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Correction to: Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial
- Source :
- Digital.CSIC. Repositorio Institucional del CSIC, instname, Ann Hematol
- Publication Year :
- 2021
-
Abstract
- This analysis from the phase II BRIGHT AML 1003 trial reports the long-term efficacy and safety of glasdegib + low-dose cytarabine (LDAC) in patients with acute myeloid leukemia ineligible for intensive chemotherapy. The multicenter, open-label study randomized (2:1) patients to receive glasdegib + LDAC (de novo, n = 38; secondary acute myeloid leukemia, n = 40) or LDAC alone (de novo, n = 18; secondary acute myeloid leukemia, n = 20). At the time of analysis, 90% of patients had died, with the longest follow-up since randomization 36 months. The combination of glasdegib and LDAC conferred superior overall survival (OS) versus LDAC alone; hazard ratio (HR) 0.495; (95% confidence interval [CI] 0.325–0.752); p = 0.0004; median OS was 8.3 versus 4.3 months. Improvement in OS was consistent across cytogenetic risk groups. In a post-hoc subgroup analysis, a survival trend with glasdegib + LDAC was observed in patients with de novo acute myeloid leukemia (HR 0.720; 95% CI 0.395–1.312; p = 0.14; median OS 6.6 vs 4.3 months) and secondary acute myeloid leukemia (HR 0.287; 95% CI 0.151–0.548; p < 0.0001; median OS 9.1 vs 4.1 months). The incidence of adverse events in the glasdegib + LDAC arm decreased after 90 days’ therapy: 83.7% versus 98.7% during the first 90 days. Glasdegib + LDAC versus LDAC alone continued to demonstrate superior OS in patients with acute myeloid leukemia; the clinical benefit with glasdegib + LDAC was particularly prominent in patients with secondary acute myeloid leukemia. ClinicalTrials.gov identifier: NCT01546038.<br />Open Access funding enabled and organized by Projekt DEAL. This study was funded by Pfizer.
- Subjects :
- Male
Oncology
medicine.medical_specialty
Low dose cytarabine
Glasdegib
Antineoplastic Agents
law.invention
Randomized controlled trial
law
Internal medicine
hemic and lymphatic diseases
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Secondary Acute Myeloid Leukemia
In patient
Secondary acute myeloid leukemi
Aged
Aged, 80 and over
Hematology
Acute myeloid leukemia
business.industry
Phenylurea Compounds
Cytarabine
Correction
Neoplasms, Second Primary
General Medicine
Middle Aged
Survival Analysis
Clinical trial
Leukemia, Myeloid, Acute
Treatment Outcome
Benzimidazoles
Female
business
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Digital.CSIC. Repositorio Institucional del CSIC, instname, Ann Hematol
- Accession number :
- edsair.doi.dedup.....df25aca21278bc88b7787e214a6153f9