Title :

Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study.

Author(s) :

Roubaud, Guilhem [Auteur]
Institut Bergonié [Bordeaux]
Özgüroğlu, M. [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Matsubara, N. [Auteur]
Mehra, N. [Auteur]
Kolinsky, M. P. [Auteur]
Procopio, G. [Auteur]
Feyerabend, S. [Auteur]
Joung, J. Y. [Auteur]
Gravis, Gwenaelle [Auteur]
Institut Paoli-Calmettes [IPC]
Nishimura, K. [Auteur]
Gedye, C. [Auteur]
Padua, C. [Auteur]
Shore, N. [Auteur]
Thiery-Vuillemin, Antoine [Auteur]
Centre Hospitalier Régional Universitaire de Besançon [CHRU Besançon]
Saad, F. [Auteur]
Van Alphen, R. [Auteur]
Carducci, M. A. [Auteur]
Desai, C. [Auteur]
Brickel, N. [Auteur]
Poehlein, C. [Auteur]
Del Rosario, P. [Auteur]
Fizazi, Karim [Auteur]
Institut Gustave Roussy [IGR]

Journal title :

European Journal of Cancer

Abbreviated title :

Eur J Cancer

Volume number :

170

Pages :

73-84

Publication date :

2022-05-24

ISSN :

1879-0852

English keyword(s) :

PROfound
Metastatic castration-resistant prostate
cancer
Olaparib
Safety
Adverse-event management

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Background Based on PROfound, olaparib is approved for patients with metastatic castration-resistant prostate cancer following disease progression on at least enzalutamide or abiraterone and who carry relevant alterations ...
Show more >Background Based on PROfound, olaparib is approved for patients with metastatic castration-resistant prostate cancer following disease progression on at least enzalutamide or abiraterone and who carry relevant alterations in DNA repair genes. To facilitate continued olaparib treatment as long as the patient derives benefit, we describe further safety assessments from PROfound focusing on the four most common adverse events (AEs) and events of special interest. Methods Patients were randomized (2:1) to olaparib tablets (300 mg bid) or control (enzalutamide or abiraterone) until disease progression or unacceptable toxicity. Safety was assessed through AE reporting and laboratory assessments. Safety data were also collected from all patients in the control group who experienced radiographic disease progression and subsequently crossed over to olaparib treatment. Results 256 patients received olaparib and 130 control. Incidence rates for the four most commonly occurring AEs in the olaparib group (all-causality) were anaemia 50%, nausea 43%, fatigue/asthenia 42% and decreased appetite 31%. All were mostly Grade 1 and 2 and all peaked within the first 2 months of treatment as the events were managed where appropriate, primarily with dose interruptions or dose reductions. The extent of bone metastases at baseline or prior taxane use was not associated with the rate of anaemia. Pneumonitis was reported in 2% and 1.5% of patients in the olaparib and control groups, respectively, and one patient (0.4%) in the olaparib group experienced an event of MDS/AML after a 30-day follow-up period. Venous thromboembolic events occurred in 8% of olaparib and 3% of control patients. Conclusions The four most common AEs observed in PROfound were generally manageable without the need for treatment discontinuation, allowing patients to remain on treatment for as long as they were deriving clinical benefit.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2023-11-15T04:07:43Z
2024-05-06T06:57:46Z