Paclitaxel (Taxol(R)) was recently tested in patients with relapsed an
d refractory lymphoma in two phase II clinical trials using two differ
ent infusion schedules. The first, reported from the NCI (USA), used a
96-hour intravenous continuous infusion schedule, and the second, fro
m our group, used a 3-hour infusion. In the NCI trial, 29 evaluable pa
tients were treated with 140 mg/m(2) every three weeks, which achieved
a 17% response rate (all PRs); while we treated 96 evaluable patients
with 200 mg/m(2) every three weeks, which achieved a 25% response rat
e (10 CRs and 14 PRs, 95% CI: 17%-35%). In our trial, patients with re
lapsed (not primary refractory) intermediate-grade lymphoma had a resp
onse rate of 50%, and those with relapsed low-grade lymphoma had a res
ponse rate of 31%. In a follow-up trial, 12 patients who failed to res
pond to 3-hour infusion of paclitaxel were crossed over to receive pac
litaxel by 96-hour infusion. None of the 12 evaluable patients achieve
d a major clinical response. Similarly, of 25 patients treated with cy
closporine A and paclitaxel after failing therapy with single-agent pa
clitaxel, only one patient (4%) responded. We conclude that paclitaxel
has a promising single-agent activity: most prominently in patients w
ith relapsed intermediate-grade lymphoma. Paclitaxel-based combination
programs are currently being evaluated in our institution.