Objective. The aim of this study was to determine the effectiveness and tox
icity of monthly treatment with intravenous paclitaxel for women with advan
ced or recurrent uterine papillary serous carcinoma (UPSC).
Methods. Consenting women with histologically confirmed advanced (FIGO stag
e III or IV) or recurrent UPSC were treated on an Institutional Review Boar
d approved protocol of a 24-h intravenous infusion of 200 mg/m(2) of paclit
axel every 3 weeks. Both measurable and nonmeasurable disease cases were en
rolled. Treatment was continued until disease progression, patient intolera
nce, or tin women with nonmeasurable disease) completion of six courses.
Results. Twenty patients received from 1 to 11 cycles of therapy. Two women
died of disease after 1 cycle of therapy and were not evaluable for respon
se. Among 13 women with measurable tumor receiving 2 or more cycles of ther
apy, 4 had a complete clinical response and 6 had a partial response (objec
tive response rate, 77%). The median time to progression was 7.3 months (ra
nge, 2-21 months). All 3 remaining patients with measurable disease had sta
ble disease for a median of 6 months. The 5 patients without evaluable dise
ase received 5 to 6 cycles of adjuvant paclitaxel. Three developed recurren
ce (range, 4-10 months; median, 7.2 months). Neutropenia was the major toxi
city. Eleven of the 20 patients required G-CSF support, and 9 were hospital
ized for neutropenic fever. One woman had reversible cardiac symptoms, whic
h might have been related to paclitaxel treatment. At the time of analysis
(mean follow-up, 23 months; range, 4.3-59.9 months), 13 women had died of d
isease, 4 were alive with disease, and 2 were disease free. All 3 disease-f
ree patients had been treated for nonmeasurable advanced stage disease.
Conclusion. Paclitaxel appears to have excellent activity in the treatment
of advanced or recurrent UPSC, an uncommon but aggressive malignancy. Longe
r survival appears to be more common among women with small-volume disease.
(C) 2001 Academic Press.