Efficacy of Venetoclax Combined with Decitabine-Based Treatment for Heavily Pre-Treated Relapsed or Refractory AML Patients in a Real-World Setting

Tong, Juan; Zhao, Ning; Hu, Xinting; Yao, Wen; Cheng, Ying; Zhou, Li; Liu, Huilan; Geng, Li; Sun, Zimin; Zheng, Changcheng

doi:10.2147/cmar.s316561

Cited by 9 publications

(3 citation statements)

References 23 publications

(40 reference statements)

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“…Through data mining FAERS, the new and rare AEs can be evaluated and detected. Compared with the previous clinical studies on VEN [ 18 – 21 ], this study was based on a large sample size and a long time span, and found new AE signals, filling the gap in the study of VEN related AEs in the real world. It is of great significance to understand the safety of VEN.…”

Section: Discussionmentioning

confidence: 98%

“…Our research results also show that off-label use accounts for 12.2% (2,339/19,107) of the total number of reports, which indicates that off-label use seems to be very common in clinical use of VEN. The AML is the most indication, accounting for more than 1/3, CLL is close to 1/3, and the remaining 1/3 are currently unapproved indications [ 20 , 21 , 42 ]. Although off-label use gives patients hope and some efficacy, it also brings a higher risk of AEs than conventional use, which requires careful evaluation and treatment by clinicians [ 43 , 44 ].…”

Section: Discussionmentioning

confidence: 99%

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A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

et al. 2022

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Background Venetoclax (VEN) is the first selective small molecule Bcl-2 inhibitor approved by FDA and used in adult chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and some acute myeloid leukemia (AML). However, the long-term safety of VEN in large sample population was unknown. This study evaluated the adverse events (AEs) of VEN from FDA Adverse Event Reporting System (FAERS) since its approval in 2016 by data mining. Methods The disproportionality analyses, including four algorithms of reporting odd ratio (ROR), proportional reporting ratio (PRR), bayesian configuration promotion neural network (BCPNN), and multi item gamma poisson shrinker (MGPS), were employed to quantify the signals of VEN-associated AEs. Results From the FAERS database, a total of 8,379,682 reports were collected during the study period. After removing the duplication, the number of reports with VEN as the primary suspect (PS) was 19,107. The 19,107 cases of AEs involved 27 organ systems, 256 significant PTs which conforming to the four algorithms. Unexpected serious AEs, such as pleural effusion, splenic infarction, atrial fibrillation, skin squamous cell carcinoma, etc., have signals. The median time of occurrence of AEs related to VEN was 31 days (inter quartile range [IQR] 7–131 days), and half of the reported AEs occurred within 1 month after administration. Conclusion Our research has found new significant AEs signals of VEN, which improved its safety information in real-world after marketing approval, and contributed to its risk control of use in clinic.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

et al. 2022

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“…A phase II study in refractory/relapsed (R/R) AML patients has shown that venetoclax monotherapy can achieve an overall response rate (ORR) of 19% [ 9 ]. The ORR of venetoclax combined with decitabine-based treatment for heavily pre-treated R/R AML patients was 45.5% and the CR rate was 40.9% [ 10 ]. Venetoclax combined with fludarabine, cytarabine, granulocyte colony-stimulating factor and idarubicin (FLAG-IDA) achieved a high response rate in R/R AML [ 11 ].…”

Section: Introductionmentioning

confidence: 99%

Addition of venetoclax to myeloablative conditioning regimens for allogeneic hematopoietic stem cell transplantation in high-risk AML

et al. 2023

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Background Venetoclax monotherapy is an effective option for patients with acute myeloid leukemia (AML). Venetoclax has also been used in non-myeloablative conditioning allogeneic hematopoietic stem cell transplantation (allo-HSCT) for high-risk AML with a tolerable toxicity profile. However, the efficacy and safety of a venetoclax-containing myeloablative conditioning (MAC) allo-HSCT regimen for high-risk AML have not been evaluated. Objective To evaluate the safety and efficacy of a MAC regimen containing venetoclax for high-risk AML. Study design From 25 February 2021 to 4 September 2022, a total of 31 patients with high-risk AML who underwent allo-HSCT and a MAC regimen with venetoclax were analyzed. Results At the time of transplantation, 21 patients were in first complete remission (CR1), 4 were in a second complete remission (CR2), and 6 in non-remission (NR). Twenty-four patients (77.4%) were minimal residual disease (MRD)-positive before transplant. The FLT3-ITD gene mutation was present in 51.6% of patients. NUP98 rearrangement, MLL rearrangement or MLL-PTD and DEK::CAN fusion genes were found in 5 (16.1%), 7(22.6%) and 2 (6.5%) patients, respectively. Twenty-nine (93.6%) patients underwent haploidentical allo-HSCT. The median follow-up time was 278 days (range: 52–632 days). The 100-day cumulative incidence of grade 3 to 4 acute graft-versus-host disease (aGVHD) was 16.1% (95%CI, 7.2–36.0%). The 180-day cumulative incidence of moderate to severe chronic graft-versus-host disease (cGVHD) was 7.1% (95%CI, 1.9–26.9%). Cumulative incidence of 100-day cytomegalovirus (CMV) viraemia and 100-day Epstein-Barr virus (EBV) viraemia was 61.6% (95%CI, 46.5–81.4%) and 3.2% (95%CI, 0.4–22.2%), respectively. The 600-day overall survival (OS) and leukemia-free survival (LFS) were 80.9% (95%CI, 63.5–93.6%) and 81.3% (95%CI, 64.2–93.7%), respectively. The 600-day relapse incidence (RI) and non-relapse mortality (NRM) was 6.9% (95%CI, 1.8–26.3%) and 11.7% (95%CI, 3.9–35.0%). Conclusion Our study shows that the addition of venetoclax to a MAC allo-HSCT was feasible, safe and effective for high-risk AML patients.

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Efficacy of venetoclax combined with decitabine conditioning regimen for allogeneic hematopoietic stem cell transplantation in high-risk and elderly patients with myeloid neoplasms

Zheng,

Gao,

et al. 2023

Ann Hematol

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Efficacy of Venetoclax Combined with Decitabine-Based Treatment for Heavily Pre-Treated Relapsed or Refractory AML Patients in a Real-World Setting

Cited by 9 publications

References 23 publications

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for venetoclax

Addition of venetoclax to myeloablative conditioning regimens for allogeneic hematopoietic stem cell transplantation in high-risk AML

Efficacy of venetoclax combined with decitabine conditioning regimen for allogeneic hematopoietic stem cell transplantation in high-risk and elderly patients with myeloid neoplasms

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