Geriatric subgroup of AGITG MAX trial: International randomized phase III trial of capecitabine (C), bevacizumab (B), and mitomycin C (M) in first-line metastatic colorectal cancer (CRC)

Background: In an aging population a greater proportion of geriatric patients will be considered for systemic chemotherapy. CRC is a common cancer and will be a major health issue in geriatrics. Methods: MAX, a three arm study of C v CB v CBM, found an improvement in PFS with addition of B (+ MMC) to C (Tebbutt NC et al. JCO 2010; 28(19): 3191‐3198). This analysis assesses effect of adding B (+ MMC) to C on PFS, OS, RR and toxicity in geriatric patients (age >75y). Results: 99 patients (21%) were >75y. Number/Median age: C 37/78.5y (75.2‐86), CB 32/78.7y (75.2‐84.9), CBM 30/80.2y (75.2‐83.4). Baseline characteristics were well balanced. 88% commenced C dose of 2000mg/m2/day, d1‐14, q21 (61% for <75y). ECOG 0‐1 for 88%. Comorbidities were: (%) Ex/smoker 13/2, diabetes 15, HT 56, IHD 15, CVA/TIA 10. These are similar to reported rates (http://www.aihw.gov.au/cdarf/data‐pages/incidence‐prevalence/index.cfm) in this population. Proportion receiving all three chemotherapy drugs at some time (5FU/oxaliplatin/irinotecan) was 10% >75y v 20% <75y. RR, median PFS & OS reported in Table. Interaction test for OS, RR and PFS revealed no impact of age. Gd 3‐4 tox for >75y C/CB/CBM respectively was (%); vomiting 5/13/3, diarrhea 19/22/20, stomatitis 3/0/3, HT 0/3/3, thrombosis/thrombus/embolism 5/6/13, cardiac 0/6 (3 Gd5)/3. There was one perforation (Gd5) in C. Grade 2/3 HFS (%) was 38/59/53. One Gd 3‐4 neutropenia episode in CB, no Gd 3‐4 thrombocytopenia. Overall, toxicity rate similar to <75 y. Conclusions: Significant improvement in PFS with addition of B to C was seen in this geriatric population, similar to results of ITT group and those <75yrs. Treatment was well tolerated with no signal of increased toxicity when compared to those <75yrs, including VTE/ATE. (Table presented).