Preoperative chemoradiotherapy versus preoperative radiotherapy in rectal cancer patients: assessment of acute toxicity and treatment compliance - Report of the 22921 randomised trial conducted by the EORTC Radiotherapy Group
Preoperative chemoradiotherapy versus preoperative radiotherapy in rectal cancer patients: assessment of acute toxicity and treatment compliance - Report of the 22921 randomised trial conducted by the EORTC Radiotherapy Group
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DOI：
10.1016/j.ejca.2003.09.032
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发表时间：
2004-01-01
影响因子：
8.4
通讯作者：
Briffaux, A
中科院分区：
文献类型：
--
作者：
Bosset, JF;Calais, G;Briffaux, A
欧洲癌症研究和治疗组织（EORTC）22921四组随机试验质疑术前放化疗（XRT-CT）与术前放疗（XRT）的价值，以及T3-T4 MO可切除直肠癌患者中额外术后化疗（CT）与无化疗的价值。我们报告了2001年1月之前进入试验的患者的两种治疗方式的术前毒性、治疗依从性和早期死亡（手术后30天内的所有死亡）。XRT组（A组）接受45戈伊，25次/5周。XRT-CT组（B组）在XRT的第1周和第5周的基础上加用两个疗程的CT。每个CT疗程：给予5-氟尿嘧啶（5-FU）350 mg/m2/d和甲酰四氢叶酸（LV）20 mg/m2/d。A组和B组分别有398例和400例患者开始治疗。A组和B组中2 +级急性腹泻的发生率分别为17.3%和34.3%（P < 0.005）。其他副作用保持不变或仅轻微增加。A组和B组的RT依从性分别为98.5%和95.5%。在B组中，78.7%和71.1%的患者在第一和第二疗程分别接受了计划CT剂量的95-105%。6例患者术前死亡，B组2例死于毒性。两组均有8例患者（1%）在术后30天内死亡。在方案中推荐的剂量下，在术前XRT中添加5-FU-LV略微增加了急性毒性的量。然而，对放射方案的依从性或手术的可行性并没有降低。(C)2003 Elsevier Ltd.保留所有权利。
The European Organisation for Research and Treatment of Cancer (EORTC) 22921 four-arm randomised trial questioned the value of preoperative chemoradiation (XRT-CT) versus preoperative radiation (XRT) and the value of additional postoperative chemotherapy (CT) versus none in T3-T4 MO resectable rectal cancer patients. We report on the preoperative toxicity, treatment compliance and early deaths (all deaths up to 30 days after surgery) of the two treatment modalities in patients who were entered into trial before January 2001. In the XRT Group (group A), patients received 45 Gy, 25 fractions over 5 weeks. In the XRT-CT Group (group B), two 5-day courses of CT were added to the first and fifth weeks of XRT. For each CT course: 5-fluorouracil (5-FU) 350 mg/m(2)/day and Leucovorin (LV) 20 mg/m(2)/day were given. 398 and 400 patients started treatment in groups A and B, respectively. Grade 2 + acute diarrhoea occurred in 17.3 and 34.3% of patients in groups A and B, respectively (P < 0.005). The other side-effects remained unchanged or were only marginally increased. The compliance with RT was 98.5 and 95.5% in groups A and B, respectively. In group B, 78.7 and 71.1% of the patients received 95-105% of the planned CT doses at the first and second courses, respectively. 6 patients died preoperatively, 2 from toxicity in group B. 8 patients (1%) died within the 30 days after surgery in both groups. At the doses recommended in the protocol, the addition of 5-FU-LV to preoperative XRT slightly increased the amount of acute toxicity. However, the compliance with the radiation protocol or the feasibility of surgery did not decrease. (C) 2003 Elsevier Ltd. All rights reserved.