Adjuvant Olaparib for Patients with
Adult
Antineoplastic Agents
/ adverse effects
Breast Neoplasms
/ drug therapy
Chemotherapy, Adjuvant
Disease-Free Survival
Double-Blind Method
Female
Genes, BRCA1
Genes, BRCA2
Germ-Line Mutation
Humans
Mastectomy
Middle Aged
Phthalazines
/ adverse effects
Piperazines
/ adverse effects
Poly(ADP-ribose) Polymerase Inhibitors
/ adverse effects
Receptor, ErbB-2
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
24 06 2021
24 06 2021
Historique:
pubmed:
4
6
2021
medline:
8
7
2021
entrez:
3
6
2021
Statut:
ppublish
Résumé
Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P = 0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest. Among patients with high-risk, HER2-negative early breast cancer and germline
Sections du résumé
BACKGROUND
Poly(adenosine diphosphate-ribose) polymerase inhibitors target cancers with defects in homologous recombination repair by synthetic lethality. New therapies are needed to reduce recurrence in patients with
METHODS
We conducted a phase 3, double-blind, randomized trial involving patients with human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with
RESULTS
A total of 1836 patients underwent randomization. At a prespecified event-driven interim analysis with a median follow-up of 2.5 years, the 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (difference, 8.8 percentage points; 95% confidence interval [CI], 4.5 to 13.0; hazard ratio for invasive disease or death, 0.58; 99.5% CI, 0.41 to 0.82; P<0.001). The 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (difference, 7.1 percentage points; 95% CI, 3.0 to 11.1; hazard ratio for distant disease or death, 0.57; 99.5% CI, 0.39 to 0.83; P<0.001). Olaparib was associated with fewer deaths than placebo (59 and 86, respectively) (hazard ratio, 0.68; 99% CI, 0.44 to 1.05; P = 0.02); however, the between-group difference was not significant at an interim-analysis boundary of a P value of less than 0.01. Safety data were consistent with known side effects of olaparib, with no excess serious adverse events or adverse events of special interest.
CONCLUSIONS
Among patients with high-risk, HER2-negative early breast cancer and germline
Identifiants
pubmed: 34081848
doi: 10.1056/NEJMoa2105215
pmc: PMC9126186
mid: NIHMS1734943
doi:
Substances chimiques
Antineoplastic Agents
0
Phthalazines
0
Piperazines
0
Poly(ADP-ribose) Polymerase Inhibitors
0
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
olaparib
WOH1JD9AR8
Banques de données
ClinicalTrials.gov
['NCT02032823']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
2394-2405Subventions
Organisme : NCI NIH HHS
ID : UG1 CA189867
Pays : United States
Organisme : NCI NIH HHS
ID : UG1 CA233324
Pays : United States
Organisme : NCI NIH HHS
ID : U10CA180868
Pays : United States
Organisme : NCI NIH HHS
ID : U10CA180822
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180822
