Background: A prospective Phase II study of Taxol in young adult patients w
ith 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 (media
n dose 60 Gy; range 51-61 Gy). Additionally, 22 patients were treated adjuv
antly 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/m(2) given as a 3 h intravenous infusion monthly. Neurological an
d 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 (rang
e 1-13) were administered. Taxol-related toxicity included: partial alopeci
a (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 cultur
e negative neutropenic fever. No treatment-related deaths were observed. Th
ree patients (13%) demonstrated a neuroradiographic partial response, 16 pa
tients (67%) demonstrated stable disease and 5 patients (21%) had progressi
ve disease following a single cycle of Taxol. Time to tumor progression ran
ged from 2-26 months (median 7.5 months). Nineteen patients were offered al
ternative chemotherapy after failing Taxol of whom 13 clinically responded.
Survival ranged from 3-56 months (median 18.5 months). Four patients are a
live, 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 ana
plastic astrocytomas.