Dataset Information

A retrospective comparison of salvage intensive chemotherapy versus venetoclax-combined regimen in patients with relapsed/refractory acute myeloid leukemia (AML).

ABSTRACT:

Background

Evidence that a venetoclax (VEN)-combined regimen is effective in relapsed/refractory acute myeloid leukemia (R/R AML) is emerging. However, it is unknown how VEN-combined low intensity treatment compares to intensive chemotherapy (IC) in medically fit patients with R/R AML.

Methods

We compared AML patients who received IC (n = 89) to those who received a VEN in combination with hypomethylating agents or low dose cytarabine (VEN combination) (n = 54) as their first- or second-line salvage after failing anthracycline-containing intensive chemotherapy.

Results

The median age was 49 years, and significantly more patients in the VEN combination group were in their second salvage and had received prior stem cell transplantation (SCT). Overall response rates including CR, CRi, and MLFS were comparable (44.0% for IC vs. 59.3% for VEN combination, p = 0.081), but VEN combination group compared to IC group tended to show lower treatment related mortality. The rate of bridging to SCT was the same (68.5%), but the percentage of SCT at blast clearance was significantly higher in the VEN-combined group (62.3% vs. 86.5%, p = 0.010). After median follow-up periods of 22.5 (IC) and 11.3 months (VEN combination), the median overall survival was 8.9 (95% CI, 5.4-12.4) and 12.4 months (95% CI, 9.5-15.2) (p = 0.724), respectively.

Conclusion

VEN combination provides a comparable anti-leukemic response and survival to salvage IC, and provide a bridge to SCT with better disease control in medically-fit patients with R/R AML.

SUBMITTER: Park S

PROVIDER: S-EPMC8949776 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

A retrospective comparison of salvage intensive chemotherapy <i>versus</i> venetoclax-combined regimen in patients with relapsed/refractory acute myeloid leukemia (AML).

Park Silvia S Kwag Daehun D Kim Tong Yoon TY Lee Jong Hyuk JH Lee Joon Yeop JY Min Gi June GJ Park Sung Soo SS Yahng Seung-Ah SA Jeon Young-Woo YW Shin Seung-Hwan SH Yoon Jae-Ho JH Lee Sung-Eun SE Cho Byung Sik BS Eom Ki-Seong KS Kim Yoo-Jin YJ Lee Seok S Min Chang-Ki CK Cho Seok-Goo SG Lee Jong Wook JW Kim Hee-Je HJ

Therapeutic advances in hematology 20220323

<h4>Background</h4>Evidence that a venetoclax (VEN)-combined regimen is effective in relapsed/refractory acute myeloid leukemia (R/R AML) is emerging. However, it is unknown how VEN-combined low intensity treatment compares to intensive chemotherapy (IC) in medically fit patients with R/R AML.<h4>Methods</h4>We compared AML patients who received IC (<i>n</i> = 89) to those who received a VEN in combination with hypomethylating agents or low dose cytarabine (VEN combination) (<i>n</i> = 54) as th ...[more]

PMID: 35340720

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Project description:BackgroundWe aim to analyze the efficacy and safety of Venetoclax (Ven) added to cladribine + cytarabine + granulocyte colony-stimulating factor (G-CSF) ± idarubicin or mitoxantrone (CLAG ± Ida/Mito) regimen as a salvage treatment of relapsed/refractory acute myeloid leukemia (RR-AML).MethodsA single-center, retrospective, cohort study was performed. Patients with RR-AML, being treated with CLAG ± Ida/Mito with versus without Ven, were retrospectively studied. The endpoints of this study were to evaluate the rate of composite complete remission (CRc), measurable residual disease (MRD), event-free survival (EFS), overall survival (OS), and relapse between CLAG and CLAG + Ven groups.ResultsSixty-nine patients were included, with a median age of 37 (range, 18-65) years. Thirty-one patients underwent one cycle of salvage treatment of CLAG ± Ida/Mito with Ven and 38 without. In the CLAG + Ven group, 24 (77.4%) patients acquired response, including 22 (71.0%) with composite complete remission (CRc) and 15 (48.4%) MRD-negative CRc, which was significantly higher than those (CRc 47.4%, p = 0.048; MRD-negative CRc 18.4%, p = 0.008) in the CLAG group. Subgroup analysis showed that patients without response after two courses of induction therapy, or patients with FLT3 mutations seemed to benefit more from CLAG ± Ida/Mito + Ven than CLAG ± Ida/Mito in acquiring CRc. With a median follow-up of 13 (95% CI 10.5-15.5) months, the CLAG + Ven group had a median OS of 22.9 (95% CI 19.6-26.2) months and EFS of 15.7 (95% CI 11.1-20.2) months. In contrast, the CLAG group had a median OS of 18.6 (95% CI 14.7-22.6) months and EFS of 10.7 (95% CI 6.6-14.8) months. Although not statistically significant, patients in the CLAG + Ven group showed a potential survival advantage compared to the CLAG group. AEs including all grade and grade 3/4 occurred at similar frequencies in the two groups.ConclusionsVen added to CLAG ± Ida/Mito might improve the outcome of the patients with RR-AML, with well toleration, and a randomized controlled trial is needed to explored.