医脉通编译，转载请务必注明出处

2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会在芝加哥举办。6月4日上午的消化系统（结直肠）肿瘤壁报专场上，中山大学附属第六医院的邓艳红教授在壁报上呈现了一项摘要号为TPS3637的研究，该项试验称为OPTICAL研究，在局部晚期结肠癌患者中比较FOLFOX或CAPOX的围手术期化疗与术后化疗的效果，医脉通整理如下：

在高危II期和III期结肠癌（CC）患者中，根治性手术序贯FOLFOX或者CAPOX方案的辅助化疗已经成为一种标准治疗。然而，这些患者中的20%～30%将会进展为远处转移，最终导致死亡。围手术期化疗是一种存在潜在获益的有希望的治疗策略，对于根除微小转移可能更有效。此外，术前肿瘤缩小不仅有利于外科医生移除所有肿瘤而且还能降低手术过程中肿瘤细胞扩散。

随着近期影像学技术的进步，术前计算机断层扫描成为衡量肿瘤浸润深度和识别预后较差（可能从围手术期化疗获益）结肠癌患者的一种可靠方法。由此研究人员开展了一项随机研究将FOLFOX或者CAPOX方案的围手术期化疗与术后化疗进行比较，以探索他们是否可以改善影像学分期，局部晚期但是可切除的结肠癌患者的无疾病生存期。

该试验是一项两组，多中心，开放标签，前瞻性，随机III期研究。738例符合要求的局部晚期（壁外深度≥5mm的T4或T3）结肠癌患者将被随机分配，按照1:1的比例，接受围手术期化疗（6个周期的mFOLFOX6或者4个周期的CAPOX序贯手术联合再一次6个周期的mFOLFOX或者4个周期的CAPOX）或者术后化疗（手术序贯12个周期的mFOLFOX6或者8个周期的CAPOX）。

该项研究的主要目标是3年无病存活率。次要目标是在R0切除率，总生存期（OS），无复发生存期（RFS），原发肿瘤降期方面的疗效，以及围手术期方案的耐受性和术后并发症。临床试验信息：NCT02572141。

会议专题》》》2016年ASCO年会专题报道

原文摘要：

FOLFOX or CAPOX perioperative chemotherapy versus postoperative chemotherapy for locally advanced colon cancer: OPTICAL study.(AbstractTPS3637)

Authors：Yanhong Deng, Huabin Hu,et al

Session Type：Poster Session

Background: In patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography is a robust method for measuring the depth of tumor invasion and identifying the CC patients with poor prognosis, who may benefit from perioperative chemotherapy. We conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOX or CAPOX regimens compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, locally advanced, but resectable colon cancer. 

Methods: This trial is a two-arm, multicenter, open labelled, prospective, randomized phase III studies. 738 eligible patients with locally advanced (T4 or T3 with extramural depth≧5 mm) CC patients will be randomly assigned, in a 1:1 ratio, to receive either perioperative (6 cycles of mFOLFOX6 or 4 cycles of CAPOX followed by surgery and a further 6 cycles of mFOLFOX6 or 4 cycles of CAPOX) or postoperative chemotherapy (surgery followed by 12 cycles of mFOLFOX6 or 8 cycles of CAPOX). The primary objective of this study is 3-year disease-free survival. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications. Clinical trial information: NCT02572141.

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