Portal de Periódicos da CAPES

Strategies to design clinical studies to identify predictive biomarkers in cancer research

2016; Elsevier BV; Volume: 53; Linguagem: Inglês

10.1016/j.ctrv.2016.12.005

1532-1967

Jose Luis Pérez‐Gracia, Miguel F. Sanmamed, Ana Bosch, Ana Patiño‐García, Kurt A. Schalper, Víctor Segura, Joaquim Bellmunt, Josep Tabernero, Christopher J. Sweeney, Toni K. Choueiri, Miguel Martín, Juan P. Fusco, María E. Rodríguez-Ruiz, Alfonso Calvo, Celia Prior, Luis Paz‐Ares, Rubén Pı́o, Enrique González‐Billalabeitia, Álvaro González Hernández, David Páez, Josep M. Piulats, Alfonso Gúrpide, Mapi Andueza, Guillermo de Velasco, Roberto Pazo, Enrique Grande, Pilar Nicolás, Francisco Abad‐Santos, Jesús García-Donás, Daniel Castellano, María J. Pajares, Cristina Suárez, Rámón Colomer, Luis M. Montuenga, Ignacio Melero,

Colorectal Cancer Treatments and Studies

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.