Download Supplemental Figure 1 - Clinical Cancer Research

Forero et al
January 10, 2015
TBCRC 019: A phase II trial of nab-PAC with or without the anti-death receptor 5
monoclonal antibody tigatuzumab in patients with triple negative breast cancer
Authors: Andres Forero-Torres1*, Katherine E. Varley2, Vandana Gupta Abramson3,
Yufeng Li1, Christos Vaklavas1, Nancy U. Lin4, Minetta C. Liu5, Hope S. Rugo6, Rita
Nanda7, Anna Maria Storniolo8, Tiffany A. Traina9, Sujata Patil9, Catherine H. Van
Poznak10, Julie R. Nangia11, William Johnson Irvin Jr.12, Helen Krontiras1, Jennifer F. De
Los Santos1, Paul Haluska13, William Grizzle1, Richard M. Meyers2, Antonio C. Wolff14,
on behalf of the Translational Breast Cancer Research Consortium (TBCRC)
Authors Affiliations:
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1
University of Alabama at Birmingham, Birmingham, AL;
HudsonAlpha Institute for Biotechnology, Huntsville, AL; 3Vanderbilt-Ingram Cancer
Center, Nashville, TN; 4Dana-Farber Cancer Institute, Boston, MA; 5Georgetown
University Hospital, Washington, DC; 6University of California, San Francisco Helen
Diller Family Comprehensive Cancer Center, San Francisco, CA; 7The University of
Chicago, Chicago, IL; 8Indiana University Melvin and Bren Simon Cancer Center,
Indianapolis, IN; 9Memorial Sloan-Kettering Cancer Center, New York, NY; 10University
of Michigan, Ann Arbor, MI; 11Baylor College of Medicine, Houston, TX;
North Carolina, Chapel Hill, NC;
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13
12
University of
Mayo Clinic College of Medicine, Rochester, MN;
Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore, MD.
* To whom Correspondence should be sent:
Andres Forero-Torres, M.D.
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Forero et al
January 10, 2015
University of Alabama at Birmingham
Comprehensive Cancer Center
NP2510; 1530 3rd Avenue South
Birmingham, AL 35294
Phone #: 205-9347167; FAX #: 205-9969995
[email protected]
Conflict of interest: A.F.T. received research support from Daiichi Sankyo and Celgene
to conduct clinical and laboratory research (paid to the University of Alabama at
Birmingham). The following authors have the following conflict of interest to disclose:
M.C.L. and T.A.T. have received research support from Celgene. The remaining authors
have no conflict of interest to disclose.
Presentation / Publications: Data from this work have been partially reported at the
ASCO Annual Meeting in 2011 and 2013 (Abstract # TPS 128 and 1052 respectively).
Running Head: Phase 2 trial of Tigatuzumab/nab-PAC in Patients with TNBC
Keywords: Tigatuzumab, nab-PAC, Monoclonal, Antibody, Triple negative, Breast
Cancer
Financial Support: This study was supported by the Susan G Komen for the Cure
Promise Grant (KG090969), the University of Alabama at Birmingham Breast Cancer
Specialized Program of Research Excellence Award # NCI P50CA089019 from the
National Cancer Institute, Daiichi Sankyo and Celgene. The Translational Breast Cancer
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January 10, 2015
Research Consortium is supported by the Breast Cancer Research Foundation, the Avon
Foundation, and Susan G. Komen for the Cure.
Title: 159 characters. Statement: 150 words. Abstract: 250 words. Text: 4056 words.
References: 41. Tables: 4. Figures: 2.
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January 10, 2015
Supplementary Data (for publication only)
1. Definition of Drug related Toxicities for the Interim Safety Cohort: Drug related
toxicities in the first 6 patients enrolled in the TIG/nab-PAC arm of the study were
defined as: a) any grade 3 or 4 non-hematologic toxicity (except anorexia, alopecia,
nausea, fatigue, fever without neutropenia); b) failure to recover to baseline (except
alopecia) after delaying the next dose by more than 2 weeks; c) grade 3 or 4 neutropenia
complicated by fever > 38.5 oC or infection, or grade 4 neutropenia of a least 7 days
duration; or d) grade 4 thrombocytopenia, or grade 3 thrombocytopenia complicated by
hemorrhage. Enrollment in the arm was scheduled to stop if more than 3 of the first 6
patients experienced drug related toxicities.
2. Definition of Adequate Organ and Bone Marrow Function for Eligibility:
Adequate organ and bone marrow function was defined in the protocol as hemoglobin >
9.0 g/dL; absolute neutrophil count > 1.5 X 109/L; a platelet count > 100 X 109/L; serum
creatinine < 2 mg/dL; aspartate aminotransferase (AST), alanine aminotransferase (ALT),
and alkaline phosphatase (AP) < 2.5 times the upper limit of normal (ULN) in subjects
with no liver metastasis and < 5 times the ULN in subjects with liver metastasis, and total
bilirubin < 1.5 times the ULN.
3. Supplemental Figure 1: Graphs depicting the seven genes whose expression in
patient tumors were significantly associated with response to therapy (FDR<0.05). For
each of the seven genes the log2 (relative expression) is plotted on the y-axis, and the
patients’ responses to therapy are plotted on the x-axis.
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Supplemental Figure 1
Seven genes whose expression in patient tumors were
significantly associated with response to therapy (FDR<0.05)
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