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First-Line Chemotherapy With Epirubicin, Paclitaxel, and Carboplatin for Advanced Ovarian Cancer: A Phase I/II Study of the Arbeitsgemeinschaft Gynäkologische Onkologie Ovarian Cancer Study Group

From the Frauenklinik St. Vincentius Krankenhaus, Karlsruhe; Frauenklinik Medizinische Hochschule, Hannover; Universitätsfrauenklinik, Freiburg; Universitätsfrauenklinik München, Grosshadern; Universitätsfrauenklinik, Dresden; Universitätsfrauenklinik München rechts der Isar; Frauenklinik Klinikum Stralsund; and Universitäts-frauenklinik, Kiel, Germany.

Address reprint requests to Andreas du Bois, MD, PhD, AGO study secretary, St Vincentius Khs, Suedendstr 32, D-76,137 Karlsruhe, Germany; Email dubois{at}klinik.uni-karlsruhe.de

PURPOSE: Despite the progress that has been achieved over the years, survival rates in patients with advanced ovarian cancer are still disappointing. New methods to improve the efficiency of first-line chemotherapy are warranted. One method to improve results is to add more non–cross-resistant drugs to platinum-paclitaxel combination regimens. Anthracyclines are among the candidates for incorporation as the "third drug" into first-line regimens for advanced ovarian cancer.

PATIENTS AND METHODS: We performed a phase I/II trial with escalating doses of epirubicin (60, 75, and 90 mg/m²) combined with fixed doses of paclitaxel and carboplatin in 27 previously untreated patients with advanced gynecologic malignancies.

RESULTS: Dose-limiting toxicity occurred at dose level 2 (75 mg/m² epirubicin) and consisted of myelosuppression (neutropenia, thrombocytopenia). No dose-limiting, nonhematologic toxicities were observed. The maximum tolerable dose was epirubicin 60 mg/m² (E) combined with a 3-hour infusion of paclitaxel 175 mg/m² (T) and carboplatin AUC 5 (Carbo). Preliminary analysis indicated promising activity against ovarian cancer.

CONCLUSION: The three-drug combination ET-Carbo, given according to the outlined dose and schedule, should be considered for further phase III evaluation. A randomized German-French intergroup trial comparing ET-Carbo with carboplatin-paclitaxel has already been initiated.

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