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Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial

Identifieur interne : 005E15 ( Main/Exploration ); précédent : 005E14; suivant : 005E16

Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial

Auteurs : L. Gladieff [France] ; A. Ferrero [Italie] ; G. De Rauglaudre [France] ; C. Brown [Australie] ; P. Vasey [Australie] ; A. Reinthaller [Autriche] ; E. Pujade-Lauraine [France] ; N. Reed [Royaume-Uni] ; D. Lorusso [Italie] ; S. Siena [Italie] ; H. Helland [Norvège] ; L. Elit [Canada] ; S. Mahner [Allemagne]

Source :

RBID : Pascal:12-0212499

Descripteurs français

English descriptors

Abstract

Background: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial. Patients and methods: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety. Results: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N = 183, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm). Conclusion: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.


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<name sortKey="Gladieff, L" sort="Gladieff, L" uniqKey="Gladieff L" first="L." last="Gladieff">L. Gladieff</name>
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<country>France</country>
<placeName>
<region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
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<name sortKey="Ferrero, A" sort="Ferrero, A" uniqKey="Ferrero A" first="A." last="Ferrero">A. Ferrero</name>
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<country>Italie</country>
<placeName>
<settlement type="city">Turin</settlement>
<region type="région" nuts="2">Piémont</region>
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<author>
<name sortKey="De Rauglaudre, G" sort="De Rauglaudre, G" uniqKey="De Rauglaudre G" first="G." last="De Rauglaudre">G. De Rauglaudre</name>
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<s1>Department of clinical Oncology, Institut Sainte-Catherine</s1>
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<region type="region">Provence-Alpes-Côte d'Azur</region>
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<name sortKey="Vasey, P" sort="Vasey, P" uniqKey="Vasey P" first="P." last="Vasey">P. Vasey</name>
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<wicri:noRegion>University of Queensland</wicri:noRegion>
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<sZ>7 aut.</sZ>
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<region type="region">Île-de-France</region>
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<settlement type="city">Rome</settlement>
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<name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S." last="Siena">S. Siena</name>
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<country>Canada</country>
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<country>Allemagne</country>
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<settlement type="city">Hambourg</settlement>
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<date when="2012">2012</date>
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<idno type="wicri:Area/PascalFrancis/Corpus">001389</idno>
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<title xml:lang="en" level="a">Carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in partially platinum-sensitive ovarian cancer patients: results from a subset analysis of the CALYPSO phase III trial</title>
<author>
<name sortKey="Gladieff, L" sort="Gladieff, L" uniqKey="Gladieff L" first="L." last="Gladieff">L. Gladieff</name>
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<region type="region">Occitanie (région administrative)</region>
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<settlement type="city">Toulouse</settlement>
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<name sortKey="De Rauglaudre, G" sort="De Rauglaudre, G" uniqKey="De Rauglaudre G" first="G." last="De Rauglaudre">G. De Rauglaudre</name>
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<region type="region">Provence-Alpes-Côte d'Azur</region>
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<name sortKey="Vasey, P" sort="Vasey, P" uniqKey="Vasey P" first="P." last="Vasey">P. Vasey</name>
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<sZ>5 aut.</sZ>
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<country>Australie</country>
<wicri:noRegion>University of Queensland</wicri:noRegion>
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<name sortKey="Reinthaller, A" sort="Reinthaller, A" uniqKey="Reinthaller A" first="A." last="Reinthaller">A. Reinthaller</name>
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<s1>Department of Gynecology and Gynecologic Oncology, Medical University of Vienna - General Hospital of Vienna</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>6 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Pujade Lauraine, E" sort="Pujade Lauraine, E" uniqKey="Pujade Lauraine E" first="E." last="Pujade-Lauraine">E. Pujade-Lauraine</name>
<affiliation wicri:level="3">
<inist:fA14 i1="07">
<s1>Department of Medical Oncology, Medicale Hopital Hotel-Dieu and Universite Paris Descartes</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>7 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>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Reed, N" sort="Reed, N" uniqKey="Reed N" first="N." last="Reed">N. Reed</name>
<affiliation wicri:level="1">
<inist:fA14 i1="08">
<s1>Gartnavel General Hospital, Beatson Oncology Centre</s1>
<s2>Glasgow</s2>
<s3>GBR</s3>
