Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria
Most hyperprogression disease (HPD) definitions are based on tumor growth rate (TGR). However, there is still no consensus on how to evaluate this phenomenon. We investigated two independent cohorts of patients with advanced solid tumors treated in phase I trials with (i) programmed cell death 1 (PD...
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| Veröffentlicht in: | Clinical cancer research 2020-04, Vol.26 (8), p.1846-1855 |
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| creator | Matos, Ignacio Martin-Liberal, Juan García-Ruiz, Alonso Hierro, Cinta Ochoa de Olza, Maria Viaplana, Cristina Azaro, Analia Vieito, Maria Braña, Irene Mur, Gemma Ros, Javier Mateos, Jose Villacampa, Guillermo Berché, Roger Oliveira, Mafalda Alsina, Maria Elez, Elena Oaknin, Ana Muñoz-Couselo, Eva Carles, Joan Felip, Enriqueta Rodón, Jordi Tabernero, Josep Dienstmann, Rodrigo Perez-Lopez, Raquel Garralda, Elena |
| description | Most hyperprogression disease (HPD) definitions are based on tumor growth rate (TGR). However, there is still no consensus on how to evaluate this phenomenon.
We investigated two independent cohorts of patients with advanced solid tumors treated in phase I trials with (i) programmed cell death 1 (PD-1)/PD-L1 antibodies in monotherapy or combination and (ii) targeted agents (TA) in unapproved indications. A Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-based definition of hyperprogression was developed. The primary endpoint was the assessment of the rate of HPD in patients treated with ICIs or TAs using both criteria (RECIST and TGR) and the impact on overall survival (OS) in patients who achieved PD as best response.
Among 270 evaluable patients treated with PD-1/PD-L1 inhibitors, 29 PD-1/PD-L1-treated patients (10.7%) had HPD by RECIST definition. This group had a significantly lower OS (median of 5.23 months; 95% CI, 3.97-6.45) when compared with the non-HPD progressor group (median, 7.33 months; 95% CI, 4.53-10.12; HR = 1.73, 95% CI, 1.05-2.85;
= 0.04). In a subset of 221 evaluable patients, 14 (6.3%) were categorized as HPD using TGR criteria, differences in median OS (mOS) between this group (mOS 4.2 months; 95% IC, 2.07-6.33) and non-HPD progressors (
= 44) by TGR criteria (mOS 6.27 months; 95% CI, 3.88-8.67) were not statistically significant (HR 1.4, 95% IC, 0.70-2.77;
= 0.346). Among 239 evaluable patients treated with TAs, 26 (10.9%) were classified as having HPD by RECIST and 14 using TGR criteria in a subset of patients. No differences in OS were observed between HPD and non-HPD progressors treated with TAs.
HPD measured by TGR or by RECIST was observed in both cohorts of patients; however, in our series, there was an impact on survival only in the immune-checkpoint inhibitor cohort when evaluated by RECIST. We propose a new way to capture HPD using RECIST criteria that is intuitive and easy to use in daily clinical practice. |
| doi_str_mv | 10.1158/1078-0432.CCR-19-2226 |
| format | Article |
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We investigated two independent cohorts of patients with advanced solid tumors treated in phase I trials with (i) programmed cell death 1 (PD-1)/PD-L1 antibodies in monotherapy or combination and (ii) targeted agents (TA) in unapproved indications. A Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-based definition of hyperprogression was developed. The primary endpoint was the assessment of the rate of HPD in patients treated with ICIs or TAs using both criteria (RECIST and TGR) and the impact on overall survival (OS) in patients who achieved PD as best response.
