Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy for Locally Advanced Head and Neck Cancer: A Randomized Phase II Trial
Cetuximab and Radiotherapy Versus Cisplatin and Radiotherapy for Locally Advanced Head and Neck Cancer: A Randomized Phase II Trial
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DOI：
10.1200/jco.2015.63.1671
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发表时间：
2016-02-10
影响因子：
45.3
通讯作者：
Grisanti, Salvatore
中科院分区：
文献类型：
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作者：
Magrini, Stefano Maria;Buglione, Michela;Grisanti, Salvatore
目的：目前还没有直接比较放疗（RT）联合顺铂（CDDP）与联合西妥昔单抗（CTX）作为局部晚期头颈部鳞状细胞癌一线治疗的随机试验。在这项随机试验中，我们比较了这两种治疗方案的依从性，毒性和effictiveness.Patients and MethodsEligible患者被随机分配在1：1的比例接受CDDP 40 mg/m（2）每周一次或CTX 400 mg/m（2）作为负荷剂量，然后CTX 250 mg/m（2）每周一次伴随根治性RT。对于主要终点，治疗依从性被定义为治疗停止和药物剂量减少的天数。根据美国国家癌症研究所通用毒性标准定义急性毒性率。疗效终点是局部无复发生存，无转移生存，癌症特异性生存，和总survival.ResultsThe研究被提前终止，因为缓慢的收益后，招募70例患者。13%的CTX组患者和0%的CDDP组患者RT中断超过10天（P = 0.05）。CTX组和CDDP组的药物剂量减少率分别为34%和53%（差异无统计学意义）。两组之间的毒性特征不同，CDDP组的血液学、肾脏和胃肠道毒性更常见，CTX组的皮肤毒性和营养支持需求更常见。与治疗相关的严重不良事件，包括4例与1例中毒性死亡，CTX组更高（19%比3%，P = 0.044）。局部区域控制，失败的模式，和生存率之间的治疗arms.ConclusionCTX伴随RT降低依从性和急性毒性率增加。两组的疗效结局相似。这些结果提出了适当选择头颈癌患者的问题，这些患者可以从CTX联合RT中获益。（C）2015年美国临床肿瘤学会
PurposeNo randomized trials have been conducted to directly compare radiotherapy (RT) with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced squamous cell carcinoma of the head and neck. In this randomized trial, we compared these two treatment regimens in terms of compliance, toxicity, and efficacy.Patients and MethodsEligible patients were randomly assigned in a 1:1 ratio to receive either CDDP 40 mg/m(2) once per week or CTX 400 mg/m(2) as loading dose followed by CTX 250 mg/m(2) once per week concomitant to radical RT. For primary end points, compliance to treatment was defined as number of days of treatment discontinuation and drug dosage reduction. The acute toxicity rate was defined according to the National Cancer Institute Common Toxicity Criteria. Efficacy end points were local recurrence-free survival, metastasis-free survival, cancer-specific survival, and overall survival.ResultsThe study was discontinued early because of slow accrual after the enrollment of 70 patients. RT discontinuation for more than 10 days occurred in 13% of patients given CTX and 0% given CDDP (P = .05). Drug dosage reduction occurred in 34% given CTX and 53% given CDDP (difference not significant). Toxicity profiles differed between the two arms, with hematologic, renal, and GI toxicities more frequent in the CDDP arm, and cutaneous toxicity and the need for nutritional support more frequent in the CTX arm. Serious adverse events related to treatment, including four versus one toxic deaths, were higher in the CTX arm(19% v 3%, P = .044). Locoregional control, patterns of failure, and survivals were similar between the treatment arms.ConclusionCTX concomitant to RT lowered compliance and increased acute toxicity rates. Efficacy outcomes were similar in both arms. These results raise the issue of appropriately selecting patients with head and neck cancer who can benefit from CTX in combination with RT. (C) 2015 by American Society of Clinical Oncology