Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.
State Key Laboratory of Trauma, Burns and Combined Injury, Chongqing, China.
Cancer Med. 2023 Jun;12(11):12377-12387. doi: 10.1002/cam4.5938. Epub 2023 May 10.
Refractory and relapsed acute myeloid leukemia (r/rAML) is associated with a difficult prognosis; clinical trials are typically suggested despite lack of a recognized standard of care. Combinatorial chemotherapy regimens utilized for r/rAML salvage play a crucial role in battling this invasive phase. Although it is characterized by a low response rate, CLAG is a traditional regimen used in r/rAML. We aimed to compare the efficacy and toxicity of CLAG+PLD to explore whether there was any improvement with the addition of pegylated liposomal doxorubicin (PLD) to CLAG METHODS: A total of 110 r/rAML patients were retrospectively analyzed from February 2017 to June 2020 at the Medical Center of Hematology, XinQiao Hospital, the 303rd Hospital of the Chinese People's Liberation Army, and Central Hospital of Chang Sha, Hunan Province. The response, overall survival (OS), disease-free survival (DFS), and side effects in 110 r/rAML patients were evaluated retrospectively. Of these, 55 patients were administered CLAG+PLD, while 55 patients received CLAG alone as salvage therapy.
In the CLAG+PLD group, there were 27 (49.1%) cases of complete response (CR) with no measurable residual disease (MRD-), 12 (21.8%) cases of CR with positive MRD (MRD+), 5 (9.1%) cases of partial response (PR), 11 (20%) cases of no response (NR), and no cases of death during the cycles. The response rates in the CLAG group were lower: CR was reached in 24 (46.6%) patients with MRD-, 6 (10.9%) patients with MRD+, 10 (18.2%) patients with PR, 13 (23.6%) patients with NR, and 2 (3.6%) patients who passed away, one from infection and the other from cerebral hemorrhage. The median OS and DFS were not attained in the CLAG+PLD group during the 2-year OS and DFS follow-up, while both values were 10 months in the CLAG group (p = 0.023 and p = 0.045, respectively). The results of the Cox regression analysis for the CLAG+PLD group were strongly illustrative of the importance of hematopoietic stem cell transplantation (HSCT) following salvage therapy. No increased toxicity was observed in the CLAG+PLD group.
CLAG+PLD is a potential salvage regimen for r/r AML that has a similar toxicity profile to CLAG and that improves response rates, 2-year OS, and DFS relative to CLAG.
难治性和复发性急性髓系白血病（r/rAML）预后较差；尽管缺乏公认的标准治疗方法，但通常建议进行临床试验。用于挽救 r/rAML 的联合化疗方案在对抗这一侵袭性阶段中起着至关重要的作用。虽然 CLAG 方案的反应率较低，但它是 r/rAML 中常用的传统方案。我们旨在比较 CLAG+PLD 的疗效和毒性，以探讨在 CLAG 中加入聚乙二醇化脂质体阿霉素（PLD）是否会有所改善。
回顾性分析 2017 年 2 月至 2020 年 6 月在解放军第 303 医院血液病医学中心、湖南省长沙市中心医院接受治疗的 110 例 r/rAML 患者的资料。回顾性评估 110 例 r/rAML 患者的反应、总生存期（OS）、无病生存期（DFS）和不良反应。其中，55 例患者接受 CLAG+PLD 治疗，55 例患者接受 CLAG 作为挽救性治疗。
在 CLAG+PLD 组中，27 例（49.1%）患者达到完全缓解（CR）且无微小残留病（MRD-），12 例（21.8%）患者达到 CR 且 MRD 阳性（MRD+），5 例（9.1%）患者达到部分缓解（PR），11 例（20%）患者无反应（NR），且在治疗周期内无死亡。CLAG 组的反应率较低：24 例（46.6%）患者达到 CR 且 MRD-，6 例（10.9%）患者达到 CR 且 MRD+，10 例（18.2%）患者达到 PR，13 例（23.6%）患者达到 NR，2 例（3.6%）患者死亡，1 例死于感染，另 1 例死于脑出血。在 2 年 OS 和 DFS 随访中，CLAG+PLD 组的中位 OS 和 DFS 均未达到，而 CLAG 组的中位 OS 和 DFS 均为 10 个月（p=0.023 和 p=0.045）。CLAG+PLD 组的 Cox 回归分析结果表明，造血干细胞移植（HSCT）是挽救治疗后的重要因素。CLAG+PLD 组未观察到毒性增加。
CLAG+PLD 是 r/rAML 的一种潜在挽救治疗方案，与 CLAG 相比，其具有相似的毒性特征，并可提高反应率、2 年 OS 和 DFS。
