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Research Articles

Personalized Antibodies for Gastroesophageal Adenocarcinoma (PANGEA): A Phase II Study Evaluating an Individualized Treatment Strategy for Metastatic Disease

Daniel V.T. Catenacci, Stephanie Moya, Samantha Lomnicki, Leah M. Chase, Bryan F. Peterson, Natalie Reizine, Lindsay Alpert, Namrata Setia, Shu-Yuan Xiao, John Hart, Uzma D. Siddiqui, D. Kyle Hogarth, Oliver S. Eng, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Paul Chang, Sunil Narula, Murtuza Rampurwala, Yuan Ji, Theodore Karrison, Chih-Yi Liao, Blase N. Polite and Hedy L. Kindler
Daniel V.T. Catenacci
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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  • For correspondence: dcatenac@bsd.uchicago.edu
Stephanie Moya
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Samantha Lomnicki
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Leah M. Chase
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Bryan F. Peterson
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Natalie Reizine
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Lindsay Alpert
2The University of Chicago, Department of Pathology, Chicago, Illinois.
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Namrata Setia
2The University of Chicago, Department of Pathology, Chicago, Illinois.
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Shu-Yuan Xiao
2The University of Chicago, Department of Pathology, Chicago, Illinois.
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John Hart
2The University of Chicago, Department of Pathology, Chicago, Illinois.
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Uzma D. Siddiqui
3The University of Chicago, Department of Medicine, Center for Endoscopic Research and Therapeutics (CERT), Chicago, Illinois.
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D. Kyle Hogarth
4The University of Chicago, Department of Medicine, Section of Pulmonology, Chicago, Illinois.
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  • ORCID record for D. Kyle Hogarth
Oliver S. Eng
5The University of Chicago, Department of Surgery, Chicago, Illinois.
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Kiran Turaga
5The University of Chicago, Department of Surgery, Chicago, Illinois.
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Kevin Roggin
5The University of Chicago, Department of Surgery, Chicago, Illinois.
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Mitchell C. Posner
5The University of Chicago, Department of Surgery, Chicago, Illinois.
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Paul Chang
6The University of Chicago, Department of Radiology, Chicago, Illinois.
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Sunil Narula
7The University of Chicago, New Lennox, Illinois.
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Murtuza Rampurwala
8The University of Chicago, Orland Park, Illinois.
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Yuan Ji
9The University of Chicago, Department of Public Health Sciences, Chicago, Illinois.
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Theodore Karrison
9The University of Chicago, Department of Public Health Sciences, Chicago, Illinois.
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Chih-Yi Liao
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Blase N. Polite
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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Hedy L. Kindler
1The University of Chicago, Section of Hematology/Oncology, Department of Medicine, Chicago, Illinois.
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DOI: 10.1158/2159-8290.CD-20-1408
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Abstract

The one-year and median overall survival (mOS) rates of advanced gastroesophageal adenocarcinomas (GEA) are ∼50% and <12 months, respectively. Baseline spatial and temporal molecular heterogeneity of targetable alterations may be a cause of failure of targeted/immunooncologic therapies. This heterogeneity, coupled with infrequent incidence of some biomarkers, has resulted in stalled therapeutic progress. We hypothesized that a personalized treatment strategy, applied at first diagnosis then serially over up to three treatment lines using monoclonal antibodies combined with optimally sequenced chemotherapy, could contend with these hurdles. This was tested using a novel clinical expansion-platform type II design with a survival primary endpoint. Of 68 patients by intention-to-treat, the one-year survival rate was 66% and mOS was 15.7 months, meeting the primary efficacy endpoint (one-sided P = 0.0024). First-line response rate (74%), disease control rate (99%), and median progression-free survival (8.2 months) were superior to historical controls. The PANGEA strategy led to improved outcomes warranting a larger randomized study.

Significance: This study highlights excellent outcomes achieved by individually optimizing chemotherapy, biomarker profiling, and matching of targeted therapies at baseline and over time for GEA. Testing a predefined treatment strategy resulted in improved outcomes versus historical controls. Therapeutic resistance observed in correlative analyses suggests that dual targeted inhibition may be beneficial.

Footnotes

  • Note: Supplementary data for this article are available at Cancer Discovery Online (http://cancerdiscovery.aacrjournals.org/).

  • Cancer Discov 2021;11:1–18

  • Received September 28, 2020.
  • Revision received November 1, 2020.
  • Accepted November 18, 2020.
  • Published first November 24, 2020.
  • ©2020 American Association for Cancer Research.
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This OnlineFirst version was published on January 21, 2021
doi: 10.1158/2159-8290.CD-20-1408

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Personalized Antibodies for Gastroesophageal Adenocarcinoma (PANGEA): A Phase II Study Evaluating an Individualized Treatment Strategy for Metastatic Disease
Daniel V.T. Catenacci, Stephanie Moya, Samantha Lomnicki, Leah M. Chase, Bryan F. Peterson, Natalie Reizine, Lindsay Alpert, Namrata Setia, Shu-Yuan Xiao, John Hart, Uzma D. Siddiqui, D. Kyle Hogarth, Oliver S. Eng, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Paul Chang, Sunil Narula, Murtuza Rampurwala, Yuan Ji, Theodore Karrison, Chih-Yi Liao, Blase N. Polite and Hedy L. Kindler
Cancer Discov January 21 2021 DOI: 10.1158/2159-8290.CD-20-1408

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Personalized Antibodies for Gastroesophageal Adenocarcinoma (PANGEA): A Phase II Study Evaluating an Individualized Treatment Strategy for Metastatic Disease
Daniel V.T. Catenacci, Stephanie Moya, Samantha Lomnicki, Leah M. Chase, Bryan F. Peterson, Natalie Reizine, Lindsay Alpert, Namrata Setia, Shu-Yuan Xiao, John Hart, Uzma D. Siddiqui, D. Kyle Hogarth, Oliver S. Eng, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Paul Chang, Sunil Narula, Murtuza Rampurwala, Yuan Ji, Theodore Karrison, Chih-Yi Liao, Blase N. Polite and Hedy L. Kindler
Cancer Discov January 21 2021 DOI: 10.1158/2159-8290.CD-20-1408
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