Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial.
Identifieur interne : 000403 ( PubMed/Corpus ); précédent : 000402; suivant : 000404Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial.
Auteurs : Robert L. Coleman ; Amit M. Oza ; Domenica Lorusso ; Carol Aghajanian ; Ana Oaknin ; Andrew Dean ; Nicoletta Colombo ; Johanne I. Weberpals ; Andrew Clamp ; Giovanni Scambia ; Alexandra Leary ; Robert W. Holloway ; Margarita Amenedo Gancedo ; Peter 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 C. Harding ; Mitch Raponi ; James Sun ; Kevin K. Lin ; Heidi Giordano ; Jonathan A. LedermannSource :
- Lancet (London, England) [ 1474-547X ] ; 2017.
Abstract
Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma.
DOI: 10.1016/S0140-6736(17)32440-6
PubMed: 28916367
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial.</title><author><name sortKey="Coleman, Robert L" sort="Coleman, Robert L" uniqKey="Coleman R" first="Robert L" last="Coleman">Robert L. Coleman</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: rcoleman@mdanderson.org.</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>Department of Medicine, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Lorusso, Domenica" sort="Lorusso, Domenica" uniqKey="Lorusso D" first="Domenica" last="Lorusso">Domenica Lorusso</name><affiliation><nlm:affiliation>Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Aghajanian, Carol" sort="Aghajanian, Carol" uniqKey="Aghajanian C" first="Carol" last="Aghajanian">Carol Aghajanian</name><affiliation><nlm:affiliation>Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name><affiliation><nlm:affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Dean, Andrew" sort="Dean, Andrew" uniqKey="Dean A" first="Andrew" last="Dean">Andrew Dean</name><affiliation><nlm:affiliation>Department of Oncology, St John of God Subiaco Hospital, Subiaco, WA, 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>Gynecologic Cancer Program, European Institute of Oncology and University of Milan-Bicocca, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Weberpals, Johanne I" sort="Weberpals, Johanne I" uniqKey="Weberpals J" first="Johanne I" last="Weberpals">Johanne I. Weberpals</name><affiliation><nlm:affiliation>Ottawa Hospital Research Institute, Ottawa, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Clamp, Andrew" sort="Clamp, Andrew" uniqKey="Clamp A" first="Andrew" last="Clamp">Andrew Clamp</name><affiliation><nlm:affiliation>Department of Medical Oncology, Christie National Health Service Foundation Trust and University of Manchester, Manchester, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Scambia, Giovanni" sort="Scambia, Giovanni" uniqKey="Scambia G" first="Giovanni" last="Scambia">Giovanni Scambia</name><affiliation><nlm:affiliation>Gynecologic Oncology, Università Cattolica Roma, Rome, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Leary, Alexandra" sort="Leary, Alexandra" uniqKey="Leary A" first="Alexandra" last="Leary">Alexandra Leary</name><affiliation><nlm:affiliation>Group d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Gynecological Unit, Department of Medicine, Gustave Roussy Cancer Center and Institut National de la Santé et de la Recherche Médicale U981, Villejuif, France.</nlm:affiliation></affiliation></author><author><name sortKey="Holloway, Robert W" sort="Holloway, Robert W" uniqKey="Holloway R" first="Robert W" last="Holloway">Robert W. Holloway</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gancedo, Margarita Amenedo" sort="Gancedo, Margarita Amenedo" uniqKey="Gancedo M" first="Margarita Amenedo" last="Gancedo">Margarita Amenedo Gancedo</name><affiliation><nlm:affiliation>Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Fong, Peter C" sort="Fong, Peter C" uniqKey="Fong P" first="Peter C" last="Fong">Peter C. Fong</name><affiliation><nlm:affiliation>Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Goh, Jeffrey C" sort="Goh, Jeffrey C" uniqKey="Goh J" first="Jeffrey C" last="Goh">Jeffrey C. Goh</name><affiliation><nlm:affiliation>Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="O Malley, David M" sort="O Malley, David M" uniqKey="O Malley D" first="David M" last="O'Malley">David M. O'Malley</name><affiliation><nlm:affiliation>Gynecologic Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Armstrong, Deborah K" sort="Armstrong, Deborah K" uniqKey="Armstrong D" first="Deborah K" last="Armstrong">Deborah K. Armstrong</name><affiliation><nlm:affiliation>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Garcia Donas, Jesus" sort="Garcia Donas, Jesus" uniqKey="Garcia Donas J" first="Jesus" last="Garcia-Donas">Jesus Garcia-Donas</name><affiliation><nlm:affiliation>HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Swisher, Elizabeth M" sort="Swisher, Elizabeth M" uniqKey="Swisher E" first="Elizabeth M" last="Swisher">Elizabeth M. Swisher</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Floquet, Anne" sort="Floquet, Anne" uniqKey="Floquet A" first="Anne" last="Floquet">Anne Floquet</name><affiliation><nlm:affiliation>Groupe d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Institut Bergonié, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Konecny, Gottfried E" sort="Konecny, Gottfried