Cisplatin (P), vinblastine (V) and bleomycin (B) combination chemotherapy in recurrent or advanced granulosa(-theca) cell tumours of the ovary. An EORTC gynaecological cancer cooperative group study

The aim of this study was to investigate the clinical activity and toxicity of a modified PVB regimen (cisplatin, vinblastine and bleomycin) in patien ts with advanced or recurrent, pure granulosa cell tumours (GCTs) or mixed granulosa-theca cell tumours (GTCTs). The PVB regimen consisted of cisplati n (P) 20 mg/m(2) intravenous (i.v.) days 1-5, vinblastine (V) 0.15 mg/kg i. v. days 1-2 and bleomycin (B) 30 mg i.v. on day 2, and 15 mg on day 15, for 28 days. 38 eligible patients were entered in this trial. Prior to PVB all patients underwent surgery and 13 received postoperative radio- or other p rior chemotherapy. The median number of PVB cycles was 4 in both groups. In the group of 25 patients who had received prior surgery only, 7 and 6 pati ents had complete and partial responses, respectively (response rate: 52%, 95% confidence limits: 31.3-72.2%). At a median follow-up of 39 months, 6 p atients were alive with no evidence of disease, 6 were alive with disease, 12 died due to malignant disease and 1 died due to intercurrent disease. Th e median time to progression was 13.9 months. The median survival was 25.4 months. 3-year survival was 49% (95% confidence limits: 29-69%). In the gro up of 13 patients who had previously received postoperative radio- or chemo therapy, 5 complete and 5 partial responses were observed on PVB (response Fate: 77%, 95% confidence limit: 46.2-95.0%). At a median follow-up of 50 m onths, 6 patients were still alive, only 1 without evidence of disease, 6 d ied due to malignant disease and 1 died due to intercurrent disease. The me dian time to progression was 19.3 months. The median duration of survival w as 41.1 months. Accompanying toxicity was distributed in a similar pattern for both groups. Severe toxicity was mainly documented as haematological to xicity, nausea/vomiting and alopecia. Furthermore cisplatin-related periphe ral neurotoxicity and mild/moderate signs of bleomycin-related pulmonary to xicity were observed. The present data confirm the therapeutic activity of the PVB regimen in advanced/recurrent GCTs. The response rate was moderatel y high compared with previous studies, with a median duration of response o f 20 months for both groups. (C) 1999 Elsevier Science Ltd. All rights rese rved.