Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recommendations on incorporating patient-reported outcomes in clinical trials in epithelial ovarian cancer.
Identifieur interne : 000C24 ( Main/Exploration ); précédent : 000C23; suivant : 000C25Fifth Ovarian Cancer Consensus Conference of the Gynecologic Cancer InterGroup: Recommendations on incorporating patient-reported outcomes in clinical trials in epithelial ovarian cancer.
Auteurs : Florence Joly [France] ; Felix Hilpert [Allemagne] ; Aikou Okamoto [Japon] ; Gavin Stuart [Canada] ; Kasunori Ochiai [Japon] ; Michael Friedlander [Australie]Source :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2017.
Descripteurs français
- KwdFr :
- Essais cliniques comme sujet (), Femelle, Guides de bonnes pratiques cliniques comme sujet, Humains, Mesures des résultats rapportés par les patients, Récidive tumorale locale (), Résultat thérapeutique, Survie sans rechute, Tumeurs de l'ovaire (), Tumeurs de l'ovaire (mortalité), Tumeurs épithéliales épidermoïdes et glandulaires (), Tumeurs épithéliales épidermoïdes et glandulaires (mortalité).
- MESH :
- mortalité : Tumeurs de l'ovaire, Tumeurs épithéliales épidermoïdes et glandulaires.
- Essais cliniques comme sujet, Femelle, Guides de bonnes pratiques cliniques comme sujet, Humains, Mesures des résultats rapportés par les patients, Récidive tumorale locale, Résultat thérapeutique, Survie sans rechute, Tumeurs de l'ovaire, Tumeurs épithéliales épidermoïdes et glandulaires.
English descriptors
- KwdEn :
- Clinical Trials as Topic (methods), Disease-Free Survival, Female, Humans, Neoplasm Recurrence, Local (therapy), Neoplasms, Glandular and Epithelial (mortality), Neoplasms, Glandular and Epithelial (therapy), Ovarian Neoplasms (mortality), Ovarian Neoplasms (therapy), Patient Reported Outcome Measures, Practice Guidelines as Topic, Treatment Outcome.
- MESH :
- methods : Clinical Trials as Topic.
- mortality : Neoplasms, Glandular and Epithelial, Ovarian Neoplasms.
- therapy : Neoplasm Recurrence, Local, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms.
- Disease-Free Survival, Female, Humans, Patient Reported Outcome Measures, Practice Guidelines as Topic, Treatment Outcome.
Abstract
Despite the support for including patient-reported outcomes (PROs) and health-related quality of life in clinical trials, there have been deficiencies in how these have been assessed and reported in epithelial ovarian cancer (EOC) clinical trials. To redress this, the 5th Ovarian Cancer Consensus Conference, included a plenary session entitled 'How to include PROs in clinical trials'. The perspective is a summary of the recommendations made by the Gynecologic Cancer InterGroup unanimously agreed on the importance of PROs and PRO end-points in EOC clinical trials. They recognised that effort must be made to ensure the integrity of collection of PRO data and to avoid missing data. PRO end-points should be based on the PRO hypotheses, be context specific and reflect the patient population and the objectives of treatment (e.g. first line, maintenance therapy, early or late relapse). The PRO end-points inform the choice of PRO measures used in the trial and how the results are analysed and reported. There was agreement that progression-free survival should be supported by PROs among patients with late relapse (platinum sensitive) and that progression-free survival alone was not sufficient as the primary end-point of clinical trials in patients with platinum resistant/refractory EOC and PROs should be included as either the primary/co-primary end-point in this subset of patients. Novel approaches to measure the benefit of palliative chemotherapy such as time until definitive deterioration of Health-Related Quality of Life were recommended. There was consensus to endorse the ISOQOL and CONSORT-PRO guidelines on the inclusion and reporting of PRO endpoints in protocols and that all future EOC Gynecologic Cancer InterGroup trials should adhere to these.
