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Highlights of This Issue 2593 SPECIAL FEATURES CCR Translations 2595 Oncolytic Virotherapy Needs Trials, Not Access Programs Kevin J. Harrington See article, p. 2734 Molecular Pathways 2598 Molecular Pathways: Tumor-Derived Microvesicles and Their Interactions with Immune Cells In Vivo Ferdinando Pucci and Mikael J. Pittet CCR Focus 2606 PFS: The Endpoint We Love and Love to Hate Susan E. Bates 2607 Overview: Progression-Free Survival as an Endpoint in Clinical Trials with Solid Tumors Ronald L. Korn and John J. Crowley 2613 Missing Data and Measurement Variability in Assessing Progression- Free Survival Endpoint in Randomized Clinical Trials Rajeshwari Sridhara, Sumithra J. Mandrekar, and Lori E. Dodd 2621 The Imaging Viewpoint: How Imaging Affects Determination of Progression-Free Survival Daniel Carl Sullivan, Lawrence H. Schwartz, and Binsheng Zhao 2629 The Clinical Viewpoint: Definitions, Limitations of RECIST, Practical Considerations of Measurement Liza C. Villaruz and Mark A. Socinski 2637 Assessment of Audit Methodologies for Bias Evaluation of Tumor Progression in Oncology Clinical Trials Jenny J. Zhang, Lijun Zhang, Huanyu Chen, Anthony J. Murgo, Lori E. Dodd, Richard Pazdur, and Rajeshwari Sridhara 2646 Modeling the Relationship between Progression-Free Survival and Overall Survival: The Phase II/III Trial Mary W. Redman, Bryan H. Goldman, Michael LeBlanc, Anne Schott, and Laurence H. Baker HUMAN CANCER BIOLOGY 2657 Aberrant BAF57 Signaling Facilitates Prometastatic Phenotypes Sucharitha Balasubramaniam, Clay E.S. Comstock, Adam Ertel, Kwang Won Jeong, Michael R. Stallcup, Sankar Addya, Peter A. McCue, William F. Ostrander Jr, Michael A. Augello, and Karen E. Knudsen 2668 Relapsed Classic E-Cadherin (CDH1)Mutated Invasive Lobular Breast Cancer Shows a High Frequency of HER2 (ERBB2) Gene Mutations Jeffrey S. Ross, Kai Wang, Christine E. Sheehan, Ann B. Boguniewicz, Geoff Otto, Sean R. Downing, James Sun, Jie He, John A. Curran, Siraj Ali, Roman Yelensky, Doron Lipson, Gary Palmer, Vincent A. Miller, and Philip J. Stephens CANCER THERAPY: PRECLINICAL 2677 Potent Antimyeloma Activity of a Novel ERK5/CDK Inhibitor Stela Alvarez-Fern andez, Mar a Jesús Ortiz-Ruiz, Tracy Parrott, Sara Zaknoen, Enrique M. Ocio, Jesús San Miguel, Francis J. Burrows, Azucena Espar s-Ogando, and Atanasio Pandiella 2688 Concomitant BRAF and PI3K/mTOR Blockade Is Required for Effective Treatment of BRAF V600E Colorectal Cancer Erin M. Coffee, Anthony C. Faber, Jatin Roper, Mark J. Sinnamon, Gautam Goel, Lily Keung, Wei Vivian Wang, Loredana Vecchione, Veerle de Vriendt, Barbara J. Weinstein, Roderick T. Bronson, Sabine Tejpar, Ramnik J. Xavier, Jeffrey A. Engelman, Eric S. Martin, and Kenneth E. Hung Contents Clinical Cancer Research The Journal of Clinical and Translational Research May 15, 2013 Volume 19 Number 10 The Journal of Clinical and Translational Research iii www.aacrjournals.org on July 15, 2018. © 2013 American Association for Cancer Research. clincancerres.aacrjournals.org Downloaded from

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Highlights of This Issue 2593

SPECIAL FEATURES

CCR Translations

2595 Oncolytic Virotherapy Needs Trials,Not Access ProgramsKevin J. HarringtonSee article, p. 2734

Molecular Pathways

2598 Molecular Pathways: Tumor-DerivedMicrovesicles and Their Interactionswith Immune Cells In VivoFerdinando Pucci and Mikael J. Pittet

CCR Focus

2606 PFS: The Endpoint We Love and Loveto HateSusan E. Bates

2607 Overview: Progression-Free Survivalas an Endpoint in Clinical Trials withSolid TumorsRonald L. Korn and John J. Crowley

