Perioperative Chemotherapy Including Bevacizumab in Potentially Curable Metastatic Colorectal Cancer: Long-Term Follow-Up of the ASSO-LM1 Trial

Simple Summary The primary aim of this multicenter trial was to evaluate the efficacy, safety and survival outcomes of perioperative chemotherapy with XELOX combined with the anti-VEGF targeted agent bevacizumab in patients with potentially curable metastatic colorectal cancer (mCRC). Six cycles of systemic therapy were administered preoperatively (the sixth cycle did not include bevacizumab) and another six postoperative cycles were given starting 5 weeks after surgery. A total of 35 patients eventually underwent surgery with a resectability (R0) rate of 97%. Three patients developed wound-healing complications, while no postoperative bleeding was reported. Efficacy results for response in 38 eligible patients confirmed an ORR of 66%. Survival analysis revealed a significant improvement in overall survival in the perioperative therapy group when comparing patients who underwent complete perioperative therapy with XELOX and bevacizumab versus those who received XELOX and bevacizumab in the neoadjuvant setting only.Abstract In 2007, the ASSO-LM1 trial, a multicenter prospective study, was initiated to investigate the resectability (R0) rate following preoperative combination therapy with XELOX and bevacizumab in patients with potentially resectable colorectal liver metastases. Six cycles of systemic therapy were administered preoperatively, although the sixth cycle did not include bevacizumab, resulting in 5 weeks between the last bevacizumab dose and surgery. Treatment with bevacizumab plus XELOX was restarted for another six cycles postoperatively. In total, 43 patients were enrolled in the ASSO-LM1 trial. Eight patients were ineligible for resection due to protocol violation and progression in two patients. The resectability of operated patients was 97% with 34 R0 resections and one R1 resection. Postoperative morbidity occurred in 22% of patients, of which three operative revisions were related to the primary tumor resection. Efficacy results for response in 38 eligible patients confirmed an ORR of 66%, 31% SD and 3% PD according to RECIST. Preoperative grade 3/4 adverse events were 17% diarrhea, 5% HFS and 5% thromboembolic events. Overall survival significantly differed depending upon the fulfillment of adjuvant treatment in curative resected patients (59.1 mo vs. 30.8 mo). In conclusion, the ASSO-LM1 trial is a hypothesis-generating study confirming the prognostic benefits of perioperative therapy with XELOX and bevacizumab in patients with metastatic colorectal cancer confined to the liver.