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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 : 000079 ( Pmc/Curation ); précédent : 000078; suivant : 000080

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

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 :

RBID : PMC:3419956

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.


Url:
DOI: 10.1038/bjc.2012.307
PubMed: 22836511
PubMed Central: 3419956

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PMC:3419956

Le document en format XML

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<name sortKey="Wagner, U" sort="Wagner, U" uniqKey="Wagner U" first="U" last="Wagner">U. Wagner</name>
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<institution>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of Gießen and Marburg, Baldingerstrasse</institution>
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<institution>Department of Obstetrics & Gynecology Medical University Innsbruck</institution>
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<country xml:lang="fr">Norvège</country>
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<name sortKey="Heywood, M" sort="Heywood, M" uniqKey="Heywood M" first="M" last="Heywood">M. Heywood</name>
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<institution>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</institution>
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<country>Canada</country>
</nlm:aff>
<country xml:lang="fr">Canada</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<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>
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<country>Australia</country>
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<country xml:lang="fr">Australie</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<name sortKey="Vergote, I" sort="Vergote, I" uniqKey="Vergote I" first="I" last="Vergote">I. Vergote</name>
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<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>
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<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>
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<name sortKey="Fossati, R" sort="Fossati, R" uniqKey="Fossati R" first="R" last="Fossati">R. Fossati</name>
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<institution>Department of Oncology, Mario Negri Institute</institution>
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<country xml:lang="fr">Italie</country>
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, Camperdown, New South Wales,
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<country xml:lang="fr">Australie</country>
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<name sortKey="Lauraine, E P" sort="Lauraine, E P" uniqKey="Lauraine E" first="E P" last="Lauraine">E P Lauraine</name>
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<institution>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</institution>
, Paris,
<country>France</country>
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<country xml:lang="fr">France</country>
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<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>
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<author>
<name sortKey="Marth, C" sort="Marth, C" uniqKey="Marth C" first="C" last="Marth">C. Marth</name>
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<institution>Department of Obstetrics & Gynecology Medical University Innsbruck</institution>
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</nlm:aff>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<author>
<name sortKey="Largillier, R" sort="Largillier, R" uniqKey="Largillier R" first="R" last="Largillier">R. Largillier</name>
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<institution>Centre Azuréen de Cancérologie</institution>
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<wicri:regionArea># see nlm:aff country strict</wicri:regionArea>
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<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>
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<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>
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<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>
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<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>
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<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>
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</TEI>
<pmc article-type="research-article">
<pmc-dir>properties open_access</pmc-dir>
<front>
<journal-meta>
<journal-id journal-id-type="nlm-ta">Br J Cancer</journal-id>
<journal-id journal-id-type="iso-abbrev">Br. J. Cancer</journal-id>
<journal-title-group>
<journal-title>British Journal of Cancer</journal-title>
