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 : 000F10 ( Ncbi/Curation ); précédent : 000F09; suivant : 000F11Final 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.
Abstract
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.
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.
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
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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<author><name sortKey="Piccirillo, M C" sort="Piccirillo, M C" uniqKey="Piccirillo M" first="M C" last="Piccirillo">M C Piccirillo</name>
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<author><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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<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>
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<country xml:lang="fr">Allemagne</country>
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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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, Innsbruck,<country>Austria</country>
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<country xml:lang="fr">Autriche</country>
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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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<country xml:lang="fr">France</country>
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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>
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<author><name sortKey="Brown, C" sort="Brown, C" uniqKey="Brown C" first="C" last="Brown">C. Brown</name>
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, 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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<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>
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<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>
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<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>
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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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