Among 270 evaluable patients treated with PD-1/PD-L1 inhibitors, 29 PD-1/PD-L1-treated patients (10.7%) had HPD by RECIST definition. This group had a significantly lower OS (median of 5.23 months; 95% CI, 3.97-6.45) when compared with the non-HPD progressor group (median, 7.33 months; 95% CI, 4.53-10.12; HR = 1.73, 95% CI, 1.05-2.85;
= 0.04). In a subset of 221 evaluable patients, 14 (6.3%) were categorized as HPD using TGR criteria, differences in median OS (mOS) between this group (mOS 4.2 months; 95% IC, 2.07-6.33) and non-HPD progressors (
= 44) by TGR criteria (mOS 6.27 months; 95% CI, 3.88-8.67) were not statistically significant (HR 1.4, 95% IC, 0.70-2.77;
= 0.346). Among 239 evaluable patients treated with TAs, 26 (10.9%) were classified as having HPD by RECIST and 14 using TGR criteria in a subset of patients. No differences in OS were observed between HPD and non-HPD progressors treated with TAs.
HPD measured by TGR or by RECIST was observed in both cohorts of patients; however, in our series, there was an impact on survival only in the immune-checkpoint inhibitor cohort when evaluated by RECIST. We propose a new way to capture HPD using RECIST criteria that is intuitive and easy to use in daily clinical practice.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-19-2226</identifier><identifier>PMID: 31757877</identifier><language>eng</language><publisher>United States</publisher><subject>Aged ; Disease Progression ; Female ; Follow-Up Studies ; Humans ; Immune Checkpoint Inhibitors - therapeutic use ; Immunotherapy - methods ; Male ; Middle Aged ; Molecular Targeted Therapy - methods ; Neoplasms - diagnostic imaging ; Neoplasms - drug therapy ; Neoplasms - immunology ; Neoplasms - pathology ; Response Evaluation Criteria in Solid Tumors ; Retrospective Studies ; Survival Rate ; Treatment Outcome ; Tumor Burden - drug effects</subject><ispartof>Clinical cancer research, 2020-04, Vol.26 (8), p.1846-1855</ispartof><rights>2019 American Association for Cancer Research.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-b8cb6eaf74970ad43709d2d80fe8df108498c89ad419919a6a84164f55db3cac3</citedby><cites>FETCH-LOGICAL-c408t-b8cb6eaf74970ad43709d2d80fe8df108498c89ad419919a6a84164f55db3cac3</cites><orcidid>0000-0001-9152-8799 ; 0000-0002-1068-9601 ; 0000-0002-2495-8139 ; 0000-0003-0129-3020</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,3356,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31757877$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Matos, Ignacio</creatorcontrib><creatorcontrib>Martin-Liberal, Juan</creatorcontrib><creatorcontrib>García-Ruiz, Alonso</creatorcontrib><creatorcontrib>Hierro, Cinta</creatorcontrib><creatorcontrib>Ochoa de Olza, Maria</creatorcontrib><creatorcontrib>Viaplana, Cristina</creatorcontrib><creatorcontrib>Azaro, Analia</creatorcontrib><creatorcontrib>Vieito, Maria</creatorcontrib><creatorcontrib>Braña, Irene</creatorcontrib><creatorcontrib>Mur, Gemma</creatorcontrib><creatorcontrib>Ros, Javier</creatorcontrib><creatorcontrib>Mateos, Jose</creatorcontrib><creatorcontrib>Villacampa, Guillermo</creatorcontrib><creatorcontrib>Berché, Roger</creatorcontrib><creatorcontrib>Oliveira, Mafalda</creatorcontrib><creatorcontrib>Alsina, Maria</creatorcontrib><creatorcontrib>Elez, Elena</creatorcontrib><creatorcontrib>Oaknin, Ana</creatorcontrib><creatorcontrib>Muñoz-Couselo, Eva</creatorcontrib><creatorcontrib>Carles, Joan</creatorcontrib><creatorcontrib>Felip, Enriqueta</creatorcontrib><creatorcontrib>Rodón, Jordi</creatorcontrib><creatorcontrib>Tabernero, Josep</creatorcontrib><creatorcontrib>Dienstmann, Rodrigo</creatorcontrib><creatorcontrib>Perez-Lopez, Raquel</creatorcontrib><creatorcontrib>Garralda, Elena</creatorcontrib><title>Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Most hyperprogression disease (HPD) definitions are based on tumor growth rate (TGR). However, there is still no consensus on how to evaluate this phenomenon.