</journal-title-group>
<issn pub-type="ppub">0007-0920</issn>
<issn pub-type="epub">1532-1827</issn>
<publisher>
<publisher-name>Nature Publishing Group</publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="pmid">22836511</article-id>
<article-id pub-id-type="pmc">3419956</article-id>
<article-id pub-id-type="pii">bjc2012307</article-id>
<article-id pub-id-type="doi">10.1038/bjc.2012.307</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Clinical Study</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>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</article-title>
<alt-title alt-title-type="running">Combination chemotherapy for platinum-sensitive ovarian cancer</alt-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname>Wagner</surname>
<given-names>U</given-names>
</name>
<xref ref-type="aff" rid="aff1">1</xref>
<xref ref-type="corresp" rid="caf1">*</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Marth</surname>
<given-names>C</given-names>
</name>
<xref ref-type="aff" rid="aff2">2</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Largillier</surname>
<given-names>R</given-names>
</name>
<xref ref-type="aff" rid="aff3">3</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Kaern</surname>
<given-names>J</given-names>
</name>
<xref ref-type="aff" rid="aff4">4</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Brown</surname>
<given-names>C</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Heywood</surname>
<given-names>M</given-names>
</name>
<xref ref-type="aff" rid="aff6">6</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Bonaventura</surname>
<given-names>T</given-names>
</name>
<xref ref-type="aff" rid="aff7">7</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Vergote</surname>
<given-names>I</given-names>
</name>
<xref ref-type="aff" rid="aff8">8</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Piccirillo</surname>
<given-names>M C</given-names>
</name>
<xref ref-type="aff" rid="aff9">9</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Fossati</surname>
<given-names>R</given-names>
</name>
<xref ref-type="aff" rid="aff10">10</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Gebski</surname>
<given-names>V</given-names>
</name>
<xref ref-type="aff" rid="aff5">5</xref>
</contrib>
<contrib contrib-type="author">
<name>
<surname>Lauraine</surname>
<given-names>E P</given-names>
</name>
<xref ref-type="aff" rid="aff11">11</xref>
</contrib>
<aff id="aff1">
<label>1</label>
<institution>Department of Gynecology, Gynecologic Endocrinology and Oncology, University Hospital of Gießen and Marburg, Baldingerstrasse</institution>
, 35043 Marburg,
<country>Germany</country>
</aff>
<aff id="aff2">
<label>2</label>
<institution>Department of Obstetrics & Gynecology Medical University Innsbruck</institution>
, Innsbruck,
<country>Austria</country>
</aff>
<aff id="aff3">
<label>3</label>
<institution>Centre Azuréen de Cancérologie</institution>
, Mougins,
<country>France</country>
</aff>
<aff id="aff4">
<label>4</label>
<institution>Department of Gynecologic Oncology, The Norwegian Radium Hospital</institution>
, Oslo,
<country>Norway</country>
</aff>
<aff id="aff5">
<label>5</label>
<institution>NHMRC Clinical Trials Centre</institution>
, Camperdown, New South Wales,
<country>Australia</country>
</aff>
<aff id="aff6">
<label>6</label>
<institution>Department of Gyn Oncology, Gordon & Leslie Diamond Health Centre</institution>
, Vancouver, British Columbia,
<country>Canada</country>
</aff>
<aff id="aff7">
<label>7</label>
<institution>Department of Medical Oncology, Newcastle Mater Misericordia Hospital</institution>
, Newcastle, NSW,
<country>Australia</country>
</aff>
<aff id="aff8">
<label>8</label>
<institution>Department of Obstetrics and Gynaecology, University Hospital Leuven, Leuven Cancer Institute</institution>
, Leuven,
<country>Belgium</country>
</aff>
<aff id="aff9">
<label>9</label>
<institution>Clinical Trials Unit, National Cancer Institute of Napoli</institution>
, Napoli,
<country>Italy</country>
</aff>
<aff id="aff10">
<label>10</label>
<institution>Department of Oncology, Mario Negri Institute</institution>
, Milan,
<country>Italy</country>
</aff>
<aff id="aff11">
<label>11</label>
<institution>Department of Medical Oncology, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre</institution>
, Paris,
<country>France</country>
</aff>
</contrib-group>
<author-notes>
<corresp id="caf1">
<label>*</label>
E-mail:
<email>uwe.wagner@med.uni-marburg.de</email>
</corresp>
</author-notes>
<pub-date pub-type="ppub">
<day>07</day>
<month>08</month>
<year>2012</year>
</pub-date>
<pub-date pub-type="epub">
<day>26</day>
<month>07</month>
<year>2012</year>
</pub-date>
<volume>107</volume>
<issue>4</issue>
<fpage>588</fpage>
<lpage>591</lpage>
<history>
<date date-type="received">
<day>28</day>
<month>03</month>
<year>2012</year>
</date>
<date date-type="rev-recd">
<day>13</day>
<month>06</month>
<year>2012</year>
</date>
