clinical cancer research table of contents · nisha unni, dhivya r. sudhan, and carlos l. arteaga...

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SPECIAL FEATURES Highlights of This Issue 3475 CCR Translations 3477 The Need for Neddylation: A Key to Achieving NED in Uveal Melanoma Jessica Yang, Omid Hamid, and Richard D. Carvajal See related article, p. 3741 3480 Tamoxifen Resistance Trumped and Oral Selective Estrogen Receptor Degraders Arrive V. Craig Jordan See related articles, p. 3681 and p. 3510 3483 Neratinib: Inching Up on the Cure Rate of HER2 þ Breast Cancer? Nisha Unni, Dhivya R. Sudhan, and Carlos L. Arteaga See related article, p. 3486 CCR Drug Updates 3486 U.S. Food and Drug Administration Approval: Neratinib for the Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer Harpreet Singh, Amanda J. Walker, Laleh Amiri-Kordestani, Joyce Cheng, Shenghui Tang, Pamela Balcazar, Kimberly Barnett-Ringgold, Todd R. Palmby, Xianhua Cao, Nan Zheng, Qi Liu, Jingyu Yu, William F. Pierce, Selena R. Daniels, Rajeshwari Sridhara, Amna Ibrahim, Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, and Richard Pazdur See related commentary, p. 3483 Review 3492 Data Analysis Strategies in Medical Imaging Chintan Parmar, Joseph D. Barry, Ahmed Hosny, John Quackenbush, and Hugo J.W.L. Aerts Perspectives 3500 Report from the SWOG Radiation Oncology Committee: Research Objectives Workshop 2017 Paul Okunieff, Katherine Casey-Sawicki, Natalie A. Lockney, Bradford S. Hoppe, Heiko Enderling, Chelsea Pinnix, James Welsh, Sunil Krishnan, Greg Yothers, Martin Brown, Susan Knox, Robert Bristow, Paul Spellman, Timur Mitin, Nima Nabavizadeh, Jerry Jaboin, H. Charles Manning, Felix Feng, Susan Galbraith, Abhishek A. Solanki, Matthew M. Harkenrider, Richard Tuli, Roy H. Decker, Steven E. Finkelstein, Charles C. Hsu, Chul S. Ha, Reshma Jagsi, Dean Shumway, Megan Daly, Tony J.C. Wang, Thomas J. Fitzgerald, Fran Laurie, David T. Marshall, David Raben, Louis Constine, Charles R. Thomas Jr, and Lisa A. Kachnic CLINICAL TRIALS: TARGETED THERAPY 3510 A First-in-Human Study of the New Oral Selective Estrogen Receptor Degrader AZD9496 for ER þ /HER2 Advanced Breast Cancer Erika P. Hamilton, Manish R. Patel, Anne C. Armstrong, Richard D. Baird, Komal Jhaveri, Matthias Hoch, Teresa Klinowska, Justin P.O. Lindemann, Shethah R. Morgan, Gaia Schiavon, Hazel M. Weir, and Seock-Ah Im See related commentary, p. 3480 CLINICAL TRIALS: IMMUNOTHERAPY 3519 A Multi-center Phase I Trial of Ipilimumab in Patients with Myelodysplastic Syndromes following Hypomethylating Agent Failure Amer M. Zeidan, Hanna A. Knaus, Tara M. Robinson, Andrea M.H. Towlerton, Edus H. Warren, Joshua F. Zeidner, Amanda L. Blackford, Amy S. Duffield, David Rizzieri, Mark G. Frattini, Yair M. Levy, Mark A. Schroeder, Anna Ferguson, Katherine E. Sheldon, Amy E. DeZern, Ivana Gojo, Steven D. Gore, Howard Streicher, Leo Luznik, and B. Douglas Smith August 1, 2018 Volume 24 Number 15 Clinical Cancer Research Table of Contents iv on March 29, 2020. © 2018 American Association for Cancer Research. clincancerres.aacrjournals.org Downloaded from

