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The High-Dose Aldesleukin “Select” Trial: A Trial to Prospectively Validate Predictive Models of Response Treatment in Patients with Metastatic Renal Cell Carcinoma

Identifieur interne : 000E99 ( Main/Exploration ); précédent : 000E98; suivant : 000F00

The High-Dose Aldesleukin “Select” Trial: A Trial to Prospectively Validate Predictive Models of Response Treatment in Patients with Metastatic Renal Cell Carcinoma

Auteurs : David F. Mcdermott [États-Unis] ; Su-Chun Cheng [États-Unis] ; Sabina Signoretti [États-Unis] ; Kim A. Margolin [États-Unis] ; Joseph I. Clark [États-Unis] ; Jeffrey A. Sosman [États-Unis] ; Janice P. Dutcher [États-Unis] ; Theodore F. Logan [États-Unis] ; Brendan D. Curti [États-Unis] ; Marc S. Ernstoff [États-Unis] ; Leonard Appleman [États-Unis] ; Michael K. K. Wong [États-Unis] ; Nikhil I. Khushalani [États-Unis] ; Leslie Oleksowicz [États-Unis] ; Ulka N. Vaishampayan [États-Unis] ; James W. Mier [États-Unis] ; David J. Panka [États-Unis] ; Rupal S. Bhatt [États-Unis] ; Alexandra S. Bailey [États-Unis] ; Bradley C. Leibovich [États-Unis] ; Eugene D. Kwon [États-Unis] ; Fairooz F. Kabbinavar [États-Unis] ; Arie S. Belldegrun [États-Unis] ; Robert A. Figlin [États-Unis] ; Allan J. Pantuck [États-Unis] ; Meredith M. Regan [États-Unis] ; Michael B. Atkins

Source :

Clinical cancer research : an official journal of the American Association for Cancer Research [ 1078-0432 ] ; 2014.

RBID : PMC:4315731

Descripteurs français

KwdFr :
- Adulte, Adulte d'âge moyen, Antinéoplasiques (administration et posologie), Facteurs de risque, Humains, Interleukine-2 (administration et posologie), Interleukine-2 (analogues et dérivés), Métastase tumorale, Néphrocarcinome (anatomopathologie), Néphrocarcinome (mortalité), Néphrocarcinome (traitement médicamenteux), Pronostic, Protéines recombinantes (administration et posologie), Résultat thérapeutique, Sujet âgé, Tumeurs du rein (anatomopathologie), Tumeurs du rein (mortalité), Tumeurs du rein (traitement médicamenteux).
MESH :
- administration et posologie : Antinéoplasiques, Interleukine-2, Protéines recombinantes.
- analogues et dérivés : Interleukine-2.
- anatomopathologie : Néphrocarcinome, Tumeurs du rein.
- mortalité : Néphrocarcinome, Tumeurs du rein.
- traitement médicamenteux : Néphrocarcinome, Tumeurs du rein.
- Adulte, Adulte d'âge moyen, Facteurs de risque, Humains, Métastase tumorale, Pronostic, Résultat thérapeutique, Sujet âgé.

English descriptors

KwdEn :
- Adult, Aged, Antineoplastic Agents (administration & dosage), Carcinoma, Renal Cell (drug therapy), Carcinoma, Renal Cell (mortality), Carcinoma, Renal Cell (pathology), Humans, Interleukin-2 (administration & dosage), Interleukin-2 (analogs & derivatives), Kidney Neoplasms (drug therapy), Kidney Neoplasms (mortality), Kidney Neoplasms (pathology), Middle Aged, Neoplasm Metastasis, Prognosis, Recombinant Proteins (administration & dosage), Risk Factors, Treatment Outcome.
MESH :
- chemical , administration & dosage : Antineoplastic Agents, Interleukin-2, Recombinant Proteins.
- chemical , analogs & derivatives : Interleukin-2.
- drug therapy : Carcinoma, Renal Cell, Kidney Neoplasms.
- mortality : Carcinoma, Renal Cell, Kidney Neoplasms.
- pathology : Carcinoma, Renal Cell, Kidney Neoplasms.
- Adult, Aged, Humans, Middle Aged, Neoplasm Metastasis, Prognosis, Risk Factors, Treatment Outcome.

