Olaparib Tolerability and the Management of Common Adverse Events in Patients With mCRPC

[Balsam01]

TAKE-HOME MESSAGE

This study of patients from the PROfound study investigated the prolonged safety and tolerability of olaparib to aid in the understanding of clinical management of the common adverse events (AEs) associated with the use of olaparib for metastatic castration-resistant prostate cancer. In total, there were 256 patients in the olaparib group and 130 patients in the control group. Anaemia (50%), nausea (43%), fatigue/asthenia (42%), and decreased appetite (31%) were the most commonly occurring AEs in the olaparib group. Most of the AEs occurred/peaked within 2 months, were of grade 1 and 2, and were managed with symptomatic care and dose adjustments. The other serious AEs occurred less frequently and the rates of these AEs were comparable between the two groups.

This study demonstrates encouraging results regarding the benefit of continued use of olaparib and shows that the AEs are generally manageable without the need for treatment discontinuation.

– Kamal Sahu, MD

Abstract

This abstract is available on the publisher's site.

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.

CLINICALTRIALS

gov registration number: NCT02987543.

Topic Alerts

Click on any of these tags to subscribe to Topic Alerts. Once subscribed, you can get a single, daily email any time PracticeUpdate publishes content on the topics that interest you.

Visit your Preferences and Settings section to Manage All Topic Alerts

Advanced Prostate Cancer Tags

Advanced Prostate Cancer Colleague Insights

Copyright © 2022 Elsevier Inc. All rights reserved.

Additional Info

Article Citation

European Journal of Cancer

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

Eur. J. Cancer 2022 May 18;170(2022)73-84, G Roubaud, M Özgüroğlu, N Penel, N Matsubara, N Mehra, MP Kolinsky, G Procopio, S Feyerabend, JY Joung, G Gravis, K Nishimura, C Gedye, C Padua, N Shore, A Thiery-Vuillemin, F Saad, R van Alphen, MA Carducci, C Desai, N Brickel, C Poehlein, P Del Rosario, K Fizazi