Forsyth P, Cairncross G, Stewart D, Goodyear M, Wainman N, Eisenhauer E
Department of Medicine, Tom Baker Cancer Centre and Clinical Neurosciences, Foothills Hospital, Calgary, Alberta, Canada.
Invest New Drugs. 1996;14(2):203-6. doi: 10.1007/BF00210791.
We conducted a phase II study to determine the response to, and toxicity of, docetaxel (Taxotere; Rhône Poulenc Rorer Pharmaceuticals, Inc) in patients with recurrent malignant glioma.
Eighteen patients with recurrent malignant glioma were treated with 100 mg/m2 (no prior chemotherapy) or 75 mg/m2 (prior adjuvant chemotherapy) of docetaxel intravenously over 1 hour, every 3 weeks. Premedication with dexamethasone, diphenhydramine and ranitidine or cimetidine was given to all patients. Five (28%) had gioblastoma multiforme (GBM) and the rest other malignant gliomas. Eleven (61%) had an ECOG performance status of 0 or 1, and 13 (72%) were on corticosteroids at the start of treatment. Rigorous response criteria were used. All were eligible and evaluable for response.
No complete or partial responses were observed; the objective response rate was 0% (95% confidence interval: 0-15.3%). Patients received a median of 2 cycles (range, 1-6). Grade 3 or 4 neutropenia occurred in 17 (94%) patients and was associated with fever that required intravenous antibiotics in 4 (22%) patients. An additional patient received intravenous antibiotics for an infection not associated with neutropenia. Six (33%) patients had mild hypersensitivity reactions. Onychodystrophy, peripheral edema and peripheral neuropathy were uncommon and mild.
Docetaxel has no significant activity in patients with recurrent malignant glioma.
我们开展了一项II期研究，以确定多西他赛（泰索帝；罗纳普朗克乐安制药公司）对复发性恶性胶质瘤患者的疗效及毒性。
18例复发性恶性胶质瘤患者接受多西他赛治疗，100 mg/m²（未接受过化疗）或75 mg/m²（接受过辅助化疗），静脉滴注1小时，每3周1次。所有患者均接受地塞米松、苯海拉明和雷尼替丁或西咪替丁预处理。5例（28%）为多形性胶质母细胞瘤（GBM），其余为其他恶性胶质瘤。11例（61%）患者的东部肿瘤协作组（ECOG）体能状态为0或1，13例（72%）患者在治疗开始时正在使用皮质类固醇。采用严格的疗效标准。所有患者均符合纳入标准且可评估疗效。
未观察到完全缓解或部分缓解；客观缓解率为0%（95%置信区间：0 - 15.3%）。患者接受的中位周期数为2个周期（范围：1 - 6个周期）。17例（94%）患者发生3级或4级中性粒细胞减少，其中4例（22%）患者因发热需要静脉使用抗生素。另有1例患者因与中性粒细胞减少无关的感染接受静脉抗生素治疗。6例（33%）患者出现轻度过敏反应。甲营养不良、外周性水肿和周围神经病变不常见且症状较轻。
多西他赛对复发性恶性胶质瘤患者无显著活性。
