Bosset J F, Calais G, Daban A, Berger C, Radosevic-Jelic L, Maingon P, Bardet E, Pierart M, Briffaux A
Besançon University Hospital, Boulevard Fleming, F-25030, Besancon Cedex, France.
Eur J Cancer. 2004 Jan;40(2):219-24. doi: 10.1016/j.ejca.2003.09.032.
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 M0 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/m2/day and Leucovorin (LV) 20 mg/m2/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.
欧洲癌症研究与治疗组织（EORTC）22921四臂随机试验对术前放化疗（XRT-CT）与术前放疗（XRT）的价值，以及T3-T4 M0可切除直肠癌患者术后辅助化疗（CT）与不进行辅助化疗的价值提出了质疑。我们报告了2001年1月前进入试验的患者中两种治疗方式的术前毒性、治疗依从性和早期死亡情况（术后30天内的所有死亡）。在XRT组（A组），患者在5周内接受45 Gy，分25次照射。在XRT-CT组（B组），在XRT的第一周和第五周增加两个为期5天的CT疗程。每个CT疗程：给予5-氟尿嘧啶（5-FU）350 mg/m²/天和亚叶酸（LV）20 mg/m²/天。A组和B组分别有398例和400例患者开始治疗。A组和B组分别有17.3%和34.3%的患者发生2级及以上急性腹泻（P<0.005）。其他副作用保持不变或仅略有增加。A组和B组放疗的依从性分别为98.5%和95.5%。在B组，分别有78.7%和71.1%的患者在第一个和第二个疗程接受了计划CT剂量的95%-105%。6例患者术前死亡，B组有2例死于毒性反应。两组均有8例患者（1%）在术后30天内死亡。按照方案推荐的剂量，术前XRT加用5-FU-LV会使急性毒性略有增加。然而，放疗方案的依从性或手术的可行性并未降低。
