Outcome And Dose Intensity (Di) In The Elderly Subgroup Of The Agitg Max Phase Iii Trial Of Capecitabine (C), Bevacizumab (B), And Mitomycin C (M) In First-Line Metastatic Colorectal Cancer (Crc)

3621 Background: With age the frequency of cancer and chronic disease increases. CRC is a common cancer and treatment with chemotherapy and biological agents will be a major health issue in the elderly. Methods: MAX, a three arm study of C vs CB vs CBM, found an improvement in PFS with addition of B (+/− M) to C. This analysis assesses effect of adding B (+/− M) to C on PFS, OS, RR, Dose delivered and toxicity in elderly patients (age >75y). Results: 21% were >75y. Number/Median age: C 37/78.5y, CB 32/78.7y, CBM 30/80.2y. Baseline characteristics were balanced. 88% commenced C dose of 2,000mg/m2/day, d1-14, q21 (61% for <75y). 88% ECOG 0-1. Proportion receiving all 3 chemotherapy drugs at some time (5FU/oxaliplatin/irinotecan) was 10% >75y v 20% <75y. Percentage dose and number of cycles of C, B and M received, median PFS and OS reported in table. Interaction test for OS 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, HT 0/3/3, thrombosis/thrombus/embolism 5/6/13, cardiac 0/6 (3 Gd5)/3. There was 1 perforation (Gd5) in C. Grade 2/3 HFS (%) was 38/59/53. One Gd 3/4 neutropenia episode in CB. Overall, toxicity rate similar to <75 y. Conclusions: DI and number of cycles of C, B and M did not differ in those >75yrs compared to those <75yrs, noting more patients were commenced on 2,000mg/m2/day if age >75 yrs. Significant improvement in PFS with addition of B to C was seen in the elderly group. There was no signal of increased toxicity, including rates of VTE/ATE for those age >75yrs. Dose delivered PFS OS <75y >75y <75y (m) >75y (m) <75y (m) >75y (m) Dose intensity (%) Ave No. of cycles Dose intensity (%) Ave No. of cycles C 94.1 9.9 93.2 6.6 5.8 5.6 - 20.0 13.4 C B 90.6 99.7 11.3 11.7 85.6 99.3 9.1 9.3 8.5 p=0.001 HR 0.65 (CI 0.5-0.84) 8.8 p=0.01 HR 0.53 (CI 0.32-0.86) 20.4 15.7 C B M 90.8 99.8 99.4 10.7 10.5 3.4 85.2 99.1 99.8 10.6 10.7 3.0 7.8 p=0.002 HR 0.66 (CI 0.51-0.86) 10.4 p=0.0002 HR 0.38 (CI 0.23-0.64) 16.1 19.9 Interaction test for age p=0.24 p=0.16