E" uniqKey="Konecny G" first="Gottfried E" last="Konecny">Gottfried E. Konecny</name><affiliation><nlm:affiliation>Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mcneish, Iain A" sort="Mcneish, Iain A" uniqKey="Mcneish I" first="Iain A" last="Mcneish">Iain A. Mcneish</name><affiliation><nlm:affiliation>Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Scott, Clare L" sort="Scott, Clare L" uniqKey="Scott C" first="Clare L" last="Scott">Clare L. Scott</name><affiliation><nlm:affiliation>Royal Melbourne Hospital, Parkville, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Cameron, Terri" sort="Cameron, Terri" uniqKey="Cameron T" first="Terri" last="Cameron">Terri Cameron</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Maloney, Lara" sort="Maloney, Lara" uniqKey="Maloney L" first="Lara" last="Maloney">Lara Maloney</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Isaacson, Jeff" sort="Isaacson, Jeff" uniqKey="Isaacson J" first="Jeff" last="Isaacson">Jeff Isaacson</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Goble, Sandra" sort="Goble, Sandra" uniqKey="Goble S" first="Sandra" last="Goble">Sandra Goble</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Grace, Caroline" sort="Grace, Caroline" uniqKey="Grace C" first="Caroline" last="Grace">Caroline Grace</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Harding, Thomas C" sort="Harding, Thomas C" uniqKey="Harding T" first="Thomas C" last="Harding">Thomas C. Harding</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Raponi, Mitch" sort="Raponi, Mitch" uniqKey="Raponi M" first="Mitch" last="Raponi">Mitch Raponi</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, James" sort="Sun, James" uniqKey="Sun J" first="James" last="Sun">James Sun</name><affiliation><nlm:affiliation>Foundation Medicine, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Kevin K" sort="Lin, Kevin K" uniqKey="Lin K" first="Kevin K" last="Lin">Kevin K. Lin</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Giordano, Heidi" sort="Giordano, Heidi" uniqKey="Giordano H" first="Heidi" last="Giordano">Heidi Giordano</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</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>University College London Cancer Institute and University College London Hospitals, London, UK.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28916367</idno><idno type="pmid">28916367</idno><idno type="doi">10.1016/S0140-6736(17)32440-6</idno><idno type="wicri:Area/PubMed/Corpus">000403</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000403</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial.</title><author><name sortKey="Coleman, Robert L" sort="Coleman, Robert L" uniqKey="Coleman R" first="Robert L" last="Coleman">Robert L. Coleman</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: rcoleman@mdanderson.org.</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>Department of Medicine, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Lorusso, Domenica" sort="Lorusso, Domenica" uniqKey="Lorusso D" first="Domenica" last="Lorusso">Domenica Lorusso</name><affiliation><nlm:affiliation>Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Aghajanian, Carol" sort="Aghajanian, Carol" uniqKey="Aghajanian C" first="Carol" last="Aghajanian">Carol Aghajanian</name><affiliation><nlm:affiliation>Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Oaknin, Ana" sort="Oaknin, Ana" uniqKey="Oaknin A" first="Ana" last="Oaknin">Ana Oaknin</name><affiliation><nlm:affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Dean, Andrew" sort="Dean, Andrew" uniqKey="Dean A" first="Andrew" last="Dean">Andrew Dean</name><affiliation><nlm:affiliation>Department of Oncology, St John of God Subiaco Hospital, Subiaco, WA, 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>Gynecologic Cancer Program, European Institute of Oncology and University of Milan-Bicocca, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Weberpals, Johanne I" sort="Weberpals, Johanne I" uniqKey="Weberpals J" first="Johanne I" last="Weberpals">Johanne I. Weberpals</name><affiliation><nlm:affiliation>Ottawa Hospital Research Institute, Ottawa, ON, Canada.</nlm:affiliation></affiliation></author><author><name sortKey="Clamp, Andrew" sort="Clamp, Andrew" uniqKey="Clamp A" first="Andrew" last="Clamp">Andrew Clamp</name><affiliation><nlm:affiliation>Department of Medical Oncology, Christie National Health Service Foundation Trust and University of Manchester, Manchester, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Scambia, Giovanni" sort="Scambia, Giovanni" uniqKey="Scambia G" first="Giovanni" last="Scambia">Giovanni Scambia</name><affiliation><nlm:affiliation>Gynecologic Oncology, Università Cattolica Roma, Rome, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Leary, Alexandra" sort="Leary, Alexandra" uniqKey="Leary A" first="Alexandra" last="Leary">Alexandra Leary</name><affiliation><nlm:affiliation>Group d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Gynecological Unit, Department of Medicine, Gustave Roussy Cancer Center and Institut National de la Santé et de la Recherche Médicale U981, Villejuif, France.