Resisting RECIST-Uniformity Versus Clinical Validity.
Identifieur interne : 000430 ( PubMed/Checkpoint ); précédent : 000429; suivant : 000431Resisting RECIST-Uniformity Versus Clinical Validity.
Auteurs : Michelle K. Wilson [Canada] ; Michael L. Friedlander ; Stephanie Lheureux ; William Small ; Andrés Poveda ; Eric Pujade-Lauraine ; Katherine Karakasis ; Monica Bacon ; Valerie Bowering ; Tanya Chawla ; Amit M. OzaSource :
- International journal of gynecological cancer : official journal of the International Gynecological Cancer Society [ 1525-1438 ] ; 2017.
Abstract
The Response Evaluation Criteria in Solid Tumors (RECIST) International Working Group developed criteria for tumor response and progression to standardize radiological assessment in patients receiving chemotherapy in phase 2 trials. However, it is unclear whether the defined percentage change in tumor size and volume reflects true clinical benefit for the patient. The RECIST criteria were designed to improve objectivity in trials, but not to replace clinical decision making. The aim of this study was to understand clinicians' opinions about RECIST in current oncology practice.
DOI: 10.1097/IGC.0000000000001062
PubMed: 28692635
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Resisting RECIST-Uniformity Versus Clinical Validity.</title><author><name sortKey="Wilson, Michelle K" sort="Wilson, Michelle K" uniqKey="Wilson M" first="Michelle K" last="Wilson">Michelle K. Wilson</name><affiliation wicri:level="1"><nlm:affiliation>*Auckland City Hospital, Auckland, New Zealand; †Prince of Wales Hospital, Sydney, Australia; ‡Princess Margaret Cancer Centre, Toronto, Ontario Canada; §Department of Radiation Oncology, Loyol University, Chicago, IL; ‖Instituto Valenciano de Oncologia, Valencia, Spain; ¶Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and #Gynecologic Group Intergroup, Kingston, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>*Auckland City Hospital, Auckland, New Zealand; †Prince of Wales Hospital, Sydney, Australia; ‡Princess Margaret Cancer Centre, Toronto, Ontario Canada; §Department of Radiation Oncology, Loyol University, Chicago, IL; ‖Instituto Valenciano de Oncologia, Valencia, Spain; ¶Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and #Gynecologic Group Intergroup, Kingston</wicri:regionArea><wicri:noRegion>Kingston</wicri:noRegion></affiliation></author><author><name sortKey="Friedlander, Michael L" sort="Friedlander, Michael L" uniqKey="Friedlander M" first="Michael L" last="Friedlander">Michael L. Friedlander</name></author><author><name sortKey="Lheureux, Stephanie" sort="Lheureux, Stephanie" uniqKey="Lheureux S" first="Stephanie" last="Lheureux">Stephanie Lheureux</name></author><author><name sortKey="Small, William" sort="Small, William" uniqKey="Small W" first="William" last="Small">William Small</name></author><author><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name></author><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name></author><author><name sortKey="Karakasis, Katherine" sort="Karakasis, Katherine" uniqKey="Karakasis K" first="Katherine" last="Karakasis">Katherine Karakasis</name></author><author><name sortKey="Bacon, Monica" sort="Bacon, Monica" uniqKey="Bacon M" first="Monica" last="Bacon">Monica Bacon</name></author><author><name sortKey="Bowering, Valerie" sort="Bowering, Valerie" uniqKey="Bowering V" first="Valerie" last="Bowering">Valerie Bowering</name></author><author><name sortKey="Chawla, Tanya" sort="Chawla, Tanya" uniqKey="Chawla T" first="Tanya" last="Chawla">Tanya Chawla</name></author><author><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28692635</idno><idno type="pmid">28692635</idno><idno type="doi">10.1097/IGC.0000000000001062</idno><idno type="wicri:Area/PubMed/Corpus">000306</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000306</idno><idno type="wicri:Area/PubMed/Curation">000304</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Curation">000304</idno><idno type="wicri:Area/PubMed/Checkpoint">000304</idno><idno type="wicri:explorRef" wicri:stream="Checkpoint" wicri:step="PubMed">000304</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Resisting RECIST-Uniformity Versus Clinical Validity.</title><author><name sortKey="Wilson, Michelle K" sort="Wilson, Michelle K" uniqKey="Wilson M" first="Michelle K" last="Wilson">Michelle K. Wilson</name><affiliation wicri:level="1"><nlm:affiliation>*Auckland City Hospital, Auckland, New Zealand; †Prince of Wales Hospital, Sydney, Australia; ‡Princess Margaret Cancer Centre, Toronto, Ontario Canada; §Department of Radiation Oncology, Loyol University, Chicago, IL; ‖Instituto Valenciano de Oncologia, Valencia, Spain; ¶Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and #Gynecologic Group Intergroup, Kingston, Canada.