Diagnosis of first relapse and its impact on quality of life in patients with advanced ovarian cancer (AGO-OVAR 19/II).

Abstract

e17609 Background: Maintenance or improvement of health-related quality of life (QoL) is one of the major goals for patients with advanced ovarian cancer (OC). QoL is influenced by symptoms of disease on the one and beneficial or adverse effects of surgical and systemic treatment on the other side. In addition, QoL is also an important patient centered endpoint in clinical trials to support primary endpoints such as progression-free survival (PFS). This analysis evaluates the impact of the diagnosis of first relapse on QoL. Methods: Patients with primary OC were included before start of treatment. QoL was assessed by the cancer-specific questionnaires EORTC QLQ‐C30 and QLQ‐OV28 and the generic EQ‐5D 3L at baseline and every 3 months thereafter, to describe the influence of treatment and course of disease on QoL. QoL data within 100 days before and after the first relapse were compared (part 2 of NCT02828618). QoL scales were analyzed by repeated measures regression. We report model-based pre- and post-recurrence means and p-values for the difference in means. Results: In total, 269 had a PFS event with a median PFS of 20.3 months. This analysis includes 186 patients; 122 with QoL assessment before and after relapse and 50 and 14 with assessment only before or after relapse. Median age was 62.5 years (range 31 – 90). The number of evaluable answers for each domain ranged between 166 and 172 before recurrence and 135 and 137 after recurrence. Global QoL decreased from 61.4 to 48.4 points (p < 0.001) with the diagnosis of recurrence. The following scales showed a deterioration of at least 10 points: Social functioning (65.7- > 52.6), fatigue (55.8 - > 44.5), appetite loss (22.5 - > 33.4), emotional functioning (65.2 - > 54.9), role functioning (56.5 - > 46.4); (all p < 0.001). EQ-5D 3L visual analogue scale showed a deterioration from 66.4 to 55.0 (p < 0.001). Conclusions: The event of first relapse is associated with a significant and clinically relevant deterioration of global QoL including several subscales. Therefore, prolongation of PFS preserves QoL, which supports the role of PFS as meaningful primary endpoint in ovarian cancer trials. Clinical trial information: NCT02828618.