Accepted Manuscript Hot Topic The Landscape of Precision Cancer Medicine Clinical Trials in the United States Nitin Roper, Kristian D. Stensland, Ryan Hendricks, Matthew D. Galsky PII: DOI: Reference:
S0305-7372(15)00043-2 http://dx.doi.org/10.1016/j.ctrv.2015.02.009 YCTRV 1378
To appear in:
Cancer Treatment Reviews Cancer Treatment Reviews
Received Date: Revised Date: Accepted Date:
26 November 2014 19 February 2015 20 February 2015
Please cite this article as: Roper, N., Stensland, K.D., Hendricks, R., Galsky, M.D., The Landscape of Precision Cancer Medicine Clinical Trials in the United States, Cancer Treatment Reviews Cancer Treatment Reviews (2015), doi: http://dx.doi.org/10.1016/j.ctrv.2015.02.009
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Precision Cancer Medicine Clinical Trials The Landscape of Precision Cancer Medicine Clinical Trials in the United States
Nitin Roper MD1, Kristian D. Stensland MD2,3, Ryan Hendricks2, Matthew D. Galsky MD2 1
Weill Cornell Medical College, New York, NY 2Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, 3 Departments of Surgery and Urology, Lahey Clinic, Burlington, MA
Address correspondence to: Matthew D. Galsky, MD Icahn School of Medicine at Mount Sinai 1 Gustave L Levy Place New York, NY 10801 [email protected] Word Count: 2110 Number of tables: 2 Number of figures: 3 Number of supplementary tables: 3 Number of appendices: 1 Abstract word count: 247
This work was presented, in part, at the American Society of Clinical Oncology (ASCO) 2014 meeting.
Precision Cancer Medicine Clinical Trials Abstract PURPOSE: Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective ―precision cancer medicine‖ clinical trials in the U.S. METHODS: We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as ―precision cancer medicine‖ if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. RESULTS: Of the initial 18,797 trials identified, 9,094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), p
S0305-7372(15)00043-2 http://dx.doi.org/10.1016/j.ctrv.2015.02.009 YCTRV 1378
To appear in:
Cancer Treatment Reviews Cancer Treatment Reviews
Received Date: Revised Date: Accepted Date:
26 November 2014 19 February 2015 20 February 2015
Please cite this article as: Roper, N., Stensland, K.D., Hendricks, R., Galsky, M.D., The Landscape of Precision Cancer Medicine Clinical Trials in the United States, Cancer Treatment Reviews Cancer Treatment Reviews (2015), doi: http://dx.doi.org/10.1016/j.ctrv.2015.02.009
This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Precision Cancer Medicine Clinical Trials The Landscape of Precision Cancer Medicine Clinical Trials in the United States
Nitin Roper MD1, Kristian D. Stensland MD2,3, Ryan Hendricks2, Matthew D. Galsky MD2 1
Weill Cornell Medical College, New York, NY 2Department of Medicine, Division of Hematology/Oncology, Tisch Cancer Institute, New York, NY, 3 Departments of Surgery and Urology, Lahey Clinic, Burlington, MA
Address correspondence to: Matthew D. Galsky, MD Icahn School of Medicine at Mount Sinai 1 Gustave L Levy Place New York, NY 10801 [email protected] Word Count: 2110 Number of tables: 2 Number of figures: 3 Number of supplementary tables: 3 Number of appendices: 1 Abstract word count: 247
This work was presented, in part, at the American Society of Clinical Oncology (ASCO) 2014 meeting.
Precision Cancer Medicine Clinical Trials Abstract PURPOSE: Advances in tumor biology and multiplex genomic analysis have ushered in the era of precision cancer medicine. Little is currently known, however, about the landscape of prospective ―precision cancer medicine‖ clinical trials in the U.S. METHODS: We identified all adult interventional cancer trials registered on ClinicalTrials.gov between September 2005 and May 2013. Trials were classified as ―precision cancer medicine‖ if a genomic alteration in a predefined set of 88 genes was required for enrollment. Baseline characteristics were ascertained for each trial. RESULTS: Of the initial 18,797 trials identified, 9,094 (48%) were eligible for inclusion: 684 (8%) were classified as precision cancer medicine trials and 8410 (92%) were non-precision cancer medicine trials. Compared with non-precision cancer medicine trials, precision cancer medicine trials were significantly more likely to be phase II [RR 1.19 (1.10-1.29), p
