TY - JOUR
T1 - Guidelines for Management of Treatment-Emergent Adverse Events During Rucaparib Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer
AU - Labadie, Brian W.
AU - Morris, David S.
AU - Bryce, Alan H.
AU - Given, Robert
AU - Zhang, Jingsong
AU - Abida, Wassim
AU - Chowdhury, Simon
AU - Patnaik, Akash
N1 - Funding Information:
A Patnaik has served in a consulting or advisory role for Exelixis, Janssen, and Jounce Therapeutics; has received honoraria from Clovis Oncology, Merck, Prime Inc., and Roche; and has received research funding from Clovis Oncology, Progenics, Bristol Myers Squibb, and GlaxoSmithKline; and has received clinical trial support from Laekna and AstraZeneca outside the submitted work.
Funding Information:
Medical writing and editorial assistance were provided by Nathan Yardley and Frederique H. Evans of Ashfield MedComms, an Ashfield Health company (Middletown, CT, USA), and funded by Clovis Oncology, Inc.
Funding Information:
W Abida has served in a consulting or advisory role for Clovis Oncology, Daiichi Sankyo, Janssen Pharmaceuticals, MORE Health, and ORIC Pharmaceuticals; has received financial support for travel and/or accommodation from Clovis Oncology and ORIC Pharmaceuticals; has received personal fees from Roche, Medscape, and Onclive, outside the submitted work; and his institution has received research funding from Clovis Oncology, AstraZeneca, and Zenith Epigenetics. He is funded by National Cancer Institute (NCI) Cancer Center Support Grant P30 CA 008748, NCI Prostate Specialized Program of Research Excellence (SPORE) grant P50 CA092629-16, Department of Defense Prostate Cancer Research Program grant W81XWH-17-1-0124, and a Prostate Cancer Foundation Young Investigator Award.
Funding Information:
S Chowdhury has served in a consulting or advisory role and/or on speakers bureaus for Clovis Oncology, Astellas, Bayer, BeiGene, Janssen, and Pfizer; received honoraria from GlaxoSmithKline; received financial support for travel and accommodation from Clovis Oncology and BeiGene: and holds stock in Curve.life; grants from Sanofi; personal fees from Huma, Remedy, Telix, Novartis, and Astra Zeneca, during the conduct of the study.
Funding Information:
DS Morris has served in a consulting/advisory role for and received research funding from Clovis Oncology, AstraZeneca, Astellas, Bayer, Dendreon, Merck, Janssen, and Pfizer.
Publisher Copyright:
© 2022 Labadie et al.
PY - 2022
Y1 - 2022
N2 - Purpose: The US Food and Drug Administration has recently granted accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib as treatment for men with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious germ-line or somatic BRCA1 or BRCA2 (BRCA) alteration. As the safety profile of this new addition to the mCRPC treatment landscape may be unfamiliar to clinicians and patients, we summarize the data from the literature and provide practical guidelines for the management of treatment-emergent adverse events (TEAEs) that may occur during rucaparib treatment. Materials and Methods: Safety data were identified from PubMed and congress publica-tions of trials involving men with mCRPC treated with oral rucaparib monotherapy (600 mg twice daily). Management guidelines for TEAEs were developed based on trial protocols, prescribing information, oncology association guidance, and the authors’ clinical experience. Results: In clinical trials of men with mCRPC who received rucaparib (n = 193), TEAEs observed were consistent with that of other PARP inhibitors. The most frequent any-grade TEAEs included gastrointestinal events, asthenia/fatigue, anemia, increased alanine/aspartate aminotransferase, rash, and thrombocytopenia; the most frequent grade ≥3 TEAE was anemia. The majority of TEAEs were self-limiting and did not require treatment modification or interruption. Here, we provide recommendations on management of the most common TEAEs reported with rucaparib as well as other TEAEs of interest. Conclusion: Rucaparib’s recent approval for treatment of BRCA-mutant mCRPC is practice changing. Proper management of TEAEs will allow maximum treatment benefit for patients receiving rucaparib.
AB - Purpose: The US Food and Drug Administration has recently granted accelerated approval of the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib as treatment for men with metastatic castration-resistant prostate cancer (mCRPC) associated with a deleterious germ-line or somatic BRCA1 or BRCA2 (BRCA) alteration. As the safety profile of this new addition to the mCRPC treatment landscape may be unfamiliar to clinicians and patients, we summarize the data from the literature and provide practical guidelines for the management of treatment-emergent adverse events (TEAEs) that may occur during rucaparib treatment. Materials and Methods: Safety data were identified from PubMed and congress publica-tions of trials involving men with mCRPC treated with oral rucaparib monotherapy (600 mg twice daily). Management guidelines for TEAEs were developed based on trial protocols, prescribing information, oncology association guidance, and the authors’ clinical experience. Results: In clinical trials of men with mCRPC who received rucaparib (n = 193), TEAEs observed were consistent with that of other PARP inhibitors. The most frequent any-grade TEAEs included gastrointestinal events, asthenia/fatigue, anemia, increased alanine/aspartate aminotransferase, rash, and thrombocytopenia; the most frequent grade ≥3 TEAE was anemia. The majority of TEAEs were self-limiting and did not require treatment modification or interruption. Here, we provide recommendations on management of the most common TEAEs reported with rucaparib as well as other TEAEs of interest. Conclusion: Rucaparib’s recent approval for treatment of BRCA-mutant mCRPC is practice changing. Proper management of TEAEs will allow maximum treatment benefit for patients receiving rucaparib.
KW - Adverse drug reaction
KW - Metastatic castration-resistant prostate cancer
KW - Poly(ADP-ribose) polymerase inhibitors
KW - Rucaparib
UR - http://www.scopus.com/inward/record.url?scp=85125063920&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85125063920&partnerID=8YFLogxK
U2 - 10.2147/CMAR.S335962
DO - 10.2147/CMAR.S335962
M3 - Article
AN - SCOPUS:85125063920
VL - 14
SP - 673
EP - 686
JO - Cancer Management and Research
JF - Cancer Management and Research
SN - 1179-1322
ER -