title: Assessment of the value of confirming responses in clinical trials in oncology.
abstract: The requirement for a second assessment to confirm initial tumour response is required by all response guidelines. Its rationale, however, is not clear. We have conducted this study to compare validity of response rate assessment determined with and without secondary confirmation. Using specified criteria, nine trials of one single cytotoxic drug including 416 patients were selected from a pharmaceutical database. Objective response rates were determined by a single determination and by two separate determinations. 81 responses (19.5%, [15.8-23.6%]) were scored by the confirmation method and 97 responses (23.3% [19.3-27.7%]) by the no-confirmation method. The Kappa (kappa) coefficient of 0.89 indicates good agreement between both methods. This is the first study that systematically compares response rates calculated with and without performing response confirmation. Results show good agreement between both methods. We suggest that assessing response without confirmation may be the preferred method. These results should be confirmed by additional studies in a variety of cancer settings.
authors: Medical Oncology Department, Clínica Universitaria de Navarra, Pamplona, Spain. jlgracia@unav.es
authors: Jose Luis
authors: JL
authors: Perez-Gracia
authors: Maria
authors: M
authors: Muñoz
authors: Grant
authors: G
authors: Williams
authors: Jun
authors: J
authors: Wu
authors: Eva
authors: E
authors: Carrasco
authors: Ignacio
authors: I
authors: Garcia-Ribas
authors: Ana
authors: A
authors: Peiro
authors: Jose Maria
authors: JM
authors: Lopez-Picazo
authors: Alfonso
authors: A
authors: Gurpide
authors: Ana
authors: A
authors: Chopitea
authors: Salvador
authors: S
authors: Martín-Algarra
authors: Jesus
authors: J
authors: García-Foncillas
authors: Johannes
authors: J
authors: Blatter
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic / Q000706:statistics & numerical data*; D018450:Disease Progression; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents