Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD, USA.
Int J Radiat Oncol Biol Phys. 2012 Apr 1;82(5):1845-50. doi: 10.1016/j.ijrobp.2011.02.062. Epub 2011 May 19.
To report the mature data of a prospective Phase II trial designed to evaluate the efficacy of an epidermal growth factor receptor inhibitor cetuximab (CTX) added to the concurrent therapy of weekly paclitaxel/carboplatin (PC) and daily radiation therapy (RT).
From 2005 to 2009, a total of 43 patients were enrolled in the study. The median follow-up was 31 months (range, 9-59 months). All patients had Stage III/IV disease at presentation, and 67% had oropharyngeal primaries. The weekly IV dose schedules were CTX 250 mg/m(2) (400 mg/m(2) IV loading dose 1 week before RT), paclitaxel 40 mg/m(2), and carboplatin AUC 2. RT was given at 1.8 Gy per day to 70.2 Gy. Intensity-modulated RT was used in 70% of cases.
All patients completed the planned RT dose, 74% without any treatment breaks. The planned CTX and PC cycles were completed in 70% (91% with at least seven of planned nine cycles) and 56% (93% with at least seven of planned eight cycles) of patients, respectively. Toxicity included Grade 3 mucositis (79%), rash (9%), leucopenia (19%), neutropenia (19%), and RT dermatitis (16%). The complete response (CR) rate at the completion of therapy was 84%. The estimated 3-year local regional control rate was 72%. Six patients with an initial CR subsequently experienced a local recurrence, 10 patients experienced distant progression. The median overall survival and disease-free survivals have not been reached. The 3-year actuarial overall survival and disease-free survival were 59% and 58%, respectively.
The addition of CTX to weekly PC and daily RT was well tolerated and resulted in encouraging local control and survival rates.
报告一项旨在评估表皮生长因子受体抑制剂西妥昔单抗（CTX）联合每周紫杉醇/卡铂（PC）联合每日放疗（RT）同期治疗疗效的前瞻性 II 期试验的成熟数据。
2005 年至 2009 年，共纳入 43 例患者。中位随访时间为 31 个月（范围 9-59 个月）。所有患者均为 III/IV 期初诊疾病，67%为口咽原发病灶。每周 IV 剂量方案为 CTX 250 mg/m²（RT 前 1 周给予 400 mg/m² 静脉推注负荷剂量），紫杉醇 40 mg/m²，卡铂 AUC 2。RT 剂量为 1.8 Gy/d，总剂量 70.2 Gy。70%的病例采用调强放疗。
所有患者均完成了计划的 RT 剂量，74%的患者未中断治疗。计划的 CTX 和 PC 周期分别完成了 70%（91%至少完成了计划的 9 个周期中的 7 个周期）和 56%（93%至少完成了计划的 8 个周期中的 7 个周期）。毒性包括 3 级黏膜炎（79%）、皮疹（9%）、白细胞减少（19%）、中性粒细胞减少（19%）和 RT 性皮炎（16%）。治疗结束时完全缓解（CR）率为 84%。估计 3 年局部区域控制率为 72%。6 例初始 CR 的患者随后出现局部复发，10 例患者出现远处进展。中位总生存期和无病生存期均未达到。3 年的总生存率和无病生存率分别为 59%和 58%。
CTX 联合每周 PC 和每日 RT 治疗耐受性良好，局部控制率和生存率令人鼓舞。