We investigated two independent cohorts of patients with advanced solid tumors treated in phase I trials with (i) programmed cell death 1 (PD-1)/PD-L1 antibodies in monotherapy or combination and (ii) targeted agents (TA) in unapproved indications. A Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-based definition of hyperprogression was developed. The primary endpoint was the assessment of the rate of HPD in patients treated with ICIs or TAs using both criteria (RECIST and TGR) and the impact on overall survival (OS) in patients who achieved PD as best response.
Among 270 evaluable patients treated with PD-1/PD-L1 inhibitors, 29 PD-1/PD-L1-treated patients (10.7%) had HPD by RECIST definition. This group had a significantly lower OS (median of 5.23 months; 95% CI, 3.97-6.45) when compared with the non-HPD progressor group (median, 7.33 months; 95% CI, 4.53-10.12; HR = 1.73, 95% CI, 1.05-2.85;
= 0.04). In a subset of 221 evaluable patients, 14 (6.3%) were categorized as HPD using TGR criteria, differences in median OS (mOS) between this group (mOS 4.2 months; 95% IC, 2.07-6.33) and non-HPD progressors (
= 44) by TGR criteria (mOS 6.27 months; 95% CI, 3.88-8.67) were not statistically significant (HR 1.4, 95% IC, 0.70-2.77;
= 0.346). Among 239 evaluable patients treated with TAs, 26 (10.9%) were classified as having HPD by RECIST and 14 using TGR criteria in a subset of patients. No differences in OS were observed between HPD and non-HPD progressors treated with TAs.
HPD measured by TGR or by RECIST was observed in both cohorts of patients; however, in our series, there was an impact on survival only in the immune-checkpoint inhibitor cohort when evaluated by RECIST. We propose a new way to capture HPD using RECIST criteria that is intuitive and easy to use in daily clinical practice.</description><subject>Aged</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Immune Checkpoint Inhibitors - therapeutic use</subject><subject>Immunotherapy - methods</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Molecular Targeted Therapy - methods</subject><subject>Neoplasms - diagnostic imaging</subject><subject>Neoplasms - drug therapy</subject><subject>Neoplasms - immunology</subject><subject>Neoplasms - pathology</subject><subject>Response Evaluation Criteria in Solid Tumors</subject><subject>Retrospective Studies</subject><subject>Survival Rate</subject><subject>Treatment Outcome</subject><subject>Tumor Burden - drug effects</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kM1OwzAQhC0EoqXwCKAcuaR4HSe2j8gUWqkSUmmvWE7itIbmBzsB9e1J1MJpV9qZ2d0PoVvAU4CYPwBmPMQ0IlMpVyGIkBCSnKExxDELI5LE533_pxmhK-8_MAYKmF6iUQQsZpyxMXqXumk7Z6ttMD80xjWu3jrjvf02wZP1RnsT_Nh2FyzKsqtMKHcm-2xqW7XBotrZ1La188HGDwGrmVy8rQOYQiCdbY2z-hpdFHrvzc2pTtDmebaW83D5-rKQj8swo5i3YcqzNDG6YFQwrHMaMSxyknNcGJ4XgDkVPOOin4AQIHSiOYWEFnGcp1Gms2iC7o-5_f1fnfGtKq3PzH6vK1N3XpHhY8GxIL00PkozV3vvTKEaZ0vtDgqwGtCqAZsasKkerQKhBrS97-60oktLk_-7_lhGvx8ndMU</recordid><startdate>20200415</startdate><enddate>20200415</enddate><creator>Matos, Ignacio</creator><creator>Martin-Liberal, Juan</creator><creator>García-Ruiz, Alonso</creator><creator>Hierro, Cinta</creator><creator>Ochoa de Olza, Maria</creator><creator>Viaplana, Cristina</creator><creator>Azaro, Analia</creator><creator>Vieito, Maria</creator><creator>Braña, Irene</creator><creator>Mur, Gemma</creator><creator>Ros, Javier</creator><creator>Mateos, Jose</creator><creator>Villacampa, Guillermo</creator><creator>Berché, Roger</creator><creator>Oliveira, Mafalda</creator><creator>Alsina, Maria</creator><creator>Elez, Elena</creator><creator>Oaknin, Ana</creator><creator>Muñoz-Couselo, Eva</creator><creator>Carles, Joan</creator><creator>Felip, Enriqueta</creator><creator>Rodón, Jordi</creator><creator>Tabernero, Josep</creator><creator>Dienstmann, Rodrigo</creator><creator>Perez-Lopez, Raquel</creator><creator>Garralda, Elena</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-9152-8799</orcidid><orcidid>https://orcid.org/0000-0002-1068-9601</orcidid><orcidid>https://orcid.org/0000-0002-2495-8139</orcidid><orcidid>https://orcid.org/0000-0003-0129-3020</orcidid></search><sort><creationdate>20200415</creationdate><title>Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria</title><author>Matos, Ignacio ; Martin-Liberal, Juan ; García-Ruiz, Alonso ; Hierro, Cinta ; Ochoa de Olza, Maria ; Viaplana, Cristina ; Azaro, Analia ; Vieito, Maria ; Braña, Irene ; Mur, Gemma ; Ros, Javier ; Mateos, Jose ; Villacampa, Guillermo ; Berché, Roger ; Oliveira, Mafalda ; Alsina, Maria ; Elez, Elena ; Oaknin, Ana ; Muñoz-Couselo, Eva ; Carles, Joan ; Felip, Enriqueta ; Rodón, Jordi ; Tabernero, Josep ; Dienstmann, Rodrigo ; Perez-Lopez, Raquel ; Garralda, Elena</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-b8cb6eaf74970ad43709d2d80fe8df108498c89ad419919a6a84164f55db3cac3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Aged</topic><topic>Disease Progression</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Humans</topic><topic>Immune Checkpoint Inhibitors - therapeutic use</topic><topic>Immunotherapy - methods</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Molecular Targeted Therapy - methods</topic><topic>Neoplasms - diagnostic imaging</topic><topic>Neoplasms - drug therapy</topic><topic>Neoplasms - immunology</topic><topic>Neoplasms - pathology</topic><topic>Response Evaluation Criteria in Solid Tumors</topic><topic>Retrospective Studies</topic><topic>Survival Rate</topic><topic>Treatment Outcome</topic><topic>Tumor Burden - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Matos, Ignacio</creatorcontrib><creatorcontrib>Martin-Liberal, Juan</creatorcontrib><creatorcontrib>García-Ruiz, Alonso</creatorcontrib><creatorcontrib>Hierro, Cinta</creatorcontrib><creatorcontrib>Ochoa de Olza, Maria</creatorcontrib><creatorcontrib>Viaplana, Cristina</creatorcontrib><creatorcontrib>Azaro, Analia</creatorcontrib><creatorcontrib>Vieito, Maria</creatorcontrib><creatorcontrib>Braña, Irene</creatorcontrib><creatorcontrib>Mur, Gemma</creatorcontrib><creatorcontrib>Ros, Javier</creatorcontrib><creatorcontrib>Mateos, Jose</creatorcontrib><creatorcontrib>Villacampa, Guillermo</creatorcontrib><creatorcontrib>Berché, Roger</creatorcontrib><creatorcontrib>Oliveira, Mafalda</creatorcontrib><creatorcontrib>Alsina, Maria</creatorcontrib><creatorcontrib>Elez, Elena</creatorcontrib><creatorcontrib>Oaknin, Ana</creatorcontrib><creatorcontrib>Muñoz-Couselo, Eva</creatorcontrib><creatorcontrib>Carles, Joan</creatorcontrib><creatorcontrib>Felip, Enriqueta</creatorcontrib><creatorcontrib>Rodón, Jordi</creatorcontrib><creatorcontrib>Tabernero, Josep</creatorcontrib><creatorcontrib>Dienstmann, Rodrigo</creatorcontrib><creatorcontrib>Perez-Lopez, Raquel</creatorcontrib><creatorcontrib>Garralda, Elena</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Matos, Ignacio</au><au>Martin-Liberal, Juan</au><au>García-Ruiz, Alonso</au><au>Hierro, Cinta</au><au>Ochoa de Olza, Maria</au><au>Viaplana, Cristina</au><au>Azaro, Analia</au><au>Vieito, Maria</au><au>Braña, Irene</au><au>Mur, Gemma</au><au>Ros, Javier</au><au>Mateos, Jose</au><au>Villacampa, Guillermo</au><au>Berché, Roger</au><au>Oliveira, Mafalda</au><au>Alsina, Maria</au><au>Elez, Elena</au><au>Oaknin, Ana</au><au>Muñoz-Couselo, Eva</au><au>Carles, Joan</au><au>Felip, Enriqueta</au><au>Rodón, Jordi</au><au>Tabernero, Josep</au><au>Dienstmann, Rodrigo</au><au>Perez-Lopez, Raquel</au><au>Garralda, Elena</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2020-04-15</date><risdate>2020</risdate><volume>26</volume><issue>8</issue><spage>1846</spage><epage>1855</epage><pages>1846-1855</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Most hyperprogression disease (HPD) definitions are based on tumor growth rate (TGR). However, there is still no consensus on how to evaluate this phenomenon.