<date date-type="accepted">
<day>18</day>
<month>06</month>
<year>2012</year>
</date>
</history>
<permissions>
<copyright-statement>Copyright © 2012 Cancer Research UK</copyright-statement>
<copyright-year>2012</copyright-year>
<copyright-holder>Cancer Research UK</copyright-holder>
<license license-type="open-access" xlink:href="http://creativecommons.org/licenses/by-nc-sa/3.0/">
<license-p>From twelve months after its original publication, this work is licensed under the Creative Commons Attribution-NonCommercial-Share Alike 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by-nc-sa/3.0/</license-p>
</license>
</permissions>
<abstract>
<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>
</abstract>
<kwd-group>
<kwd>CALYPSO</kwd>
<kwd>pegylated liposomal doxorubicin</kwd>
<kwd>recurrent ovarian cancer</kwd>
<kwd>overall survival</kwd>
<kwd>platinum-sensitive</kwd>
<kwd>carboplatin</kwd>
<kwd>paclitaxel</kwd>
</kwd-group>
</article-meta>
</front>
<floats-group>
<fig id="fig1">
<label>Figure 1</label>
<caption>
<p>Overall survival in patients receiving carboplatin-paclitaxel or carboplatin-PLD for platinum-sensitive recurrent ovarian cancer. Abbreviation: PLD, pegylated liposomal doxorubicin.</p>
</caption>
<graphic xlink:href="bjc2012307f1"></graphic>
</fig>
<table-wrap id="tbl1">
<label>Table 1</label>
<caption>
<title>Baseline characteristics</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="center"></col>
<col align="char" char=""></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th align="center" valign="top" charoff="50">
<bold>CD
<italic>n</italic>
=466</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>CP
<italic>n</italic>
=509</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td colspan="2" align="center" valign="top" charoff="50">
<italic>n</italic>
(%)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Median age, years</td>
<td align="center" valign="top" charoff="50">60.5</td>
<td align="center" valign="top" charoff="50">61.0</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>ECOG performance status</italic>
<xref ref-type="fn" rid="t1-fn2">a</xref>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 0</td>
<td align="char" valign="top" char="(" charoff="50">286 (61)</td>
<td align="char" valign="top" char="(" charoff="50">317 (62)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="(" charoff="50">159 (34)</td>
<td align="char" valign="top" char="(" charoff="50">164 (32)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 2</td>
<td align="char" valign="top" char="(" charoff="50">13 (3)</td>
<td align="char" valign="top" char="(" charoff="50">15 (3)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Primary disease site ovarian</td>
<td align="char" valign="top" char="(" charoff="50">415 (89)</td>
<td align="char" valign="top" char="(" charoff="50">451 (89)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Papillary/serous histology</td>
<td align="char" valign="top" char="(" charoff="50">334 (72)</td>
<td align="char" valign="top" char="(" charoff="50">366 (72)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Initial FIGO stage</italic>
<xref ref-type="fn" rid="t1-fn2">a</xref>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> I/II</td>
<td align="char" valign="top" char="(" charoff="50">52 (11)</td>
<td align="char" valign="top" char="(" charoff="50">59 (12)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> III/IV</td>
<td align="char" valign="top" char="(" charoff="50">401 (86)</td>
<td align="char" valign="top" char="(" charoff="50">427 (84)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Number of previous therapy lines</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="(" charoff="50">408 (88)</td>
<td align="char" valign="top" char="(" charoff="50">421 (83)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 2</td>
<td align="char" valign="top" char="(" charoff="50">58 (12)</td>
<td align="char" valign="top" char="(" charoff="50">87 (17)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50">Prior taxane</td>
<td align="char" valign="top" char="(" charoff="50">462 (99)</td>
<td align="char" valign="top" char="(" charoff="50">500 (99)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Median interval since prior therapy</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 6–12 months</td>
<td align="char" valign="top" char="(" charoff="50">162 (35)</td>
<td align="char" valign="top" char="(" charoff="50">182 (36)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> >12 months</td>
<td align="char" valign="top" char="(" charoff="50">304 (65)</td>
<td align="char" valign="top" char="(" charoff="50">326 (64)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Measurable disease</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Yes</td>
<td align="char" valign="top" char="(" charoff="50">281 (60)</td>
<td align="char" valign="top" char="(" charoff="50">321 (63)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> No</td>
