Preoperative chemoradiotherapy with capecitabine is considered as a standard of care for locally advanced rectal cancer. The “Tratamiento de Tumores Digestivos” group (TTD) previously reported in a randomized Ph II study that the addition of Bevacizumab to capecitabine-RT conferred no differences in the pre-defined efficacy endpoint (pathological complete response). We present the follow-up results of progression-free survival, distant relapse-free survival, and overall survival data at 3 and 5 years. Patients (pts) were randomized to receive 5 weeks of radiotherapy (45 Gy/25 fractions) with concurrent Capecitabine 825 mg/m2 twice daily, 5 days per week with (arm A) or without (arm b) bevacizumab (5 mg/kg once every 2 weeks). In our study, the addition of bevacizumab to capecitabine and radiotherapy in the neoadjuvant setting shows no differences in pathological complete response (15.9% vs 10.9%), distant relapse-free survival (81.0 vs 80.4 and 76.2% vs 78.2% at 3 and 5 years respectively), disease-free survival (75% vs 71.7 and 68.1% vs 69.57% at 3 and 5 years respectively) nor overall survival at 5-years of follow-up (81.8% vs 86.9%). the addition of bevacizumab to capecitabine plus radiotherapy does not confer statistically significant advantages neither in distant relapse-free survival nor in disease-free survival nor in Overall Survival in the short or long term. EudraCT number: 2009–010192-24 . Clinicaltrials.gov number: NCT01043484 .

中文翻译：

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卡培他滨联合贝伐单抗和外照射治疗作为可切除的局部晚期直肠腺癌患者的术前治疗的II期随机试验：长期结果

卡培他滨的术前放化疗被认为是局部晚期直肠癌的治疗标准。“ Tratamiento de Tumores Digestivos”小组（TTD）先前在一项随机II期研究中报告说，将贝伐单抗加入卡培他滨-RT不会使预定义功效终点（病理完全缓解）产生差异。我们提供了3年和5年无进展生存期，远距无复发生存期以及总体生存期数据的随访结果。患者（pts）随机接受5周放疗（45 Gy / 25分数），同时并用卡培他滨825 mg / m2每天两次，每周5天，使用（A组）或不使用（B组）贝伐单抗（5 mg / kg）每2周一次）。在我们的研究中 在新辅助治疗中，将贝伐单抗加到卡培他滨和放疗中显示病理完全缓解（15.9％vs 10.9％），远距无复发生存率（分别为31.0和80.4 vs. 80.4和76.2％vs 78.2％）无差异，无病生存期（分别为3年和5年，分别为75％vs. 71.7和68.1％vs 69.57％）或5年随访的总体生存率（81.8％vs 86.9％）。在卡培他滨加放疗中加入贝伐珠单抗联合放疗在远期无复发生存率，无病生存率或短期或长期总生存率方面均无统计学意义。EudraCT号：2009–010192-24。Clinicaltrials.gov编号：NCT01043484。无病生存期（分别为3年和5年，分别为75％vs. 71.7和68.1％vs 69.57％）或5年随访的总体生存率（81.8％vs 86.9％）。在卡培他滨加放疗中加入贝伐珠单抗联合放疗在远期无复发生存率，无病生存率或短期或长期总生存率方面均无统计学意义。EudraCT号：2009–010192-24。Clinicaltrials.gov编号：NCT01043484。无病生存期（分别为3年和5年，分别为75％vs. 71.7和68.1％vs 69.57％）或5年随访的总体生存率（81.8％vs 86.9％）。在卡培他滨加放疗中加入贝伐珠单抗联合放疗在远期无复发生存率，无病生存率或短期或长期总生存率方面均无统计学意义。EudraCT号：2009–010192-24。Clinicaltrials.gov编号：NCT01043484。2009–010192-24。Clinicaltrials.gov编号：NCT01043484。2009–010192-24。Clinicaltrials.gov编号：NCT01043484。