Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG): clinical trial design for rare ovarian tumours.
Identifieur interne : 000C25 ( Main/Exploration ); précédent : 000C24; suivant : 000C26Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup (GCIG): clinical trial design for rare ovarian tumours.
Auteurs : A F Leary [France] ; M. Quinn [Australie] ; K. Fujiwara [Japon] ; R L Coleman [États-Unis] ; E. Kohn [États-Unis] ; T. Sugiyama [Japon] ; R. Glasspool [Royaume-Uni] ; I. Ray-Coquard [France] ; N. Colombo [Italie] ; M. Bacon [Japon] ; A. Zeimet [Autriche] ; A. Westermann [Pays-Bas] ; E. Gomez-Garcia [Mexique] ; D. Provencher [Canada] ; S. Welch [Canada] ; W. Small [États-Unis] ; D. Millan [Royaume-Uni] ; A. Okamoto [Japon] ; G. Stuart [Canada] ; K. Ochiai [Japon]Source :
- Annals of oncology : official journal of the European Society for Medical Oncology [ 1569-8041 ] ; 2017.
Descripteurs français
- KwdFr :
- MESH :
- anatomopathologie : Tumeurs de l'ovaire.
- Femelle, Humains, Plan de recherche, Tumeurs de l'ovaire.
English descriptors
- KwdEn :
- MESH :
- pathology : Ovarian Neoplasms.
- therapy : Ovarian Neoplasms.
- Female, Humans, Research Design.
Abstract
This manuscript reports the consensus statements on designing clinical trials in rare ovarian tumours reached at the fifth Ovarian Cancer Consensus Conference (OCCC) held in Tokyo, November 2015. Three important questions were identified concerning rare ovarian tumours (rare epithelial ovarian cancers (eOC), sex-cord stromal tumours (SCST) and germ cell tumours (GCT)): (i) What are the research and trial issues that are unique to rare ovarian tumours? There is a lack of randomised phase III data defining standards of care which makes it difficult to define control arms, but identifies unmet needs that merit investigation. Internationally agreed upon diagnostic criteria, expert pathological review and translational research are crucial. (ii) What should be investigated in rare eOC, GCT and SCST? Trials dedicated to each rare ovarian tumour should be encouraged. Nonetheless, where the question is relevant, rare eOC can be included in eOC trials but with rigorous stratification. Although there is emerging evidence suggesting that rare eOC have different molecular profiles, trials are needed to define new type-specific standards for each rare eOC (clear cell, low grade serous and mucinous). For GCTs, a priority is reducing toxicities from treatment while maintaining cure rates. Both a robust prognostic scoring system and more effective treatments for de novo poor prognosis and relapsed GCTs are needed. For SCSTs, validated prognostic markers as well as alternatives to the current standard of bleomycin/etoposide/cisplatin (BEP) should be identified. (iii) Are randomised trials feasible? Randomised controlled trials (RCT) should be feasible in any of the rare tumours through international collaboration. Ongoing trials have already demonstrated the feasibility of RCT in rare eOC and SCST. Mucinous OC may be considered for inclusion, stratified, into RCTs of non-gynaecological mucinous tumours, while RCTs in high risk or relapsed GCT may be carried out as a subset of male and/or paediatric germ cell studies.