We investigated two independent cohorts of patients with advanced solid tumors treated in phase I trials with (i) programmed cell death 1 (PD-1)/PD-L1 antibodies in monotherapy or combination and (ii) targeted agents (TA) in unapproved indications. A Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-based definition of hyperprogression was developed. The primary endpoint was the assessment of the rate of HPD in patients treated with ICIs or TAs using both criteria (RECIST and TGR) and the impact on overall survival (OS) in patients who achieved PD as best response.
Among 270 evaluable patients treated with PD-1/PD-L1 inhibitors, 29 PD-1/PD-L1-treated patients (10.7%) had HPD by RECIST definition. This group had a significantly lower OS (median of 5.23 months; 95% CI, 3.97-6.45) when compared with the non-HPD progressor group (median, 7.33 months; 95% CI, 4.53-10.12; HR = 1.73, 95% CI, 1.05-2.85;
= 0.04). In a subset of 221 evaluable patients, 14 (6.3%) were categorized as HPD using TGR criteria, differences in median OS (mOS) between this group (mOS 4.2 months; 95% IC, 2.07-6.33) and non-HPD progressors (
= 44) by TGR criteria (mOS 6.27 months; 95% CI, 3.88-8.67) were not statistically significant (HR 1.4, 95% IC, 0.70-2.77;
= 0.346). Among 239 evaluable patients treated with TAs, 26 (10.9%) were classified as having HPD by RECIST and 14 using TGR criteria in a subset of patients. No differences in OS were observed between HPD and non-HPD progressors treated with TAs.
HPD measured by TGR or by RECIST was observed in both cohorts of patients; however, in our series, there was an impact on survival only in the immune-checkpoint inhibitor cohort when evaluated by RECIST. We propose a new way to capture HPD using RECIST criteria that is intuitive and easy to use in daily clinical practice.</abstract><cop>United States</cop><pmid>31757877</pmid><doi>10.1158/1078-0432.CCR-19-2226</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-9152-8799</orcidid><orcidid>https://orcid.org/0000-0002-1068-9601</orcidid><orcidid>https://orcid.org/0000-0002-2495-8139</orcidid><orcidid>https://orcid.org/0000-0003-0129-3020</orcidid><oa>free_for_read</oa></addata></record> |
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| source | MEDLINE; American Association for Cancer Research; EZB-FREE-00999 freely available EZB journals; Alma/SFX Local Collection |
| subjects | Aged Disease Progression Female Follow-Up Studies Humans Immune Checkpoint Inhibitors - therapeutic use Immunotherapy - methods Male Middle Aged Molecular Targeted Therapy - methods Neoplasms - diagnostic imaging Neoplasms - drug therapy Neoplasms - immunology Neoplasms - pathology Response Evaluation Criteria in Solid Tumors Retrospective Studies Survival Rate Treatment Outcome Tumor Burden - drug effects |
| title | Capturing Hyperprogressive Disease with Immune-Checkpoint Inhibitors Using RECIST 1.1 Criteria |
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