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Page 1: Clinical Cancer Research Table of Contents · Nisha Unni, Dhivya R. Sudhan, and Carlos L. Arteaga See related article, p. 3486 CCR Drug Updates 3486 U.S. Food and Drug Administration

SPECIAL FEATURES

Highlights of This Issue 3475

CCR Translations

3477 The Need for Neddylation: A Key to AchievingNED in Uveal MelanomaJessica Yang, Omid Hamid, and Richard D. CarvajalSee related article, p. 3741

3480 Tamoxifen Resistance Trumped and Oral SelectiveEstrogen Receptor Degraders ArriveV. Craig JordanSee related articles, p. 3681 and p. 3510

3483 Neratinib: Inching Up on the Cure Rate of HER2þ

Breast Cancer?Nisha Unni, Dhivya R. Sudhan, and Carlos L. ArteagaSee related article, p. 3486

CCR Drug Updates

3486 U.S. Food and Drug Administration Approval:Neratinib for the Extended Adjuvant Treatmentof Early-Stage HER2-Positive Breast CancerHarpreet Singh, Amanda J. Walker, Laleh Amiri-Kordestani,Joyce Cheng, Shenghui Tang, Pamela Balcazar,Kimberly Barnett-Ringgold, Todd R. Palmby, Xianhua Cao,Nan Zheng, Qi Liu, Jingyu Yu, William F. Pierce,Selena R. Daniels, Rajeshwari Sridhara, Amna Ibrahim,Paul G. Kluetz, Gideon M. Blumenthal, Julia A. Beaver, andRichard PazdurSee related commentary, p. 3483

Review

3492 Data Analysis Strategies in Medical ImagingChintan Parmar, Joseph D. Barry, Ahmed Hosny,John Quackenbush, and Hugo J.W.L. Aerts

Perspectives

3500 Report from the SWOG Radiation OncologyCommittee: Research Objectives Workshop2017Paul Okunieff, Katherine Casey-Sawicki,Natalie A. Lockney, Bradford S. Hoppe, Heiko Enderling,Chelsea Pinnix, James Welsh, Sunil Krishnan,Greg Yothers, Martin Brown, Susan Knox, Robert Bristow,Paul Spellman, Timur Mitin, Nima Nabavizadeh,Jerry Jaboin, H. Charles Manning, Felix Feng,Susan Galbraith, Abhishek A. Solanki,Matthew M. Harkenrider, Richard Tuli, Roy H. Decker,Steven E. Finkelstein, Charles C. Hsu, Chul S. Ha,Reshma Jagsi, Dean Shumway, Megan Daly,Tony J.C. Wang, Thomas J. Fitzgerald, Fran Laurie,David T. Marshall, David Raben, Louis Constine,Charles R. Thomas Jr, and Lisa A. Kachnic

CLINICAL TRIALS: TARGETED THERAPY

3510 A First-in-Human Study of the New OralSelective Estrogen Receptor Degrader AZD9496 forERþ/HER2� Advanced Breast CancerErika P. Hamilton, Manish R. Patel, Anne C. Armstrong,Richard D. Baird, Komal Jhaveri, Matthias Hoch,Teresa Klinowska, Justin P.O. Lindemann,Shethah R. Morgan, Gaia Schiavon, Hazel M. Weir, andSeock-Ah ImSee related commentary, p. 3480

CLINICAL TRIALS: IMMUNOTHERAPY

3519 A Multi-center Phase I Trial of Ipilimumab inPatients with Myelodysplastic Syndromesfollowing Hypomethylating Agent FailureAmer M. Zeidan, Hanna A. Knaus, Tara M. Robinson,AndreaM.H. Towlerton, EdusH.Warren, Joshua F. Zeidner,Amanda L. Blackford, Amy S. Duffield, David Rizzieri,Mark G. Frattini, Yair M. Levy, Mark A. Schroeder,Anna Ferguson, Katherine E. Sheldon, Amy E. DeZern,Ivana Gojo, Steven D. Gore, Howard Streicher, Leo Luznik,and B. Douglas Smith

