Abstract
5008 Background: Ovarian cancers show considerable heterogeneity in their response to chemotherapy. We sought to establish whether an ATP-based tumour chemosensitivity assay (ATP-TCA) could aid the choice of chemotherapy and improve outcome, based on encouraging results from a previous case control study (Kurbacher et al., Anti-Cancer Drugs 1998; 9: 51–7). Methods: The primary aim of this randomized open label trial was to determine response rate and progression free survival (PFS) following chemotherapy in patients with platinum-resistant recurrent ovarian cancer treated according to the ATP-TCA, or by physician’s choice. All patients showing evidence of progression within 6 months of cessation of primary platinum-based therapy were eligible, if they were fit for further chemotherapy. The study was designed to accrue 180 patient equally between the two arms to detect a 20% difference in outcome with 80% power and 99% confidence. Results: A total of 180 patients were randomised to assay-directed (n = 94) or physician’s choice chemotherapy (n = 86). In each case, tumor or ascitic fluid was sent from the treating centres (n = 10) for assay to one of two central laboratories (UK or Germany). Median follow-up at analysis was 18 months. Treatment choice was balanced between the groups, with increased use of combination therapy in the physician’s choice arm during the study. Response was assessable in 147 patients with 31.5% of patients achieving a partial/complete response in the physician’s choice group, compared with 40.5% in the assay-directed group. ITT analysis showed a median progression-free survival (PFS) of 93 days in the physician’s choice group and 104 days in the assay-directed group (Logrank p < 0.14). There was no difference in overall survival between the groups, and none of the differences observed achieved statistical significance. Conclusions: This study shows a trend towards improved response and PFS for assay-directed treatment with high response rates in both arms, probably due to the balanced use of combination therapy designed using the ATP-TCA in this poor prognosis group of patients. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration CanTech Ltd., LANCE CanTech Ltd., LANCE
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