Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial

C. J. Gratzke; K. Fizazi; N. D. Shore; M. R. Smith; S. Feyerabend; M. Grabbert; J. Carles; T. Lebret; E. Vjaters; P. Werbrouck; M. Miskic; J. Ortiz; A. Schmall; M. A. Le Berre; F. Verholen

doi:10.1016/j.annonc.2021.08.1143

Abstract

Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are generally asymptomatic and may receive prolonged treatment with androgen receptor inhibitors (ARIs). Understanding the burden and time course of adverse events (AEs) commonly associated with ARIs that may impact patients' daily life will help inform optimal treatment selection for men with nmCRPC. We present analyses of time to AEs of interest associated with some ARIs (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these AEs, grade 3/4 AEs, and serious AEs from ARAMIS. Method(s): Men with nmCRPC were randomized 2:1 to darolutamide (DARO; n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. The cumulative incidence of AEs was analyzed using Kaplan-Meier estimates for the first 24 months of the double-blind (DB) period to ensure >10% of the population in each treatment cohort. Time interval-specific analysis determined new event rates at each scheduled study visit. Result(s): During the first 24 months of the DB period, the incidence of AEs of interest in the DARO group was low and

Original language	English
Article number	630P
Pages (from-to)	S664-S664
Journal	Annals of Oncology
Volume	32
Issue number	Supplement 5
DOIs	https://doi.org/10.1016/j.annonc.2021.08.1143
Publication status	Published - 2021
Externally published	Yes
Event	European Society of Medical Oncology (ESMO) Congress - virtual, Lugano, Switzerland Duration: 17 Sept 2021 → 21 Sept 2021 https://www.urotoday.com/calendar-events/476.html https://beyondspringpharma.com/european-society-for-medical-oncology-esmo-congress-2021/ https://www.radioonkologie.mri.tum.de/de/event/esmo-congress-2021-european-society-medical-oncology

Field of Science*

3.2 Clinical medicine
3.1 Basic medicine

Publication Type*

3.3. Publications in conference proceedings indexed in Web of Science and/or Scopus database

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1016/j.annonc.2021.08.1143

Cite this

Gratzke, C. J., Fizazi, K., Shore, N. D., Smith, M. R., Feyerabend, S., Grabbert, M., Carles, J., Lebret, T., Vjaters, E., Werbrouck, P., Miskic, M., Ortiz, J., Schmall, A., Le Berre, M. A., & Verholen, F. (2021). Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial. Annals of Oncology, 32(Supplement 5), S664-S664. Article 630P. https://doi.org/10.1016/j.annonc.2021.08.1143

@article{b5d4760300c840788848687f721d6f9a,

title = "Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial",

abstract = "Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are generally asymptomatic and may receive prolonged treatment with androgen receptor inhibitors (ARIs). Understanding the burden and time course of adverse events (AEs) commonly associated with ARIs that may impact patients' daily life will help inform optimal treatment selection for men with nmCRPC. We present analyses of time to AEs of interest associated with some ARIs (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these AEs, grade 3/4 AEs, and serious AEs from ARAMIS. Method(s): Men with nmCRPC were randomized 2:1 to darolutamide (DARO; n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. The cumulative incidence of AEs was analyzed using Kaplan-Meier estimates for the first 24 months of the double-blind (DB) period to ensure >10% of the population in each treatment cohort. Time interval-specific analysis determined new event rates at each scheduled study visit. Result(s): During the first 24 months of the DB period, the incidence of AEs of interest in the DARO group was low and ",

author = "Gratzke, {C. J.} and K. Fizazi and Shore, {N. D.} and Smith, {M. R.} and S. Feyerabend and M. Grabbert and J. Carles and T. Lebret and E. Vjaters and P. Werbrouck and M. Miskic and J. Ortiz and A. Schmall and {Le Berre}, {M. A.} and F. Verholen",

year = "2021",

doi = "10.1016/j.annonc.2021.08.1143",

language = "English",

volume = "32",

pages = "S664--S664",

journal = "Annals of Oncology",

issn = "0923-7534",

publisher = "Elsevier Ltd.",

number = "Supplement 5",

note = "European Society of Medical Oncology (ESMO) Congress, ESMO 2021 ; Conference date: 17-09-2021 Through 21-09-2021",

url = "https://www.urotoday.com/calendar-events/476.html, https://beyondspringpharma.com/european-society-for-medical-oncology-esmo-congress-2021/, https://www.radioonkologie.mri.tum.de/de/event/esmo-congress-2021-european-society-medical-oncology",

