Je-Hwan Lee, Jung-Hee Lee, Dae-Young Kim, Eun-Hye Hur, and Kyoo-Hyung Lee, Asan Medical Center, University of Ulsan College of Medicine, Seoul; Hawk Kim and Yunsuk Choi, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan; Young-Don Joo and Sung-Nam Lim, Haeundae Paik Hospital, Inje University College of Medicine; Won-Sik Lee and Sang-Min Lee, Busan Paik Hospital, Inje University College of Medicine, Busan; Sung Hwa Bae and Hun Mo Ryoo, Daegu Catholic University Medical Center, Catholic University of Daegu School of Medicine; Min Kyoung Kim and Myung Soo Hyun, Yeungnam University Hospital, Yeungnam University College of Medicine; Junglim Lee, Daegu Fatima Hospital, Daegu; Dae Young Zang and Hyo Jung Kim, Hallym University Sacred Heart Hospital, Hallym University, Anyang; Jihyun Kwon, Chungbuk National University Hospital, Cheongju; and Gyeong Won Lee, Gyeongsang National University Hospital, Gyeongsang National University, Jinju, Republic of Korea.
J Clin Oncol. 2017 Aug 20;35(24):2754-2763. doi: 10.1200/JCO.2017.72.8618. Epub 2017 Jun 20.
Purpose We compared two induction regimens, idarubicin (12 mg/m/d for 3 days) versus high-dose daunorubicin (90 mg/m/d for 3 days), in young adults with newly diagnosed acute myeloid leukemia (AML). Patients and Methods A total of 299 patients (149 randomly assigned to cytarabine plus idarubicin [AI] and 150 assigned to cytarabine plus high-dose daunorubicin [AD]) were analyzed. All patients received cytarabine (200 mg/m/d for 7 days). Results Complete remission (CR) was induced in 232 patients (77.6%), with no difference in CR rates between the AI and AD arms (80.5% v 74.7%, respectively; P = .224). At a median follow-up time of 34.9 months, survival and relapse rates did not differ between the AI and AD arms (4-year overall survival, 51.1% v 54.7%, respectively; P = .756; cumulative incidence of relapse, 35.2% v 25.1%, respectively; P = .194; event-free survival, 45.5% v 50.8%, respectively; P = .772). Toxicity profiles were also similar in the two arms. Interestingly, overall and event-free survival times of patients with FLT3 internal tandem duplication (ITD) mutation were significantly different (AI v AD: median overall survival, 15.5 months v not reached, respectively; P = .030; event-free survival, 11.9 months v not reached, respectively; P = .028). Conclusion This phase III trial comparing idarubicin with high-dose daunorubicin did not find significant differences in CR rates, relapse, and survival. Significant interaction between the treatment arm and the FLT3-ITD mutation was found, and high-dose daunorubicin was more effective than idarubicin in patients with FLT3-ITD mutation.
我们比较了两种诱导方案，阿糖胞苷联合伊达比星（12 mg/m/d，连用 3 天）与阿糖胞苷联合高剂量柔红霉素（90 mg/m/d，连用 3 天），用于治疗新诊断的急性髓系白血病（AML）的年轻患者。
共纳入 299 例患者（149 例随机分配至阿糖胞苷联合伊达比星组[AI]，150 例分配至阿糖胞苷联合高剂量柔红霉素组[AD]）。所有患者均接受阿糖胞苷（200 mg/m/d，连用 7 天）治疗。
232 例患者（77.6%）诱导完全缓解（CR），AI 组与 AD 组 CR 率无差异（分别为 80.5%和 74.7%，P =.224）。中位随访时间为 34.9 个月时，AI 组与 AD 组的生存和复发率无差异（4 年总生存率分别为 51.1%和 54.7%，P =.756；复发累积发生率分别为 35.2%和 25.1%，P =.194；无事件生存率分别为 45.5%和 50.8%，P =.772）。两组的毒性谱也相似。有趣的是，FLT3 内部串联重复（ITD）突变患者的总生存时间和无事件生存时间存在显著差异（AI 组 vs AD 组：中位总生存时间分别为 15.5 个月和未达到，P =.030；中位无事件生存时间分别为 11.9 个月和未达到，P =.028）。
这项比较伊达比星与高剂量柔红霉素的 III 期临床试验未发现 CR 率、复发和生存方面存在显著差异。治疗组与 FLT3-ITD 突变之间存在显著的相互作用，且高剂量柔红霉素在 FLT3-ITD 突变患者中的疗效优于伊达比星。
