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

Abstract

Background In phase 1 trials, an important entry criterion is life expectancy predicted to be more than 90 days, 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. Methods 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.Results 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 2.1 months vs 1.2 months respectively, P = 0.016; median overall survival 10.9 months vs 2.1 months respectively, P \ 0.001). In the multivariate analysis, age (60 years 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. Conclusions The RMH prognostic score is a strong tool to predict the prognosis of esophagogastric cancer patients who might participate in a phase 1 trial.

Clinical outcome and prognostic factors for Asian patients in Phase I clinical trials

“…This study also showed results consistent with that of previous studies validating the RMH score [ 7 – 10 , 18 ]. As in other studies which have demonstrated the utility of this score in various types of cancers [ 7 , 8 , 18 ], it showed the prognostic score is effective when applied to a population of varied tumour types, and demonstrates broad applications for clinical trials involving all cancers. The RMH model (Model 1) also significantly predicted the 90-day mortality rate.…”

Blood-based Markers in the Prognostic Prediction of Esophagogastric Junction Cancer

“…Nevertheless, Zhou et al conducted a retrospective study on EJA patients who underwent radical surgery to find that it was the higher preoperative lymphocyte-monocyte ratio (LMR), not NLR or PLR, that independently predicts poor OS [35]. There were a few studies focusing on the association between absolute neutrophil (NE), lymphocyte (LY) or platelet (PLT) counts and EJC prognosis [26,34,[36][37][38]. However, only Fuchs et al found that abnormally low blood levels of LY (HR = 1.31, 95% CI: 1.05 -1.63, p = 0.0015) and high levels of NE (HR = 1.52, 95% CI: 1.17 -1.99, p < 0.0001) were both candidates for predicting risk of EJC patients who underwent 4-month, first-line chemotherapy (platinum and/or fluoropyrimidine with or without an anthracycline) [37].…”