Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2
Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2
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DOI：
10.1200/jco.2009.25.8376
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发表时间：
2010-04-01
影响因子：
45.3
通讯作者：
Conroy, Thierry
中科院分区：
文献类型：
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作者：
Gerard, Jean-Pierre;Azria, David;Conroy, Thierry
目的新辅助放化疗被认为是T3-4 M0直肠癌的标准治疗方法。在这种情况下，我们将新辅助放疗加卡培他滨与剂量强化放疗加卡培他滨和奥沙利铂进行比较。患者和方法我们将患者随机分配接受5周的放疗45戈伊/25次，同时卡培他滨800 mg/m2，每日两次，每周5天（Cap 45）或放疗50戈伊/25次，卡培他滨800 mg/m2每日两次，每周5天;奥沙利铂50 mg/m2，每周1次（Capox 50）。主要终点是完全灭菌的手术标本（ypCR）。结果五百九十八例患者被随机分配到接收帽45（n = 299）或Capox 50（n = 299）。Capox 50组发生的术前3 - 4级毒性更多（25 vs11%; P <0.001）。两组中98%的患者进行了手术。两组的保守手术率（75%）或术后60天死亡率（0.3%）无差异。Cap 45和Capox 50的ypCR率分别为13.9%和19.2%（P = 0.09）。当ypCR与yp少量残留细胞结合时，Cap 45和Capox 50的比率分别为28.9%和39.4%（P = 0.008）。Cap 45和Capox 50的阳性直肠周缘（0 - 2 mm）率分别为19.3%和9.9%（P = 0.02）。结论奥沙利铂的益处未得到证实，该药物不应与同步照射一起使用。Cap 50值得对T3-4直肠癌进行研究。J Clin Oncol 28：1638-1644. (C)2010年美国临床肿瘤学会
PurposeNeoadjuvant chemoradiotherapy is considered a standard approach for T3-4 M0 rectal cancer. In this situation, we compared neoadjuvant radiotherapy plus capecitabine with dose-intensified radiotherapy plus capecitabine and oxaliplatin.Patients and MethodsWe randomly assigned patients to receive 5 weeks of treatment with radiotherapy 45 Gy/25 fractions with concurrent capecitabine 800 mg/m(2) twice daily 5 days per week (Cap 45) or radiotherapy 50 Gy/25 fractions with capecitabine 800 mg/m(2) twice daily 5 days per week and oxaliplatin 50 mg/m(2) once weekly (Capox 50). The primary end point was complete sterilization of the operative specimen (ypCR).ResultsFive hundred ninety-eight patients were randomly assigned to receive Cap 45 (n = 299) or Capox 50 (n = 299). More preoperative grade 3 to 4 toxicity occurred in the Capox 50 group (25 v 11%; P < .001). Surgery was performed in 98% of patients in both groups. There were no differences between groups in the rate of conservative surgery (75%) or postoperative deaths at 60 days (0.3%). The ypCR rate was 13.9% with Cap 45 and 19.2% with Capox 50 (P = .09). When ypCR was combined with yp few residual cells, the rate was respectively 28.9% with Cap 45 and 39.4% with Capox 50 (P = .008). The rate of positive circumferential rectal margins (between 0 and 2 mm) was 19.3% with Cap 45 and 9.9% with Capox 50 (P = .02).ConclusionThe benefit of oxaliplatin was not demonstrated and this drug should not be used with concurrent irradiation. Cap 50 merits investigation for T3-4 rectal cancers. J Clin Oncol 28: 1638-1644. (C) 2010 by American Society of Clinical Oncology