Nese M, de Bellis R, Urtiarte R, Di Landro J
Departamento de Hematología Clínica, Facultad de Medicina, Montevideo, Uruguay.
Sangre (Barc). 1994 Jun;39(3):183-6.
To evaluate the efficacy of the combination, alpha-interferon (IFN)-hydroxyurea (HU) in the treatment of patients with Philadelphia positive chronic myelogenous leukaemia (Ph'-CML).
A prospective study was started in 1988 in which 30 patients with chronic phase, low-risk Ph'-CML, according to Kantarjian's staging system, were included. They were treated with IFN at a dose of 5 MU/m2 subcutaneously twice a week plus HU in doses between 0.5 and 3 g/m2/day. The clinic and biologic controls performed twice a month included granulocyte alkaline phosphatase, and cytogenetic studies of bone-marrow and peripheral blood were carry out every third month. The quality and duration of haematologic and cytogenetic remissions were evaluated, along with the untoward effect of the treatment. Survival was estimated in accordance to the Kaplan Meier method.
The mean age was 49 years (range: 17-70) and the M/F ratio was 18/12. The median follow-up was 51 months (range: 8-89). Twenty patients were in early- and four late-chronic phase. Complete haematological remission (CHR) was achieved in 26 patients (87%) with a median of 52 months and an estimated global median survival of 81 months. Cytogenetic response was seen in 11 patients (52%) of the 21 who were evaluable after 11 months of treatment. Disappearance of Ph' (complete cytogenetic response) was seen in 6 cases (28%). The incidence of early blast crisis in the first three years was, respectively, 0%, 3% and 6%. The treatment toxicity was negligible in most cases, having to suppress the treatment only in one patient due to persistent fever.
The association of IFN and HU is effective and well tolerated in patients with low-risk CML, and it improves survival in CHR and overall survival.
评估α-干扰素（IFN）联合羟基脲（HU）治疗费城染色体阳性慢性粒细胞白血病（Ph'-CML）患者的疗效。
1988年开展了一项前瞻性研究，纳入了30例根据坎塔尔吉安分期系统处于慢性期、低风险Ph'-CML的患者。他们接受皮下注射IFN，剂量为5 MU/m²，每周两次，加用HU，剂量为0.5至3 g/m²/天。每月进行两次的临床和生物学检查包括粒细胞碱性磷酸酶，每三个月进行一次骨髓和外周血的细胞遗传学研究。评估血液学和细胞遗传学缓解的质量和持续时间，以及治疗的不良反应。根据Kaplan-Meier方法估计生存率。
平均年龄为49岁（范围：17 - 70岁），男女比例为18/12。中位随访时间为51个月（范围：8 - 89个月）。20例患者处于慢性早期，4例处于慢性晚期。26例患者（87%）实现了完全血液学缓解（CHR），中位缓解时间为52个月，估计总体中位生存期为81个月。在21例治疗11个月后可评估的患者中，11例（52%）出现了细胞遗传学反应。6例（28%）患者出现了Ph'染色体消失（完全细胞遗传学反应）。前三年早期急变期的发生率分别为0%、3%和6%。大多数情况下治疗毒性可忽略不计，仅1例患者因持续发热而不得不中止治疗。
IFN与HU联合治疗低风险CML患者有效且耐受性良好，可提高CHR患者的生存率和总体生存率。
