimir | - |
dc.contributor.author | Ku, Grace | - |
dc.contributor.author | Miller, Catherine | - |
dc.contributor.author | Zhang, Meng | - |
dc.contributor.author | Tatsch, Fernando | - |
dc.contributor.author | Potluri, Jalaja | - |
dc.contributor.author | Schmidt, Xenia | - |
dc.contributor.author | Recher, Christian | - |
dc.date.accessioned | 2022-10-17T04:16:43Z | - |
dc.date.available | 2022-10-17T04:16:43Z | - |
dc.date.created | 2022-10-14 | - |
dc.date.issued | 2022-10 | - |
dc.identifier.citation | Clinical Lymphoma Myeloma & Leukemia, Vol.22, p. S214 | - |
dc.identifier.issn | 2152-2650 | - |
dc.identifier.uri | https://hdl.handle.net/10371/186145 | - |
dc.description.abstract | © 2022 Elsevier Inc.Context: In VIALE-A (NCT02993523) and VIALE-C (NCT03069352), Ven+azacitidine (Aza) and low-dose cytarabine (LDAC), respectively, improved outcomes in pts with intensive chemotherapy (IC)-ineligble newly diagnosed AML. Objective: To explore outcomes in pts with G-CSFu. Design: VIALE-A/C, dosing and treatment schedule were previously described. G-CSFu was given per institutional practice. Pts who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) were analyzed by G-CSFu. Results: In VIALE-A/C, baseline demographics were similar in Ven-treated pts regardless of G-CSFu. In VIALE-A, 190/286 pts (66%) treated with Ven+Aza and 41/145(28%) pts treated with placebo (PBO)+Aza achieved CR/CRi; 93(49%) and 10(24%) pts with CR/CRi received G-CSF (median time to first G-CSFu[range], 36d[2–483] and 35d[4–127]), respectively. Median duration of response (mDOR) for CR/CRi (95% CI) was not reached (NR; 17.5–NR) and 12.9mo(7.9–17.3) in the Ven+Aza+G-CSF and Ven+Aza+non-G-CSF groups, respectively; DOR at 12mo was 67% and 53%. Among 164 evaluable pts, measurable residual disease response (MRD<10–3) was achieved by 67, of whom 38(57%) had G-CSFu. Median overall survival (mOS[95% CI) was NR(NR–NR) with Ven+Aza+G-CSF and was 21.1mo(15.2–NR) with Ven+Aza+non-G-CSF; 12-mo OS rates were 83% and 71%. Post-remission Gr ≥3 neutropenia and febrile neutropenia (FN) rates were 33%(n=31) and 39%(n=36) with Ven+Aza+G-CSF, and 29%(n=28) and 20%(n=19) with Ven+Aza+non-G-CSF, respectively. Median durations of post-remission Gr ≥3 neutropenia and FN were 12.5d and 8d (Ven+Aza+G-CSF), and 16d and 10.5d (Ven+Aza+non-G-CSF). In VIALE-C, 69/143 pts (48%) treated with Ven+LDAC and 9/68(13%) pts treated with PBO+LDAC achieved CR/CRi; 30(43%) and 2(22%) received G-CSF (median time to first G-CSFu[range], 30d[2–459] and 229d[169–289]), respectively. mDOR was 10.8(4.9–17.8) and 11.8mo(5.9–NR) in the Ven+LDAC+G-CSF and Ven+LDAC+non-G-CSF groups, respectively; DOR at 12mo was 45% and 49%. mOS was 20.8mo(11.9–NR) with Ven+LDAC+G-CSF and 13.7mo(10.8–NR) with Ven+LDAC+non-G-CSF; 12-mo OS were ~68% and ~57%; 9/64 evaluable pts achieved MRD<10–3, of whom 6(67%) had G-CSFu. Post-remission Gr ≥3 neutropenia and FN rates were 53%(n=16) and 23%(n=7) with Ven+LDAC+G-CSF, and 51%(n=20) and 8%(n=3) with Ven+LDAC+non-G-CSF, respectively. Median durations of post-remission Gr≥3 neutropenia and FN were 15d and 6d(Ven+LDAC+G-CSF), and 12.5d and 29d(Ven+LDAC+non-G-CSF). Conclusions: Gr ≥3 neutropenia and FN with G-CSFu trended towards shorter duration, without negative impact on DOR or OS. | - |
dc.language | 영어 | - |
dc.publisher | CIG MEDIA GROUP, LP | - |
dc.title | AML-119 The Impact of Post-Remission Granulocyte Colony-Stimulating Factor (G-CSF) Use (G-CSFu) in the Phase 3 Studies of Venetoclax (Ven) Combination Treatments in Patients (Pts) With Newly Diagnosed Acute Myeloid Leukemia (AML) | - |
dc.type | Article | - |
dc.identifier.doi | 10.1016/S2152-2650(22)01223-X | - |
dc.citation.journaltitle | Clinical Lymphoma Myeloma & Leukemia | - |
dc.identifier.scopusid | 2-s2.0-85138139061 | - |
dc.citation.startpage | S214 | - |
dc.citation.volume | 22 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Inho | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
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