August 1, 2018 � Volume 24 � Number 15

Clinical Cancer Research

Table ofContents

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PRECISION MEDICINE AND IMAGING

3528 The Landscape of Actionable GenomicAlterations in Cell-Free Circulating Tumor DNAfrom 21,807 Advanced Cancer PatientsOliver A. Zill, Kimberly C. Banks, Stephen R. Fairclough,Stefanie A. Mortimer, James V. Vowles, Reza Mokhtari,David R. Gandara, Philip C. Mack, Justin I. Odegaard,Rebecca J. Nagy, Arthur M. Baca, Helmy Eltoukhy,Darya I. Chudova, Richard B. Lanman, andAmirAli Talasaz

3539 Validation of a Plasma-Based ComprehensiveCancer Genotyping Assay Utilizing OrthogonalTissue- and Plasma-Based MethodologiesJustin I. Odegaard, John J. Vincent, Stefanie Mortimer,James V. Vowles, Bryan C. Ulrich, Kimberly C. Banks,Stephen R. Fairclough, Oliver A. Zill, Marcin Sikora,Reza Mokhtari, Diana Abdueva, Rebecca J. Nagy,Christine E. Lee, Lesli A. Kiedrowski, Cloud P. Paweletz,Helmy Eltoukhy, Richard B. Lanman, Darya I. Chudova,and AmirAli Talasaz

3550 Exome Sequencing of Plasma DNA Portrays theMutation Landscape of Colorectal Cancer andDiscovers Mutated VEGFR2 Receptors asModulators of Antiangiogenic TherapiesRodrigo A. Toledo, Elena Garralda, Maria Mitsi,

Tirso Pons, Jorge Monsech, Estela Vega, �Alvaro Otero,Maria I. Albarran, Natalia Ba~nos, Yolanda Dur�an,Victoria Bonilla, Francesca Sarno,Marta Camacho-Artacho, Tania Sanchez-Perez,

Sofia Perea, Rafael �Alvarez, Alba De Martino,Daniel Lietha, Carmen Blanco-Aparicio, Antonio Cubillo,Orlando Domínguez, Jorge L. Martínez-Torrecuadrada,and Manuel Hidalgo

3560 Immunogenomic Analyses of Advanced SerousOvarian Cancer Reveal Immune Score is a StrongPrognostic Factor and an Indicator ofChemosensitivityDapeng Hao, Jie Liu, Meng Chen, JingJing Li, Li Wang,Xiaobo Li, Qi Zhao, and Li-jun Di

3572 Intraoperative Resection Guidance withPhotoacoustic and Fluorescence MolecularImaging Using an Anti–B7-H3 Antibody-Indocyanine Green Dual Contrast AgentKatheryne E. Wilson, Sunitha V. Bachawal, andJ€urgen K. Willmann

3583 A New Approach to Predict Progression-freeSurvival in Stage IV EGFR-mutant NSCLC Patientswith EGFR-TKI TherapyJiangdian Song, Jingyun Shi, Di Dong, Mengjie Fang,Wenzhao Zhong, Kun Wang, Ning Wu, Yanqi Huang,Zhenyu Liu, Yue Cheng, Yuncui Gan, Yongzhao Zhou,Ping Zhou, Bojiang Chen, Changhong Liang, Zaiyi Liu,Weimin Li, and Jie Tian

3593 Clinicopathological Risk Factors for an InvasiveBreast Cancer Recurrence after Ductal CarcinomaIn Situ—A Nested Case–Control StudyLindy L. Visser, Lotte E. Elshof, Michael Schaapveld,Koen van de Vijver, Emma J. Groen,Mathilde M. Almekinders, Carolien Bierman,Flora E. van Leeuwen, Emiel J. Rutgers,Marjanka K. Schmidt, Esther H. Lips, and Jelle Wesseling

