Department of Oncology, Radiation Oncology, University of Torino, via Genova 3, 10126 Turin, Italy.
Med Oncol. 2013;30(2):581. doi: 10.1007/s12032-013-0581-0. Epub 2013 Apr 19.
Neo-adjuvant chemo-radiotherapy (CT-RT) has been shown to decrease local recurrence rate in locally advanced rectal cancer. This multicenter phase II trial was conducted to evaluate the feasibility, safety and effectiveness of a combination of pre-operative radiotherapy and concurrent Capecitabine plus Oxaliplatin (XELOXART Trial). From October 2008 to May 2011, fifty consecutive patients affected with T3/T4 and/or N+ rectal cancer were enrolled. Treatment protocol consisted of 50.4 Gy in 28 fractions, Oxaliplatin 60 mg/m(2) once a week for 6 weeks and oral Capecitabine 825 mg/m(2) twice daily from day 1 to 14 and from day 22 to 35. Surgery was planned 6-8 weeks after. Main endpoints were pathological complete response rate (pCR) and the type of surgery performed compared to the planned one at diagnosis. 50 patients were included; pCR (ypT0N0M0) was achieved in 6 patients (12 %). Tumour downstaging was observed in 27 patients (54 %), and nodal downstaging in 32 patients (64 %). A total of 32 patients had lower rectal cancer, with 24 candidate for abdominal-perineal resection. At the end of CT-RT, a total of 12/24 (50 %) underwent conservative surgery. Grade 3 toxicity (fatigue and diarrhoea) occurred in 4 % of patients; grade 4 sensory neuropathy occurred in 2 % of patients. Perioperative complications of any grade occurred in 10 % of patients. Pre-operative CT-RT with Capecitabine-Oxaliplatin was well tolerated and resulted in an encouraging sphincter preservation and tumour downstaging rate. No improvements in terms of pathological complete response rate were shown.
新辅助放化疗（CT-RT）已被证明可降低局部晚期直肠癌的局部复发率。这项多中心 II 期试验旨在评估术前放疗联合卡培他滨和奥沙利铂（XELOXART 试验）的可行性、安全性和有效性。从 2008 年 10 月至 2011 年 5 月，连续纳入 50 例 T3/T4 和/或 N+直肠癌患者。治疗方案包括 50.4Gy/28 次分割，奥沙利铂 60mg/m²每周一次，共 6 周，卡培他滨 825mg/m²每天两次，第 1 天至第 14 天和第 22 天至第 35 天。手术计划在 6-8 周后进行。主要终点是病理完全缓解率（pCR）和与诊断时计划的手术类型。共纳入 50 例患者；6 例（12%）达到病理完全缓解（ypT0N0M0）。27 例（54%）肿瘤降期，32 例（64%）淋巴结降期。共有 32 例低位直肠癌患者，其中 24 例为腹会阴切除术候选者。在 CT-RT 结束时，共有 12/24（50%）接受了保肛手术。3 级毒性（乏力和腹泻）发生率为 4%；4 级感觉神经毒性发生率为 2%。任何级别的围手术期并发症发生率为 10%。卡培他滨-奥沙利铂的术前 CT-RT 耐受性良好，保肛率和肿瘤降期率令人鼓舞。病理完全缓解率无改善。
