Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients
Identifieur interne : 005C51 ( Main/Curation ); précédent : 005C50; suivant : 005C52Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients
Auteurs : U. Wagner [Allemagne] ; C. Marth [Autriche] ; R. Largillier [France] ; J. Kaern [Norvège] ; C. Brown [Australie] ; M. Heywood [Canada] ; T. Bonaventura [Australie] ; I. Vergote [Belgique] ; M. C. Piccirillo [Italie] ; R. Fossati [Italie] ; V. Gebski [Australie] ; E. P. Lauraine [France]Source :
- British journal of cancer [ 0007-0920 ] ; 2012.
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Abstract
BACKGROUND: The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin- paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature. METHODS: Women with ROC relapsing > 6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here. RESULTS: A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio=0.99 (95% confidence interval 0.85, 1.16); log-rank P = 0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P<0.001). CONCLUSION: Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.
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Vergote</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</s1><s2>Leuven</s2><s3>BEL</s3><sZ>8 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M. C." last="Piccirillo">M. C. Piccirillo</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Clinical Trials Unit, National Cancer Institute of Napoli</s1><s2>Napoli</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Napoli</wicri:noRegion></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R." last="Fossati">R. Fossati</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Oncology, Mario Negri Institute</s1><s2>Milan</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V." last="Gebski">V. Gebski</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. 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Wagner</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of GieBen and Marburg, Baldingerstrasse</s1><s2>35043 Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>35043 Marburg</wicri:noRegion><wicri:noRegion>Baldingerstrasse</wicri:noRegion><wicri:noRegion>35043 Marburg</wicri:noRegion></affiliation></author><author><name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C." last="Marth">C. Marth</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Obstetrics & Gynecology Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Department of Obstetrics & Gynecology Medical University Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R." last="Largillier">R. Largillier</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Centre Azuréen de Cancérologie</s1><s2>Mougins</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Mougins</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion></affiliation></author><author><name sortKey="Kaern, J" sort="Kaern, J" uniqKey="Kaern J" first="J." last="Kaern">J. Kaern</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Gynecologic Oncology, The Norwegian Radium Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>4 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C." last="Brown">C. Brown</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M." last="Heywood">M. Heywood</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</s1><s2>Vancouver, British Columbia</s2><s3>CAN</s3><sZ>6 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Vancouver, British Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Bonaventura, T" sort="Bonaventura, T" uniqKey="Bonaventura T" first="T." last="Bonaventura">T. Bonaventura</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</s1><s2>Newcastle, NSW</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Newcastle, NSW</wicri:noRegion></affiliation></author><author><name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I." last="Vergote">I. Vergote</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</s1><s2>Leuven</s2><s3>BEL</s3><sZ>8 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M. C." last="Piccirillo">M. C. Piccirillo</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Clinical Trials Unit, National Cancer Institute of Napoli</s1><s2>Napoli</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Napoli</wicri:noRegion></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R." last="Fossati">R. Fossati</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Oncology, Mario Negri Institute</s1><s2>Milan</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V." last="Gebski">V. Gebski</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. Lauraine</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</s1><s2>Paris</s2><s3>FRA</s3><sZ>12 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author></analytic><series><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. j. cancer</title><idno type="ISSN">0007-0920</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. j. cancer</title><idno type="ISSN">0007-0920</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Cancerology</term><term>Carboplatin</term><term>Chemotherapy</term><term>Comparative study</term><term>Doxorubicin</term><term>Human</term><term>Liposome</term><term>Ovary cancer</term><term>Paclitaxel</term><term>Pegylated form</term><term>Phase III trial</term><term>Relapse</term><term>Survival</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term><term>Survie</term><term>Forme pégylée</term><term>Doxorubicine</term><term>Liposome</term><term>Etude comparative</term><term>Chimiothérapie</term><term>Cancer de l'ovaire</term><term>Homme</term><term>Carboplatine</term><term>Récidive</term><term>Cancérologie</term><term>Paclitaxel</term><term>Anticancéreux</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin- paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature. METHODS: Women with ROC relapsing > 6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here. RESULTS: A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio=0.99 (95% confidence interval 0.85, 1.16); log-rank P = 0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P<0.001). CONCLUSION: Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.