Pays : United States
Organisme : NCI NIH HHS
ID : U10 CA180868
Pays : United States
Organisme : NCI NIH HHS
ID : UG1CA189867
Pays : United States
Investigateurs
Andrew Tutt
(A)
Charles Geyer
(C)
Judy Garber
(J)
Bella Kaufman
(B)
Christine Campbell
(C)
Gregory Yothers
(G)
Nigel Baker
(N)
Robin McConnell
(R)
Martine Piccart
(M)
Richard D Gelber
(RD)
Priya Rastogi
(P)
Simon Hollingsworth
(S)
Anitra Fielding
(A)
Larissa Korde
(L)
Giuseppe Viale
(G)
Sunil Lakhani
(S)
Peter Lucas
(P)
Giovanna Rossi
(G)
Christian Singer
(C)
Elmar Stickeler
(E)
Kelly-Anne Phillips
(KA)
Agnes Jager
(A)
Elzbieta Senkus
(E)
Monica Arnedos
(M)
Luis Fein
(L)
Eduardo-M De Dueñas
(EM)
Frederik Marmé
(F)
Gabriele Zoppoli
(G)
Óskar Jóhannsson
(Ó)
Lorenzo Gianni
(L)
Judith Bliss
(J)
Masakazu Toi
(M)
Andrea Eisen
(A)
Anne Armstrong
(A)
Niklas Loman
(N)
Judith Balmaña
(J)
Wolfgang Janni
(W)
Jonas Bergh
(J)
Tsang-Wu Liu
(TW)
Suzette Delaloge
(S)
James Ford
(J)
Priyanka Sharma
(P)
Tiffany Traina
(T)
Seock-Ah Im
(SA)
Sue Friedman
(S)
Tanja Spanic
(T)
Susan Domchek
(S)
Rita Schmutzler
(R)
Karen Gelmon
(K)
Guenther G Steger
(GG)
Barbro Linderholm
(B)
Sibylle Loibl
(S)
Shao Zhmin
(S)
Kevin Murray
(K)
Gursel Aktan
(G)
Eleanor Mcfadden
(E)
Olga Andriienko
(O)
Karen Cui
(K)
Vassiliki Karantza
(V)
Konstantinos Tryfonidis
(K)
Amal Arahmani
(A)
Evandro de Azambuja
(E)
Liesbet De Vos
(L)
Rebecca Dent
(R)
William Foulkes
(W)
Edith Olah
(E)
Maria Orr
(M)
Dan Hayes
(D)
Andrea Richardson
(A)
Chris Lord
(C)
Jos Jonkers
(J)
Jan Hoejimakers
(J)
Carl Barrett
(C)
Elizabeth Harrington
(E)
Natasha Lukashchuk
(N)
William E Barlow
(WE)
Nancy Berliner
(N)
Elizabeth Eisenhauer
(E)
Hakan Olsson
(H)
Sandra Swain
(S)
Paul Sevelda
(P)
Ferdinand Haslbauer
(F)
Monika Penzinger
(M)
Leopold Öhler
(L)
Christoph Tinchon
(C)
Richard Greil
(R)
Sonja Heibl
(S)
Rupert Bartsch
(R)
Viktor Wette
(V)
Claudia Pasterk
(C)
Ruth Helfgott
(R)
Gunda Pristauz-Telsnigg
(G)
Herbert Stöger
(H)
Angsar Weltermann
(A)
Daniel Egle
(D)
Irene Thiel
(I)
David Fuchs
(D)
Holger Rumpold
(H)
Kathrin Strasser-Weippl
(K)
Beate Rautenberg
(B)
Volkmar Müller
(V)
Marcus Schmidt
(M)
Stefan Paepke
(S)
Mustafa Aydogdu
(M)
Christoph Thomssen
(C)
Joachim Rom
(J)
Christine Mau
(C)
Peter Fasching
(P)
Uwe-Jochen Göhring
(UJ)
Thorsten Kühn
(T)
Stefanie Noeding
(S)
Sherko Kümmel
(S)
John Hackmann
(J)
Abhishek Joshi
(A)
Joanna Dewar
(J)
Michael Friedlander
(M)
Yoland Antill
(Y)
Natasha Woodward
(N)
Ehtesham Abdi
(E)
Susan Tiley
(S)
Mathew George
(M)
David Boadle
(D)
Annabel Goodwin
(A)
Andre van der Westhuizen
(A)
George Kannourakis
(G)
Nicholas Murray
(N)
Nicole McCarthy
(N)
Judith Kroep
(J)
Maaike de Boer
(M)
Joan Heijns
(J)
Franciscus Erdkamp
(F)
Sandra Bakker
(S)
Gabe Sonke
(G)
Amer Sami
(A)
John Mackey
(J)
Catherine Prady
(C)
Christine Desbiens
(C)
Erica Patocskai
(E)
Cristiano Ferrario
(C)
Louise Bordeleau
(L)
Haji Chalchal
(H)
Saroj Niraula
(S)
Ido Wolf
