Internal Medicine Department A, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel; Institute of Hematology, Davidoff Cancer Center, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel.
Internal Medicine Department A, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Israel.
Leuk Res. 2023 Oct;133:107368. doi: 10.1016/j.leukres.2023.107368. Epub 2023 Aug 4.
Venetoclax (VEN) in combination with intensive chemotherapy (IC) is increasingly used to treat patients with high-risk acute myeloid leukemia (AML). We conducted a systematic review to assess the safety and efficacy outcomes of FLAG-IDA in combination with VEN. The primary safety outcome was infection rate; the primary efficacy outcome was response to treatment (composite complete remission (CRc) and overall response rate (ORR). Risk of bias was assessed according to the ROBINS-I tool. Six studies including 221 patients with newly-diagnosed (ND AML (n = 120)) and R/R AML (n = 101) disease, were included in this systematic review. Pooling of results was not conducted due to major differences between studies. The reported rates of neutropenic fever, bacteremia, pneumonia and invasive fungal infections were at 44-55 %, 24-48 %, 12-30 % and 11-36 % of assessed patients, respectively. Time to ANC and platelet recovery ranged between 23 and 29 and 23-31 days, respectively. Early death rate was 8.7 % (14/160) patients: four patients at 30 days, additional ten in 60 days. CRc rates ranged between 53 % and 78 % for R/R AML. CRc for ND was reported by one study only (89 %). ORR were reported in 60-78 % of patients with R/R AML. Only one study reported an ORR for ND patients of 98 %. In our systematic review, FLAG-Ida plus VEN proved to be a potentially tolerable and effective regimen in ND and R/R AML patients. We suggest further evaluation and confirmation for the safety and efficacy of this new protocol in future RCTs.
维奈托克（VEN）联合强化化疗（IC）越来越多地用于治疗高危急性髓系白血病（AML）患者。我们进行了一项系统评价，以评估 FLAG-IDA 联合 VEN 的安全性和疗效结果。主要安全性结局是感染率；主要疗效结局是治疗反应（复合完全缓解（CRc）和总缓解率（ORR）。根据 ROBINS-I 工具评估偏倚风险。本系统评价纳入了 6 项研究，共 221 例新发（ND）AML（n=120）和 R/R AML（n=101）患者。由于研究之间存在较大差异，未进行结果汇总。报告的中性粒细胞减少性发热、菌血症、肺炎和侵袭性真菌感染的发生率分别为评估患者的 44-55%、24-48%、12-30%和 11-36%。ANC 和血小板恢复的时间分别为 23-29 天和 23-31 天。早期死亡率为 8.7%（14/160）患者：4 例在 30 天，另外 10 例在 60 天。R/R AML 的 CRc 率在 53%-78%之间。只有一项研究报告了 ND 的 CRc 率为 89%。R/R AML 患者的 ORR 报道在 60-78%之间。只有一项研究报告 ND 患者的 ORR 为 98%。在我们的系统评价中，FLAG-Ida 加 VEN 被证明是一种在 ND 和 R/R AML 患者中具有潜在耐受性和有效性的方案。我们建议在未来的 RCT 中进一步评估和确认这种新方案的安全性和疗效。
