Hg. Ball et al., A PHASE-II TRIAL OF PACLITAXEL IN PATIENTS WITH ADVANCED OR RECURRENTADENOCARCINOMA OF THE ENDOMETRIUM - A GYNECOLOGIC-ONCOLOGY-GROUP STUDY, Gynecologic oncology, 62(2), 1996, pp. 278-281
Objective: To determine the efficacy and toxicity of paclitaxel in adv
anced or recurrent adenocarcinoma of the endometrium. Methods: Thirty
patients with advanced or recurrent endometrial cancer with measurable
disease not previously treated with chemotherapy were treated with pa
clitaxel, 250 mg/m(2), over 24 hr with G-CSF, 5 mcg/kg/day, from Days
2 to 12. The cycle was repeated every 21 days. Patients who had receiv
ed previous pelvic radiation were treated at an initial paclitaxel dos
e of 200 mg/m(2). Twenty-eight patients were evaluable for response, a
nd 29 patients for toxicity. All patients were Gynecologic Oncology Gr
oup performance status 0, 1, or 2, Results: Complete responses were ob
served in 4 (14.3%) and partial responses in 6 patients (21.4%) for a
response rate of 35.7%. Severe (grade 3 or 4) leukopenia or thrombocyt
openia was seen in 18 and 2 patients, respectively. Grade 3 or 4 gastr
ointestinal toxicity was seen in 5, neurotoxicity in 3, anemia in 2, a
nd cardiac toxicity in 1. patients. Alopecia was reported in 16 patien
ts. Conclusions: This dose and schedule of paclitaxel are active in pa
tients with advanced or recurrent adenocarcinoma of the endometrium an
d should be considered for inclusion in phase III trials. (C) 1996 Aca
demic Press, Inc.