不使用阿糖胞苷治疗新诊断的急性早幼粒细胞白血病。

Treatment of newly diagnosed acute promyelocytic leukemia without cytarabine.

作者信息

Estey E, Thall P F, Pierce S, Kantarjian H, Keating M

机构信息

Department of Hematology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.

出版信息

J Clin Oncol. 1997 Feb;15(2):483-90. doi: 10.1200/JCO.1997.15.2.483.

DOI:10.1200/JCO.1997.15.2.483

PMID:9053469

Abstract

PURPOSE

To determine the effect of omission of cytarabine (ara-C) from treatment of newly diagnosed acute promyelocytic leukemia (APL), which allows administration of more anthracycline.

PATIENTS AND METHODS

Induction consisted of all-trans retinoic acid (ATRA) 45 mg/m2 daily until complete remission (CR) and idarubicin 12 mg/m2 daily for 4 days beginning on day 5 of ATRA. Patients in CR received two courses of idarubicin 12 mg/m2 daily for 3 days and then, until 2 years post-CR date, alternated three cycles of mercaptopurine, vincristine, methotrexate, and prednisone (POMP) with one cycle of idarubicin 12 mg/m2 daily for 2 days. Results in the 43 patients treated (41 with t(15;17) on standard or Southern analysis) were compared with those in 57 historic newly diagnosed APL patients given ara-C with either doxorubicin, amsacrine (AMSA), or daunorubicin without ATRA, using logistic and Cox regression to assess effects of non-treatment-related covariates on patient outcomes.

RESULTS

The CR rate in the current group was 77% (95% confidence interval [CI], 62% to 88%) and was not significantly different from the historic rate. In contrast, disease-free survival (DFS) in CR is superior in the current group (probability at 1 year 0.87; 95% CI, 0.73 to 1.0). This has translated into superior overall DFS for the current group (P = .03 adjusting for the predictive covariates initial WBC and platelet count; 1-year DFS probability 0.67; 95% CI, 0.52 to 0.82; median follow-up 102 weeks). The current treatment appears better both in patients with and without t(15; 17) on standard cytogenetic analysis.

CONCLUSION

Given the difficulties inherent in comparing sequential studies and recognizing the multiple differences in treatment between current and historic groups, our results suggest that a large randomized trial incorporating use of ATRA should assess the utility of omitting ara-C from treatment of newly diagnosed APL, thus allowing delivery of more anthracycline.

摘要

目的

确定在新诊断的急性早幼粒细胞白血病（APL）治疗中省略阿糖胞苷（ara-C）的效果，这使得可以给予更多的蒽环类药物。

患者和方法

诱导治疗包括每日45mg/m²的全反式维甲酸（ATRA）直至完全缓解（CR），以及从ATRA治疗的第5天开始每日12mg/m²的伊达比星，共4天。CR患者接受两个疗程的每日12mg/m²伊达比星，共3天，然后，直到CR日期后2年，交替进行三个疗程的巯嘌呤、长春新碱、甲氨蝶呤和泼尼松（POMP）与一个疗程的每日12mg/m²伊达比星，共2天。将43例接受治疗的患者（41例在标准或Southern分析中有t(15;17)）的结果与57例历史上新诊断的接受ara-C联合柔红霉素、安吖啶（AMSA）或阿霉素且未接受ATRA治疗的APL患者的结果进行比较，使用逻辑回归和Cox回归来评估非治疗相关协变量对患者预后的影响。

结果

当前组的CR率为77%（95%置信区间[CI]，62%至88%），与历史率无显著差异。相比之下，当前组CR患者的无病生存期（DFS）更好（1年时的概率为0.87；95%CI，0.73至1.0）。这转化为当前组总体DFS更好（根据预测协变量初始白细胞和血小板计数调整后P = 0.03；1年DFS概率0.67；95%CI，0.52至0.82；中位随访102周）。在标准细胞遗传学分析中有或无t(15;17)的患者中，当前治疗似乎都更好。