Clinical validation of a prognostic tool in a population of outpatients treated for incurable cancer undergoing anti-cancer therapy : PRONOPALL study
Menée en France auprès de 262 patients traités en ambulatoire pour un cancer en phase terminale (âge médian : 66 ans ; 59% de femmes), cette étude évalue la performance d'un système de score, basé sur 4 facteurs (statut de performance ECOG, nombre de sites métastatiques, niveaux sériques de lactate déshydrogénase et de sérum albumine), pour prédire la survie à deux mois et orienter la décision thérapeutique
Background : In 2008, a study of the characteristics of hospitalised patients led to the development of a prognostic tool that distinguished three populations with significantly different two-month survival rates. The goal of our study aimed at validating prospectively this prognostic tool in outpatients treated for cancer in terminal stage, based on four factors: performance status (ECOG), number of metastatic sites, serum albumin and lactate dehydrogenase.
Patients and Methods : PRONOPALL is a multicentre study of current care. 302 adult patients who met one or more of the following criteria: life expectancy under six months, performance status ≥ 2, disease progression during the previous chemotherapy regimen, were included across 16 institutions between October 2009 and October 2010. Afterwards, in order to validate the prognostic tool, the score was ciphered and correlated to patient survival.
Results : 262 patients (87%) were evaluable (27 patients excluded and 13 unknown score). Median age was 66 years [37-88], and women accounted for 59%. PS 0-1 (46%), PS 2 (37%), PS 3-4 (17%). The primary tumours were: breast (29%), colorectal (28%), lung (13%), pancreas (12%), ovary (11%), other (8%). 32% of patients presented one metastatic site, 35% had two, and 31% had more than two. The median LDH level was 398 IU/L [118-4314]; median serum albumin was 35 g/L [13-54]. According to the PRONOPALL prognostic tool, the two-month survival rate was 92% and the median survival rate was 301 days [209-348] for the 130 patients in population C, 66% and 79 days [71-114] for the 111 patients in population B, and 24% and 35 days for [14-56] the 21 patients in population A. These three populations survival were statistically different (p <0.0001).
Conclusion : PRONOPALL study confirms the three prognostic profiles defined by the combination of four factors. This PRONOPALL score is a useful decision-making tool in daily practice.
Annals of Oncology , résumé, 2016