Bevacizumab plus XELOX as neoadjuvant therapy for patients with potentially curable metastatic colorectal cancer

Abstract

4064 Background: Patients (pts) with colorectal cancer (CRC) and liver metastases have a poor prognosis and may benefit from perioperative chemotherapy and disease resection. Bevacizumab (BEV) is proven to improve outcomes in patients with metastatic CRC; however, its impact on surgical complications and hepatic regeneration following liver resection needs to be assessed. Methods: Patients with metastatic CRC with liver metastases potentially curable by resection were eligible for this single-centre, nonrandomised phase II trial. Eligibility criteria define pts at high risk of early recurrence: synchronous liver metastases; primary non-optimally resectable disease or multiple liver metastases. Pts received BEV 5mg/kg q2 weeks plus XELOX (capecitabine 3500mg/m2/day days 1–7 plus oxaliplatin 85mg/m2 day 1 of a 2-week cycle) for 6 cycles. The sixth cycle of therapy did not include BEV, resulting in 5 weeks between the last BEV dose and surgery. Therapy with BEV plus XELOX was restarted 5 weeks after surgery for another 6 cycles. Results: 54 patients have been enrolled and are evaluable having received a median of 6 cycles of BEV plus XELOX: 39 pts underwent liver resection alone, 9 pts also had primary tumor resection (2 are awaiting surgery); major liver resections were performed in 17 pts (35%). 40 pts responded (ORR 74%) and 11 had stable disease. To date, peri- and postoperative events are consistent with previous studies evaluating chemotherapy alone: there was no intra-operative increased bleeding, perioperative blood transfusions were required in only 3 pts (6 %); further surgery was necessary in a single patient. Postoperative liver function and regeneration (assessed by CT 3 months after surgery) were normal in all but one patient (prolonged liver dysfunction due to steatohepatitis). No postoperative mortality occurred and morbidity was encountered in 8 pts (17%). Mean postoperative hospital stay was 8 days (SD ± 3.8). Conclusions: These data suggest that BEV can be safely administered until 5 weeks prior to liver resection in patients with mCRC without increasing the rate of surgical or wound healing complications or severity of bleeding. They are the first to show that neoadjuvant BEV does not affect liver regeneration after resection. No significant financial relationships to disclose.