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Estimates of progression-free survival (PFS) from single-arm phase 2 consolidation/maintenance trials for recurrent ovarian cancer are usually interpreted in the context of historical controls. We illustrate how the duration of second-line therapy (SLT), the time on the investigational therapy (IT), and patient enrollment plan can affect efficacy measures from maintenance trials and might result in underpowered studies.

Identifying Clinical Improvement in Consolidation Single-Arm Phase 2 Trials in Patients With Ovarian Cancer in Second or Greater Clinical Remission