Phase II Study of Pre-operative Radiotherapy with Capecitabine and Oxaliplatin for Rectal Cancer and Carcinoembryonic Antigen as a Predictor of Pathological Tumour Response
Phase II Study of Pre-operative Radiotherapy with Capecitabine and Oxaliplatin for Rectal Cancer and Carcinoembryonic Antigen as a Predictor of Pathological Tumour Response
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DOI：
10.1177/147323001003800227
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发表时间：
2010-03-01
影响因子：
1.6
通讯作者：
Pan, Z. Z.
中科院分区：
文献类型：
--
作者：
Lin, J. Z.;Zeng, Z. F.;Pan, Z. Z.
本研究调查了直肠癌患者术前同步放疗卡培他滨和奥沙利铂的疗效和耐受性。 47 名直肠腺癌患者（T3 - T4 期；淋巴结阳性）入组并接受放射治疗（23 次，46 Gy）联合卡培他滨（1000 mg/m(2)，第 1 - 14 天和 22-35 天两次）和奥沙利铂（130 mg/m(2)，第 1 天和 22 天）（XELOX 方案）。主要终点是安全性和有效性，通过病理完全缓解（pCR）进行评估。所有患者均按计划接受术前放化疗（CRT）。最常见的严重毒性是腹泻（12.8%）；术后并发症很少见（9.8%）。所有患者的 pCR 率为 20.9%，CRT 前血清癌胚抗原（CEA 5 ng/ml）正常的患者的 pCR 率为 34.8%。综上所述，直肠癌患者术前放疗同步XELOX方案是可行且有效的。血清 CEA 可能是 pCR 的合适预测指标。
This study investigated the efficacy and tolerability of pre-operative radiotherapy with concurrent capecitabine and oxaliplatin in patients with rectal cancer. Forty-seven patients with rectal adenocarcinoma (stages T3 - T4; node-positive) were enrolled and received radiotherapy (46 Gy in 23 fractions) in combination with capecitabine (1000 mg/m(2) twice daily on days 1 - 14 and 22 35) and oxaliplatin (130 mg/m(2) on days 1 and 22) (XELOX regimen). The main endpoints were safety and efficacy, as assessed by pathological complete response (pCR). All patients received pre-operative chemoradiotherapy (CRT) as planned. The most common severe toxicity was diarrhoea (12.8%); post-operative complications were rare (9.8%). The pCR rate was 20.9% in all patients and 34.8% in patients with normal pre-CRT serum carcinoembryonic antigen (CEA 5 ng/ml). In conclusion, pre-operative radiotherapy with concurrent XELOX regimen in rectal cancer patients is feasible and effective. Serum CEA may be a suitable predictor of pCR.