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首页> 美国卫生研究院文献>other >ACTR-62. PHASE I/II STUDY OF TEMOZOLOMIDE PLUS NIMUSTINE CHEMOTHERAPY FOR RECURRENT MALIGNANT GLIOMAS: KYOTO NEURO-ONCOLOGY GROUP
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ACTR-62. PHASE I/II STUDY OF TEMOZOLOMIDE PLUS NIMUSTINE CHEMOTHERAPY FOR RECURRENT MALIGNANT GLIOMAS: KYOTO NEURO-ONCOLOGY GROUP

机译：ACTR-62。替莫洛米特+尼莫司汀化学疗法治疗恶性恶性胶质瘤的I / II期研究：京都神经肿瘤集团

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The objective of this phase I/II study was to examine the efficacy and toxicity profile of temozolomide(TMZ) plus nimustine (ACNU) Patients who had received a standard radiotherapy with one or two previous chemo-regimens were enrolled. In phase I, the maximum-tolerated dose (MTD) by TMZ (150mg/m2/day) (Day1-5) plus various doses of ACNU (30,35,40,45 mg/m2/day) (Day15) per 4 weeks was defined on a standard 3 + 3 design. In phase II, these therapeutic activity and safety of this regimen were evaluated. Forty-nine eligible patients were enrolled. The median age was 50 years-old. Eighty percent had a KPS of 70100. Histologies were glioblastoma(73%), anaplastic astrocytoma(22%), anaplastic oligodendroglioma(4%). In phase I, 15 patients were treated at four cohorts by TMZ plus ACNU. MTD was TMZ (150/mg/m2) plus ACNU (40mg/m2). In phase II, 40 patients were treated at the dose of cohort 3 (MTD). Thirty-five percent of patients experienced grade 3 or 4 toxicities, mainly hematologic. The overall response rate was 11% (4/37). Sixty-eight percent (25/37) had stable disease. Twenty-two percent (8/37) showed progression. Progression free survival (PFS) at 6 and 12 month were 24% (95%CI, 12–35%) and 8% (95%CI, 4–15%). Median PFS was 13 months(95%CI, 9.2–17.2months). Overall survival (OS) at 6 and 12 were 78% (95%CI, 67–89%) and 49% (95%CI, 33–57%). Median OS was 11.8 months (95%CI, 8.2–14.5months). This phase I/II study showed a moderate toxicity in hematology and may has a promising efficacy in OS, without inferiority in PFS.
机译：I / II期研究的目的是检查替莫唑胺（TMZ）加上尼莫斯汀（ACNU）的疗效和毒性特征，这些患者曾接受过标准放疗并曾接受过一种或两种以前的化学疗法。在阶段I中，TMZ的最大耐受剂量（MTD）（150mg / m2 /天）（第1-5天）加ACNU的各种剂量（30,35,40,45 mg / m2 /天）（第15天）每4在标准的3 + 3设计中定义了周数。在阶段II中，评估了该方案的这些治疗活性和安全性。入选了四十九名合格患者。中位年龄为50岁。 80％的KPS为70100。组织学为胶质母细胞瘤（73％），间变性星形细胞瘤（22％），间变性少突胶质细胞瘤（4％）。在第一阶段，TMZ加ACNU在四个队列中治疗了15名患者。 MTD为TMZ（150 / mg / m2）加ACNU（40mg / m2）。在第二阶段，以队列3（MTD）的剂量治疗了40名患者。 35％的患者出现3级或4级毒性，主要是血液学毒性。总体回应率为11％（4/37）。百分之六十八（25/37）的病情稳定。 22％（8/37）的病情进展。 6和12个月的无进展生存期（PFS）分别为24％（95％CI，12–35％）和8％（95％CI，4–15％）。 PFS中位数为13个月（95％CI，9.2-17.2个月）。 6和12岁时的总生存率（OS）为78％（95％CI，67-89％）和49％（95％CI，33-57％）。 OS中位数为11.8个月（95％CI，8.2–14.5个月）。这项I / II期研究显示血液学中度毒性，并且在OS中可能具有有希望的疗效，而在PFS方面则不逊色。

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