Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma

Carcinoma d'ovari recurrent; Rucaparib

Detalles Bibliográficos
Autores: Oza, Amit M., Lorusso, Domenica, Oaknin Benzaquen, Ana Mazaltob, Dean, Andrew, Colombo, Nicoletta, Aghajanian, Carol
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Institución:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositorio:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:11351/6307
Acceso en línea:https://hdl.handle.net/11351/6307
Access Level:acceso abierto
Palabra clave:Ovaris - Tumors
Medicaments antineoplàstics - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Ovarian Epithelial
Other subheadings::Other subheadings::Other subheadings::/drug therapy
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma epitelial de ovario
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local
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oai_identifier_str oai:recercat.cat:11351/6307
network_acronym_str ES
network_name_str España
repository_id_str
dc.title.none.fl_str_mv Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
title Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
spellingShingle Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
Oza, Amit M.
Ovaris - Tumors
Medicaments antineoplàstics - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Ovarian Epithelial
Other subheadings::Other subheadings::Other subheadings::/drug therapy
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma epitelial de ovario
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local
title_short Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
title_full Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
title_fullStr Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
title_full_unstemmed Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
title_sort Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian Carcinoma
dc.creator.none.fl_str_mv Oza, Amit M.
Lorusso, Domenica
Oaknin Benzaquen, Ana Mazaltob
Dean, Andrew
Colombo, Nicoletta
Aghajanian, Carol
author Oza, Amit M.
author_facet Oza, Amit M.
Lorusso, Domenica
Oaknin Benzaquen, Ana Mazaltob
Dean, Andrew
Colombo, Nicoletta
Aghajanian, Carol
author_role author
author2 Lorusso, Domenica
Oaknin Benzaquen, Ana Mazaltob
Dean, Andrew
Colombo, Nicoletta
Aghajanian, Carol
author2_role author
author
author
author
author
dc.contributor.none.fl_str_mv Institut Català de la Salut
[Oza AM] Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. [Lorusso D] Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. [Aghajanian C] Memorial Sloan Kettering Cancer Center, New York, NY. [Oaknin A] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Dean A] St John of God Subiaco Hospital, Subiaco, WA, Australia. [Colombo N] University of Milan-Bicocca and European Institute of Oncology, Milan, Italy
Vall d'Hebron Barcelona Hospital Campus
dc.subject.none.fl_str_mv Ovaris - Tumors
Medicaments antineoplàstics - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Ovarian Epithelial
Other subheadings::Other subheadings::Other subheadings::/drug therapy
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma epitelial de ovario
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local
topic Ovaris - Tumors
Medicaments antineoplàstics - Ús terapèutic
DISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Ovarian Epithelial
Other subheadings::Other subheadings::Other subheadings::/drug therapy
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, Local
ENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma epitelial de ovario
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
ENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica local
description Carcinoma d'ovari recurrent; Rucaparib
publishDate 2020
dc.date.none.fl_str_mv 2020
2021
2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11351/6307
url https://hdl.handle.net/11351/6307
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Journal of Clinical Oncology;38(30)
https://doi.org/10.1200/JCO.19.03107
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv American Society of Clinical Oncology
publisher.none.fl_str_mv American Society of Clinical Oncology
dc.source.none.fl_str_mv Scientia
reponame:Recercat. Dipósit de la Recerca de Catalunya
instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
instname_str Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
reponame_str Recercat. Dipósit de la Recerca de Catalunya
collection Recercat. Dipósit de la Recerca de Catalunya
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869411422060937216