}

Gratzke, CJ, Fizazi, K, Shore, ND, Smith, MR, Feyerabend, S, Grabbert, M, Carles, J, Lebret, T, Vjaters, E, Werbrouck, P, Miskic, M, Ortiz, J, Schmall, A, Le Berre, MA & Verholen, F 2021, 'Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial', Annals of Oncology, vol. 32, no. Supplement 5, 630P, pp. S664-S664. https://doi.org/10.1016/j.annonc.2021.08.1143

TY - JOUR

T1 - Time course profile of adverse events of interest and serious adverse events with darolutamide in the ARAMIS trial

AU - Gratzke, C. J.

AU - Fizazi, K.

AU - Shore, N. D.

AU - Smith, M. R.

AU - Feyerabend, S.

AU - Grabbert, M.

AU - Carles, J.

AU - Lebret, T.

AU - Vjaters, E.

AU - Werbrouck, P.

AU - Miskic, M.

AU - Ortiz, J.

AU - Schmall, A.

AU - Le Berre, M. A.

AU - Verholen, F.

PY - 2021

Y1 - 2021

N2 - Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are generally asymptomatic and may receive prolonged treatment with androgen receptor inhibitors (ARIs). Understanding the burden and time course of adverse events (AEs) commonly associated with ARIs that may impact patients' daily life will help inform optimal treatment selection for men with nmCRPC. We present analyses of time to AEs of interest associated with some ARIs (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these AEs, grade 3/4 AEs, and serious AEs from ARAMIS. Method(s): Men with nmCRPC were randomized 2:1 to darolutamide (DARO; n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. The cumulative incidence of AEs was analyzed using Kaplan-Meier estimates for the first 24 months of the double-blind (DB) period to ensure >10% of the population in each treatment cohort. Time interval-specific analysis determined new event rates at each scheduled study visit. Result(s): During the first 24 months of the DB period, the incidence of AEs of interest in the DARO group was low and

AB - Background: Men with nonmetastatic castration-resistant prostate cancer (nmCRPC) are generally asymptomatic and may receive prolonged treatment with androgen receptor inhibitors (ARIs). Understanding the burden and time course of adverse events (AEs) commonly associated with ARIs that may impact patients' daily life will help inform optimal treatment selection for men with nmCRPC. We present analyses of time to AEs of interest associated with some ARIs (fatigue, falls, fracture, hypertension, mental impairment, and rash) and the cumulative incidence of these AEs, grade 3/4 AEs, and serious AEs from ARAMIS. Method(s): Men with nmCRPC were randomized 2:1 to darolutamide (DARO; n=955) or placebo (PBO; n=554) while continuing androgen deprivation therapy. The cumulative incidence of AEs was analyzed using Kaplan-Meier estimates for the first 24 months of the double-blind (DB) period to ensure >10% of the population in each treatment cohort. Time interval-specific analysis determined new event rates at each scheduled study visit. Result(s): During the first 24 months of the DB period, the incidence of AEs of interest in the DARO group was low and

UR - https://www-webofscience-com.db.rsu.lv/wos/woscc/full-record/WOS:000700527701096

U2 - 10.1016/j.annonc.2021.08.1143

DO - 10.1016/j.annonc.2021.08.1143

M3 - Meeting Abstract

SN - 0923-7534

VL - 32

SP - S664-S664

JO - Annals of Oncology

JF - Annals of Oncology

IS - Supplement 5

M1 - 630P

T2 - European Society of Medical Oncology (ESMO) Congress

Y2 - 17 September 2021 through 21 September 2021

ER -