Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 2416-2428 |
| Number of pages | 13 |
| Journal | New Engl. J. Med. |
| Volume | 381 |
| Issue number | 25 |
| DOIs | |
| Publication status | Published - 2019 |
Keywords
- bevacizumab
- olaparib
- placebo
- antineoplastic agent
- nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor
- phthalazine derivative
- piperazine derivative
- acute myeloid leukemia
- adult
- advanced cancer
- aged
- anemia
- aplastic anemia
- Article
- cancer grading
- cancer survival
- controlled study
- disease exacerbation
- double blind procedure
- drug efficacy
- drug safety
- drug tolerability
- drug withdrawal
- fatigue
- female
- follow up
- gene mutation
- human
- hypertension
- major clinical study
- myelodysplastic syndrome
- nausea
- outcome assessment
- ovary cancer
- phase 3 clinical trial
- priority journal
- progression free survival
- quality of life
- randomized controlled trial
- tumor suppressor gene
- clinical trial
- maintenance chemotherapy
- middle aged
- mortality
- multicenter study
- multimodality cancer therapy
- ovary tumor
- very elderly
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
- Bevacizumab
- Combined Modality Therapy
- Double-Blind Method
- Female
- Humans
- Maintenance Chemotherapy
- Middle Aged
- Ovarian Neoplasms
- Phthalazines
- Piperazines
- Poly(ADP-ribose) Polymerase Inhibitors
- Progression-Free Survival
- Quality of Life
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Olaparib plus bevacizumab as first-line maintenance in ovarian cancer : New England Journal of Medicine. / Ray-Coquard, I.; Pautier, P.; Pignata, S. et al.
In: New Engl. J. Med., Vol. 381, No. 25, 2019, p. 2416-2428.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Olaparib plus bevacizumab as first-line maintenance in ovarian cancer
T2 - New England Journal of Medicine
AU - Ray-Coquard, I.
AU - Pautier, P.
AU - Pignata, S.
AU - Pérol, D.
AU - González-Martín, A.
AU - Berger, R.
AU - Fujiwara, K.
AU - Vergote, I.
AU - Colombo, N.
AU - Mäenpää, J.
AU - Selle, F.
AU - Sehouli, J.
AU - Lorusso, D.
AU - Guerra Alía, E.M.
AU - Reinthaller, A.
AU - Nagao, S.
AU - Lefeuvre-Plesse, C.
AU - Canzler, U.
AU - Scambia, G.
AU - Lortholary, A.
AU - Marmé, F.
AU - Combe, P.
AU - De Gregorio, N.
AU - Rodrigues, M.
AU - Buderath, P.
AU - Dubot, C.
AU - Burges, A.
AU - You, B.
AU - Pujade-Lauraine, E.
AU - Harter, P.
N1 - Cited By :5 Export Date: 28 February 2020 CODEN: NEJMA Correspondence Address: Ray-Coquard, I.; Centre Léon Bérard, 28 Prom. Léa et Napoléon Bullukian, France; email: isabelle.ray-coquard@lyon.unicancer.fr Chemicals/CAS: bevacizumab, 216974-75-3, 1438851-35-4; olaparib, 763113-22-0; Bevacizumab; olaparib; Phthalazines; Piperazines; Poly(ADP-ribose) Polymerase Inhibitors Funding details: AstraZeneca France Funding details: Merck Funding details: Takeda Oncology Funding details: Eisai Funding details: Merck Sharp and Dohme, MSD Funding details: Takeda Pharmaceutical Company Funding details: Baxter International Funding details: Regeneron Pharmaceuticals Funding details: Roche Funding details: Stryker Funding details: Celgene Funding details: Deutsche Forschungsgemeinschaft, DFG Funding details: GlaxoSmithKline, GSK Funding details: Novartis Funding details: Mochida Pharmaceutical Company Funding details: Pfizer Funding details: Amgen Funding details: Eli Lilly and Company Funding details: Electrochemical Society, ECS Funding details: Clovis Oncology Funding details: Bristol-Myers Squibb, BMS Funding details: Bayer Funding details: Shionogi Funding details: Kyowa Hakko Kirin Funding details: Asahi Kasei Pharma Corporation Funding details: Daiichi Sankyo Company Funding details: K.F. Hein Fonds Funding details: Technische Universität Dresden, TUD Funding details: Medizinische Universität Wien Funding details: Medizinischen Fakultät Heidelberg, Universität Heidelberg Funding text 1: Supported by Association de Recherche Cancers Gynécolo-giques (ARCAGY) Research, AstraZeneca, Merck Sharp & Dohme (a subsidiary of Merck), and F. Hoffmann–La Roche. Funding text 2: Dr. Ray-Coquard reports receiving consulting fees and travel support from Roche and AstraZeneca, consulting fees from PharmaMar, Genmab, Pfizer, Tesaro, and