3602 Paclitaxel Plasma Concentration after the FirstInfusion Predicts Treatment-LimitingPeripheral NeuropathyDaniel L. Hertz, Kelley M. Kidwell, Kiran Vangipuram,Feng Li, Manjunath P. Pai, Monika Burness,Jennifer J. Griggs, Anne F. Schott, Catherine Van Poznak,Daniel F. Hayes, Ellen M. Lavoie Smith, andN. Lynn Henry

TRANSLATIONAL CANCER MECHANISMSAND THERAPY

3611 A Rationally Designed Fully Human EGFRvIII:CD3-Targeted Bispecific Antibody RedirectsHuman T Cells to Treat Patient-derivedIntracerebral Malignant GliomaPatrick C. Gedeon, Teilo H. Schaller, Satish K. Chitneni,Bryan D. Choi, Chien-Tsun Kuan, Carter M. Suryadevara,David J. Snyder, Robert J. Schmittling, Scott E. Szafranski,Xiuyu Cui, Patrick N. Healy, James E. Herndon II,Roger E. McLendon, Stephen T. Keir, Gary E. Archer,Elizabeth A. Reap, Luis Sanchez-Perez, Darell D. Bigner,and John H. Sampson

3632 Tryptophan Metabolism Contributes toRadiation-Induced Immune CheckpointReactivation in GlioblastomaPravin Kesarwani, Antony Prabhu, Shiva Kant,Praveen Kumar, Stewart F. Graham, Katie L. Buelow,George D. Wilson, C. Ryan Miller, andPrakash Chinnaiyan

3644 Targeting Merkel Cell Carcinoma by EngineeredT Cells Specific to T-Antigens of Merkel CellPolyomavirusIoannis Gavvovidis, Matthias Leisegang,Gerald Willimsky, Natalie Miller, Paul Nghiem, andThomas Blankenstein

3656 Enhanced Therapeutic Activity of Non-Internalizing Small-Molecule-Drug ConjugatesTargeting Carbonic Anhydrase IX inCombination with Targeted Interleukin-2Samuele Cazzamalli, Barbara Ziffels, FontaineWidmayer,Patrizia Murer, Giovanni Pellegrini, Francesca Pretto,Sarah Wulhfard, and Dario Neri

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3668 MEIS1 and MEIS2 Expression and ProstateCancer Progression: A Role For HOXB13 BindingPartners in Metastatic DiseaseRaj R. Bhanvadia, Calvin VanOpstall, Hannah Brechka,Nimrod S. Barashi, Marc Gillard, Erin M. McAuley,Juan Manuel Vasquez, Gladell Paner, Wen-Ching Chan,Jorge Andrade, Angelo M. De Marzo, Misop Han,Russell Z. Szmulewitz, and Donald J. Vander Griend

3681 BQ323636.1, a Novel Splice Variant toNCOR2, asa Predictor for Tamoxifen-Resistant BreastCancerChun Gong, Ellen P.S. Man, Ho Tsoi, Terence K.W. Lee,Paul Lee, Sai-Ting Ma, Lai-San Wong, Mai-Yee Luk,Emad A. Rakha, Andrew R. Green, Ian O. Ellis,Eric W.-F. Lam, Kwok-Leung Cheung, and Ui-Soon KhooSee related commentary, p. 3480

3692 Epigenome-wide SRC-1–Mediated GeneSilencing Represses Cellular Differentiation inAdvanced Breast CancerElspeth Ward, Damir Varešlija, Sara Charmsaz,Ailis Fagan, Alacoque L. Browne, Nicola Cosgrove,Sin�ead Cocchiglia, Siobhan P. Purcell, Lance Hudson,Sudipto Das, Darran O'Connor, Philip J. O'Halloran,Andrew H. Sims, Arnold D. Hill, and Leonie S. Young

