Division of Surgical Oncology, Department of Surgery, Nagoya Graduate School of Medicine, 65, Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.
Jpn J Clin Oncol. 2011 Aug;41(8):1041-4. doi: 10.1093/jjco/hyr084.
In Western countries, the standard treatment for locally advanced rectal cancer is preoperative chemoradiotherapy followed by total mesorectal excision. On the other hand, in Japan, treatment results without radiotherapy are by no means inferior; therefore, extrapolation of results of preoperative treatment in Western countries to Japan is controversial. We consider that survival may be improved by preoperative treatment with new anticancer agents as they are expected not only to decrease the local recurrence rate but also to prevent distant metastases. We are conducting a multicentre Phase II study to evaluate the safety and efficacy of neoadjuvant chemotherapy using XELOX plus bevacizumab without radiotherapy in patients with locally advanced rectal cancer. The primary endpoint of the study is treatment compliance. Secondary endpoints are overall survival, disease-free survival, local recurrence-free survival, objective response rate, R0 resection rate and adverse events. Thirty patients are required for this study.
在西方国家，局部晚期直肠癌的标准治疗方法是术前放化疗加全直肠系膜切除术。另一方面，在日本，不进行放疗的治疗结果也绝不逊色；因此，将西方国家术前治疗的结果外推到日本存在争议。我们认为，通过使用新的抗癌药物进行术前治疗可以提高生存率，因为这些药物不仅有望降低局部复发率，还可以预防远处转移。我们正在进行一项多中心 II 期研究，评估在局部晚期直肠癌患者中不进行放疗而使用 XELOX 加贝伐单抗进行新辅助化疗的安全性和疗效。该研究的主要终点是治疗依从性。次要终点是总生存期、无病生存期、局部无复发生存期、客观缓解率、R0 切除率和不良事件。这项研究需要 30 名患者。