Clovis Oncology, and grant support and consulting fees from Merck Sharp & Dohme; Dr. Pautier, receiving advisory board fees from AstraZeneca; Dr. Pignata, receiving honoraria from AstraZeneca, Roche, Merck Sharp & Dohme, Pfizer, Tesaro, Clovis Oncology, and Pharma-Mar; Dr. Pérol, receiving fees for training and advisory fees from Roche, fees for training, advisory fees, and travel support from AstraZeneca, and grant support from MSDAVENIR; Dr. González-Martín, receiving consulting fees, lecture fees, and travel support from AstraZeneca and PharmaMar, grant support, consulting fees, lecture fees, and travel support from Tesaro and Roche, and consulting fees from Clovis Oncology, Merck Sharp & Dohme, Pfizer, ImmunoGen, Genmab, and Novartis; Dr. Berger, receiving travel support from Roche, Merck, Biocad, Clovis Oncology, and Advaxis, lecture fees and travel support from AstraZeneca, and advisory board fees from PharmaMar; Dr. Fujiwara, receiving grant support from Kaken Pharmaceutical, Shionogi, GlaxoSmithKline, Eli Lilly, ImmunoGen, Onco-Therapy Science, and Regeneron Pharmaceuticals, grant support and consulting fees from Pfizer, Eisai, and Taiho, grant support, consulting fees, and honoraria from Merck Sharp & Dohme, grant support and honoraria from Zeria Pharmaceutical, and honoraria from Nippon Kayaku, Kyowa Hakko Kirin, Janssen, Daiichi Sankyo, and Mochida Pharmaceutical; Dr. Vergote, receiving consulting fees, paid to his institution, from Advaxis, Eisai, Merck Sharp & Dohme Belgium, F. Hoffmann–La Roche, Millennium Pharmaceuticals, Oncoinvent, and Sotio, consulting fees, paid to his institution, and travel support from Roche, Genmab, PharmaMar, Clovis Oncology, AstraZeneca, Tesaro, and ImmunoGen, grant support, paid to his institution, from Amgen, Stichting tegen Kanker, and Roche, research support from Oncoinvent and Genmab, and travel support from Takeda Oncology; Dr. Colombo, receiving advisory board fees from Roche, Clovis Oncology, Pfizer, Merck Sharp & Dohme, Biocad, ImmunoGen, and Takeda and advisory board fees and lecture fees from AstraZeneca, Tesaro, and PharmaMar; Dr. Mäenpää, receiving consulting fees from AstraZeneca, Clovis Oncology, Merck Sharp & Dohme, and Orion Pharma and consulting fees and travel support from Roche and Tesaro; Dr. Selle, receiving consulting fees, lecture fees, fees for serving on a speakers bureau, and travel support from Roche, lecture fees, fees for serving on a speakers bureau, and travel support from AstraZeneca, Tesaro, and PharmaMar, lecture fees from Clovis Oncology, and lecture fees and travel support from Merck Sharp & Dohme; Dr. Sehouli, receiving advisory board fees and travel support from AstraZeneca and grant support, advisory board fees, and travel support from Clovis Oncology, Tesaro, and Roche; Dr. Lorusso, receiving grant support and advisory board fees from ImmunoGen, Genmab, PharmaMar, Clovis Oncology, Tesaro, Merck, and AstraZeneca; Dr. Guerra Alía, receiving consulting fees, advisory board fees, and travel support from Roche, consulting fees and advisory board fees from Clovis Oncology, Tesaro, PharmaMar, AstraZeneca, Merck Sharp & Dohme, and Glaxo-SmithKline, and travel support from Baxter and GlaxoSmith-Kline/Tesaro; Dr. Reinthaller, receiving grant support, lecture fees, advisory board fees, and travel support from Roche, lecture fees, advisory board fees, and travel support from Amgen, Astra-Zeneca, PharmaMar, and Tesaro, and lecture fees and advisory board fees from Merck Sharp & Dohme and Vifor Pharma; Dr. Nagao, receiving grant support from PFDeNA, Tosoh, and Toray and lecture fees from Chugai, AstraZeneca, Mochida Pharmaceutical, and Asahi Kasei Medical; Dr. Lefeuvre-Plesse, receiving advisory board fees from AstraZeneca and participating in a medical congress for Novartis, Pfizer, Roche, and Pierre Fabre; Dr. Canzler, receiving honoraria from AstraZeneca, Roche, and Eli Lilly; Dr. Scambia, receiving honoraria from AstraZeneca, Tesaro, and Roche; Dr. Lortholary, receiving advisory board fees from AstraZeneca and participating in a medical congress for Novartis, Pfizer, and Roche; Dr. Marmé, receiving fees for serving as principal investigator of a clinical trial, advisory board fees, and lecture