Improved therapy with cisplatin regimens for patients with ovarian carcinoma (FIGO III and IV) as measured by surgical end-staging (second-look surgery) - the Mount Sinai experience

Between 1974 and 1982, 273 patients with epithelial cancer of the ovary (FIGO Stages III and IV) were randomized in four therapeutic trials. Trial I tested Adriamycin (ADM) plus cisplatin (DDP) versus DDP alone versus thiotepa (TSPA) plus methotrexate (MTX). The superiority of ADM plus DDP in producing the best response rate led to the use of this combination as the reference arm in the subsequent three trials. All investigational arms included cisplatin plus other drugs (cyclophosphamide, Adriamycin, hexamethylmelamine, and thiotepa) in various combinations. Eligibility for second-look required complete clinical remission and completion of at least ten cycles of chemotherapy. To date, 73 second-look operations have been performed on randomized patients (64 per cent of eligible patients). An additional 43 non-randomized patients had second-look and are analysed separately. Between 40 and 46 per cent of patients treated with cisplatin regimens had no disease at second-look. Degree of cell differentiation and amount of residual disease after initial laparotomy did not influence either eligibility for second-look or amount of disease found at second-look. Performance status and age did influence eligibility. Surgical technique and adverse effects are described.