Paclitaxel, cisplatin, and epirubicin first-line chemotherapy in stage IIIand IV ovarian carcinoma - Long term results of a phase II study

BACKGROUND. The combination of paclitaxel with cisplatin or carboplatin has become the preferred chemotherapy regimen in the treatment of epithelial o varian carcinoma. Anthracyclines also have activity in this disease. We con ducted a Phase II study by using the combination of paclitaxel, cisplatin, and epirubicin for the treatment of advanced ovarian carcinoma. METHODS. Forty consecutive patients with optimally (n = 7) or suboptimally (n = 33) debulked advanced ovarian carcinoma (International Federation of G ynecology and Obstetrics (FIGO) Stage III or IV) were treated with paclitax el, 135 mg/m(2), as a 3-hour intravenous infusion, cisplatin 75 mg/m(2) int ravenously (i.v.), and epirubicin 50 mg/m(2) i.v. every 3 weeks on an outpa tient basis. Granulocyte-colony stimulating factor was administered at a do se of 5 mu g/kg/day on Days 5-9. RESULTS, Among 28 patients with measurable disease, 24 (86%%) achieved an o bjective response including 19 complete and 5 partial responses. Among 18 p atients who underwent reassessment laparotomy, pathologic complete response was confirmed in 9 patients. At a minimum follow-up of 40 months, the medi an overall survival had not been reached whereas the median time to progres sion for all patients was 18.7 months. The median remission duration for wo men with measurable disease who responded to treatment was 14 months. The t reatment was well tolerated without toxic deaths; the most common toxicity was Grade 3/4 neutropenia that occurred in 30% of patients. Significant neu ropathy (Grade 2 or higher) developed in only 8% of patients. CONCLUSIONS. The combination of paclitaxel, cisplatin, and epirubicin is a well tolerated outpatient regimen with significant activity in the treatmen t of advanced epithelial ovarian carcinoma. Cancer 2000;89:1547-54. (C) 200 0 American Cancer Society.