Impact of patient- And clinician-reported cumulative toxicity on quality of life in patients with metastatic castration-naïve prostate cancer

Claudia S.E.W. Schuurhuizen, Patricia Marino, Annemarie M.J. Braamse, Laurien M. Buffart, Florence Joly, Karim Fizazi, Muriel Habibian, Jean Marie Boher, Michel Soulie, Stéphane Oudard, Inge R.H.M. Konings, Henk M.W. Verheul, Joost Dekker, Gwenaelle Gravis

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    Abstract

    Background: Current toxicity evaluation is primarily focused on high-grade adverse events (AEs) reported by clinicians. However, the cumulative effect of multiple lower-grade AEs may also impact patients’ quality of life (QoL). Further, patient-reported toxicity may be more representative of patients’ treatment experiences. This study aimed to determine whether cumulative toxicity comprising all-grade AEs is more associated with QoL than cumulative toxicity comprising high-grade AEs only, and whether patient-reported cumulative toxicity is more associated with QoL than clinician-reported cumulative toxicity. Methods: Patients with metastatic castration-naïve prostate cancer participating in the phase III GETUG-AFU 15 trial completed questionnaires on AEs (at 3 and 6 months) and QoL (at baseline and 3 and 6 months). Clinicians reported AEs during clinical visits. Cumulative toxicity scores were calculated for clinicians and patients in 3 ways: total number of high-grade AEs, total number of all-grade AEs, and total number of all AEs multiplied by their grade (severity score). Relationships between cumulative toxicity scores and QoL were studied using longitudinal regression analyses; unstandardized (B) and standardized regression coefficients (β) are reported. Results: Of 385 patients, 184 with complete QoL and toxicity data were included. Clinician-reported all-grade AEs (B, –2.2; 95% CI, –3.3 to –1.1; P<.01) and severity score (B, –1.4; 95% CI, –2.2 to –0.7; P<.01) were associated with deteriorated physical QoL, whereas the total number of high-grade AEs was not. All patient-reported scores were significantly (P<.01 for all) associated with deteriorated physical and global QoL. Standardized regression coefficients indicated that patient-reported toxicity scores were more associated with QoL outcomes than clinician-reported scores, with the strongest association found for the all-grade AEs and severity cumulative toxicity scores. Conclusions: Patient- and clinician-based cumulative toxicity scores comprising all-grade AEs better reflect impact on patient QoL than toxicity scores comprising high-grade AEs only. To assess the effect of toxicity on QoL, patient-reported cumulative toxicity scores are preferred.

    Original languageEnglish
    Pages (from-to)1481-1488
    Number of pages8
    JournalJNCCN Journal of the National Comprehensive Cancer Network
    Volume16
    Issue number12
    DOIs
    Publication statusPublished - 1 Dec 2018

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