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.
Identifieur interne : 000529 ( PubMed/Corpus ); précédent : 000528; suivant : 000530Olaparib 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.
Auteurs : Eric Pujade-Lauraine ; Jonathan A. Ledermann ; Frédéric Selle ; Val Gebski ; Richard T. Penson ; Amit M. Oza ; Jacob Korach ; Tomasz Huzarski ; Andrés Poveda ; Sandro Pignata ; Michael Friedlander ; Nicoletta Colombo ; Philipp Harter ; Keiichi Fujiwara ; Isabelle Ray-Coquard ; Susana Banerjee ; Joyce Liu ; Elizabeth S. Lowe ; Ralph Bloomfield ; Patricia PautierSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
English descriptors
- KwdEn :
- Antineoplastic Agents (therapeutic use), Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Humans, Maintenance Chemotherapy, Middle Aged, Mutation, Ovarian Neoplasms (drug therapy), Ovarian Neoplasms (genetics), Ovarian Neoplasms (pathology), Phthalazines (therapeutic use), Piperazines (therapeutic use), Tablets.
- MESH :
- chemical , therapeutic use : Antineoplastic Agents, Phthalazines, Piperazines.
- drug therapy : Ovarian Neoplasms.
- genetics : Ovarian Neoplasms.
- pathology : Ovarian Neoplasms.
- Double-Blind Method, Female, Genes, BRCA1, Genes, BRCA2, Humans, Maintenance Chemotherapy, Middle Aged, Mutation, Tablets.
Abstract
Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib.
DOI: 10.1016/S1470-2045(17)30469-2
PubMed: 28754483
Links to Exploration step
pubmed:28754483Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">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.</title><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><affiliation><nlm:affiliation>Medical Oncology Department, Université Paris Descartes, AP-HP, Paris, France. Electronic address: epujade@arcagy.org.</nlm:affiliation></affiliation></author><author><name sortKey="Ledermann, Jonathan A" sort="Ledermann, Jonathan A" uniqKey="Ledermann J" first="Jonathan A" last="Ledermann">Jonathan A. Ledermann</name><affiliation><nlm:affiliation>Department of Oncology, University College London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Selle, Frederic" sort="Selle, Frederic" uniqKey="Selle F" first="Frédéric" last="Selle">Frédéric Selle</name><affiliation><nlm:affiliation>Hôpital Tenon, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation><nlm:affiliation>Department of Biostatistics and Research Methodology, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Penson, Richard T" sort="Penson, Richard T" uniqKey="Penson R" first="Richard T" last="Penson">Richard T. Penson</name><affiliation><nlm:affiliation>Department of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name><affiliation><nlm:affiliation>Princess Margaret Cancer Centre, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Korach, Jacob" sort="Korach, Jacob" uniqKey="Korach J" first="Jacob" last="Korach">Jacob Korach</name><affiliation><nlm:affiliation>Gynecologic Oncology Department, Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel.</nlm:affiliation></affiliation></author><author><name sortKey="Huzarski, Tomasz" sort="Huzarski, Tomasz" uniqKey="Huzarski T" first="Tomasz" last="Huzarski">Tomasz Huzarski</name><affiliation><nlm:affiliation>Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name><affiliation><nlm:affiliation>Instituto Valenciano de Oncología, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Pignata, Sandro" sort="Pignata, Sandro" uniqKey="Pignata S" first="Sandro" last="Pignata">Sandro Pignata</name><affiliation><nlm:affiliation>Istituto Tumori Pascale di Napoli, Naples, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name><affiliation><nlm:affiliation>Department of Medical Oncology, University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Nicoletta" sort="Colombo, Nicoletta" uniqKey="Colombo N" first="Nicoletta" last="Colombo">Nicoletta Colombo</name><affiliation><nlm:affiliation>Gynecology Department, University of Milan-Bicocca and Istituto Europeo Oncología, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Harter, Philipp" sort="Harter, Philipp" uniqKey="Harter P" first="Philipp" last="Harter">Philipp Harter</name><affiliation><nlm:affiliation>Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.