Improving real-world evaluation of patient- and physician-reported tolerability: niraparib for recurrent ovarian cancer (NiQoLe)

Florence Joly ¹, Fernando Bazan ², Delphine Garbay ³

¹Department of Medical Oncology, Centre François Baclesse, University Unicaen, Caen, France.
²Department of Oncology, CHRU Besançon-Hôpital Jean Minjoz, Besançon, France.
³Medical Oncology Department, Clinique Tivoli-Ducos, Bordeaux, France.
⁴Department of Clinical Research and Innovation, Centre Léon-Bérard, Lyon, France.
⁵Department of Medical Oncology, Centre Anticancer Antoine Lacassagne, Nice, France.
⁶Medical Oncology Department, CHU d'Orléans, Orléans, France.
⁷Oncology Department, Oncogard-Polyclinique KenVal Institut de Cancérologie du Gard, Nimes, France.
⁸Medical Oncology Department, Centre d'Oncologie de Gentilly, Nancy, France.
⁹Department of Medical Oncology, Pôle Santé Léonard de Vinci, Chambray-Lès-Tours, France.
¹⁰Department of Medical Oncology, Centre Armoricain d'Oncologie, Plérin, France.
¹¹Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.
¹²Department of Medical Oncology, Institut du Cancer Avignon Provence, Avignon, France.
¹³Department of Medical Oncology, Institut Bergonié, Bordeaux, France.
¹⁴Department of Medical Oncology, Centre Léon-Bérard, Lyon, France.
¹⁵Medical Oncology Department, Groupe Hospitalier Mutualiste (GHM) de Grenoble, Grenoble, France.
¹⁶Department of Medical Oncology, Nord University Hospital, Saint Etienne, France.
¹⁷Medical Oncology Department, Institut de Cancérologie de Lorraine (ICL), Vandoeuvre-Lès-Nancy, France.
¹⁸Department of Medical Oncology, Clinique Mutualiste de l'Estuaire, Saint-Nazaire, France.
¹⁹Medical Oncology Department, CHU de Poitiers-Hôpital de la Milétrie, Poitiers, France.
²⁰Université Paris Cité, APHP, Department of Medical Oncology, Hôpital Cochin, Paris, France.
²¹Medical Oncology Department, Centre Hospitalier de la Côte Basque, Bayonne, France.
²²Department of Medical Oncology, Médipôle de Savoie, Challes-les-Eaux, France.
²³Medical Oncology Service, Fleyriat Hospital Center, Bourg en Bresse, France.
²⁴Department of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.
²⁵Department of Medical Oncology, Saint Malo Hospital, Saint Malo, France.
²⁶Department of Medical Oncology, Centre Jean-Perrin, Clermont-Ferrand, France.
²⁷Medical Oncology Department, Montpellier Cancer Institute (ICM), Montpellier, France.
²⁸Department of Medical and Surgical Oncology and Hematology, Institut of Cancer Strasbourg (ICANS), Strasbourg, France.

⁰Department of Medical Oncology, Centre François Baclesse, University Unicaen, Caen, France.

Jnci Cancer Spectrum +

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December 14, 2024

View abstract on PubMed

Summary

Maintenance niraparib for platinum-sensitive recurrent ovarian cancer often requires dose modification within three months. Digital patient-reported outcomes reveal a significant burden of fatigue and adverse events underestimated by physicians.

Area Of Science

Oncology
Pharmacovigilance
Patient-Reported Outcomes

Background

Maintenance niraparib with an individualized starting dose (ISD) is standard for platinum-sensitive recurrent ovarian cancer (PSROC).
Patient perspectives on the burden of long-term maintenance therapy are not well-documented in real-world settings.

Purpose Of The Study

To evaluate physician-reported adverse events (AEs) leading to treatment modification in the first three months of ISD niraparib maintenance therapy in PSROC patients.
To assess patient-reported outcomes (PROs) including symptomatic AEs, fatigue, and impact on daily life.

Main Methods

The multicenter NiQoLe study enrolled 139 PSROC patients receiving ISD niraparib.
Physician-reported AEs and treatment modifications were primary endpoints.
Patient-reported outcomes (PRO-CTCAE, FACT-F) were collected weekly via electronic devices.

Main Results

Most patients (80%) started niraparib at 200 mg/day; 62% required dose modification within three months.
Physician-reported grade ≥3 AEs occurred in 24% of patients, with thrombocytopenia being common.
Patient-reported severe AEs affected 66%, with persistent fatigue noted in 33% at baseline.

Conclusions

Individualized starting dose niraparib frequently requires modification in routine practice within the first three months.
Physicians tend to underestimate the severity of patient-reported symptoms and fatigue.
Remote digital self-reporting of AEs is feasible and provides valuable patient-centered data, enhancing toxicity assessment in real-world studies.