Abstract

Purpose

High-dose aldesleukin (HD IL-2) received FDA approval for the treatment of mRCC in 1992, producing a 14% objective response rate (ORR) and durable remissions. Retrospective studies suggested that clinical and pathologic features could predict for benefit. The Cytokine Working Group conducted this prospective trial to validate proposed predictive markers of response to HD IL-2.

Experimental Design

Standard HD IL-2 was administered to prospectively evaluate whether the ORR of mRCC patients with “good” predictive pathologic features based on an “integrated selection” model (ISM) (e.g. clear-cell histology sub-classification and carbonic anhydrase-9 (CA-9) IHC staining) was significantly higher than the ORR of a historical, unselected population. Archived tumor was collected for pathologic analysis including tumor programmed death-ligand 1 (PD-L1) expression.

Results

120 eligible patients enrolled between 11/06 and 7/09; 70% were MSKCC intermediate risk, 96% had clear cell RCC and 99% had prior nephrectomy. The independently assessed ORR was 25% (30/120, 95% CI = 17.5%–33.7%, p=0.0014) (3 CR, 27 PR) and was higher than a historical ORR. Thirteen patients (11%) remained progression-free at 3 years and the median OS was 42.8 months. ORR was not statistically different by ISM classification (“good-risk” 23% vs. “poor-risk” 30%, (p=0.39)). ORR was positively associated with tumor PD-L1 expression (p=0.01) by IHC.

Conclusions

In this prospective, biomarker validation study, HD IL-2 produced durable remissions and prolonged survival in both “good” and “poor-risk” patients. The proposed ISM was unable to improve the selection criteria. Novel markers (e.g. tumor PD-L1expression) appeared useful, but require independent validation.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4315731

DOI: 10.1158/1078-0432.CCR-14-1520
PubMed: 25424850
PubMed Central: 4315731

Affiliations:

Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">The High-Dose Aldesleukin “Select” Trial: A Trial to Prospectively Validate Predictive Models of Response Treatment in Patients with Metastatic Renal Cell Carcinoma</title>
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<author><name sortKey="Clark, Joseph I" sort="Clark, Joseph I" uniqKey="Clark J" first="Joseph I." last="Clark">Joseph I. Clark</name>
<affiliation wicri:level="2"><nlm:aff id="A5">Loyola University, Stritch School of Medicine, Chicago, IL</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Illinois</region>
</placeName>
<wicri:cityArea>Loyola University, Stritch School of Medicine, Chicago</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Sosman, Jeffrey A" sort="Sosman, Jeffrey A" uniqKey="Sosman J" first="Jeffrey A." last="Sosman">Jeffrey A. Sosman</name>
<affiliation wicri:level="2"><nlm:aff id="A6">Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Tennessee</region>
</placeName>
<wicri:cityArea>Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Dutcher, Janice P" sort="Dutcher, Janice P" uniqKey="Dutcher J" first="Janice P." last="Dutcher">Janice P. Dutcher</name>
<affiliation wicri:level="2"><nlm:aff id="A7">Our Lady Of Mercy Medical Center, New York, NY</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Our Lady Of Mercy Medical Center, New York</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Logan, Theodore F" sort="Logan, Theodore F" uniqKey="Logan T" first="Theodore F." last="Logan">Theodore F. Logan</name>
<affiliation wicri:level="2"><nlm:aff id="A8">Indiana University, Simon Cancer Center, Indianapolis, IN</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Indiana</region>
</placeName>
<wicri:cityArea>Indiana University, Simon Cancer Center, Indianapolis</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Curti, Brendan D" sort="Curti, Brendan D" uniqKey="Curti B" first="Brendan D." last="Curti">Brendan D. Curti</name>
<affiliation wicri:level="2"><nlm:aff id="A9">Providence Cancer Center, Earle A. Chiles Research Institute, Portland, OR</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Oregon</region>
</placeName>
<wicri:cityArea>Providence Cancer Center, Earle A. Chiles Research Institute, Portland</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Ernstoff, Marc S" sort="Ernstoff, Marc S" uniqKey="Ernstoff M" first="Marc S." last="Ernstoff">Marc S. Ernstoff</name>
<affiliation wicri:level="2"><nlm:aff id="A10">Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Dartmouth, NH</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">New Hampshire</region>
</placeName>
<wicri:cityArea>Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center, Dartmouth</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Appleman, Leonard" sort="Appleman, Leonard" uniqKey="Appleman L" first="Leonard" last="Appleman">Leonard Appleman</name>
<affiliation wicri:level="2"><nlm:aff id="A11">University of Pittsburgh School of Medicine, Department of Medicine, Division of Hematology/Oncology, Pittsburgh, PA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Pennsylvanie</region>
</placeName>
<wicri:cityArea>University of Pittsburgh School of Medicine, Department of Medicine, Division of Hematology/Oncology, Pittsburgh</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Wong, Michael K K" sort="Wong, Michael K K" uniqKey="Wong M" first="Michael K. K." last="Wong">Michael K. K. Wong</name>
<affiliation wicri:level="2"><nlm:aff id="A12">Roswell Park Cancer Institute, Buffalo, NY</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Roswell Park Cancer Institute, Buffalo</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Khushalani, Nikhil I" sort="Khushalani, Nikhil I" uniqKey="Khushalani N" first="Nikhil I." last="Khushalani">Nikhil I. Khushalani</name>
<affiliation wicri:level="2"><nlm:aff id="A12">Roswell Park Cancer Institute, Buffalo, NY</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">État de New York</region>
</placeName>
<wicri:cityArea>Roswell Park Cancer Institute, Buffalo</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Oleksowicz, Leslie" sort="Oleksowicz, Leslie" uniqKey="Oleksowicz L" first="Leslie" last="Oleksowicz">Leslie Oleksowicz</name>
<affiliation wicri:level="2"><nlm:aff id="A13">Lawrence and Memorial Hospital, Waterford, CT</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Connecticut</region>
</placeName>
<wicri:cityArea>Lawrence and Memorial Hospital, Waterford</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Vaishampayan, Ulka N" sort="Vaishampayan, Ulka N" uniqKey="Vaishampayan U" first="Ulka N." last="Vaishampayan">Ulka N. Vaishampayan</name>