(I)
Elżbieta Senkus
(E)
François Duhoux
(F)
Randal d'Hondt
(R)
Sylvie Luce
(S)
Daphné t'Kint de Roodenbeke
(D)
Konstantinos Papadimitriou
(K)
Marleen Borms
(M)
Claire Quaghebeur
(C)
William Jacot
(W)
Etienne Brain
(E)
Laurence Venat-Bouvet
(L)
Alain Lortholary
(A)
Zbigniew Nowecki
(Z)
Fátima Cardoso
(F)
Richard Hayward
(R)
Santiago Bella
(S)
Mauricio Fernández Lazzaro
(M)
Norma Pilnik
(N)
Cesar Blajman
(C)
Guillermo Lerzo
(G)
Mirta Varela
(M)
Juan Jose Zarba
(JJ)
Diego Kaen
(D)
Maria Victoria Constanzo
(MV)
Joke Tio
(J)
Wulf Siggelkow
(W)
Christian Jackisch
(C)
Eva Maria Grischke
(EM)
Dirk Zahm
(D)
Sara Tato-Varela
(S)
Sabine Schmatloch
(S)
Peter Klare
(P)
Andrea Stefek
(A)
Kerstin Rhiem
(K)
Oliver Hoffmann
(O)
Mustafa Deryal
(M)
Isolde Gröll
(I)
Peter Ledwon
(P)
Christoph Uleer
(C)
Klinikum Chemnitz
(K)
Petra Krabisch
(P)
Jochem Potenberg
(J)
Maren Darsow
(M)
Tjoung-Won Park-Simon
(TW)
Heinz-Gert Höffkes
(HG)
Till-Oliver Emde
(TO)
Gerd Graffunder
(G)
Oliver Tomé
(O)
Dirk Forstmeyer
(D)
Jürgen Terhaag
(J)
Christoph Salat
(C)
Karin Kast
(K)
Steffi Weniger
(S)
Carsten Schreiber
(C)
Bernhard Heinrich
(B)
Klinikum Südstadt
(K)
Max Dieterich
(M)
Michaela Penelope Wüllner
(MP)
Raquel Andrés Conejero
(RA)
José Ángel García Sáenz
(JÁ)
Lourdes Calvo Martinez
(L)
Angels Arcusa Lanza
(A)
Serafín Morales Murillo
(S)
Fernando Henao Carrasco
(F)
Salvador Blanch Tormo
(S)
Isabel Álvarez López
(I)
Juan Ignacio Delgado Mingorance
(J)
Elena Álvarez Gomez
(E)
Marta Santisteban
(M)
Josefina Cruz Jurado
(J)
Vanesa Quiroga
(V)
Manuel Ruiz Borrego
(M)
Eduardo Martínez de Dueñas
(E)
Jose Enrique Alés Martínez
(JE)
Juan De la Haba
(J)
Noelia Martínez Jañez
(N)
Álvaro Rodríguez Lescure
(Á)
Antonio Antón Torres
(A)
Gema Llort Crusades
(G)
Santiago González-Santiago
(S)
Antonia Marquez Aragones
(A)
Ana Laura Ortega
(AL)
Agusti Barnadas Molins
(A)
José Ignacio Chacón López-Muñiz
(JI)
Miguel Martín Jiménez
(MM)
Ana Laura Santaballa Bertrán
(AL)
César Rodríguez
(C)
Lucía González Cortijo
(L)
Elisabetta Cretella
(E)
Laura Cortesi
(L)
Enzo Maria Ruggeri
(EM)
Claudio Verusio
(C)
Stefania Gori
(S)
Andrea Bonetti
(A)
Anna Maria Mosconi
(AM)
Oskar Johannsson
(O)
Guy Jerusalem
(G)
Patrick Neven
(P)
Tünde Nagy
(T)
Graziella Pinotti
(G)
Marco Colleoni
(M)
Antonio Bernardo
(A)
Eraldo Bucci
(E)
Laura Biganzoli
(L)
Konstantin Dedes
(K)
Urban Novak
(U)
Khalil Zaman
(K)
Jeremy Braybrooke
(J)
Matthew Winter
(M)
Daniel Rea
(D)
Muireann Kelleher
(M)
Sophie Barrett
(S)
Stephen Chan
(S)
Tamas Hickish
(T)
Jane Hurwitz
(J)
John Conibear
(J)
Apurna Jegannathen
(A)
Marina Parton
(M)
Rozenn Allerton
(R)
Annabel Borley
(A)
Ellen Copson
(E)
Nicola Levitt
(N)
Jean Abraham
(J)
Timothy Perren
(T)
Rebecca Roylance
(R)
Kazushige Ishida
(K)
Tatsuya Toyama
(T)
Norikazu Masuda
(N)
Junichiro Watanabe
(J)
Eriko Tokunaga
(E)
Takayuki Kinoshita
(T)
Yoshiaki Rai
(Y)
Masahiro Takada
(M)
Yasuhiro Yanagita