</div></front></TEI><double idat="0007-0920:2012:Wagner U:final:overall:survival"><INIST><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients</title><author><name sortKey="Wagner, U" sort="Wagner, U" uniqKey="Wagner U" first="U." last="Wagner">U. Wagner</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of GieBen and Marburg, Baldingerstrasse</s1><s2>35043 Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>35043 Marburg</wicri:noRegion><wicri:noRegion>Baldingerstrasse</wicri:noRegion><wicri:noRegion>35043 Marburg</wicri:noRegion></affiliation></author><author><name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C." last="Marth">C. Marth</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Obstetrics & Gynecology Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Department of Obstetrics & Gynecology Medical University Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R." last="Largillier">R. Largillier</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Centre Azuréen de Cancérologie</s1><s2>Mougins</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Mougins</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion></affiliation></author><author><name sortKey="Kaern, J" sort="Kaern, J" uniqKey="Kaern J" first="J." last="Kaern">J. Kaern</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Gynecologic Oncology, The Norwegian Radium Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>4 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C." last="Brown">C. Brown</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M." last="Heywood">M. Heywood</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</s1><s2>Vancouver, British Columbia</s2><s3>CAN</s3><sZ>6 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Vancouver, British Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Bonaventura, T" sort="Bonaventura, T" uniqKey="Bonaventura T" first="T." last="Bonaventura">T. Bonaventura</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</s1><s2>Newcastle, NSW</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Newcastle, NSW</wicri:noRegion></affiliation></author><author><name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I." last="Vergote">I. Vergote</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</s1><s2>Leuven</s2><s3>BEL</s3><sZ>8 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M. C." last="Piccirillo">M. C. Piccirillo</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Clinical Trials Unit, National Cancer Institute of Napoli</s1><s2>Napoli</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Napoli</wicri:noRegion></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R." last="Fossati">R. Fossati</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Oncology, Mario Negri Institute</s1><s2>Milan</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V." last="Gebski">V. Gebski</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. Lauraine</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</s1><s2>Paris</s2><s3>FRA</s3><sZ>12 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0338516</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0338516 INIST</idno><idno type="RBID">Pascal:12-0338516</idno><idno type="wicri:Area/PascalFrancis/Corpus">001093</idno><idno type="wicri:Area/PascalFrancis/Curation">004E24</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001122</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001122</idno><idno type="wicri:doubleKey">0007-0920:2012:Wagner U:final:overall:survival</idno><idno type="wicri:Area/Main/Merge">005F57</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin vs paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients</title><author><name sortKey="Wagner, U" sort="Wagner, U" uniqKey="Wagner U" first="U." last="Wagner">U. Wagner</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of GieBen and Marburg, Baldingerstrasse</s1><s2>35043 Marburg</s2><s3>DEU</s3><sZ>1 aut.</sZ></inist:fA14><country>Allemagne</country><wicri:noRegion>35043 Marburg</wicri:noRegion><wicri:noRegion>Baldingerstrasse</wicri:noRegion><wicri:noRegion>35043 Marburg</wicri:noRegion></affiliation></author><author><name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C." last="Marth">C. Marth</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Obstetrics & Gynecology Medical University Innsbruck</s1><s2>Innsbruck</s2><s3>AUT</s3><sZ>2 aut.