Folfox6 And Bevacizumab In Non-Optimally Resectable Liver Metastases From Colorectal Cancer: Results Of A Phase Ii Trial And Role Of Pet-Ct As Early Predictor Of Reponse.

e14108 Background: In patients (pts) with colorectal liver metastases (CLM) R0 resections significantly improve OS. In this report we present the results of a phase II trial with FOLFOX6-BV as neo-adjuvant therapy for pts with non optimally resectable CLM. Methods: Pts with initially unresectable CLM with regard to number, size or locoregional invasionand no evidence of extra-hepatic disease, received FOLFOX6 for 6 cycles (cy) and bevacizumab (BV) 5 mg/kg, every 2 weeks for 5 cy. Pts who did not reach the resectability after the first 6 cy were submitted to other 6 cy of chemotherapy and 5 of BV, then to a new surgical evaluation. CLM were initially documented by biopsy and a CT scan; moreover a PET-CT performed at baseline, within 1 month from the start of preoperative therapy and before surgery. Elective surgery was planned at least 6 weeks after the last dose of BV and 4 weeks after last dose of FOLFOX6. Results: From September 2005 and July 2009, 21 pts were enrolled (male/female: 15/6; median age: 65 years, range: 37-72 years). After 3 months of treatment 12 pts (57.1%) experienced an objective response (CR: 3, PR: 9) documented by RECIST criteria. Among CRs, one pt achieved a radiological CR, but died for toxicity (sepsis) before surgery. Thirteen pts underwent radical surgery (61.9%) and in 3 cases we documented a pCR (23%). One pt was evaluated as in SD by RECIST criteria, but the resected lesion showed the absence of neoplastic cells. Twelve pts were operated after 6 cy and 1 pt was operated after 12 cy. Six pts (46.1%) experienced minor postsurgical complications: 3 had abdominal abscess and 3 a delay in wound healing. After a median follow-up of 38.8 months, median OS was 22.5 months (range: 4-42 months). Pts achieving a reduction in the SUVmax of at least 1 unit between the first and the second PET-CT have a longer PFS (mPFS: 22 vs. 14 months, p = 0.0010). Conclusions: FOLFOX6-BV is feasible and does not increase postsurgical complications. The combination leads to a high resectability rate and increases the number of pts achieving a complete pathologic response. Early changes in PET-TC in particular in terms of reduction of SUVmax seem to be a predictor of longer PFS. No significant financial relationships to disclose.