TY - JOUR
T1 - Management of Adverse Events During Rucaparib Treatment for Relapsed Ovarian Cancer
T2 - A Review of Published Studies and Practical Guidance
AU - Lorusso, Domenica
AU - García-Donas, Jesús
AU - Sehouli, Jalid
AU - Joly, Florence
N1 - Funding Information:
This work was funded by Clovis Oncology, Inc.
Funding Information:
Writing and editorial assistance funded by Clovis Oncology, Inc., were provided by Nathan Yardley, PhD, and Shannon Davis of Ashfield Healthcare Communications (Middletown, CT, USA).
Funding Information:
Domenica Lorusso has served in a consulting or advisory role for Clovis Oncology, AstraZeneca, F. Hoffman-La Roche, ImmunoGen, Merck, PharmaMar, Takeda, and Tesaro, and has received support for travel or accommodation from F. Hoffman-La Roche and PharmaMar. Jesús García-Donas has received research funding from AstraZeneca, and has served on advisory boards for Clovis Oncology, Genentech/Roche, and Janssen. Jalid Sehouli has served in a consulting or advisory role for Clovis Oncology, AstraZeneca, Bristol-Myers Squibb, Eisai, Eli Lilly, F. Hoffman-La Roche, Merck, Pfizer Inc., Sanofi, and Tesaro, and has received support for travel or accommodation from Clovis Oncology, AstraZeneca, F. Hoffman-La Roche, PharmaMar, and Tesaro. Florence Joly has served in a consulting or advisory role for Clovis Oncology, Astellas, AstraZeneca, Bayer AG, Bristol-Myers Squibb, F. Hoffman-La Roche, Ipsen, Janssen, Merck, Novartis, Pfizer, Sanofi, and Tesaro, and has received support for travel or accommodation from Astellas, AstraZeneca, Bristol-Myers Squibb, F. Hoffman-La Roche, Ipsen, Janssen, and Tesaro.
Publisher Copyright:
© 2020, The Author(s).
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/6/1
Y1 - 2020/6/1
N2 - The poly(ADP-ribose) polymerase inhibitor rucaparib is approved as monotherapy in the treatment and maintenance settings for women with relapsed ovarian cancer in the European Union and the United States. We review the safety profile of rucaparib in both settings and provide recommendations for the clinical management of the main adverse events (AEs) that may occur during rucaparib treatment. We searched PubMed and congress proceedings for safety data on oral rucaparib monotherapy (600 mg twice daily) from clinical trials involving patients with relapsed ovarian cancer. AE management guidance was developed from clinical trial protocols, rucaparib prescribing information, oncology association guidelines, and author experience. The most frequent any-grade treatment-emergent AEs (TEAEs) included gastrointestinal symptoms, asthenia/fatigue, dysgeusia, anemia/decreased hemoglobin, and increased alanine/aspartate aminotransferase. Across clinical trials, 61.8% of patients had one or more grade 3 or higher TEAEs. Clinicians should employ close follow-up for TEAEs, particularly early in treatment, and educate patients about expected TEAEs and methods for their monitoring and management (e.g., antiemetics for nausea/vomiting, transfusions for hematologic TEAEs, or dose interruptions/reductions for moderate/severe TEAEs). Overall, 16.2% of patients discontinued rucaparib due to TEAEs. Management of AEs that may occur during rucaparib treatment is crucial for patients to obtain optimal clinical benefit by remaining on therapy and to avoid their detrimental impact on quality of life.
AB - The poly(ADP-ribose) polymerase inhibitor rucaparib is approved as monotherapy in the treatment and maintenance settings for women with relapsed ovarian cancer in the European Union and the United States. We review the safety profile of rucaparib in both settings and provide recommendations for the clinical management of the main adverse events (AEs) that may occur during rucaparib treatment. We searched PubMed and congress proceedings for safety data on oral rucaparib monotherapy (600 mg twice daily) from clinical trials involving patients with relapsed ovarian cancer. AE management guidance was developed from clinical trial protocols, rucaparib prescribing information, oncology association guidelines, and author experience. The most frequent any-grade treatment-emergent AEs (TEAEs) included gastrointestinal symptoms, asthenia/fatigue, dysgeusia, anemia/decreased hemoglobin, and increased alanine/aspartate aminotransferase. Across clinical trials, 61.8% of patients had one or more grade 3 or higher TEAEs. Clinicians should employ close follow-up for TEAEs, particularly early in treatment, and educate patients about expected TEAEs and methods for their monitoring and management (e.g., antiemetics for nausea/vomiting, transfusions for hematologic TEAEs, or dose interruptions/reductions for moderate/severe TEAEs). Overall, 16.2% of patients discontinued rucaparib due to TEAEs. Management of AEs that may occur during rucaparib treatment is crucial for patients to obtain optimal clinical benefit by remaining on therapy and to avoid their detrimental impact on quality of life.
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U2 - 10.1007/s11523-020-00715-z
DO - 10.1007/s11523-020-00715-z
M3 - Review article
C2 - 32495160
AN - SCOPUS:85086022098
VL - 15
SP - 391
EP - 406
JO - Targeted Oncology
JF - Targeted Oncology
SN - 1776-2596
IS - 3
ER -