Qin Tie-Jun, Xu Ze-Feng, Fang Li-Wei, Zhang Hong-Li, Zhang Yue, Wang Jing-Zhe, Pan Li-Juan, Hu Nai-Bo, Xiao Zhi-Jian
Chinese Academy of Medical Sciences, Tianjin, China.
Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2011 Oct;19(5):1277-82.
The purpose of this study was to assess the efficacy and toxicity of HAI regimen [(homoharringtonine 2.5 mg/(m(2)×d), days 1 - 7; cytarabine 150 mg/(m(2)×d), days 1 - 7; idarubicin 9 mg/(m(2)×d), days 1 - 7)] for induction treatment of newly diagnosed acute myeloid leukemia (AML) (except acute promyelocytic leukemia). 31 patients with newly diagnosed AML, aged 39 (14 - 58) years, were enrolled in this clinical study. The complete remission (CR) rate, especially after one course, the overall survival (OS) rate and relapse free survival (RFS) rate were estimated. The outcomes were compared between different prognostic groups according to World Health Organization (WHO) classification, genetics and initial WBC count. Safety was evaluated using standard WHO criteria. The results showed that 26 patients (84%) achieved CR after 1 course of induction. The CR rate for the patients with favorable, intermediate and unfavorable cytogenetics was 90%, 88% and 60% respectively. All 7 patients with a high initial WBC count (≥ 100×10(9)/L) obtained CR, while 19 out of 24 without a high initial WBC count obtained CR. With a median follow-up of 15(range 2-56) months, the estimated 3-year OS rate for all patients and the patients with CR was 44% and 52% respectively. The 3-year RFS rate was 51%. The patients receiving induction chemotherapy died of the chemotherapy. Profound myelosuppression was seen in all patients after the HAI induction with the median duration of neutropenia (ANC < 0.2×10(9)/L) of 16 (6 - 24) days. As the most common toxicity, severe infections (grade III-IV) involved in all the patients and the duration of febris was 6 (1 - 36) days. The incidence of septemia and invasive fungus infection were 19.4% and 45.2% respectively. The incidence of non-infection fever, increased glutamic-pyruvic transaminase (GPT), diarrhea, increased bilirubin and oral cavity mucositis were 6.5%, 6.5%, 3.2%, 3.2%, 3.2% respectively, as the more frequent severe non-hematological toxicities. It is concluded that HAI regimen is a high efficient induction schedule for the newly diagnosed AML, and archive the higher CR rate after one course than DNR/Ara-C standard induction regimen. Side effects are acceptable, except severe infection.
本研究旨在评估HAI方案[高三尖杉酯碱2.5mg/(m²×d)，第1 - 7天；阿糖胞苷150mg/(m²×d)，第1 - 7天；伊达比星9mg/(m²×d)，第1 - 7天]用于初治急性髓系白血病（AML）（急性早幼粒细胞白血病除外）诱导治疗的疗效和毒性。31例初治AML患者，年龄39（14 - 58）岁，纳入本临床研究。评估完全缓解（CR）率，尤其是1个疗程后的CR率、总生存（OS）率和无复发生存（RFS）率。根据世界卫生组织（WHO）分类、遗传学和初始白细胞计数，比较不同预后组的结果。采用WHO标准评估安全性。结果显示，26例患者（84%）在1个疗程诱导后达到CR。细胞遗传学预后良好、中等和不良的患者CR率分别为90%、88%和60%。初始白细胞计数高（≥100×10⁹/L）的7例患者均获得CR，而初始白细胞计数不高的24例患者中有19例获得CR。中位随访15（2 - 56）个月，所有患者和CR患者的3年OS率估计分别为44%和52%。3年RFS率为51%。接受诱导化疗的患者死于化疗。HAI诱导后所有患者均出现严重骨髓抑制，中性粒细胞减少（中性粒细胞绝对值<0.2×10⁹/L）的中位持续时间为16（6 - 24）天。作为最常见的毒性反应，所有患者均发生严重感染（Ⅲ - Ⅳ级），发热持续时间为6（1 - 36）天。败血症和侵袭性真菌感染的发生率分别为19.4%和45.2%。作为较常见的严重非血液学毒性反应，非感染性发热、谷丙转氨酶升高、腹泻、胆红素升高和口腔黏膜炎的发生率分别为6.5%、6.5%、3.2%、3.2%、3.2%。结论是，HAI方案是初治AML的高效诱导方案，1个疗程后CR率高于DNR/Ara - C标准诱导方案。除严重感染外，副作用可接受。