2613 Missing Data and MeasurementVariability in Assessing Progression-Free Survival Endpoint inRandomized Clinical TrialsRajeshwari Sridhara, Sumithra J. Mandrekar,and Lori E. Dodd

2621 The Imaging Viewpoint: HowImaging Affects Determination ofProgression-Free SurvivalDaniel Carl Sullivan, Lawrence H. Schwartz,and Binsheng Zhao

2629 The Clinical Viewpoint: Definitions,Limitations of RECIST, PracticalConsiderations of MeasurementLiza C. Villaruz and Mark A. Socinski

2637 Assessment of Audit Methodologiesfor Bias Evaluation of TumorProgression in Oncology ClinicalTrialsJenny J. Zhang, Lijun Zhang, Huanyu Chen,Anthony J. Murgo, Lori E. Dodd,Richard Pazdur, and Rajeshwari Sridhara

2646 Modeling the Relationship betweenProgression-Free Survival andOverall Survival: ThePhase II/III TrialMary W. Redman, Bryan H. Goldman,Michael LeBlanc, Anne Schott, andLaurence H. Baker

HUMAN CANCER BIOLOGY

2657 Aberrant BAF57 Signaling FacilitatesPrometastatic PhenotypesSucharitha Balasubramaniam,Clay E.S. Comstock, Adam Ertel,Kwang Won Jeong, Michael R. Stallcup,Sankar Addya, Peter A. McCue,William F. Ostrander Jr, Michael A. Augello,and Karen E. Knudsen

2668 Relapsed Classic E-Cadherin (CDH1)–Mutated Invasive Lobular BreastCancer Shows a High Frequency ofHER2 (ERBB2) Gene MutationsJeffrey S. Ross, KaiWang, Christine E. Sheehan,Ann B. Boguniewicz, Geoff Otto,Sean R. Downing, James Sun, Jie He,John A. Curran, Siraj Ali, Roman Yelensky,Doron Lipson, Gary Palmer, Vincent A. Miller,and Philip J. Stephens

CANCER THERAPY: PRECLINICAL

2677 Potent Antimyeloma Activity of aNovel ERK5/CDK InhibitorStela �Alvarez-Fern�andez,Mar��a Jesús Ortiz-Ruiz, Tracy Parrott,Sara Zaknoen, Enrique M. Ocio,Jesús San Miguel, Francis J. Burrows,Azucena Espar��s-Ogando, andAtanasio Pandiella

2688 Concomitant BRAF and PI3K/mTORBlockade Is Required for EffectiveTreatment of BRAFV600E ColorectalCancerErin M. Coffee, Anthony C. Faber, Jatin Roper,Mark J. Sinnamon, Gautam Goel, Lily Keung,Wei Vivian Wang, Loredana Vecchione,Veerle de Vriendt, Barbara J. Weinstein,Roderick T. Bronson, Sabine Tejpar,Ramnik J. Xavier, Jeffrey A. Engelman,Eric S. Martin, and Kenneth E. Hung

ContentsClinicalCancer

ResearchThe Journal of Clinical and Translational Research

May 15, 2013 � Volume 19 � Number 10

The Journal of Clinical and Translational Research iii www.aacrjournals.org

on July 15, 2018. © 2013 American Association for Cancer Research. clincancerres.aacrjournals.org Downloaded from

2699 Temozolomide-Mediated DNAMethylation in Human MyeloidPrecursor Cells: DifferentialInvolvement of Intrinsic andExtrinsic Apoptotic PathwaysHaiyan Wang, Shanbao Cai,Aaron Ernstberger, Barbara J. Bailey,Michael Z. Wang, Wenjing Cai,W. Scott Goebel, Magdalena B. Czader,Colin Crean, Attaya Suvannasankha,Inna Shokolenkoc, Glenn L. Wilson,Arthur R. Baluyut, Lindsey D. Mayo, andKaren E. Pollok

2710 Inhibition of Melanoma Growth bySmall Molecules That Promote theMitochondrial Localization of ATF2Tal Varsano, Eric Lau, Yongmei Feng,Marine Garrido, Loribelle Milan,Susanne Heynen-Genel, Christian A. Hassig,and Ze'ev A. Ronai