</nlm:affiliation></affiliation></author><author><name sortKey="Holloway, Robert W" sort="Holloway, Robert W" uniqKey="Holloway R" first="Robert W" last="Holloway">Robert W. Holloway</name><affiliation><nlm:affiliation>Department of Gynecologic Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Gancedo, Margarita Amenedo" sort="Gancedo, Margarita Amenedo" uniqKey="Gancedo M" first="Margarita Amenedo" last="Gancedo">Margarita Amenedo Gancedo</name><affiliation><nlm:affiliation>Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Fong, Peter C" sort="Fong, Peter C" uniqKey="Fong P" first="Peter C" last="Fong">Peter C. Fong</name><affiliation><nlm:affiliation>Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Goh, Jeffrey C" sort="Goh, Jeffrey C" uniqKey="Goh J" first="Jeffrey C" last="Goh">Jeffrey C. Goh</name><affiliation><nlm:affiliation>Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="O Malley, David M" sort="O Malley, David M" uniqKey="O Malley D" first="David M" last="O'Malley">David M. O'Malley</name><affiliation><nlm:affiliation>Gynecologic Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Armstrong, Deborah K" sort="Armstrong, Deborah K" uniqKey="Armstrong D" first="Deborah K" last="Armstrong">Deborah K. Armstrong</name><affiliation><nlm:affiliation>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Garcia Donas, Jesus" sort="Garcia Donas, Jesus" uniqKey="Garcia Donas J" first="Jesus" last="Garcia-Donas">Jesus Garcia-Donas</name><affiliation><nlm:affiliation>HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Swisher, Elizabeth M" sort="Swisher, Elizabeth M" uniqKey="Swisher E" first="Elizabeth M" last="Swisher">Elizabeth M. Swisher</name><affiliation><nlm:affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Floquet, Anne" sort="Floquet, Anne" uniqKey="Floquet A" first="Anne" last="Floquet">Anne Floquet</name><affiliation><nlm:affiliation>Groupe d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Institut Bergonié, Bordeaux, France.</nlm:affiliation></affiliation></author><author><name sortKey="Konecny, Gottfried E" sort="Konecny, Gottfried E" uniqKey="Konecny G" first="Gottfried E" last="Konecny">Gottfried E. Konecny</name><affiliation><nlm:affiliation>Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Mcneish, Iain A" sort="Mcneish, Iain A" uniqKey="Mcneish I" first="Iain A" last="Mcneish">Iain A. Mcneish</name><affiliation><nlm:affiliation>Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.</nlm:affiliation></affiliation></author><author><name sortKey="Scott, Clare L" sort="Scott, Clare L" uniqKey="Scott C" first="Clare L" last="Scott">Clare L. Scott</name><affiliation><nlm:affiliation>Royal Melbourne Hospital, Parkville, VIC, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Cameron, Terri" sort="Cameron, Terri" uniqKey="Cameron T" first="Terri" last="Cameron">Terri Cameron</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Maloney, Lara" sort="Maloney, Lara" uniqKey="Maloney L" first="Lara" last="Maloney">Lara Maloney</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Isaacson, Jeff" sort="Isaacson, Jeff" uniqKey="Isaacson J" first="Jeff" last="Isaacson">Jeff Isaacson</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Goble, Sandra" sort="Goble, Sandra" uniqKey="Goble S" first="Sandra" last="Goble">Sandra Goble</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Grace, Caroline" sort="Grace, Caroline" uniqKey="Grace C" first="Caroline" last="Grace">Caroline Grace</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Harding, Thomas C" sort="Harding, Thomas C" uniqKey="Harding T" first="Thomas C" last="Harding">Thomas C. Harding</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Raponi, Mitch" sort="Raponi, Mitch" uniqKey="Raponi M" first="Mitch" last="Raponi">Mitch Raponi</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Sun, James" sort="Sun, James" uniqKey="Sun J" first="James" last="Sun">James Sun</name><affiliation><nlm:affiliation>Foundation Medicine, Cambridge, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Lin, Kevin K" sort="Lin, Kevin K" uniqKey="Lin K" first="Kevin K" last="Lin">Kevin K. Lin</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Giordano, Heidi" sort="Giordano, Heidi" uniqKey="Giordano H" first="Heidi" last="Giordano">Heidi Giordano</name><affiliation><nlm:affiliation>Clovis Oncology, Boulder, CO, USA.</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>University College London Cancer Institute and University College London Hospitals, London, UK.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Lancet (London, England)</title><idno type="eISSN">1474-547X</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma.</div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">28916367</PMID><DateCreated><Year>2017</Year><Month>09</Month><Day>16</Day></DateCreated><DateRevised><Year>2017</Year><Month>11</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-547X</ISSN><JournalIssue CitedMedium="Internet"><Volume>390</Volume><Issue>10106</Issue><PubDate><Year>2017</Year><Month>Oct</Month><Day>28</Day></PubDate></JournalIssue><Title>Lancet (London, England)</Title><ISOAbbreviation>Lancet</ISOAbbreviation></Journal><ArticleTitle>Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double-blind, placebo-controlled, phase 3 trial.