Division of Medical Oncology, Department of Clinical and Experimental Medicine and Surgery F Magrassi e A Lanzara, Second University of Naples, Via Pansini 5, Naples 80131, Italy.
Br J Cancer. 2011 Feb 1;104(3):427-32. doi: 10.1038/sj.bjc.6606093. Epub 2011 Jan 18.
Preoperative chemoradiotherapy (CRT) improves the survival of patients with oesophageal cancer when compared with surgery alone.
We conducted a phase II, multicenter trial of FOLFOX-4 and cetuximab in patients with locally advanced oesophageal cancer (LAEC) followed by daily radiotherapy (180 cGy fractions to 5040 cGy) with concurrent weekly cetuximab. Cytokines levels potentially related to cetuximab efficacy were assessed using multiplex-bead assays and enzyme-linked immunosorbent assay at baseline, at week 8 and at week 17. Primary end point was complete pathological response rate (pCR).
In all, 41 patients were enroled. Among 30 patients who underwent surgery, a pCR was observed in 8 patients corresponding to a rate of 27%. The most frequent grade 3/4 toxicity was skin (30%) and neutropenia (30%). The 36-month survival rates were 85 and 52% in patients with pathological CR or PR vs 38 and 33% in patients with SD or PD.
Incorporating cetuximab into a preoperative regimen for LAEC is feasible; no correlation between cytokines changes and patient outcome was observed. Positron emission tomography/computed tomography study even if influenced by the small number of patients appears to be able to predict patients outcome both as early and late metabolic response.
与单独手术相比，术前放化疗（CRT）可提高食管癌患者的生存率。
我们进行了一项 II 期、多中心试验，研究了 FOLFOX-4 和西妥昔单抗在局部晚期食管癌（LAEC）患者中的应用，随后进行每日放疗（180cGy 分次至 5040cGy），同时每周给予西妥昔单抗。在基线、第 8 周和第 17 周，使用多重珠粒检测和酶联免疫吸附试验评估与西妥昔单抗疗效相关的细胞因子水平。主要终点是完全病理缓解率（pCR）。
共有 41 名患者入组。在接受手术的 30 名患者中，8 名患者（27%）出现 pCR。最常见的 3/4 级毒性是皮肤毒性（30%）和中性粒细胞减少症（30%）。病理完全缓解或部分缓解患者的 36 个月生存率分别为 85%和 52%，而疾病稳定或进展患者的生存率分别为 38%和 33%。
将西妥昔单抗纳入 LAEC 的术前方案是可行的；未观察到细胞因子变化与患者预后之间的相关性。即使受到患者数量少的影响，正电子发射断层扫描/计算机断层扫描（PET/CT）研究似乎能够预测患者的早期和晚期代谢反应，从而预测患者的预后。