<affiliation wicri:level="2"><nlm:aff id="A14">Karmanos Cancer Institute, Detroit, MI</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Michigan</region>
</placeName>
<wicri:cityArea>Karmanos Cancer Institute, Detroit</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Mier, James W" sort="Mier, James W" uniqKey="Mier J" first="James W." last="Mier">James W. Mier</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Panka, David J" sort="Panka, David J" uniqKey="Panka D" first="David J." last="Panka">David J. Panka</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Bhatt, Rupal S" sort="Bhatt, Rupal S" uniqKey="Bhatt R" first="Rupal S." last="Bhatt">Rupal S. Bhatt</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Bailey, Alexandra S" sort="Bailey, Alexandra S" uniqKey="Bailey A" first="Alexandra S." last="Bailey">Alexandra S. Bailey</name>
<affiliation wicri:level="2"><nlm:aff id="A1">Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Beth Israel Deaconess Medical Center, Dana-Farber/Harvard Cancer Center, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Leibovich, Bradley C" sort="Leibovich, Bradley C" uniqKey="Leibovich B" first="Bradley C." last="Leibovich">Bradley C. Leibovich</name>
<affiliation wicri:level="2"><nlm:aff id="A15">Department of Urology, Mayo Clinic, Rochester, MN</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Urology, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Kwon, Eugene D" sort="Kwon, Eugene D" uniqKey="Kwon E" first="Eugene D." last="Kwon">Eugene D. Kwon</name>
<affiliation wicri:level="2"><nlm:aff id="A15">Department of Urology, Mayo Clinic, Rochester, MN</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Minnesota</region>
</placeName>
<wicri:cityArea>Department of Urology, Mayo Clinic, Rochester</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Kabbinavar, Fairooz F" sort="Kabbinavar, Fairooz F" uniqKey="Kabbinavar F" first="Fairooz F." last="Kabbinavar">Fairooz F. Kabbinavar</name>
<affiliation wicri:level="2"><nlm:aff id="A16">University of California Los Angeles Medical Center, Santa Monica, CA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>University of California Los Angeles Medical Center, Santa Monica</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Belldegrun, Arie S" sort="Belldegrun, Arie S" uniqKey="Belldegrun A" first="Arie S." last="Belldegrun">Arie S. Belldegrun</name>
<affiliation wicri:level="2"><nlm:aff id="A16">University of California Los Angeles Medical Center, Santa Monica, CA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>University of California Los Angeles Medical Center, Santa Monica</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Figlin, Robert A" sort="Figlin, Robert A" uniqKey="Figlin R" first="Robert A." last="Figlin">Robert A. Figlin</name>
<affiliation wicri:level="2"><nlm:aff id="A17">Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute, West Hollywood, CA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute, West Hollywood</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Pantuck, Allan J" sort="Pantuck, Allan J" uniqKey="Pantuck A" first="Allan J." last="Pantuck">Allan J. Pantuck</name>
<affiliation wicri:level="2"><nlm:aff id="A16">University of California Los Angeles Medical Center, Santa Monica, CA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
<wicri:cityArea>University of California Los Angeles Medical Center, Santa Monica</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name>
<affiliation wicri:level="2"><nlm:aff id="A2">Dana-Farber Cancer Institute, Boston, MA</nlm:aff>
<country xml:lang="fr">États-Unis</country>
<placeName><region type="state">Massachusetts</region>
</placeName>
<wicri:cityArea>Dana-Farber Cancer Institute, Boston</wicri:cityArea>
</affiliation>
</author>
<author><name sortKey="Atkins, Michael B" sort="Atkins, Michael B" uniqKey="Atkins M" first="Michael B." last="Atkins">Michael B. Atkins</name>
<affiliation><nlm:aff id="A18">Georgetown-Lombardi Cancer Center, Washington, D.C</nlm:aff>
<wicri:noCountry code="subfield">D.C</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series><title level="j">Clinical cancer research : an official journal of the American Association for Cancer Research</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2014">2014</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Antineoplastic Agents (administration & dosage)</term>
<term>Carcinoma, Renal Cell (drug therapy)</term>