<td align="char" valign="top" char="(" charoff="50">185 (39)</td>
<td align="char" valign="top" char="(" charoff="50">188 (37)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Tumour size</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> <5 cm</td>
<td align="char" valign="top" char="(" charoff="50">377 (81)</td>
<td align="char" valign="top" char="(" charoff="50">419 (82)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾5 cm</td>
<td align="char" valign="top" char="(" charoff="50">89 (19)</td>
<td align="char" valign="top" char="(" charoff="50">90 (18)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="3" align="left" valign="top" charoff="50">
<italic>Number of sites of recurrence</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="(" charoff="50">217 (47)</td>
<td align="char" valign="top" char="(" charoff="50">245 (48)</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> >1</td>
<td align="char" valign="top" char="(" charoff="50">249 (53)</td>
<td align="char" valign="top" char="(" charoff="50">264 (52)</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t1-fn1">
<p>Abbreviations: CD=carboplatin-pegylated liposomal doxorubicin; CP=carboplatin-paclitaxel; ECOG=Eastern Cooperative Oncology Group.</p>
</fn>
<fn id="t1-fn2">
<label>a</label>
<p>Missing values to attain 100%.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl2">
<label>Table 2</label>
<caption>
<title>Number of post-study therapy lines and cross-overs</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="char" char="."></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50">
<bold>Treatment</bold>
</th>
<th align="center" valign="top" char="." charoff="50">
<bold>Patients (%)</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td colspan="2" align="left" valign="top" charoff="50">
<italic>Number of lines</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 0</td>
<td align="char" valign="top" char="." charoff="50">10</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="." charoff="50">21</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 2</td>
<td align="char" valign="top" char="." charoff="50">25</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 3</td>
<td align="char" valign="top" char="." charoff="50">21</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 4</td>
<td align="char" valign="top" char="." charoff="50">13</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 5–11</td>
<td align="char" valign="top" char="." charoff="50">10</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 2 or more lines</td>
<td align="char" valign="top" char="." charoff="50">69</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="char" valign="top" char="." charoff="50"> </td>
</tr>
<tr>
<td colspan="2" align="left" valign="top" charoff="50">
<italic>Cross-overs</italic>
<xref ref-type="fn" rid="t2-fn2">a</xref>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> CP arm</td>
<td align="char" valign="top" char="." charoff="50">68</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> CD arm</td>
<td align="char" valign="top" char="." charoff="50">43</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t2-fn1">
<p>Abbreviations: CD=carboplatin-pegylated liposomal doxorubicin; CP=carboplatin-paclitaxel.</p>
</fn>
<fn id="t2-fn2">
<label>a</label>
<p>
<italic>P</italic>
<0.001 for comparison between arms.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl3">
<label>Table 3</label>
<caption>
<title>Multivariate cox regression model of overall survival (
<italic>N</italic>
=959)</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="center"></col>
<col align="center"></col>
<col align="center"></col>
<col align="center"></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50">
<bold>Factors</bold>
</th>
<th align="center" valign="top" charoff="50">
<italic>
<bold>N</bold>
</italic>
</th>
<th align="center" valign="top" charoff="50">
<bold>HR</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>95% CI</bold>
</th>
<th align="center" valign="top" charoff="50">
<italic>
<bold>P</bold>
</italic>
<bold>-value</bold>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>TFI, months</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 6–12</td>
<td align="char" valign="top" char="." charoff="50">342</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾12</td>
<td align="char" valign="top" char="." charoff="50">617</td>
<td align="char" valign="top" char="." charoff="50">0.50</td>
<td align="char" valign="top" char="." charoff="50">0.43, 0.59</td>
<td align="char" valign="top" char="." charoff="50"><0.001</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>ECOG PS</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 0
<xref ref-type="fn" rid="t3-fn2">a</xref>
</td>
<td align="char" valign="top" char="." charoff="50">615</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾1</td>
<td align="char" valign="top" char="." charoff="50">344</td>