IMAGING, DIAGNOSIS, PROGNOSIS

2723 Identification of Prognosis-RelevantSubgroups in Patients withChemoresistant Triple-NegativeBreast CancerKe-Da Yu, Rui Zhu, Ming Zhan,Angel A. Rodriguez, Wei Yang, StephenWong,Andreas Makris, Brian D. Lehmann, Xi Chen,Ingrid Mayer, Jennifer A. Pietenpol,Zhi-Ming Shao, W. Fraser Symmans, andJenny C. Chang

CANCER THERAPY: CLINICAL

2734 Antiviral and Antitumor T-cellImmunity in Patients Treated withGM-CSF–Coding OncolyticAdenovirusAnna Kanerva, Petri Nokisalmi, Iulia Diaconu,Anniina Koski, Vincenzo Cerullo,Ilkka Liikanen, Siri T€ahtinen, Minna Oksanen,Raita Heiskanen, Saila Pesonen,Timo Joensuu, Tuomo Alanko,Kaarina Partanen, Leena Laasonen,Kalevi Kairemo, Sari Pesonen,Lotta Kangasniemi, and Akseli HemminkiSee commentary, p. 2595

2745 Sorafenib or Placebo with EitherGemcitabine or Capecitabine inPatients with HER-2–NegativeAdvanced Breast Cancer ThatProgressed during or afterBevacizumabLee S. Schwartzberg, Kurt W. Tauer,Robert C. Hermann, Grace Makari-Judson,Claudine Isaacs, J. Thaddeus Beck,Virginia Kaklamani, Edward J. Stepanski,Hope S. Rugo, Wei Wang,Katherine Bell-McGuinn, Jeffrey J. Kirshner,Peter Eisenberg, Richard Emanuelson,Mark Keaton, Ellis Levine, Diana C. Medgyesy,Rubina Qamar, Alexander Starr,Sunhee Kwon Ro, Nathalie A. Lokker, andClifford A. Hudis

2755 Neoadjuvant Chemotherapy with orwithout Zoledronic Acid in EarlyBreast Cancer—A RandomizedBiomarker Pilot StudyMatthew C. Winter, Caroline Wilson,Stuart P. Syddall, Simon S. Cross,Alyson Evans, Christine E. Ingram,Ingrid J. Jolley, Matthew Q. Hatton,Jennifer V. Freeman, Stefano Mori,Ingunn Holen, and Robert E. Coleman

2766 Phase I Study of the HedgehogPathway Inhibitor IPI-926 in AdultPatients with Solid TumorsAntonio Jimeno, Glen J. Weiss,Wilson H. Miller Jr, Scott Gettinger,Bernard J.C. Eigl, Anne Lynne S. Chang,Joi Dunbar, Shannon Devens, Kerrie Faia,Georgios Skliris, Jeff Kutok, Karl D. Lewis,Raoul Tibes, William H. Sharfman,Robert W. Ross, and Charles M. Rudin

PREDICTIVE BIOMARKERS ANDPERSONALIZED MEDICINE

2775 Molecular Profiling of AromataseInhibitor–Treated PostmenopausalBreast Tumors Identifies Immune-Related Correlates of ResistanceAnita K. Dunbier, Zara Ghazoui,Helen Anderson, Janine Salter,Ashutosh Nerurkar, Peter Osin, Roger A'hern,William R. Miller, Ian E. Smith, andMitch Dowsett

CORRECTION

2787 Correction: Chromosome 5q Loss inColorectal Flat Adenomas

iv Clinical Cancer Research

on July 15, 2018. © 2013 American Association for Cancer Research. clincancerres.aacrjournals.org Downloaded from

ABOUT THE COVER

This image is taken from a bone metastasis in a patient with stage IV relapsedinvasive CDH1 mutated lobular carcinoma of the breast. The tumor wasnegative for ERBB2 (HER2) amplification (FISH). The targeted next generationsequencing assay used in this study found an ERBB2-GRB7 putative gene fusionthat has not been previously reported. The fusion retains the kinase domain ofERBB2 (uniprot.org) which suggests that it could result in ERBB2 activation.The 17q12-21 amplicon which includes both ERBB2 and GRB7 is frequentlyamplified in breast cancer and preclinical studies suggest that it may be arecombination hotspot. An expression screening study has reported that GRB7can function as an ERBB2-dependent oncogene. GRB7 encodes an adaptorprotein that interacts with ERBB2 and has been shown in a preclinical study toenhance its transformative capacity and increase ERBB2 phosphorylationin fibroblasts. For details, see the article by Ross and colleagues on page 2668of this issue.

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