PMID- 32495160
OWN - NLM
STAT- MEDLINE
DCOM- 20210302
LR  - 20230106
IS  - 1776-260X (Electronic)
IS  - 1776-2596 (Print)
IS  - 1776-2596 (Linking)
VI  - 15
IP  - 3
DP  - 2020 Jun
TI  - Management of Adverse Events During Rucaparib Treatment for Relapsed Ovarian 
      Cancer: A Review of Published Studies and Practical Guidance.
PG  - 391-406
LID - 10.1007/s11523-020-00715-z [doi]
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.
FAU - Lorusso, Domenica
AU  - Lorusso D
AD  - Gynecologic Oncology Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, 
      Largo Agostino Gemelli 8, 00168, Rome, Italy. 
      domenica.lorusso@policlinicogemelli.it.
FAU - Garcia-Donas, Jesus
AU  - Garcia-Donas J
AD  - Medical Oncology Service, HM Hospitales-Centro Integral Oncologico Hospital de 
      Madrid Clara Campal, Madrid, Spain.
FAU - Sehouli, Jalid
AU  - Sehouli J
AD  - Department of Gynecology and Oncological Surgery, Charite University Medicine of 
      Berlin and NOGGO, Berlin, Germany.
FAU - Joly, Florence
AU  - Joly F
AD  - Medical Oncology Department, Centre Francois Baclesse, Universite Unicaen and 
      GINECO, Caen, France.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - France
TA  - Target Oncol
JT  - Targeted oncology
JID - 101270595
RN  - 0 (Indoles)
RN  - 0 (Poly(ADP-ribose) Polymerase Inhibitors)
RN  - 8237F3U7EH (rucaparib)
SB  - IM
MH  - Female
MH  - Humans
MH  - Indoles/*adverse effects
MH  - Neoplasm Recurrence, Local
MH  - Ovarian Neoplasms/*complications/drug therapy
MH  - Poly(ADP-ribose) Polymerase Inhibitors/pharmacology/*therapeutic use
PMC - PMC7283207
COIS- 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. Jesus Garcia-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.
EDAT- 2020/06/05 06:00
MHDA- 2021/03/03 06:00
PMCR- 2020/06/03
CRDT- 2020/06/05 06:00
PHST- 2020/06/05 06:00 [pubmed]
PHST- 2021/03/03 06:00 [medline]
PHST- 2020/06/05 06:00 [entrez]
PHST- 2020/06/03 00:00 [pmc-release]
AID - 10.1007/s11523-020-00715-z [pii]
AID - 715 [pii]
AID - 10.1007/s11523-020-00715-z [doi]
PST - ppublish
SO  - Target Oncol. 2020 Jun;15(3):391-406. doi: 10.1007/s11523-020-00715-z.