</nlm:affiliation><country xml:lang="fr">Canada</country><wicri:regionArea>*Auckland City Hospital, Auckland, New Zealand; †Prince of Wales Hospital, Sydney, Australia; ‡Princess Margaret Cancer Centre, Toronto, Ontario Canada; §Department of Radiation Oncology, Loyol University, Chicago, IL; ‖Instituto Valenciano de Oncologia, Valencia, Spain; ¶Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and #Gynecologic Group Intergroup, Kingston</wicri:regionArea><wicri:noRegion>Kingston</wicri:noRegion></affiliation></author><author><name sortKey="Friedlander, Michael L" sort="Friedlander, Michael L" uniqKey="Friedlander M" first="Michael L" last="Friedlander">Michael L. Friedlander</name></author><author><name sortKey="Lheureux, Stephanie" sort="Lheureux, Stephanie" uniqKey="Lheureux S" first="Stephanie" last="Lheureux">Stephanie Lheureux</name></author><author><name sortKey="Small, William" sort="Small, William" uniqKey="Small W" first="William" last="Small">William Small</name></author><author><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name></author><author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name></author><author><name sortKey="Karakasis, Katherine" sort="Karakasis, Katherine" uniqKey="Karakasis K" first="Katherine" last="Karakasis">Katherine Karakasis</name></author><author><name sortKey="Bacon, Monica" sort="Bacon, Monica" uniqKey="Bacon M" first="Monica" last="Bacon">Monica Bacon</name></author><author><name sortKey="Bowering, Valerie" sort="Bowering, Valerie" uniqKey="Bowering V" first="Valerie" last="Bowering">Valerie Bowering</name></author><author><name sortKey="Chawla, Tanya" sort="Chawla, Tanya" uniqKey="Chawla T" first="Tanya" last="Chawla">Tanya Chawla</name></author><author><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name></author></analytic><series><title level="j">International journal of gynecological cancer : official journal of the International Gynecological Cancer Society</title><idno type="eISSN">1525-1438</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The Response Evaluation Criteria in Solid Tumors (RECIST) International Working Group developed criteria for tumor response and progression to standardize radiological assessment in patients receiving chemotherapy in phase 2 trials. However, it is unclear whether the defined percentage change in tumor size and volume reflects true clinical benefit for the patient. The RECIST criteria were designed to improve objectivity in trials, but not to replace clinical decision making. The aim of this study was to understand clinicians' opinions about RECIST in current oncology practice.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">28692635</PMID><DateCreated><Year>2017</Year><Month>07</Month><Day>10</Day></DateCreated><DateRevised><Year>2017</Year><Month>09</Month><Day>22</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1525-1438</ISSN><JournalIssue CitedMedium="Internet"><Volume>27</Volume><Issue>8</Issue><PubDate><Year>2017</Year><Month>Oct</Month></PubDate></JournalIssue><Title>International journal of gynecological cancer : official journal of the International Gynecological Cancer Society</Title><ISOAbbreviation>Int. J. Gynecol. Cancer</ISOAbbreviation></Journal><ArticleTitle>Resisting RECIST-Uniformity Versus Clinical Validity.</ArticleTitle><Pagination><MedlinePgn>1619-1627</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1097/IGC.0000000000001062</ELocationID><Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The Response Evaluation Criteria in Solid Tumors (RECIST) International Working Group developed criteria for tumor response and progression to standardize radiological assessment in patients receiving chemotherapy in phase 2 trials. However, it is unclear whether the defined percentage change in tumor size and volume reflects true clinical benefit for the patient. The RECIST criteria were designed to improve objectivity in trials, but not to replace clinical decision making. The aim of this study was to understand clinicians' opinions about RECIST in current oncology practice.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">Using Web-based questionnaires, we investigated attitudes to the use of RECIST at a large comprehensive cancer center and in an international group of gynecologic cancer specialists through the Gynecologic Cancer InterGroup. The results reported here relate to the survey focusing on gynecologic cancer.