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A randomized phase III trial on maintenance treatment with bevacizumab (bev) alone or in combination with erlotinib (erlo) after chemotherapy and bev in metastatic colorectal cancer (mCRC).

3526 Background: To improve the management of patients (pts) with mCRC, it is important to identify maintenance strategies that may contribute to prolonged survival with sustained QoL. The aim of the present study was to compare bev with bev + erlo following induction treatment with chemotherapy and bev. Progression free survival (PFS) was the primary end point.


METHODS
Pts with previously untreated mCRC, performance status (PS) 0-1, and adequate hepatic/renal/hematological function were included between May 2007 and Oct 2009 at 16 sites in Sweden and Denmark. Induction treatment consisted of XELOX, XELIRI, FOLFOX or FOLFIRI (investigator's choice) + bev for 18 weeks. Pts without tumor progression were eligible for randomization to maintenance treatment with bev 7.5 mg/kg q3w +/- erlo 150 mg daily, until progression or unacceptable toxicity.


RESULTS
249 pts were enrolled, median age 66 years (range 27-84), 58% male, 67% PS 0, primary site; colon/rectum/both: 60/34/6%, 35% had primary tumor in situ, 48% had liver metastases only. 73% received oxaliplatin-containing induction treatment. Response rate on induction treatment among 231 evaluable pts were PR/SD/PD: 48/43/9%. 161 pts were randomized. Reasons for non-randomization were PD in 23 pts and intended surgery in 19 pts. Median time on maintenance treatment was 15 weeks (range 0-102). Adverse events grade III-IV occurred in 44% of pts during induction phase. In the maintenance phase 31% experienced grade III-IV toxicity, with rash in 8%, hypertension in 4% and bleeding in 2% of pts. There were 3 toxic deaths; intestinal perforation (n=2) and abdominal bleeding (n=1).


CONCLUSIONS
Maintenance treatment with bev +/- erlo after first-line chemotherapy in pts with mCRC seems to be a feasible strategy with limited side-effects. The primary study endpoint, PFS in the randomized population, will be reported at the meeting.