An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Results of a phase II open study

Abstract

19592 Background and Methods: The design was a prospective Phase II open study. Elderly (age =65 years) cancer patients (pts) of different sites were assigned to 3 different CGA categories: “fit”, “intermediate” and “frail”. Therefore, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo-) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive care”. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival. Patients who completed at least 3 months of treatment were evaluable. At December 2006, 136 pts were enrolled; 114 (mean age 73.6 years) 104 of whom stage IV were evaluable: 36 “fit”, 36 “intermediate” and 42 “frail”. At baseline no difference was found between the CGA categories as for clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). Results: At 3 months the objective clinical response to the assigned treatment was: 9 CR, 9 PR, 13 SD and 5 PD for “fit” pts; 9 PR, 14 SD and 13 PD for “intermediate” pts; 6 PR, 11 SD and 25 PD for “frail” pts. As for the correlation of CGA categories with treatment and clinical outcome: a significantly higher OR, particularly CR, in favor of fit pts was observed, ECOG PS was maintained significantly higher in frail pts, toxicity was the highest in intermediate pts, the dose intensity was highest in fit pts. At the multivariate regression analisys the independent predictive factors for the clinical response were initial CGA and dose intensity. Conclusions: The study confirms: 1) Fit pts should be treated with the most active regimens not differently from adult pts; 2) the “intermediate” group should be probably better assessed as for inclusion criteria; 3) frail pts need a more exhaustive assessment of the quality of life currently not included in the CGA. In conclusion, the CGA assessment is strongly recommended as an essential tool for the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. No significant financial relationships to disclose.