18599 Background: The aim of our study was to verify the feasibility of using the CGA as an effective instrumental tool for treatment assignment and verify its influence on clinical outcome in elderly cancer patients (pts). Methods: The study design was a prospective Phase II open study. Elderly (age ≥65 years) cancer pts were assigned to 3 different CGA categories (“Fit”, “Intermediate” and “Frail”): accordingly, 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” therapy. 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, quality of life. Patients who completed at least 3 months of treatment were evaluable. Results: At January 2006, 72 pts were enrolled (mean age 74.4 years, range 65–91, M/F 39/33), 35 of whom (34 stage IV) were evaluable: 5 were “fit”, 16 “intermediate” and 14 “frail”. At baseline no difference was found between the CGA categories in the clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). The objective clinical response to the assigned treatment was: 1 PR, 1 SD and 3 PD for “fit” pts; 1 PR, 9 SD and 6 PD for “intermediate” pts; 4 PR, 4 SD and 6 PD for “frail” pts. Comprehensively, the ORR was 17.1% and the median survival was 4.15 months; 25 out of 35 pts are alive. As for the correlation of CGA categories with treatment and clinical outcome, no difference was found in the clinical outcome variables after 3 months of treatment (ANOVA test). Our results are preliminary as the study is still in progress: the required accrual is at least 32 pts for each CGA category. Conclusions: The CGA assessment is strongly recommended as an essential component of the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. Work Supported by: MIUR, Rome, Italy: NRP No. 2004067078. No significant financial relationships to disclose.