</sZ></inist:fA14><country>Autriche</country><wicri:noRegion>Department of Obstetrics & Gynecology Medical University Innsbruck</wicri:noRegion></affiliation></author><author><name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R." last="Largillier">R. Largillier</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Centre Azuréen de Cancérologie</s1><s2>Mougins</s2><s3>FRA</s3><sZ>3 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Mougins</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion><wicri:noRegion>Centre Azuréen de Cancérologie</wicri:noRegion></affiliation></author><author><name sortKey="Kaern, J" sort="Kaern, J" uniqKey="Kaern J" first="J." last="Kaern">J. Kaern</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Gynecologic Oncology, The Norwegian Radium Hospital</s1><s2>Oslo</s2><s3>NOR</s3><sZ>4 aut.</sZ></inist:fA14><country>Norvège</country><placeName><settlement type="city">Oslo</settlement><region nuts="2">Østlandet</region></placeName></affiliation></author><author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C." last="Brown">C. Brown</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M." last="Heywood">M. Heywood</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</s1><s2>Vancouver, British Columbia</s2><s3>CAN</s3><sZ>6 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Vancouver, British Columbia</wicri:noRegion></affiliation></author><author><name sortKey="Bonaventura, T" sort="Bonaventura, T" uniqKey="Bonaventura T" first="T." last="Bonaventura">T. Bonaventura</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</s1><s2>Newcastle, NSW</s2><s3>AUS</s3><sZ>7 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Newcastle, NSW</wicri:noRegion></affiliation></author><author><name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I." last="Vergote">I. Vergote</name><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</s1><s2>Leuven</s2><s3>BEL</s3><sZ>8 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Leuven</wicri:noRegion></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M. C." last="Piccirillo">M. C. Piccirillo</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Clinical Trials Unit, National Cancer Institute of Napoli</s1><s2>Napoli</s2><s3>ITA</s3><sZ>9 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Napoli</wicri:noRegion></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R." last="Fossati">R. Fossati</name><affiliation wicri:level="3"><inist:fA14 i1="10"><s1>Department of Oncology, Mario Negri Institute</s1><s2>Milan</s2><s3>ITA</s3><sZ>10 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V." last="Gebski">V. Gebski</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>NHM RC Clinical Trials Centre</s1><s2>Camperdown, New South Wales</s2><s3>AUS</s3><sZ>5 aut.</sZ><sZ>11 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>NHM RC Clinical Trials Centre</wicri:noRegion></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E. P." last="Lauraine">E. P. Lauraine</name><affiliation wicri:level="4"><inist:fA14 i1="11"><s1>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</s1><s2>Paris</s2><s3>FRA</s3><sZ>12 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Île-de-France</region><region type="old region">Île-de-France</region><settlement type="city">Paris</settlement><settlement type="city">Paris</settlement></placeName><orgName type="university">Université Paris-Descartes</orgName></affiliation></author></analytic><series><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. j. cancer</title><idno type="ISSN">0007-0920</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">British journal of cancer</title><title level="j" type="abbreviated">Br. j. cancer</title><idno type="ISSN">0007-0920</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antineoplastic agent</term><term>Cancerology</term><term>Carboplatin</term><term>Chemotherapy</term><term>Comparative study</term><term>Doxorubicin</term><term>Human</term><term>Liposome</term><term>Ovary cancer</term><term>Paclitaxel</term><term>Pegylated form</term><term>Phase III trial</term><term>Relapse</term><term>Survival</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term><term>Survie</term><term>Forme pégylée</term><term>Doxorubicine</term><term>Liposome</term><term>Etude comparative</term><term>Chimiothérapie</term><term>Cancer de l'ovaire</term><term>Homme</term><term>Carboplatine</term><term>Récidive</term><term>Cancérologie</term><term>Paclitaxel</term><term>Anticancéreux</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin- paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature. METHODS: Women with ROC relapsing > 6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here. RESULTS: A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio=0.99 (95% confidence interval 0.85, 1.16); log-rank P = 0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43%; P<0.001). CONCLUSION: Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.