Prognostic factors in nonresectable pancreatic adenocarcinoma: A rationaleto design therapeutic trials

OBJECTIVE: Most patients with pancreatic cancer show an advanced tumor at t he time of diagnosis. In recent years, new therapies have been developed in such patients, thus forcing the analysis of factors that influence their s urvival. The present study was aimed at determining the prognostic factors in a series of 134 consecutive patients with pancreatic carcinoma not suita ble for surgical resection, due to either locally advanced tumors or metast atic spread. METHODS: First, 34 epidemiological, clinical, analytical, and tumor-related parameters recruited at admission were included in a univariate analysis o f survival by using the Kaplan-Meier method. Those significant variables in the previous step were thereafter introduced in a Cox regression procedure . A prognostic index for calculating the relative risk of death of each pat ient was also proposed. RESULTS: The median survival time in the whole series was 3.11 months, the 3, 6, and 12 months probability of survival being 51%, 28%, and 8%, respect ively. Eight of 34 variables (jaundice and toxic syndrome at admission, ser um cholesterol, iron and alanine aminotransferase concentrations, leukocyte count, baseline performance status, and the presence of distant metastases ) were selected in the univariate analysis. Of these eight parameters, the Cox regression analysis identified a preserved baseline performance status (OR 2.14, 95% CI = 1.49-3.04) and the absence of metastases (OR = 1.34, 95% CI = 1.03-1.73) as the only variables independently associated with a long er survival. Therefore, a prognostic index was constructed allowing the div ision of patients in three different groups according to their relative ris k of death (RRD) = exp (performance status x 0.7589 + presence of metastase s x 0.2891). CONCLUSIONS: The results of the present investigation suggest that baseline performance status and distant metastases should be considered in designin g and evaluating any therapeutic trial in patients with nonresectable pancr eatic carcinoma. (C) 1999 by Am. Cell. of Gastroenterology.