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Long-term follow-up of VIALE-A: Venetoclax and azacitidine in chemotherapy-ineligible untreated acute myeloid leukemia
KW. Pratz, BA. Jonas, V. Pullarkat, MJ. Thirman, JS. Garcia, H. Döhner, C. Récher, W. Fiedler, K. Yamamoto, J. Wang, SS. Yoon, O. Wolach, SP. Yeh, B. Leber, J. Esteve, J. Mayer, K. Porkka, Á. Illés, RM. Lemoli, M. Turgut, G. Ku, C. Miller, Y....
Jazyk angličtina Země Spojené státy americké
Typ dokumentu randomizované kontrolované studie, časopisecké články
Grantová podpora
AbbVie
Genentech
NLK
Free Medical Journals
od 1998 do Před 1 rokem
Wiley Free Content
od 1996 do Před 1 rokem
PubMed
38343151
DOI
10.1002/ajh.27246
Knihovny.cz E-zdroje
- MeSH
- akutní myeloidní leukemie * farmakoterapie MeSH
- azacytidin škodlivé účinky MeSH
- bicyklické sloučeniny heterocyklické * MeSH
- lidé MeSH
- následné studie MeSH
- neutropenie * MeSH
- protokoly protinádorové kombinované chemoterapie škodlivé účinky MeSH
- sulfonamidy * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
Venetoclax-azacitidine is approved for treatment of patients with newly diagnosed acute myeloid leukemia (AML) ineligible for intensive chemotherapy based on the interim overall survival (OS) analysis of the VIALE-A study (NCT02993523). Here, long-term follow-up is presented to address survival benefit and long-term outcomes with venetoclax-azacitidine. Patients with newly diagnosed AML who were ineligible for intensive chemotherapy were randomized 2:1 to receive venetoclax-azacitidine or placebo-azacitidine. OS was the primary endpoint; complete remission with/without blood count recovery (CR/CRi) was a key secondary endpoint. This final analysis was conducted when 100% of the predefined 360 OS events occurred. In VIALE-A, 431 patients were enrolled to venetoclax-azacitidine (n = 286) or placebo-azacitidine (n = 145). At 43.2 months median follow-up, median OS was 14.7 months (95% confidence interval [CI], 12.1-18.7) with venetoclax-azacitidine, and 9.6 months (95% CI, 7.4-12.7) with placebo-azacitidine (hazard ratio, 0.58 [95% CI, 0.47-0.72], p < .001); the estimated 24-month OS rate was 37.5% and 16.9%, respectively. Median OS for patients with IDH1/2 mutations and those with measurable residual disease responses was reached in this final analysis. CR/CRi rate was similar to interim analysis. Any-grade hematologic and gastrointestinal adverse events were most common in venetoclax-azacitidine and placebo-azacitidine arms, including thrombocytopenia (47% and 42%) and neutropenia (43% and 29%). No new safety signals were identified. Long-term efficacy and safety confirm venetoclax-azacitidine is an improvement in standard-of-care for patients with AML who are not eligible for intensive chemotherapy because of advanced age or comorbidities.
AbbVie Inc North Chicago Illinois USA
Abramson Cancer Center University of Pennsylvania Philadelphia Pennsylvania USA
Aichi Cancer Center Nagoya Japan
Cancer Research Center of Toulouse Toulouse France
Clinic of Hematology Department of Internal Medicine University of Genoa Genoa Italy
Dana Farber Cancer Institute Harvard Medical School Boston Massachusetts USA
Department of Internal Medicine 3 Ulm University Hospital Ulm Germany
Department of Internal Medicine China Medical University Hospital Taichung Taiwan
Department of Internal Medicine Seoul National University College of Medicine Seoul South Korea
Department of Internal Medicine University Hospital Brno and Masaryk University Brno Czech Republic
Department of Medicine McMaster University Hamilton Ontario Canada
Faculty of Medicine Department of Hematology University of Debrecen Debrecen Hungary
Genentech Inc South San Francisco California USA
IRCCS San Martino Hospital Genoa Genoa Italy
Citace poskytuje Crossref.org
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