Multicenter phase II study of gemcitabine in previously untreated patientswith advanced epithelial ovarian cancer

Gemcitabine has activity in advanced ovarian cancer, with responses in plat inum-resistant disease. This study assessed the activity of gemcitabine in previously untreated patients with advanced epithelial ovarian cancer. All patients had histologically verified invasive epithelial ovarian cancer, In ternational Federation of Gynecology and Obstetrics (FIGO) stage III/IV dis ease and no prior chemotherapy. Patients received gemcitabine 1250 mg/m(2) on days 1, 8 and 15 of a 28-day cycle. Radiological response was assessed a fter two cycles. Between December 1992 and October 1995, 35 patients were e nrolled. Of 33 evaluable patients, there was one complete response and five partial responses, for an overall response rate of 18% (95% confidence int erval 7-36%). Forty-two percent of patients had a greater than 50% decrease in their CA-125 levels. Of the 25 patients who received platinum-based che motherapy following treatment with gemcitabine, 12 achieved an overall resp onse rate of 48%. Toxicity was mild, with two episodes of WHO grade 4 neutr openia (not associated with fever) and two episodes of grade 4 thrombocytop enia (not associated with bleeding). Gemcitabine has single-agent activity for poor-prognosis patients with advanced ovarian cancer. Similar results w ith subsequent platinum-based therapy indicate a lack of cross-resistance. This, combined with gemcitabine's favorable toxicity profile, warrants test ing in comparative trials. [(C) 2001 Lippincott Williams & Wilkins.].