DOI: 10.1093/annonc/mdw662
PubMed: 27993794
Affiliations:
- Australie, Autriche, Canada, France, Italie, Japon, Mexique, Pays-Bas, Royaume-Uni, États-Unis
- Maryland, Nouvelle-Galles du Sud
- Sydney
- Université de Sydney
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Le document en format XML
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Quinn</name><affiliation wicri:level="4"><nlm:affiliation>ANZGOG Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>ANZGOG Coordinating Centre, NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW</wicri:regionArea><orgName type="university">Université de Sydney</orgName><placeName><settlement type="city">Sydney</settlement><region type="état">Nouvelle-Galles du Sud</region></placeName></affiliation></author><author><name sortKey="Fujiwara, K" sort="Fujiwara, K" uniqKey="Fujiwara K" first="K" last="Fujiwara">K. Fujiwara</name><affiliation wicri:level="1"><nlm:affiliation>GOTIC, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>GOTIC</wicri:regionArea></affiliation></author><author><name sortKey="Coleman, R L" sort="Coleman, R L" uniqKey="Coleman R" first="R L" last="Coleman">R L Coleman</name><affiliation wicri:level="1"><nlm:affiliation>G-GOC, Bethesda, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>G-GOC, Bethesda</wicri:regionArea><wicri:noRegion>Bethesda</wicri:noRegion></affiliation></author><author><name sortKey="Kohn, E" sort="Kohn, E" uniqKey="Kohn E" first="E" last="Kohn">E. Kohn</name><affiliation wicri:level="2"><nlm:affiliation>National Cancer Institute, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>National Cancer Institute, Bethesda, MD</wicri:regionArea><placeName><region type="state">Maryland</region></placeName></affiliation></author><author><name sortKey="Sugiyama, T" sort="Sugiyama, T" uniqKey="Sugiyama T" first="T" last="Sugiyama">T. Sugiyama</name><affiliation wicri:level="1"><nlm:affiliation>JGOG, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>JGOG</wicri:regionArea></affiliation></author><author><name sortKey="Glasspool, R" sort="Glasspool, R" uniqKey="Glasspool R" first="R" last="Glasspool">R. Glasspool</name><affiliation wicri:level="1"><nlm:affiliation>SGCTG, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>SGCTG</wicri:regionArea></affiliation></author><author><name sortKey="Ray Coquard, I" sort="Ray Coquard, I" uniqKey="Ray Coquard I" first="I" last="Ray-Coquard">I. Ray-Coquard</name><affiliation wicri:level="1"><nlm:affiliation>INSERM U981 Gynaecological Tumours, Gustave Roussy Cancer Center, Villejuif, France.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM U981 Gynaecological Tumours, Gustave Roussy Cancer Center, Villejuif</wicri:regionArea><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation></author><author><name sortKey="Colombo, N" sort="Colombo, N" uniqKey="Colombo N" first="N" last="Colombo">N. Colombo</name><affiliation wicri:level="1"><nlm:affiliation>MaNGO, Italy.</nlm:affiliation><country xml:lang="fr">Italie</country><wicri:regionArea>MaNGO</wicri:regionArea></affiliation></author><author><name sortKey="Bacon, M" sort="Bacon, M" uniqKey="Bacon M" first="M" last="Bacon">M. Bacon</name><affiliation wicri:level="1"><nlm:affiliation>GCIG, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>GCIG</wicri:regionArea></affiliation></author><author><name sortKey="Zeimet, A" sort="Zeimet, A" uniqKey="Zeimet A" first="A" last="Zeimet">A. Zeimet</name><affiliation wicri:level="1"><nlm:affiliation>AGO-AU, Austria.</nlm:affiliation><country xml:lang="fr">Autriche</country><wicri:regionArea>AGO-AU</wicri:regionArea></affiliation></author><author><name sortKey="Westermann, A" sort="Westermann, A" uniqKey="Westermann A" first="A" last="Westermann">A. Westermann</name><affiliation wicri:level="1"><nlm:affiliation>DGOG, The Netherlands.</nlm:affiliation><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>DGOG</wicri:regionArea></affiliation></author><author><name sortKey="Gomez Garcia, E" sort="Gomez Garcia, E" uniqKey="Gomez Garcia E" first="E" last="Gomez-Garcia">E. Gomez-Garcia</name><affiliation wicri:level="1"><nlm:affiliation>GICOM, Mexico.