(Y)
Rikiya Nakamura
(R)
Takahiro Nakayama
(T)
Yasuto Naoi
(Y)
Hiroji Iwata
(H)
Seigo Nakamura
(S)
Masato Takahashi
(M)
Kenjiro Aogi
(K)
Koichiro Tsugawa
(K)
Hirofumi Mukai
(H)
Toshimi Takano
(T)
Akihiko Osaki
(A)
Nobuaki Sato
(N)
Hideko Yamauchi
(H)
Yutaka Tokuda
(Y)
Mitsuya Ito
(M)
Takeki Sugimoto
(T)
Jay W Carlson
(JW)
Shakeela Wazeen Bahadur
(SW)
Patricia A Ganz
(PA)
Min Janice Lu
(MJ)
Monica Mirela Mita
(MM)
Joanne E Mortimer
(JE)
Jonathan A Polikoff
(JA)
Stacy D D'Andre
(SD)
Melinda L Telli
(ML)
Samantha Andrews Seaward
(SA)
Louis Fehrenbacher
(L)
Ajithkumar Puthillath
(A)
James Henry Feusner
(JH)
Kristie Ann Bobolis
(KA)
Peter David Eisenberg
(PD)
Virginia F Borges
(VF)
Alexander Terry Urquhart
(AT)
Erin Wysong Hofstatter
(EW)
Edward C McCarron
(EC)
Stephen Scott Grubbs
(SS)
Ruby Anne E Deveras
(RAE)
Reshma Lillaney Mahtani
(RL)
Elisavet Paplomata
(E)
Bradley Thomas Sumrall
(BT)
Cheryl F Jones
(CF)
Samuel N Ofori
(SN)
Kenneth N M Sumida
(KNM)
Alexandra Thomas
(A)
Deborah Weil Wilbur
(DW)
Joginder Singh
(J)
David Martens Spector
(DM)
Philip J Stella
(PJ)
Benjamin T Marchello
(BT)
Douglas Edward Merkel
(DE)
Shelly S Lo
(SS)
Pam G Khosla
(PG)
Massimo Cristofanilli
(M)
Kent F Hoskins
(KF)
Melody Ann Cobleigh
(MA)
Elyse Anne Lambiase
(EA)
Olwen Mary Hahn
(OM)
Ira Anton Oliff
(IA)
Bryan A Faller
(BA)
James Lloyd Wade
(JL)
Nafisa D Burhani
(ND)
Amaryllis Gil
(A)
Harvey E Einhorn
(HE)
Anna Maria Vita Storniolo
(AM)
Brian K Chang
(BK)
Maitri Kalra
(M)
Erwin L Robin
(EL)
Bilal Ansari
(B)
Shaker R Dakhil
(SR)
Richard L Deming
(RL)
John Thomas Cole
(JT)
David S Hanson
(DS)
Augusto C Ochoa
(AC)
Judy Ellen Garber
(JE)
Harvey Zimbler
(H)
Deborah Kay Armstrong
(DK)
Katherine H Rak Tkaczuk
(KHR)
David Andrew Riseberg
(DA)
Brian Marcial O'Connor
(BM)
Thomas H Openshaw
(TH)
Dana Zakalik
(D)
Cynthia Mahesh Vakhariya
(CM)
Anne F Schott
(AF)
Michael Steven Simon
(MS)
Thomas J Doyle
(TJ)
Kathleen J Yost
(KJ)
Patrick James Flynn
(PJ)
Richard T Zera
(RT)
Bret E B Friday
(BEB)
Kathryn J Ruddy
(KJ)
Preston D Steen
(PD)
Foluso Olabisi Ademuyiwa
(FO)
Edward A Levine
(EA)
Paul Kelly Marcom
(PK)
Cameron Blair Harkness
(CB)
Antoinette R Tan
(AR)
William J Charles
(WJ)
Charles S Kuzma
(CS)
James Earl Radford
(JE)
James N Atkins
(JN)
Madhu Unnikrishnan
(M)
Grant Richard Seeger
(GR)
Kirsten M Hotton Leu
(KMH)
Mehmet Sitki Copur
(MS)
Ralph J Hauke
(RJ)
Gamini S Soori
(GS)
Bradley A Arrick
(BA)
Jennifer G Reeder
(JG)
Deborah Lynn Toppmeyer
(DL)
Zoneddy Ruiz Dayao
(ZR)
Sylvia Adams
(S)
Tessa Cigler
(T)
Paul Michael Barr
(PM)
Jesus Del Santo Anampa Mesias
(JDS)
Lora R Weiselberg
(LR)
Bhuvaneswari Ramaswamy
(B)
Aaron Thomas Gerds
(AT)
Robert R Shenk
(RR)
Howard M Gross
(HM)
Shruti Trehan
(S)
Wajeeha Razaq
(W)
Abdul Hai Mansoor
(AH)
Thomas Benjamin Julian
(TB)
Adam Matthew Brufsky
(AM)
L Eamonn Boyle
(LE)
Nabila Chowdhury
(N)
Albert S DeNittis
(AS)
Susan M Domchek
(SM)
