Autor: |
Dong Y; Department of Surgery, Clinic Favoriten, HPB Center, Health Network Vienna, Sigmund Freud Private University Vienna, 1020 Vienna, Austria., Santol J; Department of Surgery, Clinic Favoriten, HPB Center, Health Network Vienna, Sigmund Freud Private University Vienna, 1020 Vienna, Austria., Gruenberger B; Department of Internal Medicine, Hematology and Internal Oncology, Landesklinikum Wiener Neustadt, 2700 Wiener Neustadt, Austria., Lenauer A; Department of Surgery, Landesklinikum Wiener Neustadt, 2700 Wiener Neustadt, Austria.; Department of Surgery, LHK Oberpullendorf, 7350 Oberpullendorf, Austria., Laengle F; Department of Surgery, Landesklinikum Wiener Neustadt, 2700 Wiener Neustadt, Austria., Thaler J; Department of Internal Medicine, Klinikum Wels-Grieskirchen, 4600 Wels, Austria., Piringer G; Department of Internal Medicine, Klinikum Wels-Grieskirchen, 4600 Wels, Austria.; Medical Faculty, Johannes Kepler University Linz, 4040 Linz, Austria., Eisterer W; Department of Oncology, Klinikum Klagenfurt, 9020 Klagenfurt, Austria., Djanani A; Department of Internal Medicine, Medical University of Innsbruck, 6020 Innsbruck, Austria., Stift J; Department of Pathology, Medical University of Vienna, 2700 Vienna, Austria., Gruenberger T; Department of Surgery, Clinic Favoriten, HPB Center, Health Network Vienna, Sigmund Freud Private University Vienna, 1020 Vienna, Austria. |
Abstrakt: |
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. |