Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study
Treatment of adult acute lymphoblastic leukemia (ALL): long-term follow-up of the GIMEMA ALL 0288 randomized study
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DOI：
10.1182/blood.v99.3.863
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发表时间：
2002-02-01
期刊：
影响因子：
20.3
通讯作者：
Mandelli, F
中科院分区：
文献类型：
--
作者：
Annino, L;Vegna, ML;Mandelli, F
GIMEMA ALL 0288试验旨在评价7天泼尼松（PDN）预处理对完全缓解（CR）实现和持续时间的影响，在常规4种药物诱导治疗中添加环磷酰胺（随机I）对CR率和持续时间的影响，以及CR后早期通过8种药物巩固治疗进行强化治疗（随机II）是否可以改善CR持续时间。本研究的中位随访时间为7.3年。从1988年1月至1994年4月，在登记的794名成人（> 12岁但< 60岁）患者中，778名符合条件。他们的中位年龄为27.5岁; 73%患有B系急性淋巴细胞白血病（ALL），22%患有T系疾病; 18%显示相关的髓系标志物; 216例分析患者中有47例（22%）患有费城染色体阳性ALL。在65%的病例中观察到PDN预处理的反应。627例患者（82%）达到CR。耐药患者和诱导死亡率分别为11%和7%。随机II应用于388例CR患者; 201例仅接受维持治疗，187例接受巩固治疗后接受维持治疗。复发率为60%;孤立性中枢神经系统复发占所有CR的8%，占所有复发的13%。中位生存期（总生存期[OS]）、持续完全缓解（CCR）和无病生存期（DFS）分别为2.2、2.4和2年。PDN预处理反应是影响CR实现、OS、CCR和DFS的主要独立因素;在多变量分析中，诱导期添加环磷酰胺显著影响CR实现。诱导强化和早期巩固治疗均不影响CCR和DFS持续时间。PDN预处理反应首次被证明是预测成人ALL患者疾病结局的有力因素。(C)2002年，美国血液学会。
The GIMEMA ALL 0288 trial was designed to evaluate the impact of a 7-day prednisone (PDN) pretreatment on complete remission (CR) achievement and length, the influence of the addition of cyclophosphamide (random I) to a conventional 4-drug induction on CR rate and duration, and whether an early post-CR intensification (random II) by an 8-drug consolidation could improve CR duration. Median follow-up of this study was 7.3 years. From January 1988 to April 1994, among 794 adult (> 12 but < 60 years) patients registered, 778 were eligible. Their median age was 27.5 years; 73% had B-lineage acute lymphoblastic leukemia (ALL) and 22% had T-lineage disease; 18% showed associated myeloid markers; 47 of 216 analyzed patients (22%) had Philadelphia chromosome-positive ALL. Response to PDN pretreatment was observed in 65% of cases. CR was achieved in 627 patients (82%). Resistant patients and induction death rates were 11% and 7%, respectively. Random II was applied to 388 patients with CR; 201 had maintenance alone and 187 had consolidation followed by maintenance. The relapse rate was 60%; isolated central nervous system relapses were 8% of all CRs and 13% of all relapses. Median survival (overall survival [OS]), continuous complete remission (CCR), and disease-free survival (DFS) were 2.2, 2.4, and 2 years, respectively. PDN pretreatment response resulted the main independent factor influencing CR achievement, OS, CCR, and DFS; the addition of cyclophosphamide in induction significantly influenced CR achievement in a multivariate analysis. Neither induction intensification nor early consolidation appeared to influence CCR and DFS duration. For the first time PDN pretreatment response proved to be a powerful factor predicting disease outcome in adult ALL patients. (C) 2002 by The American Society of Hematology.