</nlm:affiliation></affiliation></author><author><name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name><affiliation><nlm:affiliation>Medical Oncology Department, Centre Léon Bérard and University Claude Bernard, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Banerjee, Susana" sort="Banerjee, Susana" uniqKey="Banerjee S" first="Susana" last="Banerjee">Susana Banerjee</name><affiliation><nlm:affiliation>The Royal Marsden NHS Foundation Trust, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Joyce" sort="Liu, Joyce" uniqKey="Liu J" first="Joyce" last="Liu">Joyce Liu</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lowe, Elizabeth S" sort="Lowe, Elizabeth S" uniqKey="Lowe E" first="Elizabeth S" last="Lowe">Elizabeth S. Lowe</name><affiliation><nlm:affiliation>AstraZeneca, Gaithersburg, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bloomfield, Ralph" sort="Bloomfield, Ralph" uniqKey="Bloomfield R" first="Ralph" last="Bloomfield">Ralph Bloomfield</name><affiliation><nlm:affiliation>AstraZeneca, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Pautier, Patricia" sort="Pautier, Patricia" uniqKey="Pautier P" first="Patricia" last="Pautier">Patricia Pautier</name><affiliation><nlm:affiliation>Gustave Roussy Cancer Campus, Villejuif, France.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28754483</idno><idno type="pmid">28754483</idno><idno type="doi">10.1016/S1470-2045(17)30469-2</idno><idno type="wicri:Area/PubMed/Corpus">000529</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000529</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">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.</title><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><affiliation><nlm:affiliation>Medical Oncology Department, Université Paris Descartes, AP-HP, Paris, France. Electronic address: epujade@arcagy.org.</nlm:affiliation></affiliation></author><author><name sortKey="Ledermann, Jonathan A" sort="Ledermann, Jonathan A" uniqKey="Ledermann J" first="Jonathan A" last="Ledermann">Jonathan A. Ledermann</name><affiliation><nlm:affiliation>Department of Oncology, University College London, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Selle, Frederic" sort="Selle, Frederic" uniqKey="Selle F" first="Frédéric" last="Selle">Frédéric Selle</name><affiliation><nlm:affiliation>Hôpital Tenon, Paris, France.</nlm:affiliation></affiliation></author><author><name sortKey="Gebski, Val" sort="Gebski, Val" uniqKey="Gebski V" first="Val" last="Gebski">Val Gebski</name><affiliation><nlm:affiliation>Department of Biostatistics and Research Methodology, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Penson, Richard T" sort="Penson, Richard T" uniqKey="Penson R" first="Richard T" last="Penson">Richard T. Penson</name><affiliation><nlm:affiliation>Department of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name><affiliation><nlm:affiliation>Princess Margaret Cancer Centre, Toronto, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Korach, Jacob" sort="Korach, Jacob" uniqKey="Korach J" first="Jacob" last="Korach">Jacob Korach</name><affiliation><nlm:affiliation>Gynecologic Oncology Department, Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel.</nlm:affiliation></affiliation></author><author><name sortKey="Huzarski, Tomasz" sort="Huzarski, Tomasz" uniqKey="Huzarski T" first="Tomasz" last="Huzarski">Tomasz Huzarski</name><affiliation><nlm:affiliation>Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name><affiliation><nlm:affiliation>Instituto Valenciano de Oncología, Valencia, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Pignata, Sandro" sort="Pignata, Sandro" uniqKey="Pignata S" first="Sandro" last="Pignata">Sandro Pignata</name><affiliation><nlm:affiliation>Istituto Tumori Pascale di Napoli, Naples, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name><affiliation><nlm:affiliation>Department of Medical Oncology, University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Colombo, Nicoletta" sort="Colombo, Nicoletta" uniqKey="Colombo N" first="Nicoletta" last="Colombo">Nicoletta Colombo</name><affiliation><nlm:affiliation>Gynecology Department, University of Milan-Bicocca and Istituto Europeo Oncología, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Harter, Philipp" sort="Harter, Philipp" uniqKey="Harter P" first="Philipp" last="Harter">Philipp Harter</name><affiliation><nlm:affiliation>Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Fujiwara, Keiichi" sort="Fujiwara, Keiichi" uniqKey="Fujiwara K" first="Keiichi" last="Fujiwara">Keiichi Fujiwara</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.</nlm:affiliation></affiliation></author><author><name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name><affiliation><nlm:affiliation>Medical Oncology Department, Centre Léon Bérard and University Claude Bernard, Lyon, France.