Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer
Phase III study of mitoxantrone plus low dose prednisone versus low dose prednisone alone in patients with asymptomatic hormone refractory prostate cancer
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DOI：
10.1016/s0022-5347(05)64163-8
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发表时间：
2002-12-01
影响因子：
6.6
通讯作者：
Asmar, L
中科院分区：
文献类型：
--
作者：
Berry, W;Dakhil, S;Asmar, L
目的：我们比较了无症状、激素抵抗、进展期前列腺癌患者接受米托蒽醌联合泼尼松治疗和单用强的松治疗失败的中位时间。材料和方法：在一项多中心III期试验中，120名无症状、进展期、激素抵抗的前列腺癌患者被随机分配到米托蒽醌联合泼尼松或单用强的松治疗。(2)米托蒽醌静脉滴注，每3周1次，共6个周期，每次5 mg。泼尼松，每日两次，加或不加米托蒽醌。治疗失败的时间被评估为综合终点，包括疾病进展时间、毒性或死亡时间或开始替代治疗的时间。结果：中位随访时间为21.8个月。治疗失败的中位时间和进展的中位时间是相同的：治疗失败的时间和进展的时间，米托蒽醌和强的松组分别为8.1个月和4.1个月(p=0.017和p=0.018)。更多患者(27%或48%)在接受米托蒽醌和强的松治疗后，前列腺特异性抗原水平比只接受强的松治疗的患者(15%或24%)降低了50%或更多，p=0.007。两组的中位生存期分别为23个月和19个月，差异无统计学意义。结论：激素难治性前列腺癌患者在接受米托蒽醌和强的松联合治疗时，前列腺特异性抗原下降50%或更多，与单用强的松治疗相比，无症状但疾病进展的患者有更高的有效率。化疗组治疗失败的时间明显延长，但存活率无明显差异。
Purpose: We compared median time to treatment failure of men with asymptomatic, hormone refractory, progressive prostate cancer treated with mitoxantrone plus prednisone versus prednisone alone.Materials and Methods: In a multicenter phase III trial 120 men with asymptomatic, progressive, hormone refractory prostate cancer were randomly assigned to treatment with mitoxantrone and prednisone or prednisone alone. Patients received 12 mg./m.(2) mitoxantrone intravenously once every 3 weeks for 6 cycles and 5 mg. prednisone twice daily with or without mitoxantrone. Time to treatment failure was assessed as an aggregate end point comprised of time to disease progression, time to toxicity or death, or time to initiation of alternate therapy.Results: Median followup was 21.8 months. Median time to treatment failure and median time to progression were the same: time to treatment failure and time to progression in the mitoxantrone and prednisone group was 8.1 months compared to 4.1 months in the prednisone alone group (p = 0.017 versus p = 0.018). More patients (27 or 48%) treated with mitoxantrone and prednisone achieved a 50% or greater reduction in prostate specific antigen levels than those who received only prednisone (15 or 24%, p = 0.007). There was no significant difference in median survival between the 2 groups, which was 23 and 19 months, respectively. Death was mainly attributable to disease progression.Conclusions: Patients with hormone refractory prostate cancer who are asymptomatic but had progressive disease had a significantly higher response rate when treated with mitoxantrone and prednisone as demonstrated by the 50% or greater decrease in prostate specific antigen compared to treatment with prednisone alone. Time to treatment failure was significantly prolonged in the chemotherapy treated group but survival rates were not different.