Duration of second or greater complete clinical remission in ovarian cancer: exploring potential endpoints for clinical trials.

Overview

OBJECTIVE: To explore benchmarks for future consolidation strategies, we evaluated a strictly defined (normal CA-125 and normal CT) second-complete-remission (CR) ovarian cancer population for 1) the median progression-free survival (PFS), 2) the frequency with which second remission exceeds first, and 3) the proportion of patients in remission at given time points. METHODS: Retrospective sampling was carried out at Memorial Sloan-Kettering (10/1993-12/2000) and the Royal Marsden Hospital (1/1995-4/2003) for the following: histological confirmation and elevated CA-125 at diagnosis; primary surgery; first-and second-line platinum-based chemotherapy with CR; and no maintenance therapy. RESULTS: In 35 patients 1) the duration of first PFS was 17.8 months (95% CI, 13.2-24.5 months) and second PFS was 10.8 months (95% CI, 9.6-12.2 months); 2) the number of patients with second response longer than first was 3/35 (9%); 3) the proportion of patients remaining in second complete remission was 100% (3 months), 100% (6 months), 83% (9 months), 34% (12 months), 23% (15 months) and 8.6% (18 months), respectively. CONCLUSION: 1) The median PFS from second complete remission is short. 2) A second response is rarely longer than the first even in this second CR population. 3) The number of patients with a second response longer than the first, or the proportion of patients remaining in complete remission at given time points could be evaluated as an outcome measure in future studies.