spelling Patient-Centered Outcomes in ARIEL3, a Phase III, Randomized, Placebo-Controlled Trial of Rucaparib Maintenance Treatment in Patients With Recurrent Ovarian CarcinomaOza, Amit M.Lorusso, DomenicaOaknin Benzaquen, Ana MazaltobDean, AndrewColombo, NicolettaAghajanian, CarolOvaris - TumorsMedicaments antineoplàstics - Ús terapèuticDISEASES::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Carcinoma, Ovarian EpithelialOther subheadings::Other subheadings::Other subheadings::/drug therapyDISEASES::Neoplasms::Neoplastic Processes::Neoplasm Recurrence, LocalENFERMEDADES::neoplasias::neoplasias por tipo histológico::neoplasias glandulares y epiteliales::carcinoma::carcinoma epitelial de ovarioOtros calificadores::Otros calificadores::Otros calificadores::/farmacoterapiaENFERMEDADES::neoplasias::procesos neoplásicos::recurrencia neoplásica localCarcinoma d'ovari recurrent; RucaparibCarcinoma de ovario recurrente; RucaparibRecurrent Ovarian Carcinoma; RucaparibPURPOSE To investigate quality-adjusted progression-free survival (QA-PFS) and quality-adjusted time without symptoms or toxicity (Q-TWiST) in a post hoc exploratory analysis of the phase III ARIEL3 study of rucaparib maintenance treatment versus placebo. PATIENTS AND METHODS Patients with platinum-sensitive, recurrent ovarian carcinoma were randomly assigned to rucaparib (600 mg twice per day) or placebo. QA-PFS was calculated as progression-free survival function × the 3-level version of the EQ-5D questionnaire (EQ-5D-3L) index score function. Q-TWiST analyses were performed defining TOX as the mean duration in which a patient experienced grade ≥ 3 treatment-emergent adverse events (TEAEs) or the mean duration in which a patient experienced grade ≥ 2 TEAEs of nausea, vomiting, fatigue, and asthenia. Q-TWiST was calculated as μTOX × TOX + TWiST, with μTOX calculated using EQ-5D-3L data. RESULTS The visit cutoff was Apr 15, 2017. Mean QA-PFS was significantly longer with rucaparib versus placebo in the intent-to-treat (ITT) population (375 randomly assigned to rucaparib v 189 randomly assigned to placebo; difference, 6.28 months [95% CI, 4.85 to 7.47 months]); BRCA-mutant cohort (130 rucaparib v 66 placebo; 9.37 months [95% CI, 6.65 to 11.85 months]); homologous recombination deficient (HRD) cohort (236 rucaparib v 118 placebo; 7.93 months [95% CI, 5.93 to 9.53 months]); and BRCA wild-type/loss of heterozygosity (LOH) low patient subgroup (107 rucaparib v 54 placebo; 2.71 months [95% CI, 0.31 to 4.44 months]). With TOX defined using grade ≥ 3 TEAEs, the difference in mean Q-TWiST (rucaparib v placebo) was 6.88 months (95% CI, 5.71 to 8.23 months), 9.73 months (95% CI, 7.10 to 11.94 months), 8.11 months (95% CI, 6.36 to 9.49 months), and 3.35 months (95% CI, 1.66 to 5.40 months) in the ITT population, BRCA-mutant cohort, HRD cohort, and BRCA wild-type/LOH low patient subgroup, respectively. Q-TWiST with TOX defined using select grade ≥ 2 TEAEs also consistently favored rucaparib. CONCLUSION The significant differences in QA-PFS and Q-TWiST confirm the benefit of rucaparib versus placebo in all predefined cohorts.Supported by Clovis Oncology. Additional support was provided in part by the Ann Rife Cox Chair in Gynecology and the Judy Reis/Albert Pisani, MD, Ovarian Cancer Research Fund (to R.L.C.) and by the National Institute of Health Research Biomedical Research Centre at University College London (to J.A.L.). C.A. is supported in part by Memorial Sloan Kettering Cancer Center Support Grant P30 CA008748. Funding was also provided by US Department of Defense Ovarian Cancer Research Program OC120506, a V Foundation Translational Award, and a Stand Up To Cancer–Ovarian Cancer Research Fund Alliance–National Ovarian Cancer Coalition Dream Team Translational Research Grant (Grant No. SU2C-AACR-DT16–15; all to E.M.S.). Stand Up to Cancer is a program of the Entertainment Industry Foundation; research grants are administered by the American Association for Cancer Research, a scientific partner of Stand Up To Cancer.American Society of Clinical OncologyInstitut Català de la Salut[Oza AM] Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. [Lorusso D] Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. [Aghajanian C] Memorial Sloan Kettering Cancer Center, New York, NY. [Oaknin A] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Dean A] St John of God Subiaco Hospital, Subiaco, WA, Australia. [Colombo N] University of Milan-Bicocca and European Institute of Oncology, Milan, ItalyVall d'Hebron Barcelona Hospital Campus202120212020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/11351/6307Scientiareponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésJournal of Clinical Oncology;38(30)https://doi.org/10.1200/JCO.19.03107Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:11351/63072026-05-29T05:05:01Z
score 15,811543

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