Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients : Follow-up from the ARADES and ARAFOR Trials

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Shore , N D , Tammela , T L , Massard , C , Bono , P , Aspegren , J , Mustonen , M & Fizazi , K 2018 , ' Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients : Follow-up from the ARADES and ARAFOR Trials ' , European Urology Focus , vol. 4 , no. 4 , pp. 547-553 . https://doi.org/10.1016/j.euf.2017.01.015

Title: Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients : Follow-up from the ARADES and ARAFOR Trials
Author: Shore, Neal D.; Tammela, Teuvo L.; Massard, Christophe; Bono, P.; Aspegren, John; Mustonen, Mika; Fizazi, Karim
Contributor: University of Helsinki, Heikki Joensuu / Principal Investigator
Date: 2018
Language: eng
Number of pages: 7
Belongs to series: European Urology Focus
ISSN: 2405-4569
URI: http://hdl.handle.net/10138/299672
Abstract: Background: ODM-201, a new androgen receptor antagonist for treatment of metastatic castration-resistant prostate cancer (mCRPC), demonstrated antitumour activity and acceptable tolerability in phase 1/2 trials. Objective: To determine the antitumour activity and safety profile of extended treatment with ODM-201 in men with mCRPC. Design, setting, and participants: ARADES and ARAFOR trials with ODM-201 enrolled chemotherapy-naïve and CYP17 inhibitor (CYP17i)-naïve mCRPC patients. Both trials had extended follow-up. Here we report results for chemotherapy-naïve and CYP17i-naïve patients from both trials (data cutoff October 2014 for ARADES and April 2015 for ARAFOR) after extended follow-up. Intervention: A total of 41 chemotherapy-naïve and CYP17i-naïve patients received oral ODM-201 twice daily (total daily dose of 1200, 1400 or 1800 mg). Outcome measurements and statistical analysis: Antitumour activity was assessed in terms of prostate-specific antigen (PSA) declines and PSA/radiographic progression. Safety was assessed until disease progression and/or drug discontinuation due to any intolerable adverse event (AE). Results and limitations: ODM-201 safety data after a median treatment time of 13.5 mo (95% confidence interval [CI] 9.7–15.6, interquartile range [IQR] 7.5–22.0) were similar to those reported in the main ARADES and ARAFOR trials. The overall AE incidence was 80.5% (n = 33/41), with 58.5% (n = 24/41) of patients experiencing only grade 1–2 AEs. The most common AEs were fatigue, back pain, diarrhoea, nausea, and pain in extremity. The median times to PSA and radiological progression were 12.4 mo (95% CI 6.3–18.2, IQR 5.5–22.0) and 15.3 mo (95% CI 9.5–not reached [NR], IQR 6.3–NR), respectively. Conclusions: Extended treatment with ODM-201 (1200–1800 mg/d) was well tolerated, with no new safety concerns, and provided evidence of sustained antitumour activity in chemotherapy-naïve and CYP17i-naïve patients with mCRPC. Patient summary: Prolonged treatment with high doses of ODM-201 was well tolerated and provided long-lasting disease control in patients with mCRPC. ODM-201 represents a therapeutic treatment option for mCRPC. The ARAFOR trial (including the follow-up stage) and the follow-up component of the ARADES trial are registered with ClinicalTrials.gov as trial numbers NCT01784757 and NCT01429064. Extended treatment with ODM-201 was well tolerated and provided long-lasting disease control in chemotherapy- naïve and CYP17 inhibitor-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). ODM-201 may represent an additional effective treatment option for mCRPC. © 2017 European Association of Urology
Subject: darolutamide
oxygenase inhibitor
prostate specific antigen, abdominal pain
adult
aged
antineoplastic activity
arthralgia
Article
backache
bone pain
cancer growth
castration resistant prostate cancer
clinical article
constipation
decreased appetite
dermatitis
diarrhea
dizziness
drug safety
drug tolerability
dysgeusia
dysuria
fatigue
femoral neck fracture
follow up
gynecomastia
headache
hematuria
hot flush
human
hypertension
hyponatremia
influenza
limb pain
lung adenocarcinoma
male
metastasis
nausea
neuroendocrine carcinoma
phase 1 clinical trial
phase 2 clinical trial
rash
respiratory failure
rhinopharyngitis
rhinorrhea
side effect
somnolence
tinnitus
urine incontinence
vomiting
3122 Cancers
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