3704 Insulin-Like Growth Factor 2 mRNA-BindingProtein 3 is a Novel Post-TranscriptionalRegulator of Ewing Sarcoma MalignancyCaterina Mancarella, Michela Pasello, Selena Ventura,Andrea Grilli, Linda Calzolari, Lisa Toracchio,Pier-Luigi Lollini, Davide Maria Donati, Piero Picci,Stefano Ferrari, and Katia Scotlandi

3717 A Pan-cancer Landscape of Interactionsbetween Solid Tumors and Infiltrating ImmuneCell PopulationsDavid Tamborero, Carlota Rubio-Perez, Ferran Mui~nos,Radhakrishnan Sabarinathan, Josep M. Piulats,Aura Muntasell, Rodrigo Dienstmann, Nuria Lopez-Bigas,and Abel Gonzalez-Perez

3729 Nintedanib Is Active in Malignant PleuralMesothelioma Cell Models and InhibitsAngiogenesis and Tumor Growth In VivoViktoria Laszlo, Zsuzsanna Valko, Ildiko Kovacs,Judit Ozsvar, Mir Alireza Hoda, Thomas Klikovits,Dora Lakatos, Andras Czirok, Tamas Garay,Alexander Stiglbauer, ThomasH. Helbich, Marion Gr€oger,Jozsef Tovari, Walter Klepetko, Christine Pirker,Michael Grusch, Walter Berger, Frank Hilberg,Balazs Hegedus, and Balazs Dome

3741 Neddylation Blockade Diminishes HepaticMetastasis by Dampening Cancer Stem-LikeCells and Angiogenesis in Uveal MelanomaYanli Jin, Ping Zhang, Yun Wang, Bei Jin, Jingfeng Zhou,Jing Zhang, and Jingxuan PanSee related commentary, p. 3477

3755 Orthoxenografts of Testicular Germ Cell TumorsDemonstrate Genomic Changes Associated withCisplatin Resistance and Identify PDMP as aResensitizing AgentJosep M. Piulats, August Vidal,Francisco J. García-Rodríguez, Clara Mu~noz, Marga Nadal,Catia Moutinho, María Martínez-Iniesta, Josefina Mora,Agn�es Figueras, Elisabet Guin�o, Laura Padull�es,�Alvaro Ayt�es, David G. Molleví, Sara Puertas,Carmen Martínez-Fern�andez, Wilmar Castillo,Merce Juliachs, Victor Moreno, Purificaci�on Mu~noz,Milica Stefanovic, Miguel A. Pujana, Enric Condom,Manel Esteller, Josep R. Germ�a, Gabriel Capella,Lourdes Farr�e, Albert Morales, Francesc Vi~nals,Xavier García-del-Muro, Juli�an Cer�on, andAlberto Villanueva

3767 Phenformin-Induced Mitochondrial DysfunctionSensitizes Hepatocellular Carcinoma for DualInhibition of mTORS�onia R. Veiga, Xuemei Ge, Carol A. Mercer,

María I. Hern�andez-�Alvarez, Hala Elnakat Thomas,Javier Hernandez-Losa, Santiago Ram�on y Cajal,Antonio Zorzano, George Thomas, and Sara C. Kozma

CORRECTIONS

3781 Correction: A Phase II Study of Gefitinibfor Aggressive Cutaneous Squamous CellCarcinoma of the Head and Neck

3782 Correction: PI3K Inhibition Reduces MammaryTumor Growth and Facilitates AntitumorImmunity and Anti-PD1 Responses

RETRACTION

3783 Retraction: Update on the Application ofInterleukin-2 in the Treatment of RenalCell Carcinoma

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ABOUT THE COVER

The cover shows a section of CT-2A murine glioma cells 6 days post orthotopicimplantation. Hematoxylin and eosin staining reveals a highly invasive tumor infiltratingthe brain parenchyma. For details, see the article by Gedeon and colleagues on page 3611 ofthis issue.

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2018;24:3475-3783. Clin Cancer Res     24 (15)

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