The comparison of chemotherapy and oral chemo-free therapy for acute promyelocytic leukemia
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摘要: 目的：对比分析全口服无化疗方案与化疗方案对于初治急性早幼粒细胞白血病（APL）患者的临床疗效与安全性。方法：纳入2016年1月—2020年1月阜阳市人民医院初治APL患者共计95例，分为化疗组48例与无化疗组47例，每组又分为非高危亚组和高危亚组。化疗组使用维甲酸+亚砷酸诱导治疗，达完全缓解（CR）后予以化疗巩固治疗（HA、MA、DA、IA方案），达分子学CR后予以维甲酸联合复方黄黛片维持治疗。无化疗组给予维甲酸联合复方黄黛片双诱导，达CR后继续予以维甲酸及复方黄黛片巩固和维持治疗。2组均予以相应降白细胞、中枢神经系统白血病防治等对症支持治疗。统计和比较2组患者治疗后疗效、早期死亡率、复发率等相关指标。结果：化疗组与无化疗组比较，早期死亡率、CR率、总生存率、凝血功能相关指标差异无统计学意义（P>0.05）。化疗组高危患者首次达CR时间明显短于无化疗组高危患者（P<0.05）。化疗组复发率明显高于无化疗组，且化疗组高危患者中枢神经系统白血病发生率明显高于无化疗组高危患者（P<0.05）。与化疗组高危患者比较，无化疗组高危患者3个月时PML-RARa融合基因转阴率明显提高（P<0.05）。无化疗组不良反应发生率明显低于化疗组（P<0.05）。结论：对于PML-RARa融合基因阳性的初治APL患者，全口服无化疗方案的疗效并不低于化疗方案。在无化疗方案的高危患者中，中枢神经系统白血病的发生率及不良反应发生率显著降低，从而提高了APL患者治疗的安全性与依从性。Abstract: Objective: To compare and analyze the clinical efficacy and safety of chemo-free oral regimen and chemotherapy regimen for patients with initial treatment of acute promyelocytic leukemia(APL).Methods: A total of 95 cases of APL were included in Fuyang People's Hospital from January 2016 to January 2020. They were divided into chemotherapy group(48 cases) and chemo-free group(47 cases). Patients in chemotherapy group received retinoic acid + arsenite induction therapy, complete remission(CR) was followed by chemotherapy consolidation therapy(HA, MA, DA, IA regimen), and molecular CR was followed by retinoic acid combined with compound Huangdai tablet maintenance therapy. Patients in chemo-free group receive retinoic acid combined with compound Huangdai tablet double induction, CR was achieved, and continued to receive retinoic acid and compound Huangdai tablet consolidation and maintenance treatment. Both groups were given symptomatic supportive treatment such as leukocyte lowering and central nervous system leukemia(CNSL) prevention and treatment. The efficacy, early mortality, recurrence rate and other related indexes of the two groups were counted and compared.Results: There were no significant differences in early mortality, CR rate, overall survival rate and coagulation function in chemotherapy group compared with chemo-free group(P>0.05). The time to first CR in high-risk patients was shorter in chemotherapy group than that in chemo-free group(P<0.05). The recurrence rate in the chemo-free group was lower than that in the chemotherapy group(P<0.05). The incidence of CNSL in the high-risk patients was higher in the chemotherapy group(P<0.05). The negative conversion rate of PML-RARa fusion gene at 3 months in the high-risk patients was higher in the chemo-free group than that in the chemotherapy group(P<0.05). The rate of adverse events in the chemotherapy group was higher than that in the chemo-free group(P<0.05).Conclusion: The efficacy of total oral administration without chemotherapy is not lower than that of chemotherapy in the patients with PML-RARa fusion gene positive initial treatment of APL. In high-risk patients, the incidence of CNSL and adverse events are significantly reduced in the chemo-free regimen, leading to improved safety and compliance in APL patients.
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