DOI: 10.1016/j.ejca.2017.03.019
PubMed: 28448857
Affiliations:
- Allemagne, Australie, Canada, France, Japon
- Basse-Normandie, Hambourg, Nouvelle-Galles du Sud, Région Normandie, Région de Kantō
- Caen, Hambourg, Sydney, Tokyo
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Le document en format XML
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Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Neoplasms, Glandular and Epithelial</term><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Tumeurs de l'ovaire</term><term>Tumeurs épithéliales épidermoïdes et glandulaires</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Neoplasm Recurrence, Local</term><term>Neoplasms, Glandular and Epithelial</term><term>Ovarian Neoplasms</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Disease-Free Survival</term><term>Female</term><term>Humans</term><term>Patient Reported Outcome Measures</term><term>Practice Guidelines as Topic</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Essais cliniques comme sujet</term><term>Femelle</term><term>Guides de bonnes pratiques cliniques comme sujet</term><term>Humains</term><term>Mesures des résultats rapportés par les patients</term><term>Récidive tumorale locale</term><term>Résultat thérapeutique</term><term>Survie sans rechute</term><term>Tumeurs de l'ovaire</term><term>Tumeurs épithéliales épidermoïdes et glandulaires</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Despite the support for including patient-reported outcomes (PROs) and health-related quality of life in clinical trials, there have been deficiencies in how these have been assessed and reported in epithelial ovarian cancer (EOC) clinical trials. To redress this, the 5th Ovarian Cancer Consensus Conference, included a plenary session entitled 'How to include PROs in clinical trials'. The perspective is a summary of the recommendations made by the Gynecologic Cancer InterGroup unanimously agreed on the importance of PROs and PRO end-points in EOC clinical trials. They recognised that effort must be made to ensure the integrity of collection of PRO data and to avoid missing data. PRO end-points should be based on the PRO hypotheses, be context specific and reflect the patient population and the objectives of treatment (e.g. first line, maintenance therapy, early or late relapse). The PRO end-points inform the choice of PRO measures used in the trial and how the results are analysed and reported. There was agreement that progression-free survival should be supported by PROs among patients with late relapse (platinum sensitive) and that progression-free survival alone was not sufficient as the primary end-point of clinical trials in patients with platinum resistant/refractory EOC and PROs should be included as either the primary/co-primary end-point in this subset of patients. Novel approaches to measure the benefit of palliative chemotherapy such as time until definitive deterioration of Health-Related Quality of Life were recommended. There was consensus to endorse the ISOQOL and CONSORT-PRO guidelines on the inclusion and reporting of PRO endpoints in protocols and that all future EOC Gynecologic Cancer InterGroup trials should adhere to these.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>France</li><li>Japon</li></country><region><li>Basse-Normandie</li><li>Hambourg</li><li>Nouvelle-Galles du Sud</li><li>Région Normandie</li><li>Région de Kantō</li></region><settlement><li>Caen</li><li>Hambourg</li><li>Sydney</li><li>Tokyo</li></settlement></list><tree><country name="France"><region name="Région Normandie"><name sortKey="Joly, Florence" sort="Joly, Florence" uniqKey="Joly F" first="Florence" last="Joly">Florence Joly</name></region></country><country name="Allemagne"><region name="Hambourg"><name sortKey="Hilpert, Felix" sort="Hilpert, Felix" uniqKey="Hilpert F" first="Felix" last="Hilpert">Felix Hilpert</name></region></country><country name="Japon"><region name="Région de Kantō"><name sortKey="Okamoto, Aikou" sort="Okamoto, Aikou" uniqKey="Okamoto A" first="Aikou" last="Okamoto">Aikou Okamoto</name></region><name sortKey="Ochiai, Kasunori" sort="Ochiai, Kasunori" uniqKey="Ochiai K" first="Kasunori" last="Ochiai">Kasunori Ochiai</name></country><country name="Canada"><noRegion><name sortKey="Stuart, Gavin" sort="Stuart, Gavin" uniqKey="Stuart G" first="Gavin" last="Stuart">Gavin Stuart</name></noRegion></country><country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Friedlander, Michael" sort="Friedlander, Michael" uniqKey="Friedlander M" first="Michael" last="Friedlander">Michael Friedlander</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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