Cetuximab and irinotecan-based chemotherapy as an active and safe treatment option for elderly patients with extensively pre-treated metastatic colorectal cancer

Abstract

14528 Background: Cetuximab ( C ) has demonstrated activity both as a single agent and in combination with irinotecan (CPT11) in patients (pts) with metastatic colorectal cancer (mCRC) expressing epidermal growth factor receptor (EGFR) refractory to CPT 11 and oxaliplatin based chemotherapy. This European retrospective study explored the tolerability and activity of C combined with CPT 11 in an unselected population of elderly pts with CPT11- refractory mCRC Methods: 67 pts with mCRC aged = 70 yrs were treated with C (400 mg/m2 loading dose over 2 hours, then 250 mg/m2 over 1 hour weekly). C was given alone (2 pts), combined with CPT11 (56 pts) or CPT11 + 5FU-LV as conventional (4 pts) or chronomodulated delivery (5 pts). Treatment was administered as 2nd to 6th line. Primary endpoint was time to tumor progression (TTP). Secondary endpoints were toxicity, objective response rate (RR) (with RECIST Criteria) and overall survival (OS). Results: Median age was 77 yrs (70–84); M/F: 44/23; WHO performance status 0/1/2/unknown: 12/40/11/4; EGFR expression: + in 55 pts, - in 2 pts and unknown in 10 pts; colon/rectum/unknown: 49/14 /4. More frequent toxicities included acneiform skin rash, which occurred in 33 pts (Grade (G) 2: 24 pts, 35%; G3: 9 pts, 13%), diarrhea (G3, 11 pts, 16%; G4, 2 pts, 3%) and neutropenia (G3: 4 pts, 6%; G4: 5 pts, 7%). RR was 23% including 1 complete and 14 partial responses. Disease control rate (RR + stable disease) was 53%. No correlation was found between skin rash and response. Median TTP (intent-to treat) was 4.5 months [95% CI: 3.2 - 5.7]. Median OS was 15 months [12.0–17.9]. Conclusions: The combination of C with CPT11-based chemotherapy resulted in good activity and acceptable tolerability in elderly patients with heavily pre-treated mCRC, comparable to that of the younger patients. This treatment option can be reasonably proposed to the elderly population. No significant financial relationships to disclose.