# Symptom Monitoring in Ovarian Cancer Patients Treated with PARP Inhibitors: Agreement Between Physician- and Patient-Reported Toxicities Using PRO-CTCAE

## TL;DR

This study found poor agreement between doctors and patients on reported side effects of PARP inhibitors in ovarian cancer, highlighting the need for patient-reported outcomes.

## Contribution

The study introduces a customized PRO-CTCAE questionnaire and reveals significant underestimation of toxicities by physicians compared to patient reports.

## Key findings

- Physician-patient agreement on PARP inhibitor toxicities was poor (κ = 0–0.15) for all 12 symptoms assessed.
- Fatigue, arthralgia, rash, and insomnia showed the lowest agreement and highest under-reporting by physicians.
- Patient-reported outcomes are recommended for accurate toxicity monitoring in maintenance therapy settings.

## Abstract

PARP inhibitors improve survival in ovarian cancer patients after first-line chemotherapy and platinum-sensitive relapse. As maintenance therapies are often prolonged, assessing treatment tolerability is crucial. This cohort study evaluated the agreement between physician- and patient-reported PARPi-related toxicities and identified underestimation rates for each symptom. A total of 77 patients receiving PARPis were enrolled, and a customized PRO-CTCAE questionnaire was used to collect patient-reported toxicities. Of the cohort, 39 received PARPis in first-line maintenance and 38 for recurrence. Agreement between patients and physicians was poor across all 12 toxicities (κ = 0–0.15), with the lowest agreement and highest under-reporting for fatigue, arthralgia, rash, and insomnia. These findings support the routine use of patient-reported outcomes to improve toxicity monitoring in maintenance settings.

Background: Poly(ADP-ribose) polymerase inhibitor (PARPi) treatment in ovarian cancer patients after first-line chemotherapy and following the response to platinum-based chemotherapy at relapse is associated with survival benefits. Maintenance therapies can be administered over extended periods, making treatment tolerability assessment essential in optimizing patient outcomes. This cohort study aimed to evaluate the agreement between physician and patient reporting of PARP inhibitor-related toxicities and the rate of underestimation of each symptom considered. Methods: Patients treated with PARPis in the first-line or recurrent setting were included. A specific Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire was generated and administered to the cohort. For each toxicity, agreement between patients and physicians was assessed using Cohen’s kappa and Gwet’s AC1; in addition, the rate of toxicity under-reporting by physicians was calculated. Results: Seventy-seven ovarian cancer patients were included; 39 (50.6%) received PARPis in the first-line setting, while 38 (49.4%) were treated for recurrence. Cohen’s kappa values for agreement between patients and physicians across 12 reported toxicities ranged from 0 to 0.15, indicating poor agreement (κ < 0.20) for all assessed toxicities, with the lowest levels of agreement for decreased appetite (κ = 0), rash (κ = 0.02), headache (κ = 0.00), arthralgia (κ = 0.03), insomnia (κ = 0.03), and fatigue (κ = 0.04). When agreement was assessed using Gwet’s AC1, agreement remained poor to moderate for the majority of the symptoms evaluated. Physician under-reporting rates were higher for nausea (51.9%), rash (57.1%), headache (49.3%), arthralgia (70.2%), insomnia (48.1%), and fatigue (67.5%). Conclusions: Our results underscore the importance of systematically integrating patient-reported outcomes into clinical practice, including in maintenance settings, to ensure an accurate assessment of treatment-related toxicities.