</ArticleTitle><Pagination><MedlinePgn>1949-1961</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S0140-6736(17)32440-6</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S0140-6736(17)32440-6</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Rucaparib, a poly(ADP-ribose) polymerase inhibitor, has anticancer activity in recurrent ovarian carcinoma harbouring a BRCA mutation or high percentage of genome-wide loss of heterozygosity. In this trial we assessed rucaparib versus placebo after response to second-line or later platinum-based chemotherapy in patients with high-grade, recurrent, platinum-sensitive ovarian carcinoma.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited patients from 87 hospitals and cancer centres across 11 countries. Eligible patients were aged 18 years or older, had a platinum-sensitive, high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube carcinoma, had received at least two previous platinum-based chemotherapy regimens, had achieved complete or partial response to their last platinum-based regimen, had a cancer antigen 125 concentration of less than the upper limit of normal, had a performance status of 0-1, and had adequate organ function. Patients were ineligible if they had symptomatic or untreated central nervous system metastases, had received anticancer therapy 14 days or fewer before starting the study, or had received previous treatment with a poly(ADP-ribose) polymerase inhibitor. We randomly allocated patients 2:1 to receive oral rucaparib 600 mg twice daily or placebo in 28 day cycles using a computer-generated sequence (block size of six, stratified by homologous recombination repair gene mutation status, progression-free interval after the penultimate platinum-based regimen, and best response to the most recent platinum-based regimen). Patients, investigators, site staff, assessors, and the funder were masked to assignments. The primary outcome was investigator-assessed progression-free survival evaluated with use of an ordered step-down procedure for three nested cohorts: patients with BRCA mutations (carcinoma associated with deleterious germline or somatic BRCA mutations), patients with homologous recombination deficiencies (BRCA mutant or BRCA wild-type and high loss of heterozygosity), and the intention-to-treat population, assessed at screening and every 12 weeks thereafter. This trial is registered with ClinicalTrials.gov, number NCT01968213; enrolment is complete.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between April 7, 2014, and July 19, 2016, we randomly allocated 564 patients: 375 (66%) to rucaparib and 189 (34%) to placebo. Median progression-free survival in patients with a BRCA-mutant carcinoma was 16·6 months (95% CI 13·4-22·9; 130 [35%] patients) in the rucaparib group versus 5·4 months (3·4-6·7; 66 [35%] patients) in the placebo group (hazard ratio 0·23 [95% CI 0·16-0·34]; p<0·0001). In patients with a homologous recombination deficient carcinoma (236 [63%] vs 118 [62%]), it was 13·6 months (10·9-16·2) versus 5·4 months (5·1-5·6; 0·32 [0·24-0·42]; p<0·0001). In the intention-to-treat population, it was 10·8 months (8·3-11·4) versus 5·4 months (5·3-5·5; 0·36 [0·30-0·45]; p<0·0001). Treatment-emergent adverse events of grade 3 or higher in the safety population (372 [99%] patients in the rucaparib group vs 189 [100%] in the placebo group) were reported in 209 (56%) patients in the rucaparib group versus 28 (15%) in the placebo group, the most common of which were anaemia or decreased haemoglobin concentration (70 [19%] vs one [1%]) and increased alanine or aspartate aminotransferase concentration (39 [10%] vs none).</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Across all primary analysis groups, rucaparib significantly improved progression-free survival in patients with platinum-sensitive ovarian cancer who had achieved a response to platinum-based chemotherapy. ARIEL3 provides further evidence that use of a poly(ADP-ribose) polymerase inhibitor in the maintenance treatment setting versus placebo could be considered a new standard of care for women with platinum-sensitive ovarian cancer following a complete or partial response to second-line or later platinum-based chemotherapy.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Clovis Oncology.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Coleman</LastName><ForeName>Robert L</ForeName><Initials>RL</Initials><AffiliationInfo><Affiliation>Department of Gynecologic Oncology and Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: rcoleman@mdanderson.