</nlm:affiliation></affiliation></author><author><name sortKey="Banerjee, Susana" sort="Banerjee, Susana" uniqKey="Banerjee S" first="Susana" last="Banerjee">Susana Banerjee</name><affiliation><nlm:affiliation>The Royal Marsden NHS Foundation Trust, London, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Liu, Joyce" sort="Liu, Joyce" uniqKey="Liu J" first="Joyce" last="Liu">Joyce Liu</name><affiliation><nlm:affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lowe, Elizabeth S" sort="Lowe, Elizabeth S" uniqKey="Lowe E" first="Elizabeth S" last="Lowe">Elizabeth S. Lowe</name><affiliation><nlm:affiliation>AstraZeneca, Gaithersburg, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Bloomfield, Ralph" sort="Bloomfield, Ralph" uniqKey="Bloomfield R" first="Ralph" last="Bloomfield">Ralph Bloomfield</name><affiliation><nlm:affiliation>AstraZeneca, Cambridge, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Pautier, Patricia" sort="Pautier, Patricia" uniqKey="Pautier P" first="Patricia" last="Pautier">Patricia Pautier</name><affiliation><nlm:affiliation>Gustave Roussy Cancer Campus, Villejuif, France.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic Agents (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>Genes, BRCA1</term><term>Genes, BRCA2</term><term>Humans</term><term>Maintenance Chemotherapy</term><term>Middle Aged</term><term>Mutation</term><term>Ovarian Neoplasms (drug therapy)</term><term>Ovarian Neoplasms (genetics)</term><term>Ovarian Neoplasms (pathology)</term><term>Phthalazines (therapeutic use)</term><term>Piperazines (therapeutic use)</term><term>Tablets</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Agents</term><term>Phthalazines</term><term>Piperazines</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Female</term><term>Genes, BRCA1</term><term>Genes, BRCA2</term><term>Humans</term><term>Maintenance Chemotherapy</term><term>Middle Aged</term><term>Mutation</term><term>Tablets</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28754483</PMID><DateCreated><Year>2017</Year><Month>07</Month><Day>29</Day></DateCreated><DateCompleted><Year>2017</Year><Month>09</Month><Day>25</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>25</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>9</Issue><PubDate><Year>2017</Year><Month>Sep</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>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.</ArticleTitle><Pagination><MedlinePgn>1274-1284</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(17)30469-2</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(17)30469-2</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Olaparib, a poly(ADP-ribose) polymerase (PARP) inhibitor, has previously shown efficacy in a phase 2 study when given in capsule formulation to all-comer patients with platinum-sensitive, relapsed high-grade serous ovarian cancer. We aimed to confirm these findings in patients with a BRCA1 or BRCA2 (BRCA1/2) mutation using a tablet formulation of olaparib.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This international, multicentre, double-blind, randomised, placebo-controlled, phase 3 trial evaluated olaparib tablet maintenance treatment in platinum-sensitive, relapsed ovarian cancer patients with a BRCA1/2 mutation who had received at least two lines of previous chemotherapy. Eligible patients were aged 18 years or older with an Eastern Cooperative Oncology Group performance status at baseline of 0-1 and histologically confirmed, relapsed, high-grade serous ovarian cancer or high-grade endometrioid cancer, including primary peritoneal or fallopian tube cancer. Patients were randomly assigned 2:1 to olaparib (300 mg in two 150 mg tablets, twice daily) or matching placebo tablets using an interactive voice and web response system. Randomisation was stratified by response to previous platinum chemotherapy (complete vs partial) and length of platinum-free interval (6-12 months vs ≥12 months) and treatment assignment was masked for patients, those giving the interventions, data collectors, and data analysers. The primary endpoint was investigator-assessed progression-free survival and we report the primary analysis from this ongoing study. The efficacy analyses were done on the intention-to-treat population; safety analyses included patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov, number NCT01874353, and is ongoing and no longer recruiting patients.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Sept 3, 2013, and Nov 21, 2014, we enrolled 295 eligible patients who were randomly assigned to receive olaparib (n=196) or placebo (n=99). One patient in the olaparib group was randomised in error and did not receive study treatment. Investigator-assessed median progression-free survival was significantly longer with olaparib (19·1 months [95% CI 16·3-25·7]) than with placebo (5·5 months [5·2-5·8]; hazard ratio [HR] 0·30 [95% CI 0·22-0·41], p<0·0001). The most common adverse events of grade 3 or worse severity were anaemia (38 [19%] of 195 patients in the olaparib group vs two [2%] of 99 patients in the placebo group), fatigue or asthenia (eight [4%] vs two [2%]), and neutropenia (ten [5%] vs four [4%]). Serious adverse events were experienced by 35 (18%) patients in the olaparib group and eight (8%) patients in the placebo group. The most common in the olaparib group were anaemia (seven [4%] patients), abdominal pain (three [2%] patients), and intestinal obstruction (three [2%] patients). The most common in the placebo group were constipation (two [2%] patients) and intestinal obstruction (two [2%] patients). One (1%) patient in the olaparib group had a treatment-related adverse event (acute myeloid leukaemia) with an outcome of death.