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">Sixty medical professionals from 13 countries responded to the survey. The majority of respondents worked at a tertiary or specialist cancer center (51; 86%). Overall, 66% of respondents felt RECIST increased trial objectivity and was a good measure of response. The majority of respondents (81%) reported that they infrequently challenged RECIST evaluation. Overall, 60% felt more than 10% of patients came off trial for clinical rather than radiological progression. In the context of a new small lesion, only 35% felt that should always be considered disease progression. The importance of both clinician and radiologist input was highlighted with nontarget progression. Nontarget progression and target progression were recognized as equally important for clinical decision making (72%).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">RECIST is a key criterion for endpoint assessment in clinical trials with its value recognized by clinicians. However, this survey also highlights the practical limitations of RECIST. Disconnect can be seen between the radiological result and the clinical picture-learning from these patients is critical. Continued efforts to improve metrics assessing patient benefit in trials remains a priority.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Wilson</LastName><ForeName>Michelle K</ForeName><Initials>MK</Initials><AffiliationInfo><Affiliation>*Auckland City Hospital, Auckland, New Zealand; †Prince of Wales Hospital, Sydney, Australia; ‡Princess Margaret Cancer Centre, Toronto, Ontario Canada; §Department of Radiation Oncology, Loyol University, Chicago, IL; ‖Instituto Valenciano de Oncologia, Valencia, Spain; ¶Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Paris, France; and #Gynecologic Group Intergroup, Kingston, Canada.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Friedlander</LastName><ForeName>Michael L</ForeName><Initials>ML</Initials></Author><Author ValidYN="Y"><LastName>Lheureux</LastName><ForeName>Stephanie</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Small</LastName><ForeName>William</ForeName><Initials>W</Initials><Suffix>Jr</Suffix></Author><Author ValidYN="Y"><LastName>Poveda</LastName><ForeName>Andrés</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Pujade-Lauraine</LastName><ForeName>Eric</ForeName><Initials>E</Initials></Author><Author ValidYN="Y"><LastName>Karakasis</LastName><ForeName>Katherine</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Bacon</LastName><ForeName>Monica</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Bowering</LastName><ForeName>Valerie</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Chawla</LastName><ForeName>Tanya</ForeName><Initials>T</Initials></Author><Author ValidYN="Y"><LastName>Oza</LastName><ForeName>Amit M</ForeName><Initials>AM</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Int J Gynecol Cancer</MedlineTA><NlmUniqueID>9111626</NlmUniqueID><ISSNLinking>1048-891X</ISSNLinking></MedlineJournalInfo></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2017</Year><Month>7</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2017</Year><Month>7</Month><Day>12</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2017</Year><Month>7</Month><Day>11</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">28692635</ArticleId><ArticleId IdType="doi">10.1097/IGC.0000000000001062</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Canada</li></country></list><tree><noCountry><name sortKey="Bacon, Monica" sort="Bacon, Monica" uniqKey="Bacon M" first="Monica" last="Bacon">Monica Bacon</name><name sortKey="Bowering, Valerie" sort="Bowering, Valerie" uniqKey="Bowering V" first="Valerie" last="Bowering">Valerie Bowering</name><name sortKey="Chawla, Tanya" sort="Chawla, Tanya" uniqKey="Chawla T" first="Tanya" last="Chawla">Tanya Chawla</name><name sortKey="Friedlander, Michael L" sort="Friedlander, Michael L" uniqKey="Friedlander M" first="Michael L" last="Friedlander">Michael L. Friedlander</name><name sortKey="Karakasis, Katherine" sort="Karakasis, Katherine" uniqKey="Karakasis K" first="Katherine" last="Karakasis">Katherine Karakasis</name><name sortKey="Lheureux, Stephanie" sort="Lheureux, Stephanie" uniqKey="Lheureux S" first="Stephanie" last="Lheureux">Stephanie Lheureux</name><name sortKey="Oza, Amit M" sort="Oza, Amit M" uniqKey="Oza A" first="Amit M" last="Oza">Amit M. Oza</name><name sortKey="Poveda, Andres" sort="Poveda, Andres" uniqKey="Poveda A" first="Andrés" last="Poveda">Andrés Poveda</name><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name><name sortKey="Small, William" sort="Small, William" uniqKey="Small W" first="William" last="Small">William Small</name></noCountry><country name="Canada"><noRegion><name sortKey="Wilson, Michelle K" sort="Wilson, Michelle K" uniqKey="Wilson M" first="Michelle K" last="Wilson">Michelle K. 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