Chiang Yi-Hao, Chang Yi-Fang, Hsieh Ruey-Kuen, Lin Johnson, Chen Caleb Gonshen, Lim Ken-Hong, Lin Huan-Chau, Chang Ming-Chih
Department of Hematology-Oncology, Mackay Memorial Hospital, Taipei, Taiwan.
Asia Pac J Clin Oncol. 2012 Dec;8(4):330-6. doi: 10.1111/j.1743-7563.2011.01496.x. Epub 2012 Mar 12.
The optimal maintenance therapy for patients with acute promyelocytic leukemia (APL) who achieved complete remission (CR) and complete consolidation chemotherapy is still controversial. Whether the use of arsenic trioxide (ATO) alone or along with all-trans retinoic acid (ATRA) improves overall survival (OS) or disease-free survival (DFS) is still debated.
A retrospective reivew was conducted of 20 patients diagnosed with APL according to the French - American - British system. After achieving CR and receiving consolidation chemotherapy, nine patients were given maintenance therapy for 1 year (ATRA 45 mg/m(2) /day p.o., mercaptopurine 60 mg/m(2) /day p.o. and ATO 0.15 mg/kg/day × 5 days/week for six cycles in five patients; ATRA 45 mg/m(2) /d p.o. alternating with ATO 0.15 mg/kg/day × 5 days/week in 1 patient; ATRA only in three patients).
In all patients the rates of CR, 3-year OS and 5-year OS were 75, 71 and 57%, respectively. For patients treated with ATO maintenance, the rates were 100% for both 5-year OS and 5-year DFS. Four of six patients on ATO maintenance had grade 1 or grade 2 adverse events. Excluding the two patients who died from intracerebral hemorrhage within 4 days after diagnosis, these rates were 85, 82 and 78%, respectively.
Upfront ATO maintenance therapy for one year is safe and appears to be effective, with the benefits restricted to patients with APL with t(15;17) translocation. Larger studies will be required to confirm this observation.
对于急性早幼粒细胞白血病(APL)患者,在实现完全缓解(CR)并完成巩固化疗后,最佳维持治疗方案仍存在争议。单独使用三氧化二砷(ATO)或与全反式维甲酸(ATRA)联合使用是否能提高总生存期(OS)或无病生存期(DFS)仍存在争议。
对20例根据法国-美国-英国系统诊断为APL的患者进行回顾性研究。在实现CR并接受巩固化疗后,9例患者接受了1年的维持治疗(5例患者接受ATRA 45mg/m²/天口服、巯嘌呤60mg/m²/天口服以及ATO 0.15mg/kg/天×5天/周,共六个周期;1例患者接受ATRA 45mg/m²/天口服与ATO 0.15mg/kg/天×5天/周交替使用;3例患者仅接受ATRA)。
所有患者的CR率、3年OS率和5年OS率分别为75%、71%和57%。接受ATO维持治疗的患者,5年OS率和5年DFS率均为100%。接受ATO维持治疗的6例患者中有4例发生1级或2级不良事件。排除诊断后4天内死于脑出血的2例患者,这些率分别为85%、82%和78%。
早期进行为期一年的ATO维持治疗是安全的,且似乎有效,其益处仅限于伴有t(15;17)易位的APL患者。需要更大规模的研究来证实这一观察结果。