<sZ>8 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Glasgow</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Lorusso, D" sort="Lorusso, D" uniqKey="Lorusso D" first="D." last="Lorusso">D. Lorusso</name>
<affiliation wicri:level="3">
<inist:fA14 i1="09">
<s1>Department of Obstetrics and Gynecology, University of Sacred Heart</s1>
<s2>Roma</s2>
<s3>ITA</s3>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName>
<settlement type="city">Rome</settlement>
<region nuts="2">Latium</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Siena, S" sort="Siena, S" uniqKey="Siena S" first="S." last="Siena">S. Siena</name>
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<inist:fA14 i1="10">
<s1>Department of Oncology, Ospedale Niguarda Ca' Granda</s1>
<s2>Milano</s2>
<s3>ITA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Milano</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Helland, H" sort="Helland, H" uniqKey="Helland H" first="H." last="Helland">H. Helland</name>
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<inist:fA14 i1="11">
<s1>Department of Obstetrics and Gynecology, Haukeland University Hospital</s1>
<s2>Bergen</s2>
<s3>NOR</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>Norvège</country>
<wicri:noRegion>Bergen</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Elit, L" sort="Elit, L" uniqKey="Elit L" first="L." last="Elit">L. Elit</name>
<affiliation wicri:level="1">
<inist:fA14 i1="12">
<s1>Department of Gynecologic Oncology, Juravinski Cancer Centre</s1>
<s2>Hamilton</s2>
<s3>CAN</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Canada</country>
<wicri:noRegion>Hamilton</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Mahner, S" sort="Mahner, S" uniqKey="Mahner S" first="S." last="Mahner">S. Mahner</name>
<affiliation wicri:level="3">
<inist:fA14 i1="13">
<s1>Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf</s1>
<s2>Hamburg</s2>
<s3>DEU</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName>
<settlement type="city">Hambourg</settlement>
<region type="land" nuts="2">Hambourg</region>
</placeName>
</affiliation>
</author>
</analytic>
<series>
<title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
<imprint>
<date when="2012">2012</date>
</imprint>
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<title level="j" type="main">Annals of oncology</title>
<title level="j" type="abbreviated">Ann. oncol.</title>
<idno type="ISSN">0923-7534</idno>
</seriesStmt>
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<keywords scheme="KwdEn" xml:lang="en">
<term>Analysis</term>
<term>Antineoplastic agent</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>Patient</term>
<term>Pegylated form</term>
<term>Phase III trial</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr">
<term>Carboplatine</term>
<term>Forme pégylée</term>
<term>Liposome</term>
<term>Doxorubicine</term>
<term>Etude comparative</term>
<term>Paclitaxel</term>
<term>Cancer de l'ovaire</term>
<term>Homme</term>
<term>Malade</term>
<term>Analyse</term>
<term>Essai clinique phase III</term>
<term>Chimiothérapie</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr">
<term>Homme</term>
</keywords>
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<front>
<div type="abstract" xml:lang="en">Background: To perform a subset analysis of patients with partially platinum-sensitive recurrent ovarian cancer (ROC) who received either CD [carboplatin-pegylated liposomal doxorubicin (PLD)] or CP (carboplatin-paclitaxel) in the CALYPSO trial. Patients and methods: CALYPSO, an international phase III, non-inferiority trial, enrolled women with ROC that relapsed >6 months following first- or second-line therapy. Patients were randomized to CD or CP. Patients with a treatment-free interval of >6 and ≤12 months were evaluated for progression-free survival (PFS), the primary end point of CALYPSO trial, and safety. Results: A total of 344 partially platinum-sensitive patients were included (N = 161, CD and N =
<sub>183</sub>
, CP). The hazard ratio for PFS was 0.73 (95% confidence interval: 0.58-0.90; P = 0.004 for superiority) in favor of CD. Median PFS times were 9.4 months (CD) and 8.8 months (CP). Toxicities more common with CP versus CD included grade 3/4 neutropenia (50% versus 39%; P = 0.015), grade 2 alopecia (86% versus 9%; P < 0.001), neuropathy and hypersensitivity reactions. Hand-foot syndrome was more common with CD; however, grade 3/4 reactions were low (one patient in each arm). Conclusion: Carboplatin-PLD has a more favorable risk-benefit profile than CP in patients with partially platinum-sensitive ROC and should be considered an effective treatment option for these patients.</div>
</front>
</TEI>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>Canada</li>
<li>France</li>
<li>Italie</li>
<li>Norvège</li>
<li>Royaume-Uni</li>
</country>
<region>
<li>Hambourg</li>
<li>Latium</li>
<li>Midi-Pyrénées</li>
<li>Nouvelle-Galles du Sud</li>
<li>Occitanie (région administrative)</li>
<li>Piémont</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Vienne (Autriche)</li>
<li>Île-de-France</li>
</region>
<settlement>
<li>Avignon</li>
<li>Hambourg</li>
<li>Paris</li>
<li>Rome</li>
<li>Sydney</li>
<li>Toulouse</li>
<li>Turin</li>
<li>Vienne (Autriche)</li>
</settlement>
</list>
<tree>
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<region name="Occitanie (région administrative)">
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<name sortKey="Mahner, S" sort="Mahner, S" uniqKey="Mahner S" first="S." last="Mahner">S. Mahner</name>
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