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oza</LastName><ForeName>Amit M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Department of Medicine, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lorusso</LastName><ForeName>Domenica</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Multicentre Italian Trials in Ovarian Cancer and Gynecologic Malignancies and Gynecologic Oncology Unit, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico, Istituto Nazionale dei Tumori, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Aghajanian</LastName><ForeName>Carol</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oaknin</LastName><ForeName>Ana</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dean</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Oncology, St John of God Subiaco Hospital, Subiaco, WA, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Colombo</LastName><ForeName>Nicoletta</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Gynecologic Cancer Program, European Institute of Oncology and University of Milan-Bicocca, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Weberpals</LastName><ForeName>Johanne I</ForeName><Initials>JI</Initials><AffiliationInfo><Affiliation>Ottawa Hospital Research Institute, Ottawa, ON, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Clamp</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Christie National Health Service Foundation Trust and University of Manchester, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scambia</LastName><ForeName>Giovanni</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Gynecologic Oncology, Università Cattolica Roma, Rome, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leary</LastName><ForeName>Alexandra</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Group d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Gynecological Unit, Department of Medicine, Gustave Roussy Cancer Center and Institut National de la Santé et de la Recherche Médicale U981, Villejuif, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Holloway</LastName><ForeName>Robert W</ForeName><Initials>RW</Initials><AffiliationInfo><Affiliation>Department of Gynecologic Oncology, Florida Hospital Cancer Institute, Orlando, FL, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gancedo</LastName><ForeName>Margarita Amenedo</ForeName><Initials>MA</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Oncology Center of Galicia, La Coruña, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Fong</LastName><ForeName>Peter C</ForeName><Initials>PC</Initials><AffiliationInfo><Affiliation>Medical Oncology Department, Auckland City Hospital, Grafton, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goh</LastName><ForeName>Jeffrey C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Department of Oncology, Cancer Care Services, Royal Brisbane and Women's Hospital, Herston, QLD, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>O'Malley</LastName><ForeName>David M</ForeName><Initials>DM</Initials><AffiliationInfo><Affiliation>Gynecologic Oncology, Ohio State University, James Cancer Center, Columbus, OH, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Armstrong</LastName><ForeName>Deborah K</ForeName><Initials>DK</Initials><AffiliationInfo><Affiliation>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Garcia-Donas</LastName><ForeName>Jesus</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>HM Hospitales-Centro Integral Oncológico Hospital de Madrid Clara Campal, Madrid, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Swisher</LastName><ForeName>Elizabeth M</ForeName><Initials>EM</Initials><AffiliationInfo><Affiliation>Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Floquet</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Groupe d'Investigateurs Nationaux pour l'Étude des Cancers Ovariens et du sein and Institut Bergonié, Bordeaux, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Konecny</LastName><ForeName>Gottfried E</ForeName><Initials>GE</Initials><AffiliationInfo><Affiliation>Department of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>McNeish</LastName><ForeName>Iain A</ForeName><Initials>IA</Initials><AffiliationInfo><Affiliation>Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Scott</LastName><ForeName>Clare L</ForeName><Initials>CL</Initials><AffiliationInfo><Affiliation>Royal Melbourne Hospital, Parkville, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Cameron</LastName><ForeName>Terri</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Maloney</LastName><ForeName>Lara</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Isaacson</LastName><ForeName>Jeff</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goble</LastName><ForeName>Sandra</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grace</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harding</LastName><ForeName>Thomas C</ForeName><Initials>TC</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Raponi</LastName><ForeName>Mitch</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sun</LastName><ForeName>James</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Foundation Medicine, Cambridge, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lin</LastName><ForeName>Kevin K</ForeName><Initials>KK</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Giordano</LastName><ForeName>Heidi</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Clovis Oncology, Boulder, CO, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ledermann</LastName><ForeName>Jonathan A</ForeName><Initials>JA</Initials><AffiliationInfo><Affiliation>University College London Cancer Institute and University College London Hospitals, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>ARIEL3 investigators</CollectiveName></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate 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