Analysis of esophagogastric cancer patients enrolled in the National Cancer Institute Cancer Therapy Evaluation Program sponsored phase 1 trials.

Abstract

In phase 1 trials, an important entry criterion is life expectancy predicted to be more than 90days, which is generally difficult to predict. The Royal Marsden Hospital (RMH) prognostic score that is determined by lactate dehydrogenase level, albumin level, and number of metastatic sites of disease was developed to help project patient outcomes. There have been no systematic analyses to evaluate the utility of the RMH prognostic score for esophagogastric cancer patients. All nonpediatric phase 1 oncology trials sponsored by the National Cancer Institute Cancer Therapy Evaluation Program that began between 2001 and 2013 were considered in this review. Of 4722 patients with solid tumors, 115 patients were eligible for our analysis; 54 (47%) with cancer of the esophagus, 14 (12%) with cancer of the esopagogastric junction, and 47 (41%) with stomach cancer. Eighty-six patients (75%) had a good RMH prognostic score (0 or 1) and 29 patients (25%) had a poor RMH prognostic score (2 or 3). Disease control rates were significantly different between patients with good and poor RMH prognostic scores (49% vs 17%; two-sided Fisher's exact test P=0.004). The median treatment duration and overall survival for good and poor RMH prognostic score patients were significantly different (median treatment duration 2.1months vs 1.2months respectively, P=0.016; median overall survival 10.9months vs 2.1months respectively, P<0.001). In the multivariate analysis, age (60years or older), Eastern Cooperative Oncology Group performance status (2 or greater), and the RMH prognostic score (2 or 3) were significant predictors of poor survival. The RMH prognostic score is a strong tool to predict the prognosis of esophagogastric cancer patients who might participate in a phase 1 trial.