Incorporation of a comprehensive geriatric assessment (CGA) into a randomized phase III trial for metastatic breast cancer (MBC): The PELICAN study.

Abstract

1070 Background: PELICAN is a randomized phase III trial evaluating efficacy and safety of pegylated liposomal doxorubicin (PLD) vs. capecitabine (CAP) as first-line therapy in patients (pts) with MBC. CGA results and correlation to time to progression (TTP), overall survival (OS), and time to treatment failure (TTF) were evaluated. Methods: CGA comprised data on activities of daily living (ADL), instrumental sctivities of daily living (IADL), Karnofsky performance status (KPS), comorbidity (CIRS-G), and the number of comedications. According to CGA, pts were classified into 3 groups. Single and combined CGA items were analyzed for association with treatment burden and efficacy outcome (TTP, OS, TTF) using Fisher's exact test, Wilcoxon test, and logistic regression. Results: Data from 210 pts (105 PLD, 105 CAP) with a median age of 62 y (22-85) were analyzed. 123 pts (59%) were <65 y and 87 pts (41%) ≥65 y. CGA scores were available from 152 pts. According to CGA, 113 pts were considered fit (group 1, 74%), 15 compromised (group 2, 10%), and 24 frail (group 3, 16%). Pts with a good KPS (≥ 90%) (n=46) had a significantly longer TTP vs. pts with a worse KPS (n=44) (median KPS 100%: 8.7 mo; 90%: 8.6 mo; ≤ 90%: 3.8 mo; p=0.0027). CGA, ADL, and IADL scores, and CIRS-G did not have a significant impact on TTP. In terms of OS, a high KPS (≥ 90%) significantly increased OS (median 100%: 27.5 mo; 90%: 32.1; <90%: 18.4 mo; p=0.0034). IADL score 8 and CIRS-G 0-3 also correlated with longer OS vs. IADL score <8 (24.1 vs. 17.8 mo, p=0.0061) and CIRS-G >3 (median 0-1: 30.0 mo; 2-3: 32.1 mo; >3: 17.8 mo; p<0.0001). A high KPS increased TTF significantly (median 100%: 5.8.mo; 90%: 4.6 mo, ≤ 90%: 3.0 mo; p=0.0076). Pts with IADL score <8 had a longer TTP (13.7 vs 2.6 mo, p=0.0272), OS (22.7 vs. 4.0 mo, p=0.0031) and TTF (4.6 vs. 2.5 mo, p=0.0043) in the PLD vs. CAP arm. Conclusions: KPS was the most striking predictive factor in this analysis with respect to correlation to TTF and OS. Pts with IADL score <8 treated with PLD had better outcome than pts in CAP arm. Incorporation of CGA into a phase III trial is feasible and yields valuable information for deciding best therapy for MBC patients. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Essex Pharma Essex Pharma, Schering-Plough Essex Pharma, Schering-Plough Schering-Plough, University Hospital Hamburg-Eppendorf Schering-Plough