Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial
Robert L. Coleman,Amit M. Oza,Domenica Lorusso,Carol Aghajanian,Ana Oaknin,Andrew Dean,Nicoletta Colombo,Johanne I Weberpals,Andrew R Clamp,Giovanni Scambia,Alexandra Leary,Robert W Holloway,Margarita Amenedo Gancedo,Peter C.C. Fong,Jeffrey C. Goh,David M. O'Malley,Deborah K. Armstrong,Jesus Garcia-Donas,Elizabeth M. Swisher,Anne Floquet,Gottfried E. Konecny,Iain A. McNeish,Clare L. Scott,Terri Cameron,Lara Maloney,Jeff Isaacson,Sandra Goble,Caroline Grace,Thomas Harding,Mitch Raponi,James Sun,Kevin K. Lin,Heidi Giordano,Jonathan A. Ledermann,Martin Buck,A Dean,Michael Friedlander,J C Goh,Paul R. Harnett,G Kichenadasse,C L Scott,H Denys,Luc Dirix,Ignace Vergote,Laurie Elit,Prafull Ghatage,Amit M. Oza,Marie Plante,Diane Provencher,J I Weberpals,Stephen Welch,A Floquet,Laurence Gladieff,Florence Joly,A Leary,Alain Lortholary,Jean-Pierre Lotz,J. Medioni,Olivier Tredan,Benoit You,A El-Balat,C Hänle,P Krabisch,T Neunhöffer,M Pölcher,Pauline Wimberger,Amnon Amit,S Kovel,M Leviov,Tamar Safra,Ronnie Shapira-Frommer,Salomon M. Stemmer,Alessandra Bologna,N Colombo,Domenica Lorusso,Sandro Pignata,Roberto Sabbatini,G Scambia,Stefano Tamberi,Claudio Zamagni,P C Fong,A O'Donnell,M Amenedo Gancedo,A Casado Herraez,J Garcia-Donas,E M Guerra,A Oaknin,I Palacio,Iris L. Romero,A Sanchez,Susana Banerjee,A Clamp,Y Drew,Hani Gabra,D Jackson,Jonathan A. Ledermann,I A McNeish,Christine Parkinson,Melanie E Powell,C Aghajanian,D K Armstrong,Michael J. Birrer,Mary K. Buss,Setsuko K. Chambers,L-m Chen,Robert L. Coleman,R W Holloway,G E Konecny,L Ma,Mark A. Morgan,R T Morris,David G. Mutch,D M O'Malley,B M Slomovitz,E M Swisher,T Vanderkwaak,M Vulfovich +116 more
TLDR
This trial assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity.About:
This article is published in The Lancet.The article was published on 2017-10-28 and is currently open access. It has received 1139 citations till now. The article focuses on the topics: Rucaparib & Recurrent Ovarian Carcinoma.read more
Citations
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Pharmacokinetics and clinical response to single agent rucaparib in a dialysis dependent patient with BRCA associated breast and recurrent ovarian cancer
TL;DR: A 56-year old woman with BRCA-associated breast cancer and recurrent ovarian cancer was treated with a poly (ADP-ribose) polymerase enzyme (PARP) inhibitor, rucaparib, in the setting of dialysis-dependence which required dose modification.
Journal ArticleDOI
Role of Poly (ADP-Ribose) Polymerase inhibitors beyond BReast CAncer Gene-mutated ovarian tumours: definition of homologous recombination deficiency?
Charlie Gourley,Rowan Miller,Rowan Miller,Robert L Hollis,Jonathan A. Ledermann,Jonathan A. Ledermann +5 more
TL;DR: Clinical data support the use of PARP inhibitor maintenance therapy beyond BRCA patients and current HRD tests lack negative predictive value and more research is required to develop a composite HRD assay that provides a dynamic readout of HRD status.
Journal ArticleDOI
Systemic treatment of newly diagnosed advanced epithelial ovarian cancer: From chemotherapy to precision medicine
TL;DR: In this article, a review of different therapeutic approaches developed in first-line AOC which range from variations in dose/administration via of conventional carboplatin-based chemotherapy to the incorporation of anti-angiogenic agents and PARP inhibitors is presented.
Journal ArticleDOI
Clinical and molecular characteristics of ARIEL3 patients who derived exceptional benefit from rucaparib maintenance treatment for high-grade ovarian carcinoma.
David M. O'Malley,Amit M. Oza,Domenica Lorusso,Carol Aghajanian,Ana Oaknin,Andrew Dean,Nicoletta Colombo,Johanne I Weberpals,Andrew R Clamp,Giovanni Scambia,Alexandra Leary,Robert G. Holloway,Margarita Amenedo Gancedo,Peter C.C. Fong,Jeffrey C. Goh,Elizabeth M. Swisher,Lara Maloney,Sandra Goble,Kevin K. Lin,Tanya Todorova Kwan,Jonathan A. Ledermann,Robert E. Coleman +21 more
TL;DR: The ARIEL3 trial as mentioned in this paper showed that rucaparib treatment was associated with exceptional benefit compared with placebo: 79/375 (21.1%) vs 4/189 (2.1%), respectively (p < 0.0001).
Journal ArticleDOI
Cardiovascular Concerns in BRCA1 and BRCA2 Mutation Carriers
Kelly C. Gast,Paul V. Viscuse,Somaira Nowsheen,Tufia C. Haddad,Robert W. Mutter,Andrea E. Wahner Hendrickson,Fergus J. Couch,Kathryn J. Ruddy +7 more
TL;DR: Understanding the potential for increased cardiovascular risk in individuals with a BRCA1 or BRCa2 mutation, as well as gold standard practices for prevention, detection, and treatment of cardiac concerns in this population, is important.
