Background. We wanted to assess the efficacy and toxicity of paclitaxe
l (Taxol) in previously untreated patients with advanced ovarian cance
r. No such study had been performed at the time of initiation of this
study. Patients and methods. The study population in this analysis con
sisted of 35 previously untreated stage III ovarian cancer patients, s
uboptimally resected at primary surgery. The initial paclitaxel dose w
as 175 mg/m(2) given as a three-hour i.v, infusion every three weeks.
Results. A total of 225 paclitaxel courses were given to 35 patients o
f whom 34 were evaluable for clinical response. Nine (26%) patients ob
tained a complete response to paclitaxel, ten (29%) a partial response
, seven (21%) stable disease and eight (24%) had progressive disease.
Thus, the total response rate to paclitaxel treatment was 55% (19 of 3
4). The median duration of response for the 19 responding patients was
eight months (range 1-44.51). The median duration for nine patients w
ith clinical complete response was 16 months (range 2-44.5+). A second
-look laparotomy was performed in 15 patients after six courses of pac
litaxel. Of these, five obtained a histopathologically complete remiss
ion, five a partial remission and five stable disease, The five patien
ts with pathologically complete remissions are alive with a median pro
gressive-free survival of 24.5 months (range 15+-44.5+). The median pr
ogression-free survival for all patients was 6.1 months (range 1-44.5). Toxicity consisted mainly of neutropenia, easily controlled, Other
toxicities were myalgia/arthralgia and peripheral neuropathy. Three pa
tients experienced a severe anaphylactic reaction during the first cou
rse. Conclusion. This study showed that paclitaxel is an effective and
safe drug for first-line treatment of ovarian cancer.