Background: A prospective Phase II study of Taxol in young adult patients with recurrent anaplastic astrocytomas.
Methods: 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.
Results: 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.
Conclusions: Taxol demonstrated modest efficacy with manageable toxicity in this heavily pre-treated cohort of young adult patients with recurrent anaplastic astrocytomas.