SINGLE-AGENT PACLITAXEL IN PATIENTS WITH PREVIOUSLY UNTREATED STAGE-IV EPITHELIAL OVARIAN-CANCER

The aim of this study was to evaluate the efficacy of high-dose paclit axel in patients with previously untreated stage IV epithelial ovarian cancer. Paclitaxel was administered intravenously over 3 h at a dose of 225 mg m(-2) on a 21-day cycle for six courses, Thirty-six patients were entered into this study; all 36 were assessed for toxicity and 3 3 patients were evaluable for response. One patient had a complete res ponse and 12 patients had partial responses (overall response rate 39. 4%, 95% Cl 23-58%), The overall median duration of response was 9 mont hs (range 3.5-23+ months), The response rate to carboplatin following failure of paclitaxel within 1 year of stopping therapy was 57% (four out of seven patients). The median survival of patients was 17.2 month s, The main toxicity encountered was neutropenia which was WHO grade 3 in 11 patients (31%) and WHO grade 4 in seven patients (19%), Granulo cyte colony-stimulating factor (GCSF) was not given to any patient dur ing the study. Other toxicities were: grade 3/4 infection (11%) and na usea and vomiting (11%); grade 3 bone pain (22%), fatigue (14%), diarr hoea (3%), myalgia/arthralgia (3%) and dry eyes (3%), Transient periph eral neuropathy occurred in 16 patients (44%), and alopecia was encoun tered in most patients (grade 2/3, 78%). Paclitaxel given at 225 mg m( -2) to patients with stage IV epithelial ovarian cancer is active, wel l tolerated and does not require GCSF support.