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首页> 外文期刊>Radiotherapy and oncology: Journal of the European Society for Therapeutic Radiology and Oncology >Double blind randomized phase II study with radiation+5-fluorouracil+/-celecoxib for resectable rectal cancer.
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Double blind randomized phase II study with radiation+5-fluorouracil+/-celecoxib for resectable rectal cancer.

机译：放射+ 5-氟尿嘧啶+/-塞来昔布用于可切除直肠癌的双盲随机II期研究。

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摘要

PURPOSE: To assess the feasibility and efficacy of the COX-2 inhibitor celecoxib in conjunction with preoperative chemoradiation for patients with locally advanced rectal cancer in a double blind randomized phase II study. MATERIALS AND METHODS: Thirty-five patients of the initially planned 80 patients with locally advanced rectal cancer were treated with preoperative radiation (45 Gy; 1.8 Gy/fraction, 5 days/week) combined with 5-fluorouracil (continuous infusion, 225 mg/m(2)/day) and celecoxib (2 x 400 mg/day) or placebo. Pathological response and toxicity of study treatment were evaluated, as well as expression of COX-2 and Ki67 in tumor tissue and IL-6 in plasma as possible molecular correlates and predictors of response to treatment. RESULTS: Patients treated with celecoxib tended to show a better response (61%) when compared to those treated with placebo (35%), although not significant (p=0.13). T-downstaging and N-downstaging were also slightly higher with celecoxib. Plasma IL-6 levels and intratumoral COX2 or Ki67 were altered by chemoradiation, but were not further altered by celecoxib treatment and therefore not useful for prediction of treatment benefit. Celecoxib therapy in conjunction with chemoradiation was not associated with additional toxicity and seemed to help mitigate therapy-related pain. CONCLUSIONS: Addition of celecoxib to preoperative chemoradiation is feasible for patients with locally advanced rectal cancer. To study the individual effect of COX-2 inhibitors on pathological response phase III studies are required.
机译：目的：在一项双盲随机II期研究中，评估COX-2抑制剂塞来昔布联合术前放化疗对局部晚期直肠癌患者的可行性和疗效。材料与方法：在最初计划的80位局部晚期直肠癌患者中，有35位患者接受了术前放疗（45 Gy; 1.8 Gy /次，5天/周）联合5-氟尿嘧啶（连续输注，225 mg / m（2）/天）和塞来昔布（2 x 400 mg /天）或安慰剂。评估了研究治疗的病理反应和毒性，以及肿瘤组织中COX-2和Ki67的表达以及血浆IL-6的表达，认为它们可能是与治疗反应相关的分子和预测因子。结果：与安慰剂治疗的患者（35％）相比，塞来昔布治疗的患者倾向于显示出更好的反应（61％），尽管无统计学意义（p = 0.13）。塞来昔布的T-降级和N-降级也略高。血浆IL-6水平和肿瘤内COX2或Ki67通过化学放疗而改变，但塞来昔布治疗并未进一步改变，因此不能用于预测治疗获益。塞来昔布疗法联合化学放疗与其他毒性无关，似乎有助于减轻与治疗有关的疼痛。结论：对于局部晚期直肠癌患者，术前放化疗中加入塞来昔布是可行的。要研究COX-2抑制剂对病理反应III期研究的个体作用，需要进行研究。

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