Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.
Identifieur interne : 000460 ( Main/Exploration ); précédent : 000459; suivant : 000461Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.
Auteurs : Ashley M. Hopkins [Australie] ; Ganessan Kichenadasse [Australie] ; Chris S. Karapetis [Australie] ; Andrew Rowland [Australie] ; Michael J. Sorich [Australie]Source :
- Journal for immunotherapy of cancer [ 2051-1426 ] ; 2020.
Abstract
BACKGROUND
Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.
METHODS
The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.
RESULTS
ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).
CONCLUSIONS
ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.
DOI: 10.1136/jitc-2019-000500
PubMed: 32503948
PubMed Central: PMC7279663
Affiliations:
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Hopkins</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.</nlm:affiliation><country wicri:rule="url">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Kichenadasse, Ganessan" sort="Kichenadasse, Ganessan" uniqKey="Kichenadasse G" first="Ganessan" last="Kichenadasse">Ganessan Kichenadasse</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Karapetis, Chris S" sort="Karapetis, Chris S" uniqKey="Karapetis C" first="Chris S" last="Karapetis">Chris S. Karapetis</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Rowland, Andrew" sort="Rowland, Andrew" uniqKey="Rowland A" first="Andrew" last="Rowland">Andrew Rowland</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Sorich, Michael J" sort="Sorich, Michael J" uniqKey="Sorich M" first="Michael J" last="Sorich">Michael J. 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Hopkins</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.</nlm:affiliation><country wicri:rule="url">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Kichenadasse, Ganessan" sort="Kichenadasse, Ganessan" uniqKey="Kichenadasse G" first="Ganessan" last="Kichenadasse">Ganessan Kichenadasse</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Karapetis, Chris S" sort="Karapetis, Chris S" uniqKey="Karapetis C" first="Chris S" last="Karapetis">Chris S. Karapetis</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Rowland, Andrew" sort="Rowland, Andrew" uniqKey="Rowland A" first="Andrew" last="Rowland">Andrew Rowland</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author><author><name sortKey="Sorich, Michael J" sort="Sorich, Michael J" uniqKey="Sorich M" first="Michael J" last="Sorich">Michael J. Sorich</name><affiliation wicri:level="1"><nlm:affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>College of Medicine and Public Health, Flinders University, Adelaide, South Australia</wicri:regionArea><wicri:noRegion>South Australia</wicri:noRegion></affiliation></author></analytic><series><title level="j">Journal for immunotherapy of cancer</title><idno type="eISSN">2051-1426</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.</p></div></front></TEI><pubmed><MedlineCitation Status="In-Data-Review" Owner="NLM"><PMID Version="1">32503948</PMID><DateRevised><Year>2020</Year><Month>06</Month><Day>16</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">2051-1426</ISSN><JournalIssue CitedMedium="Internet"><Volume>8</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>Jun</Month></PubDate></JournalIssue><Title>Journal for immunotherapy of cancer</Title><ISOAbbreviation>J Immunother Cancer</ISOAbbreviation></Journal><ArticleTitle>Early tumor shrinkage identifies long-term disease control and survival in patients with lung cancer treated with atezolizumab.</ArticleTitle><ELocationID EIdType="pii" ValidYN="Y">e000500</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1136/jitc-2019-000500</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Preliminary evidence indicates that early tumor shrinkage (ETS) following immune checkpoint inhibitor (ICI) initiation may be associated with survival outcomes in patients with advanced melanoma. ETS has not been explored as a biomarker of survival outcomes or patient-reported outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with ICIs.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">The study pooled data from patients with NSCLC in the randomized trials OAK and POPLAR (atezolizumab vs docetaxel; n=1464), and single-arm atezolizumab trials BIRCH and FIR (n=797). The association between ETS (≥10% decrease in pretreatment sum-of-longest diameters of target-lesions at 6 weeks) and overall survival (OS), progression-free survival (PFS), time to deterioration (TDD) in health-related quality-of-life (HRQoL) and physical function (PF) was assessed using Cox proportional hazard analysis.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">ETS occurred in 20% of atezolizumab-treated patients with NSCLC within OAK and POPLAR and was associated with highly favorable OS (HR 0.33, p<0.001), PFS (HR 0.31, p<0.001), TDD in HRQoL (HR 0.73, p=0.01) and PF (HR 0.52, p<0.001). The results were replicated in the BIRCH and FIR data. Atezolizumab-treated patients achieving ETS had markedly improved OS compared with docetaxel-treated patients achieving ETS (24-month OS 55% vs 32%); PFS was also markedly improved (24-month PFS 31% vs 4%). In contrast, for patients not achieving ETS, atezolizumab-treatment was associated with more modest OS (24-month OS 23% vs 20%) and PFS (24-month PFS 3% vs 1%) improvement compared with docetaxel. Overall, the effect size for ETS within the atezolizumab-treated patients was significantly greater than that in the docetaxel-treated patients (P(interaction)=0.002 for OS and P(interaction)<0.001 for PFS).</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">ETS is an easily measurable biomarker, predictive of highly favorable survival and patient-reported outcomes with atezolizumab treatment for advanced NSCLC. Further, ETS identifies patients with significantly greater treatment benefit for ICI therapy.