</div></front></TEI></INIST><PMC><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin <italic>vs</italic> paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients</title><author><name sortKey="Wagner, U" sort="Wagner, U" uniqKey="Wagner U" first="U" last="Wagner">U. Wagner</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of Gießen and Marburg, Baldingerstrasse</institution>, 35043 Marburg,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C" last="Marth">C. Marth</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Department of Obstetrics & Gynecology Medical University Innsbruck</institution>, Innsbruck,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R" last="Largillier">R. Largillier</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Centre Azuréen de Cancérologie</institution>, Mougins,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kaern, J" sort="Kaern, J" uniqKey="Kaern J" first="J" last="Kaern">J. Kaern</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Gynecologic Oncology, The Norwegian Radium Hospital</institution>, Oslo,<country>Norway</country></nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C" last="Brown">C. Brown</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>NHMRC Clinical Trials Centre</institution>, Camperdown, New South Wales,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M" last="Heywood">M. Heywood</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</institution>, Vancouver, British Columbia,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bonaventura, T" sort="Bonaventura, T" uniqKey="Bonaventura T" first="T" last="Bonaventura">T. Bonaventura</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</institution>, Newcastle, NSW,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I" last="Vergote">I. Vergote</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</institution>, Leuven,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M C" last="Piccirillo">M C Piccirillo</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Clinical Trials Unit, National Cancer Institute of Napoli</institution>, Napoli,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R" last="Fossati">R. Fossati</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Department of Oncology, Mario Negri Institute</institution>, Milan,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V" last="Gebski">V. Gebski</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>NHMRC Clinical Trials Centre</institution>, Camperdown, New South Wales,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E P" last="Lauraine">E P Lauraine</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</institution>, Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">22836511</idno><idno type="pmc">3419956</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3419956</idno><idno type="RBID">PMC:3419956</idno><idno type="doi">10.1038/bjc.2012.307</idno><date when="2012">2012</date><idno type="wicri:Area/Pmc/Corpus">000079</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000079</idno><idno type="wicri:Area/Pmc/Curation">000079</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000079</idno><idno type="wicri:Area/Pmc/Checkpoint">001F45</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001F45</idno><idno type="wicri:Area/Ncbi/Merge">000F10</idno><idno type="wicri:Area/Ncbi/Curation">000F10</idno><idno type="wicri:Area/Ncbi/Checkpoint">000F10</idno><idno type="wicri:doubleKey">0007-0920:2012:Wagner U:final:overall:survival</idno><idno type="wicri:Area/Main/Merge">005628</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Final overall survival results of phase III GCIG CALYPSO trial of pegylated liposomal doxorubicin and carboplatin <italic>vs</italic> paclitaxel and carboplatin in platinum-sensitive ovarian cancer patients</title><author><name sortKey="Wagner, U" sort="Wagner, U" uniqKey="Wagner U" first="U" last="Wagner">U. Wagner</name><affiliation wicri:level="1"><nlm:aff id="aff1"><institution>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of Gießen and Marburg, Baldingerstrasse</institution>, 35043 Marburg,<country>Germany</country></nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C" last="Marth">C. Marth</name><affiliation wicri:level="1"><nlm:aff id="aff2"><institution>Department of Obstetrics & Gynecology Medical University Innsbruck</institution>, Innsbruck,<country>Austria</country></nlm:aff><country xml:lang="fr">Autriche</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R" last="Largillier">R. Largillier</name><affiliation wicri:level="1"><nlm:aff id="aff3"><institution>Centre Azuréen de Cancérologie</institution>, Mougins,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Kaern, J" sort="Kaern, J" uniqKey="Kaern J" first="J" last="Kaern">J. Kaern</name><affiliation wicri:level="1"><nlm:aff id="aff4"><institution>Department of Gynecologic Oncology, The Norwegian Radium Hospital</institution>, Oslo,<country>Norway</country></nlm:aff><country xml:lang="fr">Norvège</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C" last="Brown">C. Brown</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>NHMRC Clinical Trials Centre</institution>, Camperdown, New South Wales,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M" last="Heywood">M. Heywood</name><affiliation wicri:level="1"><nlm:aff id="aff6"><institution>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</institution>, Vancouver, British Columbia,<country>Canada</country></nlm:aff><country xml:lang="fr">Canada</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Bonaventura, T" sort="Bonaventura, T" uniqKey="Bonaventura T" first="T" last="Bonaventura">T. Bonaventura</name><affiliation wicri:level="1"><nlm:aff id="aff7"><institution>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</institution>, Newcastle, NSW,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I" last="Vergote">I. Vergote</name><affiliation wicri:level="1"><nlm:aff id="aff8"><institution>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</institution>, Leuven,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M