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">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. Apart from anaemia, toxicities with olaparib were low grade and manageable.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">AstraZeneca.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Pujade-Lauraine</LastName><ForeName>Eric</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Université Paris Descartes, AP-HP, Paris, France. Electronic address: epujade@arcagy.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ledermann</LastName><ForeName>Jonathan A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>Department of Oncology, University College London, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Selle</LastName><ForeName>Frédéric</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>Hôpital Tenon, Paris, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gebski</LastName><ForeName>Val</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Department of Biostatistics and Research Methodology, University of Sydney, Sydney, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Penson</LastName><ForeName>Richard T</ForeName><Initials>RT</Initials><AffiliationInfo><Affiliation>Department of Hematology/Oncology, Massachusetts General Hospital, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oza</LastName><ForeName>Amit M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Princess Margaret Cancer Centre, Toronto, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Korach</LastName><ForeName>Jacob</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Gynecologic Oncology Department, Sheba Medical Center, Tel Aviv University, Tel Hashomer, Israel.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huzarski</LastName><ForeName>Tomasz</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Genetics and Pathology, Pomeranian Medical University, Szczecin, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poveda</LastName><ForeName>Andrés</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Instituto Valenciano de Oncología, Valencia, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pignata</LastName><ForeName>Sandro</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Istituto Tumori Pascale di Napoli, Naples, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Friedlander</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, University of New South Wales Clinical School, Prince of Wales Hospital, Randwick, NSW, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colombo</LastName><ForeName>Nicoletta</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Gynecology Department, University of Milan-Bicocca and Istituto Europeo Oncología, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harter</LastName><ForeName>Philipp</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Gynecology and Gynecologic Oncology, Kliniken Essen Mitte, Essen, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fujiwara</LastName><ForeName>Keiichi</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Department of Gynecologic Oncology, Saitama Medical University International Medical Center, Saitama, Japan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ray-Coquard</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Centre Léon Bérard and University Claude Bernard, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Banerjee</LastName><ForeName>Susana</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>The Royal Marsden NHS Foundation Trust, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Liu</LastName><ForeName>Joyce</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Dana-Farber Cancer Institute, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lowe</LastName><ForeName>Elizabeth S</ForeName><Initials>ES</Initials><AffiliationInfo><Affiliation>AstraZeneca, Gaithersburg, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bloomfield</LastName><ForeName>Ralph</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>AstraZeneca, Cambridge, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pautier</LastName><ForeName>Patricia</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Gustave Roussy Cancer Campus, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>SOLO2/ENGOT-Ov21 investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType 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