Guilhot F, Chastang C, Michallet M, Guerci A, Harousseau J L, Maloisel F, Bouabdallah R, Guyotat D, Cheron N, Nicolini F, Abgrall J F, Tanzer J
Hôpital Jean Bernard, Poitiers, France.
N Engl J Med. 1997 Jul 24;337(4):223-9. doi: 10.1056/NEJM199707243370402.
Treatment with interferon prolongs survival in chronic myelogenous leukemia. We conducted a clinical trial to assess the efficacy of treatment with a combination of interferon and cytarabine.
Previously untreated patients with chronic myelogenous leukemia were randomly assigned to receive either hydroxyurea (50 mg per kilogram of body weight per day) and interferon alfa-2b (5 million units per square meter of body-surface area per day), or hydroxyurea and interferon in the same dosages plus monthly courses of cytarabine (20 mg per square meter per day, for 10 days). The end points were overall survival, complete hematologic remission at 6 months, and major cytogenetic response (less than 35 percent Philadelphia chromosome-positive cells in the bone marrow) at 12 months.
The trial was stopped when a sequential analysis showed a benefit of interferon and cytarabine. A significant improvement in survival was observed in the interferon-cytarabine group (360 patients) as compared with the interferon group (361 patients) (P=0.02; relative risk of death, 0.64; 95 percent confidence interval, 0.44 to 0.93). After three years, the survival rate was 85.7 percent with interferon and cytarabine and 79.1 percent with interferon alone. The rate of hematologic response was higher in the interferon-cytarabine group than in the interferon group (P=0.003). Major cytogenetic responses were observed 12 months after randomization in 126 of 311 patients treated with interferon and cytarabine (41 percent) and in 75 of 314 patients treated with interferon only (24 percent, P<0.001).
The combination of interferon and cytarabine, as compared with interferon alone, increases the rate of major cytogenetic response and prolongs survival in patients with the chronic phase of chronic myelogenous leukemia.
干扰素治疗可延长慢性粒细胞白血病患者的生存期。我们开展了一项临床试验，以评估干扰素与阿糖胞苷联合治疗的疗效。
将既往未接受治疗的慢性粒细胞白血病患者随机分为两组，一组接受羟基脲（每日每千克体重50毫克）和α-2b干扰素（每日每平方米体表面积500万单位）治疗，另一组接受相同剂量的羟基脲和干扰素治疗，外加每月一次的阿糖胞苷疗程（每日每平方米20毫克，共10天）。观察终点为总生存期、6个月时的完全血液学缓解以及12个月时的主要细胞遗传学反应（骨髓中费城染色体阳性细胞少于35%）。
序贯分析显示干扰素与阿糖胞苷联合治疗有益后，试验提前终止。与干扰素组（361例患者）相比，干扰素-阿糖胞苷组（360例患者）的生存期有显著改善（P = 0.02；死亡相对风险为0.64；95%置信区间为0.44至0.93）。三年后，干扰素与阿糖胞苷联合治疗组生存率为85.7%，干扰素单药治疗组为79.1%。干扰素-阿糖胞苷组的血液学反应率高于干扰素组（P = 0.003）。随机分组12个月后，接受干扰素与阿糖胞苷联合治疗的311例患者中有126例（41%）出现主要细胞遗传学反应，仅接受干扰素治疗的314例患者中有7... 展开
