Pilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.

OBJECTIVE: The purpose of this study was to determine the feasibility, response rate, and toxicity of paclitaxel, carboplatin, and gemcitabine as an outpatient regimen in the treatment of ovarian/non-ovarian and tubal adenocarcinoma. This is the largest completed study using this regimen as first-line treatment of these patients.

METHODS: Following cytoreductive surgery, eligible patients were initially treated with paclitaxel (175 mg/m(2) via 1 h infusion), carboplatin (AUC = 5), and gemcitabine (800 mg/m(2)) as an outpatient every 21 days. Gemcitabine (800 mg/m(2)) was repeated on day 8. After six cycles of treatment, responders were eligible for an additional three cycles of paclitaxel and gemcitabine. Colony-stimulating factors were used at the discretion of the treating physician.

RESULTS: Fifty-seven patients (median age = 58; range 41-81) with stage III/IV epithelial carcinoma of the ovary, fallopian tube, and peritoneum received a total of 476 cycles of chemotherapy. Grades 3 and 4 neutropenia developed in 19.7% and 9% of cycles while grades 3 and 4 thrombocytopenia developed in 4.2% and 1.3% of the cycles. One hundred thirty-seven (28.8%) cycles of a possible 476 cycles of gemcitabine were delayed primarily due to grades 3 and 4 neutropenia. Forty-five (84.9%) patients exhibited a complete response and three (5.7%) patients demonstrated a partial response, for a total response rate of 90.4%. Twenty-two patients developed some degree of neuropathy, although there was no reported interference with activities of daily living. The patients' median progression-free interval and median overall survival was 15.5 and 40.8 months, respectively. Forty-one of the original 57 patients were alive at the conclusion of data collection.

CONCLUSIONS: This report represents the largest completed study in the world employing this triplet regimen in the first-line treatment of advanced stage epithelial ovarian, fallopian tube, or peritoneal cancer patients. Although the study exhibited a high response rate, the neuropathy encountered in the study, and the need to eliminate gemcitabine in 54% of the patients due to bone marrow suppression merits further investigation of the dosing schedule. More recent gemcitabine data suggest that lower doses and a 2-week regimen may be as effective with less toxicity. A comparison of our results with the GOG-0182 study, that utilizes the same regimen, should be informative.