Health-related quality of life (HRQL) and progression-free survival (PFS) in patients with recurrent ovarian cancer: Results from the CALYPSO trial.

Abstract

5044 Background: In the CALYPSO trial, carboplatin (C)-pegylated liposomal doxorubicin (PLD) demonstrated superior therapeutic index (TI) vs C-paclitaxel (P) in recurrent ovarian cancer (ROC): ≥ 6 months after first- or second-line platinum-based therapy. This analysis reports on HRQL and its correlation to PFS. Methods: HRQL was measured with the EORTC QOLQC30 questionnaire and OV28 OC module. Mean change scores from baseline in HRQL subscales (5 functionnal scales and global health status) in each arm and the proportion of patients (pts) achieving clinically significant improvement (≥ 10 points) were calculated every 3 months until 12 months. Disease symptoms were assessed using the OV28 abdominal-symptom subscale (abd-symp). The potential correlation between abd-symp improvement and PFS was evaluated by a landmark analysis at 3 months. Results: Compliance was 90% at baseline and 76%, 64%, 57% at 3, 6, and 9 mo. Baseline HRQL showed already impaired global QOL (62/100) and abd-symp burden (30/100), with 90% of patients reporting abd-symp. Global QOL and abd-symp scores improved over time; at 6 mo 36% of pts met criteria for improved abd-symp. Global QOL and abd-symp scores did not show any significance between two arms at 3, 6 and 9 months measurement. However, less peripheral neuropathy (9.8 vs. 24.2), fewer other chemo side effects (9.5 vs. 16.2), and less impact on body image (3.8 vs. 10.4) were found on HRQL in C-D arm versus CP arm (all p < 0.02) at 6 months. Analysis at 3-months showed similar PFS in pts with improved abd-symp compared to those not improved (HR 0.86, p = 0.1). Conclusions: Significant differences in HRQL scores are related to differences in toxicities between arms. Global QOL and abdominal symptoms are comparable between arms and therefore independent of the impact of different therapies on PFS. Improvement in abdominal- symptoms proved not to correlate with improved PFS. Further exploration of the relationships between other HRQL domains and disease-related outcomes is needed. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Schering-Plough Schering-Plough Schering-Plough