A randomised controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician's choice in patients with recurrent platinum-resistant ovarian cancer.
Sharon Love with the TCA Ovarian Cancer Trial Group
Ovarian cancers vary in their response individual drugs and show considerable differences in their histology, molecular biology, and clinical behaviour. We sought to establish whether an ATP-based tumour chemosensitivity assay (TCA) could aid the choice of chemotherapy in these patients and improve their outcome, based on encouraging results from a previous case control study (Kurbacher et al. Anti-Cancer Drugs 1998; 9: 51-7).
The primary aim of this two-arm randomised trial was to determine the response rate and progression free survival (PFS) following chemotherapy in patients with platinum resistant recurrent ovarian cancer treated according to an ATP-based tumour chemosensitivity assay (ATP-TCA) in comparison with physician's choice. All patients showing clinical evidence of progression within 6 months of cessation of primary platinum-based therapy were eligible for the study, provided that they met standard criteria governing their fitness for further chemotherapy. The study was designed to accrue 180 patient equally distributed between two arms (assay-directed or physician's choice) to detect a 20% difference in outcome with 80% power and 99% confidence.
The follow-up for this trial is now complete and the analysis is in progress.