<td align="char" valign="top" char="." charoff="50">1.37</td>
<td align="char" valign="top" char="." charoff="50">1.17, 1.60</td>
<td align="char" valign="top" char="." charoff="50"><0.001</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>CA125, U ml</italic>
<sup>
<italic>1</italic>
</sup>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> <100</td>
<td align="char" valign="top" char="." charoff="50">316</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾100</td>
<td align="char" valign="top" char="." charoff="50">643</td>
<td align="char" valign="top" char="." charoff="50">1.78</td>
<td align="char" valign="top" char="." charoff="50">1.49, 2.14</td>
<td align="char" valign="top" char="." charoff="50"><0.001</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>Measurable disease/longest lesion, mm</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> No</td>
<td align="char" valign="top" char="." charoff="50">361</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩽50</td>
<td align="char" valign="top" char="." charoff="50">422</td>
<td align="char" valign="top" char="." charoff="50">1.28</td>
<td align="char" valign="top" char="." charoff="50">1.04, 1.57</td>
<td align="char" valign="top" char="." charoff="50">0.02</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> >50</td>
<td align="char" valign="top" char="." charoff="50">176</td>
<td align="char" valign="top" char="." charoff="50">1.78</td>
<td align="char" valign="top" char="." charoff="50">1.40, 2.26</td>
<td align="char" valign="top" char="." charoff="50"><0.001</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="5" align="left" valign="top" charoff="50">
<italic>Involved disease sites</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="." charoff="50">453</td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> >1</td>
<td align="char" valign="top" char="." charoff="50">506</td>
<td align="char" valign="top" char="." charoff="50">1.26</td>
<td align="char" valign="top" char="." charoff="50">1.05, 1.52</td>
<td align="char" valign="top" char="." charoff="50">0.014</td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t3-fn1">
<p>Abbreviations: CI=confidence interval; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; TFI=treatment-free interval.</p>
</fn>
<fn id="t3-fn2">
<label>a</label>
<p>This category includes any unknown or not applicable values.</p>
</fn>
</table-wrap-foot>
</table-wrap>
<table-wrap id="tbl4">
<label>Table 4</label>
<caption>
<title>Overall survival by treatment arm in pre-defined patient subgroups</title>
</caption>
<table frame="hsides" rules="groups" border="1">
<colgroup>
<col align="left"></col>
<col align="center"></col>
<col align="char" char=""></col>
<col align="center"></col>
<col align="char" char=""></col>
<col align="char" char=""></col>
<col align="char" char=""></col>
</colgroup>
<thead valign="bottom">
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th colspan="2" align="center" valign="top" charoff="50">
<italic>
<bold>N</bold>
</italic>
<hr></hr>
</th>
<th colspan="4" align="center" valign="top" charoff="50">
<bold>Univariate cox regression model</bold>
<hr></hr>
</th>
</tr>
<tr>
<th align="left" valign="top" charoff="50"> </th>
<th align="center" valign="top" charoff="50">
<bold>CD</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>CP</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>HR</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>95% CI</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Subgroup</bold>
<italic>
<bold>P</bold>
</italic>
<bold>-value</bold>
</th>
<th align="center" valign="top" charoff="50">
<bold>Interaction</bold>
<italic>
<bold>P</bold>
</italic>
<bold>-value</bold>
<xref ref-type="fn" rid="t4-fn2">a</xref>
</th>
</tr>
</thead>
<tbody valign="top">
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>Age, years</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> <70</td>
<td align="char" valign="top" char="." charoff="50">395</td>
<td align="char" valign="top" char="." charoff="50">423</td>
<td align="char" valign="top" char="." charoff="50">0.98</td>
<td align="char" valign="top" char="." charoff="50">0.83, 1.16</td>
<td align="char" valign="top" char="." charoff="50">0.80</td>
<td align="char" valign="top" char="." charoff="50">0.61</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾70</td>
<td align="char" valign="top" char="." charoff="50">71</td>
<td align="char" valign="top" char="." charoff="50">86</td>
<td align="char" valign="top" char="." charoff="50">1.10</td>
<td align="char" valign="top" char="." charoff="50">0.76, 1.58</td>
<td align="char" valign="top" char="." charoff="50">0.62</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>BMI, kg m</italic>
<sup>
<italic>2</italic>
</sup>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> <30</td>
<td align="char" valign="top" char="." charoff="50">378</td>
<td align="char" valign="top" char="." charoff="50">399</td>
