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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Journal ArticleDOI
Quantitative determination of niraparib and olaparib tumor distribution by mass spectrometry imaging.
Lavinia Morosi,Cristina Matteo,Tommaso Ceruti,Silvia Giordano,Marianna Ponzo,Roberta Frapolli,Massimo Zucchetti,Enrico Davoli,Maurizio D'Incalci,Paolo Ubezio +9 more
TL;DR: These data confirm the validity of targeted mass spectrometry imaging for spatial quantitative measurement of drug distribution providing fundamental information for pharmacokinetic studies, drug discovery and the study of resistance mechanisms.
Journal ArticleDOI
Antitumor activity of the poly(ADP-ribose) polymerase inhibitor rucaparib as monotherapy in patients with platinum-sensitive, relapsed, BRCA-mutated, high-grade ovarian cancer, and an update on safety.
Rebecca Kristeleit,Ana Oaknin,Isabelle Ray-Coquard,Alexandra Leary,Judith Balmaña,Yvette Drew,Amit M. Oza,Ronnie Shapira-Frommer,Susan M. Domchek,Terri Cameron,Lara Maloney,Sandra Goble,Domenica Lorusso,Jonathan A. Ledermann,Iain A. McNeish +14 more
TL;DR: In patients with platinum-sensitive, BRCA-mutated ovarian cancer, rucaparib demonstrated antitumor activity and is the first and currently the only poly(ADP-ribose) polymerase inhibitor approved by the European Commission as treatment for this population.
Journal ArticleDOI
Targeting mutations in cancer
TL;DR: The current knowledge of targetable mutations that occur in a range of cancers, including hematologic malignancies and solid tumors such as non–small cell lung cancer and breast cancer are summarized.
Journal ArticleDOI
Comprehensive profiling of BRCA1 and BRCA2 variants in breast and ovarian cancer in Chinese patients
Gao Xianqi,Nan Xiyan,Liu Yilan,Liu Rui,Wanchun Zang,Guangyu Shan,Fei Gai,Jingfeng Zhang,Lei Li,Gang Cheng,Lele Song +10 more
TL;DR: This study represents the first comprehensive meta‐analysis of Chinese BRCA1/2 variants and validates the in‐house pathogenicity interpretation procedure, thereby providing guidance for further PARP inhibitor development and companion diagnostics in the Chinese population.
Journal ArticleDOI
A phase II study of talazoparib monotherapy in patients with wild-type BRCA1 and BRCA2 with a mutation in other homologous recombination genes
Joshua J. Gruber,Anosheh Afghahi,Kirsten Timms,Alyssa Dewees,Wyatt Gross,Vasily N. Aushev,Hsin-Ta Wu,Mustafa Balcioglu,H. Sethi,Danika Scott,Jessica Foran,Alex McMillan,James M. Ford,Melinda L. Telli +13 more
TL;DR: In this article , the authors conducted Talazoparib beyond BRCA (NCT02401347) trial to evaluate talazoparaib in patients with pretreated advanced HER2-negative breast cancer ( n = 13) or other solid tumors (n = 7) with mutations in homologous recombination (HR) pathway genes other than bRCA1/2.
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.
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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.
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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.
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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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