fees from Pfizer, Tesaro, and Novartis, advisory board fees and lecture fees from Amgen, PharmaMar, Genomic Health, Eisai, and Celgene, advisory board fees from CureVac and Janssen-Cilag, and advisory board fees, paid to his institution, from Immunomedics; Dr. de Gregorio, receiving advisory fees from Roche, PharmaMar, and Amgen and advisory fees and travel support from AstraZeneca and Tesaro; Dr. Rodrigues, receiving travel support from F. Hoffmann–La Roche, advisory board fees and lecture fees from AstraZeneca, advisory board fees and travel support from Tesaro, and grant support from Bristol-Myers Squibb and Merck; Dr. Buderath, receiving advisory board fees and travel support from Roche and travel support from PharmaMar; Dr. Burges, receiving consulting fees and lecture fees from AstraZeneca, Tesaro, and Roche; Dr. You, receiving consulting fees, advisory board fees, and travel support from and participating in a medical congress for AstraZeneca, Merck Sharp & Dohme, and Bayer and receiving consulting fees and advisory board fees from Tesaro, Clovis Oncology, Amgen, Novartis, Roche, and ECS Progastrin; Dr. Pujade-Lauraine, receiving lecture fees, fees for serving on a speakers bureau, and travel support from AstraZeneca, Tesaro, and Roche, receiving lecture fees from Clovis Oncology, Incyte, and Pfizer, and being employed by ARCAGY Research; and Dr. Harter, receiving consulting fees from Sotio, Merck Sharp & Dohme, Clovis Oncology, and ImmunoGen, grant support, consulting fees, and lecture fees from Tesaro, AstraZeneca, and Roche, lecture fees from Stryker and Zai Lab, and grant support from GlaxoSmith-Kline, Boehringer Ingelheim, Medac, Genmab, and Deutsche Forschungsgemeinschaft. No other potential conflict of interest relevant to this article was reported. Funding text 3: The authors’ affiliations are as follows: Centre Léon Bérard (I.R.-C., D.P.), University Claude Bernard Lyon 1 (I.R.-C.), and Centre Hospitalier Lyon-Sud (B.Y.), Lyon, Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO) (I.R.-C., P.P., F.S., C.L.-P., A.L., P.C., M.R., C.D., B.Y., E.P.-L.), Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), Hôpital Européen Georges Pompidou (P.C.), Institut Curie, Hôpital Claudius Régaud (M.R.), and Association de Recherche Cancers Gynécologiques (ARCAGY) (E.P.-L.), Paris, Gustave Roussy, Villejuif (P.P.), Centre Eugène Marquis, Rennes (C.L.-P.), Centre Catherine de Sienne Hôpital Privé du Confluent, Nantes (A.L.), and Institut Curie, Hôpital René Huguenin, Saint Cloud (C.D.) — all in France; the Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, and Multicenter Italian Trials in Ovarian Cancer and Gynecologic Malignancies (MITO), Naples (S.P.), University of Milan–Bicocca and European Institute of Oncology IRCCS, and Mario Negri Gynecologic Oncology Group (MANGO) (N.C.), and Fondazione IRCCS Istituto Nazionale Tumori and MITO (D.L.), Milan, and Fondazi-one Policlinico Universitario A. Gemelli IRCCS, Università Cattolica, and MITO, Rome (G.S.) — all in Italy; M.D. Anderson Cancer Center Madrid (A.G.-M.), Grupo Español de Investigación en Cáncer de Ovario (GEICO) (A.G.-M., E.M.G.A.), and Hospital Universita-rio Ramón y Cajal (E.M.G.A.) — all in Madrid; Medical University of Innsbruck, University Clinic for Gynecology and Obstetrics (R.B.), and Arbeitsgemeinschaft Gynäkologische Onkologie Study Group (AGO)–Austria (R.B., A.R.), Innsbruck, and Medical University of Vienna, Vienna (A.R.) — all in Austria; Saitama Medical University International Medical Center, Hidaka (K.F.), Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama-cho (K.F., S.N.), and Hyogo Cancer Center, Akashi (S.N.) — all in Japan; University Hospital Leuven, Leuven Cancer Institute, and Belgium and Luxembourg Gynecologic Oncology Group (BGOG) — both in Leuven, Belgium (I.V.); Tampere University and University Hospital, Tampere, Finland (J.M.); the Nordic Society of Gynecologic Oncology (NSGO), Copenhagen (J.M.); and Charité–Medical University of Berlin (Campus Virchow Klinikum), Berlin (J.S.), German Society of Gynecologic Oncology (AGO) (J.S., U.C., F.M., N.G., P.B., A.B., P.H.), Universitätsklinikum Essen (P.B.), and Kliniken Essen Mitte (P.H.), Essen, Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, Dresden (U.C.), Universitätsklinikum Heidelberg, Heidelberg (F.M.), Universitätsklinikum Ulm, Ulm (N.G.), and Klinikum der Universität München, Munich (A.B.) — all in Germany. 