<td align="char" valign="top" char="." charoff="50">1.00</td>
<td align="char" valign="top" char="." charoff="50">0.85, 1.19</td>
<td align="char" valign="top" char="." charoff="50">0.98</td>
<td align="char" valign="top" char="." charoff="50">0.74</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾30</td>
<td align="char" valign="top" char="." charoff="50">88</td>
<td align="char" valign="top" char="." charoff="50">110</td>
<td align="char" valign="top" char="." charoff="50">0.95</td>
<td align="char" valign="top" char="." charoff="50">0.67, 1.35</td>
<td align="char" valign="top" char="." charoff="50">0.76</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>TFI, months</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 6–12</td>
<td align="char" valign="top" char="." charoff="50">161</td>
<td align="char" valign="top" char="." charoff="50">183</td>
<td align="char" valign="top" char="." charoff="50">1.01</td>
<td align="char" valign="top" char="." charoff="50">0.80, 1.28</td>
<td align="char" valign="top" char="." charoff="50">0.92</td>
<td align="char" valign="top" char="." charoff="50">0.86</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾12</td>
<td align="char" valign="top" char="." charoff="50">305</td>
<td align="char" valign="top" char="." charoff="50">326</td>
<td align="char" valign="top" char="." charoff="50">0.99</td>
<td align="char" valign="top" char="." charoff="50">0.81, 1.21</td>
<td align="char" valign="top" char="." charoff="50">0.90</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>Measurable disease</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> No</td>
<td align="char" valign="top" char="." charoff="50">137</td>
<td align="char" valign="top" char="." charoff="50">138</td>
<td align="char" valign="top" char="." charoff="50">0.88</td>
<td align="char" valign="top" char="." charoff="50">0.65, 1.21</td>
<td align="char" valign="top" char="." charoff="50">0.56</td>
<td align="char" valign="top" char="." charoff="50">0.31</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> Yes</td>
<td align="char" valign="top" char="." charoff="50">329</td>
<td align="char" valign="top" char="." charoff="50">371</td>
<td align="char" valign="top" char="." charoff="50">1.07</td>
<td align="char" valign="top" char="." charoff="50">0.90, 1.27</td>
<td align="char" valign="top" char="." charoff="50">0.47</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>Number of prior lines</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 1</td>
<td align="char" valign="top" char="." charoff="50">408</td>
<td align="char" valign="top" char="." charoff="50">418</td>
<td align="char" valign="top" char="." charoff="50">0.99</td>
<td align="char" valign="top" char="." charoff="50">0.84, 1.17</td>
<td align="char" valign="top" char="." charoff="50">0.92</td>
<td align="char" valign="top" char="." charoff="50">0.98</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾2</td>
<td align="char" valign="top" char="." charoff="50">58</td>
<td align="char" valign="top" char="." charoff="50">88</td>
<td align="char" valign="top" char="." charoff="50">0.97</td>
<td align="char" valign="top" char="." charoff="50">0.65, 1.46</td>
<td align="char" valign="top" char="." charoff="50">0.74</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="center" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
<tr>
<td colspan="7" align="left" valign="top" charoff="50">
<italic>ECOG PS</italic>
</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> 0</td>
<td align="char" valign="top" char="." charoff="50">295</td>
<td align="char" valign="top" char="." charoff="50">329</td>
<td align="char" valign="top" char="." charoff="50">0.99</td>
<td align="char" valign="top" char="." charoff="50">0.81, 1.20</td>
<td align="char" valign="top" char="." charoff="50">0.92</td>
<td align="char" valign="top" char="." charoff="50">0.95</td>
</tr>
<tr>
<td align="left" valign="top" charoff="50"> ⩾1</td>
<td align="char" valign="top" char="." charoff="50">171</td>
<td align="char" valign="top" char="." charoff="50">180</td>
<td align="char" valign="top" char="." charoff="50">0.99</td>
<td align="char" valign="top" char="." charoff="50">0.78, 1.27</td>
<td align="char" valign="top" char="." charoff="50">0.95</td>
<td align="char" valign="top" charoff="50"> </td>
</tr>
</tbody>
</table>
<table-wrap-foot>
<fn id="t4-fn1">
<p>Abbreviations: BMI=body mass index; CD=carboplatin-pegylated liposomal doxorubicin; CI=confidence interval; CP=carboplatin-paclitaxel; ECOG PS=Eastern Cooperative Oncology Group performance status; HR=hazard ratio; TFI=treatment-free interval.</p>
</fn>
<fn id="t4-fn2">
<label>a</label>
<p>Interaction test is the
<italic>P</italic>
-value associated with the interaction term in the Cox regression model containing treatment effect, subgroup variable, and their interaction.</p>
</fn>
</table-wrap-foot>
</table-wrap>
</floats-group>
</pmc>
</record>

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