</nlm:affiliation><country xml:lang="fr">Mexique</country><wicri:regionArea>GICOM</wicri:regionArea></affiliation></author><author><name sortKey="Provencher, D" sort="Provencher, D" uniqKey="Provencher D" first="D" last="Provencher">D. Provencher</name><affiliation wicri:level="1"><nlm:affiliation>CCTG, Vancouver, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>CCTG, Vancouver</wicri:regionArea><wicri:noRegion>Vancouver</wicri:noRegion></affiliation></author><author><name sortKey="Welch, S" sort="Welch, S" uniqKey="Welch S" first="S" last="Welch">S. Welch</name><affiliation wicri:level="1"><nlm:affiliation>PMHC, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>PMHC</wicri:regionArea></affiliation></author><author><name sortKey="Small, W" sort="Small, W" uniqKey="Small W" first="W" last="Small">W. Small</name><affiliation wicri:level="1"><nlm:affiliation>RTOG, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>RTOG</wicri:regionArea></affiliation></author><author><name sortKey="Millan, D" sort="Millan, D" uniqKey="Millan D" first="D" last="Millan">D. Millan</name><affiliation wicri:level="1"><nlm:affiliation>SGCTG, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>SGCTG</wicri:regionArea></affiliation></author><author><name sortKey="Okamoto, A" sort="Okamoto, A" uniqKey="Okamoto A" first="A" last="Okamoto">A. Okamoto</name><affiliation wicri:level="1"><nlm:affiliation>JGOG, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>JGOG</wicri:regionArea></affiliation></author><author><name sortKey="Stuart, G" sort="Stuart, G" uniqKey="Stuart G" first="G" last="Stuart">G. Stuart</name><affiliation wicri:level="1"><nlm:affiliation>CCTG, Vancouver, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>CCTG, Vancouver</wicri:regionArea><wicri:noRegion>Vancouver</wicri:noRegion></affiliation></author><author><name sortKey="Ochiai, K" sort="Ochiai, K" uniqKey="Ochiai K" first="K" last="Ochiai">K. Ochiai</name><affiliation wicri:level="1"><nlm:affiliation>JGOG, Japan.</nlm:affiliation><country xml:lang="fr">Japon</country><wicri:regionArea>JGOG</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of oncology : official journal of the European Society for Medical Oncology</title><idno type="eISSN">1569-8041</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Female</term><term>Humans</term><term>Ovarian Neoplasms (pathology)</term><term>Ovarian Neoplasms (therapy)</term><term>Research Design</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Femelle</term><term>Humains</term><term>Plan de recherche</term><term>Tumeurs de l'ovaire ()</term><term>Tumeurs de l'ovaire (anatomopathologie)</term></keywords><keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Tumeurs de l'ovaire</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Female</term><term>Humans</term><term>Research Design</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Femelle</term><term>Humains</term><term>Plan de recherche</term><term>Tumeurs de l'ovaire</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">This manuscript reports the consensus statements on designing clinical trials in rare ovarian tumours reached at the fifth Ovarian Cancer Consensus Conference (OCCC) held in Tokyo, November 2015. Three important questions were identified concerning rare ovarian tumours (rare epithelial ovarian cancers (eOC), sex-cord stromal tumours (SCST) and germ cell tumours (GCT)): (i) What are the research and trial issues that are unique to rare ovarian tumours? There is a lack of randomised phase III data defining standards of care which makes it difficult to define control arms, but identifies unmet needs that merit investigation. Internationally agreed upon diagnostic criteria, expert pathological review and translational research are crucial. (ii) What should be investigated in rare eOC, GCT and SCST? Trials dedicated to each rare ovarian tumour should be encouraged. Nonetheless, where the question is relevant, rare eOC can be included in eOC trials but with rigorous stratification. Although there is emerging evidence suggesting that rare eOC have different