Evaluation of Scores to Reflect Toxicity Impact on Quality of Life of Patients With Platinum-Resistant Ovarian Cancer: AURELIA Substudy

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Justine Lequesne Clinical Research, François Baclesse Center, Caen, France
Anticipe (Interdisciplinary Research Unit for the Prevention and Treatment of Cancer), INSERM Unit 1086, Caen, France

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Florence Joly Clinical Research, François Baclesse Center, Caen, France
Anticipe (Interdisciplinary Research Unit for the Prevention and Treatment of Cancer), INSERM Unit 1086, Caen, France
Medical Oncology Department, François Baclesse Center, Caen, France

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Julien Peron Oncology Department, Lyon-Sud Hospital, Cancer Institute of Hospices Civils de Lyon, Hospices Civils de Lyon, Lyon, France
Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Université Claude Bernard Lyon 1, Villeurbanne, France

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Isabelle Ray-Coquard Department of Medical Oncology, Centre Léon Bérard, Lyon, France

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Anne-Claire Hardy-Bessard Department of Medical Oncology, CARIO-HPCA, Plérin, France

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Frédéric Selle Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France

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Dominique Berton Department of Medical Oncology, Institut de Cancérologie de l’Ouest-René Gauducheau, Saint Herblain, France

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Philippe Follana Department of Oncology, Centre Antoine Lacassagne, Nice, France

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Michel Fabbro Medical Oncology Department, Institut Régional du Cancer de Montpellier, Montpellier, France

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Alain Lortholary Confluent Private Hospital, Institut de Cancérologie Catherine de Sienne, Nantes, France

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Eric Pujade-Lauraine ARCAGY-GINECO Université Paris Descartes, AP-HP, Paris, France

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Sophie Lefèvre-Arbogast Clinical Research, François Baclesse Center, Caen, France
Anticipe (Interdisciplinary Research Unit for the Prevention and Treatment of Cancer), INSERM Unit 1086, Caen, France

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Elodie Coquan Clinical Research, François Baclesse Center, Caen, France
Medical Oncology Department, François Baclesse Center, Caen, France

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Background: Current standards for toxicity reporting do not fully capture the impact of adverse events (AEs) on patients’ quality of life (QoL). This study aimed to evaluate the association between toxicity and QoL by using toxicity scores that take into account CTCAE grade grouping and AE duration and cumulation. Methods: Analyses were performed on the AURELIA trial dataset, including 361 patients with platinum-resistant ovarian cancer treated with chemotherapy alone or with bevacizumab. Global and physical functioning QoL were issued from the EORTC QoL Questionnaire-Core 30 (QLQ-C30), collected at baseline and 8/9 and 16/18 weeks after treatment initiation. Four toxicity scores were computed: the total number of AEs, multiplied by their grade and not, and the cumulative duration of AEs, weighted by their grade and not. Each score included all AEs or only grade 3/4 nonlaboratory or treatment-related AEs. The relationship between toxicity scores and QoL was assessed through linear mixed regression. Results: We found that 171 (47.5%) and 43 (11.9%) patients experienced at least one grade 3 or 4 AE, respectively, whereas 113 (31.4%) experienced grade 2 AEs only. Physical QoL was negatively associated with all toxicity scores when computed with all grades of AEs (all P<.01), with a weaker association when treatment-related AEs were considered. Global QoL was negatively associated with toxicity scores computed with nonlaboratory all-grade AEs only (β, –3.42 to –3.13; all P<.01). Degrees of association were lower when considering the AE duration. Conclusions: In this analysis of patients with platinum-resistant ovarian cancer, toxicity scores based on the cumulative number of AEs, modulated or not by grade, were more effective at predicting QoL changes than those based on AE duration. Toxicity impact on QoL was better reflected when grade 2 AEs were taken into account together with grade 3/4 AEs, whatever their treatment imputability, and when laboratory AEs were excluded.

Submitted July 22, 2022; final revision received November 18, 2022; accepted for publication November 21, 2022.

Author contributions: Formal analysis: Lequesne, Lefèvre-Arbogast. Methodology: Lequesne, Joly, Peron, Pujade-Lauraine, Lefèvre-Arbogast, Coquan. Resources: Joly, Ray-Coquard, Hardy-Bessard, Selle, Berton, Follana, Fabbro, Lortholary, Pujade-Lauraine. Supervision: Joly. Writing—original draft: Lequesne, Coquan. Writing—review and editing: Joly, Peron, Ray-Coquard, Hardy-Bessard, Selle, Berton, Follana, Fabbro, Lortholary, Pujade-Lauraine, Lefèvre-Arbogast.

Disclosures: Dr. Pujade-Lauraine has disclosed serving on a data safety monitoring board for Agebus and Incute; as an advisory board member for AstraZeneca and GlaxoSmithKline; and as a consultant for Roche. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Correspondence: Justine Lequesne, PhD, Clinical Research, François Baclesse Center, 3 Avenue du General Harris, 14076 Caen, France. Email: j.lequesne@baclesse.unicancer.fr

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