Phase II study of Leo 1031 (prednimustine) in advanced ovarian carcinoma

Thirty-six patients with advanced ovarian carcinoma, 21 who had not responded to conventional surgery and irradiation therapy and 15 who had not responded to conventional surgery, irradiation therapy, and chemotherapy, were treated in a phase II study with Leo 1031. Objective responses were obtained in ten (28%) of the 36 patients (two complete and eight partial responses). An additional 11 (32%) patients had stable disease. The two complete responders were in remission for 4 months. During remission, all of the patients had an improved quality of life. Myelosuppression of varying severity occurred in 11 patients; three of these patients died from their complications. Two patients developed reversible confusion and one patient became psychotic. Eight patients became euphoric during treatment. Leo 1031 might be worthwhile as a palliative chemotherapy for patients with advanced ovarian carcinoma, but the risk of euphoria must always be considered since it can lead to voluntary overdosage.