C" last="Piccirillo">M C Piccirillo</name><affiliation wicri:level="1"><nlm:aff id="aff9"><institution>Clinical Trials Unit, National Cancer Institute of Napoli</institution>, Napoli,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R" last="Fossati">R. Fossati</name><affiliation wicri:level="1"><nlm:aff id="aff10"><institution>Department of Oncology, Mario Negri Institute</institution>, Milan,<country>Italy</country></nlm:aff><country xml:lang="fr">Italie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Gebski, V" sort="Gebski, V" uniqKey="Gebski V" first="V" last="Gebski">V. Gebski</name><affiliation wicri:level="1"><nlm:aff id="aff5"><institution>NHMRC Clinical Trials Centre</institution>, Camperdown, New South Wales,<country>Australia</country></nlm:aff><country xml:lang="fr">Australie</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E P" last="Lauraine">E P Lauraine</name><affiliation wicri:level="1"><nlm:aff id="aff11"><institution>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</institution>, Paris,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">British Journal of Cancer</title><idno type="ISSN">0007-0920</idno><idno type="eISSN">1532-1827</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background:</title><p>The CALYPSO phase III trial compared CD (carboplatin-pegylated liposomal doxorubicin (PLD)) with CP (carboplatin-paclitaxel) in patients with platinum-sensitive recurrent ovarian cancer (ROC). Overall survival (OS) data are now mature.</p></sec><sec><title>Methods:</title><p>Women with ROC relapsing >6 months after first- or second-line therapy were randomised to CD or CP for six cycles in this international, open-label, non-inferiority trial. The primary endpoint was progression-free survival. The OS analysis is presented here.</p></sec><sec><title>Results:</title><p>A total of 976 patients were randomised (467 to CD and 509 to CP). With a median follow-up of 49 months, no statistically significant difference was observed between arms in OS (hazard ratio=0.99 (95% confidence interval 0.85, 1.16); log-rank <italic>P</italic>=0.94). Median survival times were 30.7 months (CD) and 33.0 months (CP). No statistically significant difference in OS was observed between arms in predetermined subgroups according to age, body mass index, treatment-free interval, measurable disease, number of lines of prior chemotherapy, or performance status. Post-study cross-over was imbalanced between arms, with a greater proportion of patients randomised to CP receiving post-study PLD (68%) than patients randomised to CD receiving post-study paclitaxel (43% <italic>P</italic><0.001).</p></sec><sec><title>Conclusion:</title><p>Carboplatin-PLD led to delayed progression and similar OS compared with carboplatin-paclitaxel in platinum-sensitive ROC.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Bafaloukos, D" uniqKey="Bafaloukos D">D Bafaloukos</name></author><author><name sortKey="Linardou, H" uniqKey="Linardou H">H Linardou</name></author><author><name sortKey="Aravantinos, G" uniqKey="Aravantinos G">G Aravantinos</name></author><author><name sortKey="Papadimitriou, C" uniqKey="Papadimitriou C">C Papadimitriou</name></author><author><name sortKey="Bamias, A" uniqKey="Bamias A">A Bamias</name></author><author><name sortKey="Fountzilas, G" uniqKey="Fountzilas G">G 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Pa" uniqKey="Vasey P">PA Vasey</name></author><author><name sortKey="Volgger, B" uniqKey="Volgger B">B Volgger</name></author><author><name sortKey="Vergote, I" uniqKey="Vergote I">I Vergote</name></author><author><name sortKey="Pignata, S" uniqKey="Pignata S">S Pignata</name></author><author><name sortKey="Ferrero, A" uniqKey="Ferrero A">A Ferrero</name></author><author><name sortKey="Sehouli, J" uniqKey="Sehouli J">J Sehouli</name></author><author><name sortKey="Lortholary, A" uniqKey="Lortholary A">A Lortholary</name></author><author><name sortKey="Kristensen, G" uniqKey="Kristensen G">G Kristensen</name></author><author><name sortKey="Jackisch, C" uniqKey="Jackisch C">C Jackisch</name></author><author><name sortKey="Joly, F" uniqKey="Joly F">F Joly</name></author><author><name sortKey="Brown, C" uniqKey="Brown C">C Brown</name></author><author><name sortKey="Le Fur, N" uniqKey="Le Fur N">N Le Fur</name></author><author><name sortKey="Du Bois, A" uniqKey="Du Bois A">A du Bois</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Weber, B" uniqKey="Weber B">B Weber</name></author><author><name sortKey="Lortholary, A" uniqKey="Lortholary A">A Lortholary</name></author><author><name sortKey="Mayer, F" uniqKey="Mayer F">F Mayer</name></author><author><name sortKey="Bourgeois, H" uniqKey="Bourgeois H">H Bourgeois</name></author><author><name sortKey="Orfeuvre, H" uniqKey="Orfeuvre H">H Orfeuvre</name></author><author><name sortKey="Combe, M" uniqKey="Combe M">M Combe</name></author><author><name sortKey="Platini, C" uniqKey="Platini C">C Platini</name></author><author><name sortKey="Cretin, J" uniqKey="Cretin J">J Cretin</name></author><author><name sortKey="Fric, D" uniqKey="Fric D">D Fric</name></author><author><name sortKey="Paraiso, D" uniqKey="Paraiso D">D Paraiso</name></author><author><name sortKey="Pujade Lauraine, E" uniqKey="Pujade Lauraine E">E 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