Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study
Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study
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DOI：
10.1182/blood-2001-12-0354
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发表时间：
2002-12-01
期刊：
影响因子：
20.3
通讯作者：
Appelbaum, FR
中科院分区：
文献类型：
--
作者：
Anderson, JE;Kopecky, KJ;Appelbaum, FR
老年人急性髓细胞白血病（AML）治疗的完全缓解率和长期生存率很低。由于米托蒽醌和依托泊苷的2期研究数据良好，我们进行了3期研究（SWOG-9333），其中55岁以上的既往未治疗AML患者随机接受米托蒽醌治疗（10 mg/m2/天x5）和依托泊苷（100 mg/m2/天× 5）[ME]或阿糖胞苷（200 mg/m2/天× 7）和柔红霉素（45 mg/m2/天× 3）[AD]作为诱导治疗。随机化按年龄、白血病发作和多药耐药表型分层。在4年的时间里，来自66家机构的328名合格患者入组。ME组患者的完全缓解率为34%（95%置信区间[CI] 26%-41%），AD治疗组患者的完全缓解率为43%（CI 35%-51%）（单侧P值0.96）。2个治疗组的耐药率分别为43%（CI 35%-51%）和34%（CI 27%-42%）（单侧P值.95）。随机分配至ME和AD诱导治疗组的患者的2年估计总生存率分别为11%（CI 6%-15%）和19%（CI 12%-25%）（单侧P值.99）。在考虑了与生存期相关的独立预后因素（核型、体能状态、年龄、白色血细胞计数）后，探索性分析表明，与AD诱导治疗相比，接受ME治疗的患者生存期更差（双尾P值0.0066）。我们的结论是，我们的研究结果并没有证明任何好处，以使用ME诱导化疗，而不是AD老年AML患者。(C)2002年，美国血液学会。
Complete remission and long-term survival rates are low for older adults treated for acute myeloid leukemia (AML). Because of favorable phase 2 data using mitoxantrone and etoposide, we conducted a phase 3 study (SWOG-9333) in which patients over 55 years of age with previously untreated AML were randomized to receive mitoxantrone (10 mg/m(2) per day x 5) and etoposide (100 mg/m(2) per day x 5) [ME], or cytarabine (200 mg/m(2) per day x 7) and daunorubicin (45 mg/m2 per day x 3) [AD] as induction therapy. The randomization was stratified by age, onset of leukemia, and multidrug resistance phenotype. Over a 4-year period, 328 eligible patients from 66 institutions were enrolled. The complete remission rate was 34% (95% confidence interval [CI] 26%-41%) for patients in the ME and 43% (CI 35%-51%) for patients in the AD treatment arm (one-tailed P value .96). The rates of resistant disease were 43% (CI 35%-51%) and 34% (CI 27%-42%), respectively, for the 2 treatment arms (one-tailed P value.95). The estimated overall survival at 2 years was 11% (CI 6%-15%) and 19% (CI 12%-25%) for patients randomized to ME and to AD induction therapy, respectively (one-tailed P value.99). After accounting for the independent prognostic factors associated with survival (karyotype, performance status, age, white blood cell count), exploratory analysis suggested there was a worse survival for patients who received ME compared with AD induction therapy (2-tailed P value.0066). We conclude that the results of our study do not demonstrate any benefit to the use of ME induction chemotherapy instead of AD in older patients with AML. (C) 2002 by The American Society of Hematology.