Usui N, Dobashi N, Asai O, Yano S, Kato A, Osawa H, Uno S, Katori M, Nagamine M, Yahagi Y, Yamaguchi Y, Saito T, Kasama K, Takei Y, Ogihara A, Yamazaki H, Kobayashi T, Tajima N, Ogawa M, Kuraishi Y
Dept. of Internal Medicine (III), Jikei University School of Medicine.
Gan To Kagaku Ryoho. 2000 Jul;27(8):1152-9.
The relationship between the total dose of daunorubicin (DNR) in induction therapy and the treatment outcome were evaluated based upon individualized doses of DNR during induction therapy for patients with acute myeloid leukemia(AML). Ninety-two previously untreated adult AML patients admitted to our hospital were analyzed for the dose of DNR required for complete remission (CR), the CR rate, disease-free survival (DFS) and overall survival (OS). The induction therapy consisted of DNR (40 mg/m2/d, i.v., from D 1 until the marrow was hypoplastic), Ara-C, prednisolone, and/or 6-thioguanine. Eighty-three out of 92 patients were assessable. Sixty-three patients entered CR (76%), of whom 52 attained CR with the first course of induction therapy. The 10-year DFS and OS rates were 31.2% and 42.3%, respectively. The median total dose of DNR in the induction therapy was 280 mg/m2 (120-480 mg/m2), which was not influenced by initial WBC count, or FAB type. These results indicate that when the dose is linked to the observed tumor response, the optimal dose of DNR in the induction therapy is around 280 mg/m2 (40 mg/m2 x 7 times), which is higher than the conventional dose of 40-60 mg/m2 for 3 days. The higher dose of DNR in the induction therapy for adult AML should be selected when the feasibility of a new drug is evaluated in a randomized trial.
基于急性髓系白血病(AML)患者诱导治疗期间柔红霉素(DNR)的个体化剂量,评估了诱导治疗中DNR的总剂量与治疗结果之间的关系。分析了我院收治的92例既往未接受治疗的成年AML患者达到完全缓解(CR)所需的DNR剂量、CR率、无病生存期(DFS)和总生存期(OS)。诱导治疗包括DNR(40mg/m²/d,静脉注射,从第1天至骨髓增生低下)、阿糖胞苷、泼尼松龙和/或6-硫鸟嘌呤。92例患者中有83例可评估。63例患者进入CR(76%),其中52例在第一个诱导疗程后达到CR。10年DFS率和OS率分别为31.2%和42.3%。诱导治疗中DNR的中位总剂量为280mg/m²(120 - 480mg/m²),不受初始白细胞计数或FAB分型的影响。这些结果表明,当剂量与观察到的肿瘤反应相关联时,诱导治疗中DNR的最佳剂量约为280mg/m²(40mg/m²×7次),高于传统的3天40 - 60mg/m²剂量。在随机试验中评估新药的可行性时,应选择较高剂量的DNR用于成人AML的诱导治疗。