ABSTRACT
PURPOSE: To identify baseline prognostic factors for survival in patients with disease progression, during or after chemotherapy for the treatment of advanced gastric or gastroesophageal junction (GEJ) cancer. MATERIALS AND METHODS: We pooled data from patients randomized between 2009 and 2012 in 2 phase III, global double-blind studies of ramucirumab for the treatment of advanced gastric or GEJ adenocarcinoma following disease progression on first-line platinum- and/or fluoropyrimidine-containing therapy (REGARD and RAINBOW). Forty-one key baseline clinical and laboratory factors common in both studies were examined. Model building started with covariate screening using univariate Cox models (significance level=0.05). A stepwise multivariable Cox model identified the final prognostic factors (entry+exit significance level=0.01). Cox models were stratified by treatment and geographic region. The process was repeated to identify baseline prognostic quality of life (QoL) parameters. RESULTS: Of 1,020 randomized patients, 953 (93%) patients without any missing covariates were included in the analysis. We identified 12 independent prognostic factors of poor survival: 1) peritoneal metastases; 2) Eastern Cooperative Oncology Group (ECOG) performance score 1; 3) the presence of a primary tumor; 4) time to progression since prior therapy <6 months; 5) poor/unknown tumor differentiation; abnormally low blood levels of 6) albumin, 7) sodium, and/or 8) lymphocytes; and abnormally high blood levels of 9) neutrophils, 10) aspartate aminotransferase (AST), 11) alkaline phosphatase (ALP), and/or 12) lactate dehydrogenase (LDH). Factors were used to devise a 4-tier prognostic index (median overall survival [OS] by risk [months]: high=3.4, moderate=6.4, medium=9.9, and low=14.5; Harrell's C-index=0.66; 95% confidence interval [CI], 0.64–0.68). Addition of QoL to the model identified patient-reported appetite loss as an independent prognostic factor. CONCLUSIONS: The identified prognostic factors and the reported prognostic index may help clinical decision-making, patient stratification, and planning of future clinical studies.
Subject(s)
Humans , Adenocarcinoma , Alkaline Phosphatase , Appetite , Aspartate Aminotransferases , Clinical Decision-Making , Disease Progression , Double-Blind Method , Drug Therapy , Esophagogastric Junction , Factor Analysis, Statistical , L-Lactate Dehydrogenase , Lymphocytes , Mass Screening , Neoplasm Metastasis , Neutrophils , Prognosis , Proportional Hazards Models , Quality of Life , Sodium , Stomach NeoplasmsABSTRACT
This study explored the value of using medical students as standardized patients (SPs) during objective structured clinical examinations for the medical interview. Evaluations by both examiners and examinees revealed that the performance of medical students as SPs provided sufficient reality and reproducibility for the objective evaluation of interview skills. The experience also offered medical students playing SPs the opportunity to learn the importance to patients of eye contact and of a sympathetic and reliable attitude on the part of physicians toward their patients during the medical interview. In conclusion, training medical students to serve as SPs for evaluating interviewing skills in the context of an objective structured clinical examination is beneficial to both the person being evaluated and to the medical student serving as the SP.