Study concept and design: Hodi, Lee, Kirkwood.
Acquisition, analysis, or interpretation of data: Hodi, Lee, McDermott, Rao, Butterfield, Tarhini, Leming, Puzanov, Shin.
Drafting of the manuscript: Hodi, Lee, Puzanov, Shin.
Critical revision of the manuscript for important intellectual content: Hodi, Lee, McDermott, Rao, Butterfield, Tarhini, Leming, Puzanov, Shin, Kirkwood.
Statistical analysis: Lee, Shin.
Administrative, technical, or material support: Hodi, McDermott, Butterfield, Tarhini, Leming, Kirkwood.
Study supervision: Hodi, Lee, Puzanov.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Hodi reports receipt of support from the Cancer Therapy Evaluation Program/National Cancer Institute (CTEP/NCI) and the Eastern Cooperative Oncology Group (ECOG) during the conduct of the study; nonfinancial support from Bristol-Myers Squibb and Sanofi/Genzyme outside the submitted work; and personal fees from Sanofi. In addition, Dr Hodi reports having a patent of unrelated work licensed to Bristol-Myers Squibb as per institutional policy, a patent 20140004112 therapeutic peptides issued, and a patent 7250291 tumor antigens and uses thereof issued. Dr Lee reports receipt of support from the National Institutes of Health (NIH; NCI). Dr McDermott reports receipt of personal fees from Bristol-Myers Squibb, Pfizer, Genentech, and Merck. Dr Butterfield reports receipt of support from ECOG. Dr Tarhini reports receipt of personal fees and grant support from Bristol-Myers Squibb, Genentech, and Merck; and grant support from Prometheus and Novarti. Dr Kirkwood reports receipt of personal fees from Bristol-Myers Squibb, Merck, Glaxo-Smith-Kline, Celgene, and Vical outside the submited work. Drs Rao, Leming, Puzanov, and Mr Shin report no disclosures.
Funding/Support: This study was coordinated by ECOG (Robert L. Comis, MD, Chair); supported in part by Public Health Service grants CA23318, CA66636, CA21115, CA80775, CA39229, CA49957, CA32291; and the NCI; NIH; the US Department of Health and Human Services; Bristol-Myers Squibb; and Genzyme.
Role of the Funders/Sponsors: The NCI participated in the design and conduct of the study, but not in the data collection, management, analysis and interpretation of the data, or in the preparation, and approval of the manuscript or decision to submit the manuscript for publication. Bristol-Myers Squibb and Genzyme had no role in the design and conduct of the trial, in the collection, management, analysis, and interpretation of the data, or in the preparation and approval of the manuscript, or decision to submit the manuscript for publication. The NCI, Bristol-Myers Squibb, and Genzyme participated in the review of the manuscript.
Disclaimer: The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NCI.
Additional Contributions: In addition to the authors, the following investigators participated in this study by contributing participants, but received no compensation: Sanjiv S. Agarwala, MD, St Luke's University Hospital-Bethlehem; Mark R. Albertini, MD, University of Wisconsin; Mitchell B. Alden, DO, Doylestown Hospital; Thomas T. Amatruda, MD, Unity Hospital; Daniel M. Anderson, MD, Regions Hospital; Jade G. Anderson, MD, Unity Hospital; Michael B. Atkins, MD, Beth Israel Deaconess Medical Center; Miklos L. Auber, MD, West Virginia University; Myron E. Bednar, MD, Hunterdon Medical Center; Michael K. Bergen, MD, Exempla Lutheran Medical Center; Kenneth B. Blankstein, MD, Hunterdon Medical Center; Sigurdur Bodvarsson, MD, Gundersen Lutheran Health System; Ernest C. Borden, MD, Cleveland Clinic Foundation; Warren S. Brenner, MD, Boca Raton Regional Hospital; Gary I. Cohen, MD, Greater Baltimore Medical Center; Justin D. Cohen, MD, Charleston Area Medical Center; Suzanne M. Cole, MD, Charleston Area Medical Center; Robert M. Conry, MD, University of Alabama at Birmingham; Edward D. Crum, MD, MetroHealth Medical Center; Shaker R. Dakhil, MD, Cancer Center of Kansas-Wichita; Morris S. Dees, MD, Orange Park Cancer Center; William T. Derosa, MD, Morristown Memorial Hospital; Lorraine S. Dougherty, MD, Doylestown Hospital; Luke P. Dreisbach, MD, Eisenhower Medical Center; Philip A. Dy, MD, Decatur Memorial Hospital; Mohammad H. Fekrazad, MD, University of New Mexico Cancer Center; Michael S. Frontiera, MD, Dean Hematology and Oncology Clinic; Vijaya K. Gadiyaram, MD, Nevada Cancer Institute; Teresa Gagliano-DeCesare, MD, Boca Raton Regional Hospital; Francois J. Geoffroy, MD, Illinois CancerCare-Peoria; Henry Gerad, MD, St Rita's Medical Center; Oscar B. Goodman, MD, Nevada Cancer Institute; Ni Gorsuch, MD, Charleston Area Medical Center; Stephen A. Grabelsky, MD, Boca Raton Regional Hospital; Sara J. Grethlein, MD, Mary Imogene Bassett Hospital; William W. Grosh, MD, University of Virginia; Randolph Hurley, MD, Regions Hospital; Nageatte Ibrahim, MD, Dana-Farber Cancer Institute; Clark S. Jean, MD, Nevada Cancer Research Foundation; Steven J. Jubelirer, MD, Charleston Area Medical Center; Howard L. Kaufman, MD, Rush University Medical Center; Ahmed A. Khalid, MD, Charleston Area Medical Center; Joseph M. Koenig, MD, Akron City Hospital; Henry B. Koon, MD, Case Western Reserve University; Andrzej P. Kudelka, MD, Stony Brook University Medical; John W. Kugler, MD, Illinois CancerCare-Peoria; Pankaj Kumar, MD, Illinois Oncology Research Associates; Timothy M. Kuzel, MD, Northwestern University; Brenda R. Larson, MD, Park Nicollet Health Services; Noel Laudi, MD, Mercy Hospital; Amy Law, MD, Eisenhower Medical Center; Donald P. Lawrence, MD, Massachusetts General Hospital; David H. Lawson, MD, Emory University; James M. Leonardo, MD, PhD, Mary Imogene Bassett Hospital; Marcia K. Liepman, MD, West Michigan Cancer Center; Theodore F. Logan, MD, Indiana University Hospital; Sameer A. Mahesh, MD, Akron City Hospital; Bassam I. Mattar, MD, Cancer Center of Kansas-Wichita; Amanda D. May, MD, Georgia Regents University; Janice M. Mehnert, MD, Rutgers Cancer Institute of New Jersey; Avanti Mehrotra, MD, North Memorial Medical Center; Sanjiv S. Modi, MD, Joliet Hematology/Oncology Associates; Manish A. Monga, MD, Wheeling Hospital; Dennis F. Moore, MD, Cancer Center of Kansas-Wichita; Stergios J. Moschos, MD, University of Pittsburgh Cancer Institute; Sujana Movva, MD, Emory University; Timothy J. Murphy, MD, Penrose-St Francis HealthCare; Suresh G. Nair, MD, Lehigh Valley Hospital; Sujatha Nallapareddy, MD, Medical Center of Aurora; Ubaid Nawaz, MD, Aurora BayCare Medical Center; James A. Neidhart, MD, San Juan Oncology Associates; Erin V. Newton, MD, Indiana University Hospital; Grzegorz S. Obara, MD, Nevada Cancer Research Foundation; Adedayo Onitilo, MD, Marshfield Clinic; Nutan K. Parikh, MD, Nevada Cancer Research Foundation; Anna C. Pavlick, MD, New York University Langone Medical Center; Andrew L. Pecora, MD, Hackensack Medical Center; Christopher G. Peterson, MD, Langlade Hospital and Cancer Center; Harlan A. Pinto, MD, VA Medical Center-Palo Alto; Maria Emelina B. Quisumbing, MD, Nevada Cancer Research Foundation; Pavan S. Reddy, MD, Cancer Center of Kansas-El Dorado; Sunil A. Reddy, MD, Stanford University; Adam I. Riker, MD, Ochsner Clinic; Wolfram E. Samlowski, MD, Nevada Cancer Research Foundation; James D. Sanchez, MD, Nevada Cancer Research Foundation; Amit Sanyal, MD, Dean Hematology and Oncology Clinic; Larry L. Schlabach, MD, Erlanger Medical Center; William H. Sharfman, MD, Johns Hopkins University; Jeffrey A. Sosman, MD, Vanderbilt University; Jonathan R. Sporn, MD, St Francis Hospital and Medical Center; Ronald L. Stephens, MD, Cancer Center of Kansas-Lawrence Memorial Hospital; Mario Sznol, MD, Yale University; Hussein A. Tawbi, MD, University of Pittsburgh Cancer Institute; Ralph D. Trochelman, MD, Akron City Hospital; Henry T. Tsai, MD, Eisenhower Medical Center; Dean G. Tsarwhas, MD, North Shore Oncology Hematology; Brian Vicuna, MD, Nevada Cancer Research Foundation; Geoffrey R. Weiss, MD, University of Virginia; Charles H. Weissman, MD, New York Oncology Hematology; Donald B. Wender, MD, Siouxland Hematology Oncology Associates; Eric D. Whitman, MD, Morristown Memorial Hospital; Diana S. Willadsen, MD, Memorial Medical Center; Michael J. Williamson, DO, IU Health Ball Memorial Hospital; Jerome D. Winegarden, MD, St Joseph Mercy Hospital - Ann Arbor; Jerry M. Winkler, MD, St Vincent Hospital Region Cancer Center; Andrew W. Yetter, MD, Vince Lombardi Cancer Clinic.