Chamberlain M C, Kormanik P
Kaiser Permanente, Department of Neurology, Baldwin Park, California 91706, USA.
J Neurooncol. 1999 May;43(1):71-8. doi: 10.1023/a:1006277631745.
A prospective Phase II study of Taxol in young adult patients with recurrent anaplastic astrocytomas.
Twenty-four patients (15 men; 9 women) ages 19-45 years (median 31.5), with recurrent anaplastic astrocytomas were treated. All patients had previously been treated with surgery and involved-field radiotherapy (median dose 60 Gy; range 51-61 Gy). Additionally, 22 patients were treated adjuvantly with nitrosourea-based chemotherapy (PCV in 17; BCNU in 5). Fourteen patients were treated with salvage chemotherapy at first recurrence with 1-2 chemotherapy regimens (median 1). Taxol was administered at a fixed dose of 175 mg/m2 given as a 3 h intravenous infusion monthly. Neurological and neuroradiographic evaluation were performed every 8 weeks after 2 courses of Taxol, operationally defined as a single cycle of Taxol.
All patients were evaluable. A median of 3.5 cycles of Taxol (range 1-13) were administered. Taxol-related toxicity included: partial alopecia (13 patients); non-disabling peripheral neuropathy (4); neutropenia (4); anemia (3); and thrombocytopenia (2). Four patients required transfusions (2 packed red blood cell; 2 platelet) and one patient was treated for culture negative neutropenic fever. No treatment-related deaths were observed. Three patients (13%) demonstrated a neuroradiographic partial response, 16 patients (67%) demonstrated stable disease and 5 patients (21%) had progressive disease following a single cycle of Taxol. Time to tumor progression ranged from 2-26 months (median 7.5 months). Nineteen patients were offered alternative chemotherapy after failing Taxol of whom 13 clinically responded. Survival ranged from 3-56 months (median 18.5 months). Four patients are alive, all are on alternative chemotherapy regimens.
Taxol demonstrated modest efficacy with manageable toxicity in this heavily pre-treated cohort of young adult patients with recurrent anaplastic astrocytomas.
一项关于紫杉醇治疗复发间变性星形细胞瘤年轻成年患者的前瞻性II期研究。
对24例年龄在19 - 45岁（中位年龄31.5岁）的复发间变性星形细胞瘤患者（15例男性；9例女性）进行了治疗。所有患者此前均接受过手术及累及野放疗（中位剂量60 Gy；范围51 - 61 Gy）。此外，22例患者接受了基于亚硝基脲的辅助化疗（17例为PCV方案；5例为BCNU方案）。14例患者在首次复发时接受了1 - 2种化疗方案的挽救性化疗（中位1种）。紫杉醇以固定剂量175 mg/m²静脉输注3小时，每月给药一次。在紫杉醇治疗2个疗程后（即一个紫杉醇治疗周期），每8周进行一次神经学和神经影像学评估。
所有患者均可评估。紫杉醇的中位治疗周期数为3.5个（范围1 - 13个）。紫杉醇相关毒性包括：部分脱发（13例患者）；非致残性周围神经病变（4例）；中性粒细胞减少（4例）；贫血（3例）；血小板减少（2例）。4例患者需要输血（2例输注浓缩红细胞；2例输注血小板），1例患者因培养阴性的中性粒细胞减少性发热接受治疗。未观察到与治疗相关的死亡。3例患者（13%）出现神经影像学部分缓解，16例患者（67%）疾病稳定，5例患者（21%）在一个紫杉醇治疗周期后疾病进展。肿瘤进展时间为2 - 26个月（中位7.5个月）。19例患者在紫杉醇治疗失败后接受了其他化疗，其中13例有临床反应。生存期为3 - 56个月（中位18.5个月）。4例患者仍存活，均接受其他化疗方案。
在这个经过大量前期治疗的复发间变性星形细胞瘤年轻成年患者队列中，紫杉醇显示出适度疗效且毒性可控。
