维奈克拉联合DA (2 + 6)治疗初治AML临床研究

Clinical Study of Venekla Combined with DA (2 + 6) in the Treatment of Newly Diagnosed AML

摘要: 目的：传统“3 + 7”方案治疗初治AML患者已经在临床上广泛应用，但是也会带来严重且长期的骨髓抑制，继而严重影响患者的生存质量，为此使用VEN + DA (2 + 6)联合用药方案作为新的诱导治疗方案治疗初治AML患者。旨在分析该联合方案的疗效及安全性。方法：本研究采取回顾性分析，共纳入51例初治AML患者。主要观察终点是诱导治疗后的总缓解率(ORR)、完全缓解(CR)、完全缓解伴不完全血细胞计数恢复(CRi)，次要观察终点是MRD阴性率，总生存期(OS)和不良反应。结果：从2022年1月至2023年1月共纳入51例患者，经过诱导治疗后ORR为94.1%，复合完全缓解率(CR + CRi)为92.2% (CR 46/51, CRi 1/51)，MRD阴性占可评估患者的88.9%。截止至随访结束，入组患者的中位总生存(OS)未达到。低危亚组OS率为92%，中高危亚组OS率为53.8%。所有的入组患者在诱导治疗期间均有3~4级的贫血、血小板减少及中性粒细胞减少。诱导治疗后白细胞 > 1 × 10⁹/L的中位时间为15天(5~24)，血小板 > 30 × 10⁹/L的中位时间为12.5天(8~26)。结论：VEN + DA (2 + 6)是安全且有效的联合用药方案。这种诱导方案较传统“3 + 7”方案取得了较高的CR率，且骨髓抑制期明显缩短。

Abstract: Objective: The traditional “3 + 7” regimen for the treatment of newly diagnosed AML patients has been widely used in clinical practice. However, it can also cause severe and long-term bone marrow suppression, which in turn seriously affects the quality of life of patients. Therefore, the VEN + DA (2 + 6) combined medication regimen is used as a new induction treatment regimen for newly diagnosed AML patients. The aim is to analyze the efficacy and safety of this combined regimen. Method: This study conducted a retrospective analysis and included a total of 51 newly diagnosed AML patients. The primary endpoints of observation were the overall response rate (ORR), complete response (CR), and complete response with incomplete recovery of blood cell count (CRi) after induction therapy. The secondary endpoints of observation were the negative rate of MRD, overall survival (OS), and adverse reactions. Result: From January 2022 to January 2023, a total of 51 patients were included. After induction therapy, the ORR was 94.1%, the composite complete response rate (CR + CRi) was 92.2% (CR 46/51, CRi 1/51), and MRD negative accounted for 88.9% of the evaluable patients. As of the end of the follow-up, the median overall survival (OS) of the enrolled patients had not been achieved. The OS rate was 92% in the low-risk subgroup and 53.8% in the medium-high-risk subgroup. All the enrolled patients had grade 3~4 anemia, thrombocytopenia and neutropenia during the induction therapy. The median time for white blood cells > 1 × 10⁹/L after induction therapy was 15 days (5~24), and the median time for platelets > 30 × 10⁹/L was 12.5 days (8~26). Conclusion: VEN + DA (2 + 6) is a safe and effective combination medication regimen. This induction protocol achieved a higher CR rate than the traditional “3 + 7” protocol, and the myelosuppression period was significantly shortened.