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摘要
Objective: This open label, multi-center pilot study aims to examine the clinical effects of bevacizumab in combination with 5-FU as a neoadjuvant therapy for the R0 resection rates of colorectal cancer (CRC) patients with untreated and unresectable liver-only metastasis. Methods: Chinese patients with untreated (primary lesion surgically removed), unresectable liver-only metastatic colorectal cancer (mCRC) were recruited from seven centers in the country. All enrolled patients received bevacizumab and 5-FU based doublet neoadjuvant chemotherapy. Bevacizumab was administered as an intravenous infusion at 5 mg/kg, twice a week and given on the first day of each cycle. The total number of cycles given pre-and post-surgery was less than 12, which does not include the last cycle of preoperative chemotherapy given without bevacizumab. The primary endpoint was R0 resection rate, and the secondary endpoints were R1 resection rate, objective response rate (ORR), progression free survival (PFS), disease free survival (DFS) and safety. Results: Fifty eligible patients were enrolled in this study, which included 39 males and 11 females, with a median age of 57 years (age range: 37-73 years). The R0 resection rate was 30.0%, and the R1 resection rate was 0.0%. Besides, for the 50 patients, the ORR was 30.0%, and the median PFS was 12.06 months (95% CI: 6.70~13.31). For the 15 patients receiving R0 resection, the median DFS was 8.57 months (95% CI: 1.84~17.74). Moreover, the overall safety of the doublet chemotherapy was good. During the study, 159 adverse events were observed in 32 patients (64.0% of 50 patients). Among them, 24 adverse events were grade 3. No adverse event equal to or higher than grade 4 was recorded. The most common bevacizumab related grade 3 adverse events were hypertension (8.0%). Among the 17 patients of surgical safety population, 5 patients (29.4%) experienced surgery-related complications. Nevertheless, only one case was pulmonary infection, and all the rest cases were local hepatic complications. Conclusion: Bevacizumab combined with 5-FU based doublet chemotherapy is a good neoadjuvant therapy for colorectal cancer patients with unresectable liver-only metastasis, which can increase R0 resection rate and has high tolerance. ? 2018, The Second Affiliated Hospital, College of Medicine, Zhejiang University.. All right reserved.
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