References
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New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
Elizabeth Eisenhauer,P. Therasse,Jan Bogaerts,Lawrence H. Schwartz,Daniel J. Sargent,Robert Ford,Janet Dancey,S. Arbuck,S. Gwyther,Margaret M. Mooney,Larry Rubinstein,Lalitha K. Shankar,Lori E. Dodd,Robert M. Kaplan,Denis Lacombe,Jaap Verweij +15 more
TL;DR: The revised RECIST includes a new imaging appendix with updated recommendations on the optimal anatomical assessment of lesions, and a section on detection of new lesions, including the interpretation of FDG-PET scan assessment is included.
Journal ArticleDOI
Niraparib Maintenance Therapy in Platinum-Sensitive, Recurrent Ovarian Cancer
Mansoor Raza Mirza,Bradley J. Monk,Jørn Herrstedt,Amit M. Oza,Sven Mahner,Sven Mahner,Andrés Redondo,Michel Fabbro,Jonathan A. Ledermann,Domenica Lorusso,Ignace Vergote,Noa Ben-Baruch,Christian Marth,Radosław Mądry,René dePont Christensen,Jonathan S. Berek,Anne Dørum,Anne Dørum,Anna V. Tinker,Andreas du Bois,Antonio González-Martín,Philippe Follana,Benedict B. Benigno,Per Rosenberg,Lucy Gilbert,Bobbie J. Rimel,Joseph Buscema,John Balser,Shefali Agarwal,Ursula A. Matulonis,Ursula A. Matulonis +30 more
TL;DR: Among patients with platinum-sensitive, recurrent ovarian cancer, the median duration of progression-free survival was significantly longer amongThose receiving niraparib than among those receiving placebo, regardless of the presence or absence of gBRCA mutations or HRD status, with moderate bone marrow toxicity.
Journal ArticleDOI
Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer.
Jonathan A. Ledermann,Philipp Harter,Charlie Gourley,Michael Friedlander,Ignace Vergote,Gordon J. S. Rustin,Clare L. Scott,Werner Meier,Ronnie Shapira-Frommer,Tamar Safra,Daniela Matei,Euan Macpherson,Claire Watkins,James Carmichael,Ursula A. Matulonis +14 more
TL;DR: Olaparib as maintenance treatment significantly improved progression-free survival among patients with platinum-sensitive, relapsed, high-grade serous ovarian cancer and the toxicity profile of olaparIB in this population was consistent with that in previous studies.
Journal ArticleDOI
Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial
Eric Pujade-Lauraine,Jonathan A. Ledermann,Frédéric Selle,Val Gebski,Richard T Penson,Amit M. Oza,Jacob Korach,Tomasz Huzarski,Andres Poveda,Sandro Pignata,Michael Friedlander,Nicoletta Colombo,Philipp Harter,Keiichi Fujiwara,Isabelle Ray-Coquard,Susana Banerjee,Joyce F. Liu,Elizabeth S. Lowe,Ralph Bloomfield,Patricia Pautier,Tomasz Byrski,Giovanni Scambia,Maria Ornella Nicoletto,Fiona Nussey,Andrew R Clamp,Richard T. Penson,Amit M. Oza,Andrés Poveda Velasco,Manuel Rodrigues,Jean-Pierre Lotz,Diane Provencher,Aleix Prat Aparicio,Laura Vidal Boixader,Clare L. Scott,Kenji Tamura,Mayu Yunokawa,Alla Lisyanskaya,Jacques Medioni,Nicolas Pécuchet,Coraline Dubot,Thibault De La Motte Rouge,Marie-Christine Kaminsky,Béatrice Weber,Alain Lortholary,Christine Parkinson,Jonathan A. Ledermann,Sarah Williams,Jonathan Cosin,James Hoffman,Marie Plante,Allan Covens,Gabe S. Sonke,Florence Joly,Anne Floquet,H. Hirte,Amnon Amit,Tjoung-Won Park-Simon,Koji Matsumoto,Sergei Tjulandin,Jae Hoon Kim,Jae Hoon Kim,Laurence Gladieff,Roberto Sabbatini,David M. O'Malley,Patrick Timmins,Daniel Kredentser,Nuria Laínez Milagro,Maria Pilar Barretina Ginesta,Ariadna Tibau Martorell,Alfonso Gómez de Liaño Lista,Belén Ojeda González,Linda Mileshkin,Masaki Mandai,Ingrid A. Boere,Petronella B. Ottevanger,Joo-Hyun Nam,Elias Abdo Filho,Salima Hamizi,Francesco Cognetti,David Warshal,Elizabeth Dickson-Michelson,Scott Kamelle,Nathalie McKenzie,Gustavo C. Rodriguez,Deborah K. Armstrong,Eva Chalas,Paul Celano,Kian Behbakht,Susan E Davidson,Stephen Welch,Limor Helpman,Ami Fishman,Ilan Bruchim,Magdalena Sikorska,Anna Słowińska,Wojciech Rogowski,Mariusz Bidziński,Beata Śpiewankiewicz,Antonio Casado Herraez,César Mendiola Fernández,Martina Gropp-Meier,Toshiaki Saito,Kazuhiro Takehara,Takayuki Enomoto,Hidemichi Watari,Chel Hun Choi,Byoung-Gie Kim,Jae Weon Kim,Jae Weon Kim,Roberto Hegg,Ignace Vergote +110 more
TL;DR: Olaparib tablet maintenance treatment provided a significant progression-free survival improvement with no detrimental effect on quality of life in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation.
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