Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer
Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer
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DOI：
10.1200/jco.2007.15.3858
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发表时间：
2008-08-01
影响因子：
45.3
通讯作者：
Glimelius, Bengt
中科院分区：
文献类型：
--
作者：
Braendengen, Morten;Tveit, Kjell M.;Glimelius, Bengt
目的尽管增加化疗的科学证据有限，但术前放化疗被认为是局部晚期直肠癌的标准治疗方法。本试验调查是否化疗作为一个多学科的治疗方法的一部分，将提高降级，生存和复发率。患者和方法的随机研究包括207例局部不可切除的T4原发性直肠癌或局部复发直肠癌在1996年至2003年期间。放疗组109例，单纯放疗组98例，放疗组109例，放疗组98例，放疗组98例，放疗组109例。CRT组82例患者（84%）和RT组74例患者（68%）进行了R 0切除术（P = 0.009）。病理完全缓解率分别为16%和7%。R 0 + R1切除后，局部复发率分别为5%和7%，远处转移率分别为26%和39%。局部控制（5年时82% v67%;对数秩P = 0.03）、治疗失败时间（63% v44%; P = 0.003）、癌症特异性生存率（72% v55%; P = 0.02）和总生存率（66% v53%; P = 0.09）均有利于CRT组。3级或4级毒性，主要是GI，分别见于28/98例（29%）和6/109例（6%）（P = .001）。晚期毒副反应无差异。结论与单纯放疗相比，CRT可改善不可切除直肠癌患者的局部控制、治疗失败时间和肿瘤特异性生存率。治疗耐受性良好。
Purpose Preoperative chemoradiotherapy is considered standard treatment for locally advanced rectal cancer, although the scientific evidence for the chemotherapy addition is limited. This trial investigated whether chemotherapy as part of a multidisciplinary treatment approach would improve downstaging, survival, and relapse rate.Patients and Methods The randomized study included 207 patients with locally nonresectable T4 primary rectal carcinoma or local recurrence from rectal carcinoma in the period 1996 to 2003. The patients received either chemotherapy (fluorouracil/leucovorin) administered concurrently with radiotherapy (50 Gy) and adjuvant for 16 weeks after surgery (CRT group, n = 98) or radiotherapy alone (50 Gy; RT group, n = 109).Results The two groups were well balanced according to pretreatment characteristics. An R0 resection was performed in 82 patients (84%) in the CRT group and in 74 patients (68%) in the RT group (P = .009). Pathologic complete response was seen in 16% and 7%, respectively. After an R0 + R1 resection, local recurrence was found in 5% and 7%, and distant metastases in 26% and 39%, respectively. Local control (82% v 67% at 5 years; log-rank P = .03), time to treatment failure (63% v 44%; P = .003), cancer-specific survival (72% v 55%; P = .02), and overall survival (66% v 53%; P = .09) all favored the CRT group. Grade 3 or 4 toxicity, mainly GI, was seen in 28 (29%) of 98 and six (6%) of 109, respectively (P = .001). There was no difference in late toxicity.Conclusion CRT improved local control, time to treatment failure, and cancer-specific survival compared with RT alone in patients with nonresectable rectal cancer. The treatments were well tolerated.