</AbstractText><CopyrightInformation>© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Hopkins</LastName><ForeName>Ashley M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia ashley.hopkins@flinders.edu.au.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kichenadasse</LastName><ForeName>Ganessan</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Karapetis</LastName><ForeName>Chris S</ForeName><Initials>CS</Initials><AffiliationInfo><Affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y" EqualContrib="Y"><LastName>Rowland</LastName><ForeName>Andrew</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y" EqualContrib="Y"><LastName>Sorich</LastName><ForeName>Michael J</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>College of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>J Immunother Cancer</MedlineTA><NlmUniqueID>101620585</NlmUniqueID><ISSNLinking>2051-1426</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">biomarkers</Keyword><Keyword MajorTopicYN="N">biostatistics</Keyword><Keyword MajorTopicYN="N">immunotherapy</Keyword><Keyword MajorTopicYN="N">tumor</Keyword></KeywordList><CoiStatement>Competing interests: MJS and AR report investigator-initiated project grants from Pfizer, outside the scope of the submitted work. CSK reports advisory board roles with AstraZeneca, Merck Sharp & Dohme, Bristol-Myers Squibb, and Roche, outside the submitted work.</CoiStatement></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>04</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>6</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>6</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>6</Month><Day>7</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32503948</ArticleId><ArticleId IdType="pii">jitc-2019-000500</ArticleId><ArticleId IdType="doi">10.1136/jitc-2019-000500</ArticleId><ArticleId IdType="pmc">PMC7279663</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>J Clin Oncol. 1998 Jan;16(1):139-44</Citation><ArticleIdList><ArticleId IdType="pubmed">9440735</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2014 Nov 27;371(22):2052-4</Citation><ArticleIdList><ArticleId IdType="pubmed">25317745</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Lung Cancer. 2018 Sep;19(5):441-449.e4</Citation><ArticleIdList><ArticleId IdType="pubmed">30017645</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Cancer. 2019 Jan;106:144-159</Citation><ArticleIdList><ArticleId IdType="pubmed">30528799</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Cancer Res. 2018 Oct 15;24(20):4960-4967</Citation><ArticleIdList><ArticleId IdType="pubmed">29685882</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2016 Nov 10;375(19):1823-1833</Citation><ArticleIdList><ArticleId IdType="pubmed">27718847</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2017 Jan 21;389(10066):255-265</Citation><ArticleIdList><ArticleId IdType="pubmed">27979383</ArticleId></ArticleIdList></Reference><Reference><Citation>J Thorac Oncol. 2018 Nov;13(11):1733-1742</Citation><ArticleIdList><ArticleId IdType="pubmed">29775807</ArticleId></ArticleIdList></Reference><Reference><Citation>Int J Clin Oncol. 2019 Mar;24(3):231-240</Citation><ArticleIdList><ArticleId IdType="pubmed">30719690</ArticleId></ArticleIdList></Reference><Reference><Citation>Clin Cancer Res. 2018 Jul 15;24(14):3292-3298</Citation><ArticleIdList><ArticleId IdType="pubmed">29685883</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Cancer. 2019 Jan;107:124-132</Citation><ArticleIdList><ArticleId IdType="pubmed">30562710</ArticleId></ArticleIdList></Reference><Reference><Citation>Br J Cancer. 2017 Sep 26;117(7):913-920</Citation><ArticleIdList><ArticleId IdType="pubmed">28950287</ArticleId></ArticleIdList></Reference><Reference><Citation>ESMO Open. 2017 Nov 14;2(5):e000275</Citation><ArticleIdList><ArticleId IdType="pubmed">29177097</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Oncol. 2017 Aug 20;35(24):2781-2789</Citation><ArticleIdList><ArticleId IdType="pubmed">28609226</ArticleId></ArticleIdList></Reference><Reference><Citation>World J Urol. 2018 Sep;36(9):1423-1429</Citation><ArticleIdList><ArticleId IdType="pubmed">29654533</ArticleId></ArticleIdList></Reference><Reference><Citation>Ann Oncol. 2015 Jun;26(6):1188-94</Citation><ArticleIdList><ArticleId IdType="pubmed">25712456</ArticleId></ArticleIdList></Reference><Reference><Citation>Medicine (Baltimore). 2018 May;97(19):e0632</Citation><ArticleIdList><ArticleId IdType="pubmed">29742701</ArticleId></ArticleIdList></Reference><Reference><Citation>J Immunother Cancer. 2019 Feb 8;7(1):39</Citation><ArticleIdList><ArticleId IdType="pubmed">30736858</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Cancer. 2015 May;51(7):800-7</Citation><ArticleIdList><ArticleId IdType="pubmed">25794604</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2016 Apr 30;387(10030):1837-46</Citation><ArticleIdList><ArticleId IdType="pubmed">26970723</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Australie</li></country></list><tree><country name="Australie"><noRegion><name sortKey="Hopkins, Ashley M" sort="Hopkins, Ashley M" uniqKey="Hopkins A" first="Ashley M" last="Hopkins">Ashley M. Hopkins</name></noRegion><name sortKey="Karapetis, Chris S" sort="Karapetis, Chris S" uniqKey="Karapetis C" first="Chris S" last="Karapetis">Chris S. Karapetis</name><name sortKey="Kichenadasse, Ganessan" sort="Kichenadasse, Ganessan" uniqKey="Kichenadasse G" first="Ganessan" last="Kichenadasse">Ganessan Kichenadasse</name><name sortKey="Rowland, Andrew" sort="Rowland, Andrew" uniqKey="Rowland A" first="Andrew" last="Rowland">Andrew Rowland</name><name sortKey="Sorich, Michael J" sort="Sorich, Michael J" uniqKey="Sorich M" first="Michael J" last="Sorich">Michael J. Sorich</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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