molecular profiles, trials are needed to define new type-specific standards for each rare eOC (clear cell, low grade serous and mucinous). For GCTs, a priority is reducing toxicities from treatment while maintaining cure rates. Both a robust prognostic scoring system and more effective treatments for de novo poor prognosis and relapsed GCTs are needed. For SCSTs, validated prognostic markers as well as alternatives to the current standard of bleomycin/etoposide/cisplatin (BEP) should be identified. (iii) Are randomised trials feasible? Randomised controlled trials (RCT) should be feasible in any of the rare tumours through international collaboration. Ongoing trials have already demonstrated the feasibility of RCT in rare eOC and SCST. Mucinous OC may be considered for inclusion, stratified, into RCTs of non-gynaecological mucinous tumours, while RCTs in high risk or relapsed GCT may be carried out as a subset of male and/or paediatric germ cell studies.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Autriche</li><li>Canada</li><li>France</li><li>Italie</li><li>Japon</li><li>Mexique</li><li>Pays-Bas</li><li>Royaume-Uni</li><li>États-Unis</li></country><region><li>Maryland</li><li>Nouvelle-Galles du Sud</li></region><settlement><li>Sydney</li></settlement><orgName><li>Université de Sydney</li></orgName></list><tree><country name="France"><noRegion><name sortKey="Leary, A F" sort="Leary, A F" uniqKey="Leary A" first="A F" last="Leary">A F Leary</name></noRegion><name sortKey="Ray Coquard, I" sort="Ray Coquard, I" uniqKey="Ray Coquard I" first="I" last="Ray-Coquard">I. Ray-Coquard</name></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Quinn, M" sort="Quinn, M" uniqKey="Quinn M" first="M" last="Quinn">M. Quinn</name></region></country><country name="Japon"><noRegion><name sortKey="Fujiwara, K" sort="Fujiwara, K" uniqKey="Fujiwara K" first="K" last="Fujiwara">K. Fujiwara</name></noRegion><name sortKey="Bacon, M" sort="Bacon, M" uniqKey="Bacon M" first="M" last="Bacon">M. Bacon</name><name sortKey="Ochiai, K" sort="Ochiai, K" uniqKey="Ochiai K" first="K" last="Ochiai">K. Ochiai</name><name sortKey="Okamoto, A" sort="Okamoto, A" uniqKey="Okamoto A" first="A" last="Okamoto">A. Okamoto</name><name sortKey="Sugiyama, T" sort="Sugiyama, T" uniqKey="Sugiyama T" first="T" last="Sugiyama">T. Sugiyama</name></country><country name="États-Unis"><noRegion><name sortKey="Coleman, R L" sort="Coleman, R L" uniqKey="Coleman R" first="R L" last="Coleman">R L Coleman</name></noRegion><name sortKey="Kohn, E" sort="Kohn, E" uniqKey="Kohn E" first="E" last="Kohn">E. Kohn</name><name sortKey="Small, W" sort="Small, W" uniqKey="Small W" first="W" last="Small">W. Small</name></country><country name="Royaume-Uni"><noRegion><name sortKey="Glasspool, R" sort="Glasspool, R" uniqKey="Glasspool R" first="R" last="Glasspool">R. Glasspool</name></noRegion><name sortKey="Millan, D" sort="Millan, D" uniqKey="Millan D" first="D" last="Millan">D. Millan</name></country><country name="Italie"><noRegion><name sortKey="Colombo, N" sort="Colombo, N" uniqKey="Colombo N" first="N" last="Colombo">N. Colombo</name></noRegion></country><country name="Autriche"><noRegion><name sortKey="Zeimet, A" sort="Zeimet, A" uniqKey="Zeimet A" first="A" last="Zeimet">A. Zeimet</name></noRegion></country><country name="Pays-Bas"><noRegion><name sortKey="Westermann, A" sort="Westermann, A" uniqKey="Westermann A" first="A" last="Westermann">A. Westermann</name></noRegion></country><country name="Mexique"><noRegion><name sortKey="Gomez Garcia, E" sort="Gomez Garcia, E" uniqKey="Gomez Garcia E" first="E" last="Gomez-Garcia">E. Gomez-Garcia</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Provencher, D" sort="Provencher, D" uniqKey="Provencher D" first="D" last="Provencher">D. Provencher</name></noRegion><name sortKey="Stuart, G" sort="Stuart, G" uniqKey="Stuart G" first="G" last="Stuart">G. Stuart</name><name sortKey="Welch, S" sort="Welch, S" uniqKey="Welch S" first="S" last="Welch">S. Welch</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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