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Oza, A.M., Cook, A.D., Pfisterer, J., Standard chemotherapy with or without bevacizumab for women with newly diagnosed ovarian cancer (ICON7): Overall survival results of a phase 3 randomised trial (2015) Lancet Oncol, 16, pp. 928-936; Moore, K., Colombo, N., Scambia, G., Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer (2018) N Engl J Med, 379, pp. 2495-2505; O'Connor, M.J., Targeting the DNA damage response in cancer (2015) Mol Cell, 60, pp. 547-560; Integrated genomic analyses of ovarian carcinoma (2011) Nature, 474, pp. 609-615; Ledermann, J., Harter, P., Gourley, C., Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: A preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial (2014) Lancet Oncol, 15, pp. 852-861; Mirza, M.R., Monk, B.J., Herrstedt, J., Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer (2016) N Engl J Med, 375, pp. 2154-2164; Coleman, R.L., Oza, A.M., Lorusso, D., Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): A randomised, double-blind, placebo-controlled, phase 3 trial (2017) Lancet, 390, pp. 1949-1961; 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Vergote, I., Pujade-Lauraine, E., Pignata, S., European network of gynaecological oncological trial groups' requirements for trials between academic groups and pharmaceutical companies (2010) Int J Gynecol Cancer, 20, pp. 476-478; Du Bois, A., Reuss, A., Pujade-Lauraine, E., European network of gynaecological oncological trial groups' requirements for trials between academic groups and industry partners - First update 2015 (2015) Int J Gynecol Cancer, 25, pp. 1328-1330; Herzog, T.J., Armstrong, D.K., Brady, M.F., Ovarian cancer clinical trial endpoints: Society of gynecologic oncology white paper (2014) Gynecol Oncol, 132, pp. 8-17; Cnaan, A., Laird, N.M., Slasor, P., Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data (1997) Stat Med, 16, pp. 2349-2380; Norquist, B.M., Brady, M.F., Harrell, M.I., Mutations in homologous recombination genes and outcomes in ovarian carcinoma patients in GOG 218: An NRG oncology/Gynecologic oncology group study (2018) Clin Cancer Res, 24, pp. 777-783; 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PY - 2019
Y1 - 2019
N2 - BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P
AB - BACKGROUND: Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS: We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS: Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P
KW - bevacizumab
KW - olaparib
KW - placebo
KW - antineoplastic agent
KW - nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor
KW - phthalazine derivative
KW - piperazine derivative
KW - acute myeloid leukemia
KW - adult
KW - advanced cancer
KW - aged
KW - anemia
KW - aplastic anemia
KW - Article
KW - cancer grading
KW - cancer survival
KW - controlled study
KW - disease exacerbation
KW - double blind procedure
KW - drug efficacy
KW - drug safety
KW - drug tolerability
KW - drug withdrawal
KW - fatigue
KW - female
KW - follow up
KW - gene mutation
KW - human
KW - hypertension
KW - major clinical study
KW - myelodysplastic syndrome
KW - nausea
KW - outcome assessment
KW - ovary cancer
KW - phase 3 clinical trial
KW - priority journal
KW - progression free survival
KW - quality of life
KW - randomized controlled trial
KW - tumor suppressor gene
KW - clinical trial
KW - maintenance chemotherapy
KW - middle aged
KW - mortality
KW - multicenter study
KW - multimodality cancer therapy
KW - ovary tumor
KW - very elderly
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Bevacizumab
KW - Combined Modality Therapy
KW - Double-Blind Method
KW - Female
KW - Humans
KW - Maintenance Chemotherapy
KW - Middle Aged
KW - Ovarian Neoplasms
KW - Phthalazines
KW - Piperazines
KW - Poly(ADP-ribose) Polymerase Inhibitors
KW - Progression-Free Survival
KW - Quality of Life
U2 - 10.1056/NEJMoa1911361
DO - 10.1056/NEJMoa1911361
M3 - Article
VL - 381
SP - 2416
EP - 2428
JO - New Engl. J. Med.
JF - New Engl. J. Med.
SN - 0028-4793
IS - 25
ER -