<term>Carcinoma, Renal Cell (mortality)</term>
<term>Carcinoma, Renal Cell (pathology)</term>
<term>Humans</term>
<term>Interleukin-2 (administration & dosage)</term>
<term>Interleukin-2 (analogs & derivatives)</term>
<term>Kidney Neoplasms (drug therapy)</term>
<term>Kidney Neoplasms (mortality)</term>
<term>Kidney Neoplasms (pathology)</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Prognosis</term>
<term>Recombinant Proteins (administration & dosage)</term>
<term>Risk Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Antinéoplasiques (administration et posologie)</term>
<term>Facteurs de risque</term>
<term>Humains</term>
<term>Interleukine-2 (administration et posologie)</term>
<term>Interleukine-2 (analogues et dérivés)</term>
<term>Métastase tumorale</term>
<term>Néphrocarcinome (anatomopathologie)</term>
<term>Néphrocarcinome (mortalité)</term>
<term>Néphrocarcinome (traitement médicamenteux)</term>
<term>Pronostic</term>
<term>Protéines recombinantes (administration et posologie)</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
<term>Tumeurs du rein (anatomopathologie)</term>
<term>Tumeurs du rein (mortalité)</term>
<term>Tumeurs du rein (traitement médicamenteux)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antineoplastic Agents</term>
<term>Interleukin-2</term>
<term>Recombinant Proteins</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Interleukin-2</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antinéoplasiques</term>
<term>Interleukine-2</term>
<term>Protéines recombinantes</term>
</keywords>
<keywords scheme="MESH" qualifier="analogues et dérivés" xml:lang="fr"><term>Interleukine-2</term>
</keywords>
<keywords scheme="MESH" qualifier="anatomopathologie" xml:lang="fr"><term>Néphrocarcinome</term>
<term>Tumeurs du rein</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Néphrocarcinome</term>
<term>Tumeurs du rein</term>
</keywords>
<keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Carcinoma, Renal Cell</term>
<term>Kidney Neoplasms</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Néphrocarcinome</term>
<term>Tumeurs du rein</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Aged</term>
<term>Humans</term>
<term>Middle Aged</term>
<term>Neoplasm Metastasis</term>
<term>Prognosis</term>
<term>Risk Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Facteurs de risque</term>
<term>Humains</term>
<term>Métastase tumorale</term>
<term>Pronostic</term>
<term>Résultat thérapeutique</term>
<term>Sujet âgé</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec id="S1"><title>Purpose</title>
<p id="P1">High-dose aldesleukin (HD IL-2) received FDA approval for the treatment of mRCC in 1992, producing a 14% objective response rate (ORR) and durable remissions. Retrospective studies suggested that clinical and pathologic features could predict for benefit. The Cytokine Working Group conducted this prospective trial to validate proposed predictive markers of response to HD IL-2.</p>
</sec>
<sec id="S2"><title>Experimental Design</title>
<p id="P2">Standard HD IL-2 was administered to prospectively evaluate whether the ORR of mRCC patients with “good” predictive pathologic features based on an “integrated selection” model (ISM) (e.g. clear-cell histology sub-classification and carbonic anhydrase-9 (CA-9) IHC staining) was significantly higher than the ORR of a historical, unselected population. Archived tumor was collected for pathologic analysis including tumor programmed death-ligand 1 (PD-L1) expression.</p>
</sec>
<sec id="S3"><title>Results</title>
<p id="P3">120 eligible patients enrolled between 11/06 and 7/09; 70% were MSKCC intermediate risk, 96% had clear cell RCC and 99% had prior nephrectomy. The independently assessed ORR was 25% (30/120, 95% CI = 17.5%–33.7%, p=0.0014) (3 CR, 27 PR) and was higher than a historical ORR. Thirteen patients (11%) remained progression-free at 3 years and the median OS was 42.8 months. ORR was not statistically different by ISM classification (“good-risk” 23% vs. “poor-risk” 30%, (p=0.39)). ORR was positively associated with tumor PD-L1 expression (p=0.01) by IHC.</p>
</sec>
<sec id="S4"><title>Conclusions</title>
<p id="P4">In this prospective, biomarker validation study, HD IL-2 produced durable remissions and prolonged survival in both “good” and “poor-risk” patients. The proposed ISM was unable to improve the selection criteria. Novel markers (e.g. tumor PD-L1expression) appeared useful, but require independent validation.</p>
</sec>
