Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe)
Menée à partir de données portant sur 139 patientes traitées par niraparib pour un cancer de l'ovaire récidivant et sensible aux sels de platine (âge médian : 70 ans), cette étude décrit les effets indésirables et les symptômes rapportés respectivement par les médecins et les patients et ayant conduit à la modification du traitement au cours des trois premiers mois
Background : Maintenance niraparib at an individualized starting dose (ISD) is established in platinum-sensitive recurrent ovarian cancer (PSROC). However, patients’ perspectives on the burden of prolonged maintenance therapy have not been reported in prospective trials or routine practice.
Methods : In the real-life multicenter NiQoLe study, patients with PSROC received ISD maintenance niraparib. The primary objective was to describe physician-reported adverse events (AEs) leading to treatment modification during the first 3 months. Secondary endpoints included patient-reported outcomes (symptomatic AEs using PRO-CTCAE, self-reported fatigue and impact on daily activities/function using FACT-F) collected remotely weekly using a specifically designed electronic device.
Results : Most (80%) of 139 treated patients (median age 70 years) began niraparib at 200 mg/day. Median treatment duration was 5.7 (range 0.2–21.4) months. During the first 3 months, 86 patients (62%) required treatment modification (median 27 days to modification). Physician-reported grade ≥3 niraparib-related AEs occurred in 34 patients (24%); 68 patients (49%) had treatment modification for AEs, predominantly thrombocytopenia. The most frequent patient-reported AEs (PRO-CTCAE) were fatigue, insomnia, constipation, and dry mouth. Self-reported AEs were severe in 66% of patients. At baseline, 33% of patients reported severe fatigue (FACT-F), which generally persisted during niraparib. Physicians systematically underestimated major patient-reported symptoms.
Conclusions : In routine practice, dose modification was often required during the first 3 months despite individualized dosing. Physicians underestimated the burden of fatigue and symptomatic AEs. Digital self-reporting of AEs is feasible, provides patient-centered information complementing physician-reported AEs, and allows fuller appreciation of toxicity in real-world studies.
JNCI Cancer Spectrum , article en libre accès, 2023