Strategies to design clinical studies to identify predictive biomarkers in cancer research
Por:
Perez-Gracia, JL, Sanmamed, MF, Bosch, A, Patino-Garcia, A, Schalper, KA, Segura, V, Bellmunt, J, Tabernero, J, Sweeney, CJ, Choueiri, TK, Martin, M, Fusco, JP, Rodriguez-Ruiz, ME, Calvo, A, Prior, C, Paz-Ares, L, Pio, R, Gonzalez-Billalabeitia, E, Hernandez, AG, Paez, D, Piulats, JM, Gurpide, A, Andueza, M, de Velasco, G, Pazo, R, Grande, E, Nicolas, P, Abad-Santos, F, Garcia-Donas, J, Castellano, D, Pajares, MJ, Suarez, C, Colomer, R, Montuenga, LM, Melero, I
Publicada:
1 feb 2017
Resumen:
The discovery of reliable biomarkers to predict efficacy and toxicity of anticancer drugs remains one of the key challenges in cancer research. Despite its relevance, no efficient study designs to identify promising candidate biomarkers have been established. This has led to the proliferation of a myriad of exploratory studies using dissimilar strategies, most of which fail to identify any promising targets and are seldom validated. The lack of a proper methodology also determines that many anti-cancer drugs are developed below their potential, due to failure to identify predictive biomarkers. While some drugs will be systematically administered to many patients who will not benefit from them, leading to unnecessary toxicities and costs, others will never reach registration due to our inability to identify the specific patient population in which they are active. Despite these drawbacks, a limited number of outstanding predictive biomarkers have been successfully identified and validated, and have changed the standard practice of oncology. In this manuscript, a multidisciplinary panel reviews how those key biomarkers were identified and, based on those experiences, proposes a methodological framework the DESIGN guidelines-to-standardize the clinical design of biomarker identification studies and to develop future research in this pivotal field. (C) 2017 The Authors. Published by Elsevier Ltd.
Filiaciones:
Perez-Gracia, JL:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Sanmamed, MF:
Yale Univ, Sch Med, Dept Immunobiol, New Haven, CT USA
Bosch, A:
Lund Univ, Dept Clin Sci, Div Oncol & Pathol, S-22100 Lund, Sweden
Patino-Garcia, A:
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra Clin, Dept Pediat, Pamplona, Spain
Univ Navarra Clin, CIMA LAB Diagnost, Pamplona, Spain
Schalper, KA:
Yale Sch Med, Dept Pathol, New Haven, CT USA
Segura, V:
Univ Navarra, IDISNA, Navarra, Spain
Univ Navarra, Bioinformat Unit, Ctr Appl Med Res CIMA, Navarra, Spain
Bellmunt, J:
Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA
Harvard Med Sch, Boston, MA USA
Tabernero, J:
Univ Autonoma Barcelona, Dept Med Oncol, Vall dHebron Univ Hosp, Barcelona, Spain
Univ Autonoma Barcelona, Inst Oncol VHIO, Barcelona, Spain
Sweeney, CJ:
Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA
Harvard Med Sch, Boston, MA USA
Choueiri, TK:
Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA
Harvard Med Sch, Boston, MA USA
Martin, M:
Univ Complutense, Inst Invest Sanitaria Gregorio Maranon, Madrid, Spain
Fusco, JP:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
Rodriguez-Ruiz, ME:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, Ctr Appl Med Res CIMA, Pamplona, Spain
Calvo, A:
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, Sch Med, Dept Histol & Pathol, Pamplona, Spain
Prior, C:
Univ Navarra, Dept Gene Therapy & Regulat Gene Express, Ctr Appl Med Res CIMA, Pamplona, Spain
Paz-Ares, L:
Hosp Univ 12 Octubre, Dept Med Oncol, Madrid, Spain
Pio, R:
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, CIMA, Program Solid Tumors & Biomarkers, E-31080 Pamplona, Spain
Gonzalez-Billalabeitia, E:
Univ Catolica San Antonio de Murcia, Hosp Univ Morales Meseguer, Dept Hematol & Med Oncol, Murcia, Spain
Hernandez, AG:
Univ Navarra Clin, Dept Biochem, Pamplona, Spain
Paez, D:
Hosp Santa Creu & Sant Pau, Dept Med Oncol, Barcelona, Spain
Piulats, JM:
Inst Catala Oncol, Dept Med Oncol, Barcelona, Spain
Gurpide, A:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Andueza, M:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
de Velasco, G:
Dana Farber Canc Inst, Dept Med Oncol, Boston, MA 02115 USA
Harvard Med Sch, Boston, MA USA
Pazo, R:
Hosp Univ Miguel Server, Dept Med Oncol, Zaragoza, Spain
Grande, E:
Hosp Univ Ramon Y Cajal, Dept Med Oncol, Madrid, Spain
Nicolas, P:
Univ Basque Country, Chair Law & Human Genome, Bizkaia, Spain
Abad-Santos, F:
Univ Autonoma Madrid, Inst Invest Sanitaria Princesa IP, Clin Pharmacol Serv, Hosp Univ Princesa,Inst Teofilo Hernando, Madrid, Spain
Garcia-Donas, J:
HM Hosp Ctr Integral Oncol HM Clara Campal, Dept Med Oncol, Madrid, Spain
Castellano, D:
Hosp Univ 12 Octubre, Dept Med Oncol, Madrid, Spain
Pajares, MJ:
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, Sch Med, Dept Histol & Pathol, Pamplona, Spain
Univ Navarra, CIMA, Program Solid Tumors & Biomarkers, E-31080 Pamplona, Spain
Suarez, C:
Univ Autonoma Barcelona, Dept Med Oncol, Vall dHebron Univ Hosp, Barcelona, Spain
Univ Autonoma Barcelona, Inst Oncol VHIO, Barcelona, Spain
Colomer, R:
Hosp Univ Princesa, Dept Oncol, Madrid, Spain
Montuenga, LM:
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, Sch Med, Dept Histol & Pathol, Pamplona, Spain
Univ Navarra, CIMA, Program Solid Tumors & Biomarkers, E-31080 Pamplona, Spain
Melero, I:
Univ Navarra Clin, Dept Oncol, Avda Pio 12,36, Pamplona 31008, Spain
Hlth Res Inst Navarra IDISNA, Pamplona, Spain
Univ Navarra, Ctr Appl Med Res CIMA, Pamplona, Spain
Green Published, Hybrid Gold
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