</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Californie</li>
<li>Connecticut</li>
<li>Illinois</li>
<li>Indiana</li>
<li>Massachusetts</li>
<li>Michigan</li>
<li>Minnesota</li>
<li>New Hampshire</li>
<li>Oregon</li>
<li>Pennsylvanie</li>
<li>Tennessee</li>
<li>Washington (État)</li>
<li>État de New York</li>
</region>
</list>
<tree><noCountry><name sortKey="Atkins, Michael B" sort="Atkins, Michael B" uniqKey="Atkins M" first="Michael B." last="Atkins">Michael B. Atkins</name>
</noCountry>
<country name="États-Unis"><region name="Massachusetts"><name sortKey="Mcdermott, David F" sort="Mcdermott, David F" uniqKey="Mcdermott D" first="David F." last="Mcdermott">David F. Mcdermott</name>
</region>
<name sortKey="Appleman, Leonard" sort="Appleman, Leonard" uniqKey="Appleman L" first="Leonard" last="Appleman">Leonard Appleman</name>
<name sortKey="Bailey, Alexandra S" sort="Bailey, Alexandra S" uniqKey="Bailey A" first="Alexandra S." last="Bailey">Alexandra S. Bailey</name>
<name sortKey="Belldegrun, Arie S" sort="Belldegrun, Arie S" uniqKey="Belldegrun A" first="Arie S." last="Belldegrun">Arie S. Belldegrun</name>
<name sortKey="Bhatt, Rupal S" sort="Bhatt, Rupal S" uniqKey="Bhatt R" first="Rupal S." last="Bhatt">Rupal S. Bhatt</name>
<name sortKey="Cheng, Su Chun" sort="Cheng, Su Chun" uniqKey="Cheng S" first="Su-Chun" last="Cheng">Su-Chun Cheng</name>
<name sortKey="Clark, Joseph I" sort="Clark, Joseph I" uniqKey="Clark J" first="Joseph I." last="Clark">Joseph I. Clark</name>
<name sortKey="Curti, Brendan D" sort="Curti, Brendan D" uniqKey="Curti B" first="Brendan D." last="Curti">Brendan D. Curti</name>
<name sortKey="Dutcher, Janice P" sort="Dutcher, Janice P" uniqKey="Dutcher J" first="Janice P." last="Dutcher">Janice P. Dutcher</name>
<name sortKey="Ernstoff, Marc S" sort="Ernstoff, Marc S" uniqKey="Ernstoff M" first="Marc S." last="Ernstoff">Marc S. Ernstoff</name>
<name sortKey="Figlin, Robert A" sort="Figlin, Robert A" uniqKey="Figlin R" first="Robert A." last="Figlin">Robert A. Figlin</name>
<name sortKey="Kabbinavar, Fairooz F" sort="Kabbinavar, Fairooz F" uniqKey="Kabbinavar F" first="Fairooz F." last="Kabbinavar">Fairooz F. Kabbinavar</name>
<name sortKey="Khushalani, Nikhil I" sort="Khushalani, Nikhil I" uniqKey="Khushalani N" first="Nikhil I." last="Khushalani">Nikhil I. Khushalani</name>
<name sortKey="Kwon, Eugene D" sort="Kwon, Eugene D" uniqKey="Kwon E" first="Eugene D." last="Kwon">Eugene D. Kwon</name>
<name sortKey="Leibovich, Bradley C" sort="Leibovich, Bradley C" uniqKey="Leibovich B" first="Bradley C." last="Leibovich">Bradley C. Leibovich</name>
<name sortKey="Logan, Theodore F" sort="Logan, Theodore F" uniqKey="Logan T" first="Theodore F." last="Logan">Theodore F. Logan</name>
<name sortKey="Margolin, Kim A" sort="Margolin, Kim A" uniqKey="Margolin K" first="Kim A." last="Margolin">Kim A. Margolin</name>
<name sortKey="Mier, James W" sort="Mier, James W" uniqKey="Mier J" first="James W." last="Mier">James W. Mier</name>
<name sortKey="Oleksowicz, Leslie" sort="Oleksowicz, Leslie" uniqKey="Oleksowicz L" first="Leslie" last="Oleksowicz">Leslie Oleksowicz</name>
<name sortKey="Panka, David J" sort="Panka, David J" uniqKey="Panka D" first="David J." last="Panka">David J. Panka</name>
<name sortKey="Pantuck, Allan J" sort="Pantuck, Allan J" uniqKey="Pantuck A" first="Allan J." last="Pantuck">Allan J. Pantuck</name>
<name sortKey="Regan, Meredith M" sort="Regan, Meredith M" uniqKey="Regan M" first="Meredith M." last="Regan">Meredith M. Regan</name>
<name sortKey="Signoretti, Sabina" sort="Signoretti, Sabina" uniqKey="Signoretti S" first="Sabina" last="Signoretti">Sabina Signoretti</name>
<name sortKey="Sosman, Jeffrey A" sort="Sosman, Jeffrey A" uniqKey="Sosman J" first="Jeffrey A." last="Sosman">Jeffrey A. Sosman</name>
<name sortKey="Vaishampayan, Ulka N" sort="Vaishampayan, Ulka N" uniqKey="Vaishampayan U" first="Ulka N." last="Vaishampayan">Ulka N. Vaishampayan</name>
<name sortKey="Wong, Michael K K" sort="Wong, Michael K K" uniqKey="Wong M" first="Michael K. K." last="Wong">Michael K. K. Wong</name>
</country>
</tree>
</affiliations>
</record>

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The High-Dose Aldesleukin “Select” Trial: A Trial to Prospectively Validate Predictive Models of Response Treatment in Patients with Metastatic Renal Cell Carcinoma

The High-Dose Aldesleukin “Select” Trial: A Trial to Prospectively Validate Predictive Models of Response Treatment in Patients with Metastatic Renal Cell Carcinoma

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