Elias Obeid
(E)
Terrence Paul Cescon
(TP)
Marc A Rovito
(MA)
Victor G Vogel
(VG)
Luis Baez-Diaz
(L)
Frank J Brescia
(FJ)
John Eric Doster
(JE)
Robert D Siegel
(RD)
Lucas Wong
(L)
Tejal Patel
(T)
Julie Rani Nangia
(JR)
Catherine Anne Jones
(CA)
George M Cannon
(GM)
Harry Douglas Bear
(HD)
Kathleen Kiernan Harnden
(KK)
Marie Elizabeth Wood
(ME)
Krishna Chaitanya Alluri
(KC)
Benjamin Buckner Bridges
(BB)
Jennifer Marie Specht
(JM)
Rubina Qamar
(R)
Matthew L Ryan
(ML)
Arlene A Gayle
(AA)
Steven James Jubelirer
(SJ)
Sobha Kurian
(S)
Mohamad Adham Salkeni
(MA)
Gustav Silander
(G)
Anna-Lotta Hallbeck
(AL)
Anna von Wachenfeldt Väppling
(A)
Elsa Curtit
(E)
Catarina Cardoso
(C)
Sofia Braga
(S)
Miguel Abreu
(M)
Mafalda Casa-Nova
(M)
Mónica Nave
(M)
Eva María Ciruelos Gil
(EM)
Judith Balmaña Gelpi
(JB)
Adela Fernández Ortega
(A)
Josep Gumà Padró
(J)
Begoña Bermejo de Las Heras
(B)
María González Cao
(M)
Juan Cueva Bañuelos
(J)
Jesús Alarcon Company
(JA)
Gemma Viñas Villaró
(G)
Laura García Estevez
(L)
Jens Huober
(J)
Steffi Busch
(S)
Tanja Fehm
(T)
Stadtklinik Baden-Baden
(S)
Antje Hahn
(A)
Andrea Grafe
(A)
Thomas Noesselt
(T)
Thomas Dewitz
(T)
Harald Wagner
(H)
Christina Bechtner
(C)
Michael Weigel
(M)
Hans-Christian Kolberg
(HC)
Thomas Decker
(T)
Jörg Thomalla
(J)
Tobias Hesse
(T)
Nadia Harbeck
(N)
Jan Schröder
(J)
Jens-Uwe Blohmer
(JU)
Marc Wolf Sütterlin
(MW)
Renske Altena
(R)
Chang-Fang Chiu
(CF)
Shin-Cheh Chen
(SC)
Ming-Feng Hou
(MF)
Yuan-Ching Chang
(YC)
Shang-Hung Chen
(SH)
Shou-Tung Chen
(ST)
Chiun-Sheng Huang
(CS)
Dah-Cherng Yeh
(DC)
Jyh-Cherng Yu
(JC)
Ling-Ming Tseng
(LM)
Wei-Pang Chung
(WP)
Audrey Mailliez
(A)
Thierry Petit
(T)
Christelle Lévy
(C)
Philippe Dalivoust
(P)
Jean-Marc Extra
(JM)
Marie-Ange Mouret-Reynier
(MA)
Anne-Claire Hardy-Bessard
(AC)
Hélène Simon
(H)
Tiffenn L'Haridon
(T)
Alice Mege
(A)
Sylvie Giacchetti
(S)
Camille Chakiba-Brugere
(C)
Alain Gratet
(A)
Virginie Pottier
(V)
Jean-Marc Ferrero
(JM)
Isabelle Tennevet
(I)
Christophe Perrin
(C)
Jean-Luc Canon
(JL)
Sofie Joris
(S)
Zhimin Shao
(Z)
Binghe Xu
(B)
ZeFei Jiang
(Z)
Qiang Sun
(Q)
Kunwei Shen
(K)
Da Pang
(D)
Jin Zhang
(J)
Shui Wang
(S)
Hongjian Yang
(H)
Ning Liao
(N)
Hong Zheng
(H)
Peifen Fu
(P)
Chuangui Song
(C)
Yongsheng Wang
(Y)
Zhimin Fan
(Z)
Cuizhi Geng
(C)
Olivier Tredan
(O)
László Landherr
(L)
Rinat Yerushalmi
(R)
Beatrice Uziely
(B)
Pierfranco Conte
(P)
Claudio Zamagni
(C)
Giampaolo Bianchini
(G)
Michelino De Laurentiis
(M)
Carlo Tondini
(C)
Vittorio Gebbia
(V)
Mariangela Ciccarese
(M)
Tomasz Sarosiek
(T)
Jacek Mackiewicz
(J)
Anna Słowińska
(A)
Ewa Kalinka
(E)
Tomasz Huzarski
(T)
Kyung Hae Jung
(KH)
Joo Hyuk Sohn
(JH)
Jee Hyun Kim
(JH)
Keun Seok Lee
(KS)
Yeon Hee Park
(YH)
Kyoung Eun Lee
(KE)
Yee Soo Chae
(YS)
Eun Kyung Cho
(EK)
Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2021 Massachusetts Medical Society.
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