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.
2007年启动的ASSO-LM1试验是一项多中心前瞻性研究，旨在探讨潜在可切除结直肠肝转移患者接受XELOX联合贝伐珠单抗术前联合治疗后R0切除率。术前共进行6周期全身治疗，其中第6周期不含贝伐珠单抗，确保末次贝伐珠单抗给药与手术间隔达5周。术后重启贝伐珠单抗联合XELOX方案继续治疗6周期。该研究共纳入43例患者，其中8例因方案违背（6例）及疾病进展（2例）不符合切除标准。接受手术患者的可切除率达97%，其中R0切除34例，R1切除1例。术后并发症发生率为22%，其中3例再次手术与原发性肿瘤切除相关。38例符合条件患者的疗效评估显示：根据RECIST标准客观缓解率达66%，疾病稳定31%，疾病进展3%。术前3/4级不良事件包括腹泻（17%）、手足综合征（5%）和血栓栓塞事件（5%）。根治性切除患者中，完成辅助治疗者与未完成者总生存期存在显著差异（59.1个月 vs 30.8个月）。本研究证实，对于肝脏局限的转移性结直肠癌患者，XELOX联合贝伐珠单抗的围手术期治疗方案具有显著预后获益，是一项具有假说生成价值的研究。
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