Su Nai-Wen, Leu Yi-Shing, Lee Jehn-Chuan, Chen Yu-Jen, Chen Hong-Wen, Liu Chung-Ji, Chang Yi-Fang
Department of Hematology and Medical Oncology, Mackay Memorial Hospital, Taipei, Taiwan, ROC.
Acta Otolaryngol. 2011 Dec;131(12):1333-40. doi: 10.3109/00016489.2011.616226. Epub 2011 Oct 23.
The low-dose regimen brought less grade 3?4 neutropenia and mucositis with similar treatment efficacy. It should be further investigated in prospective randomized clinical trials to confirm its effectiveness and tolerability.
This nonrandomized study compared the efficacy and toxicity profiles of two dose levels of cisplatin/5-fluorouracil (5-FU) as the chemoradiotherapy regimen for the treatment of locally advanced squamous cell carcinoma of the head and neck.
Concurrent chemotherapy consisted of two dose levels: a low dose (cisplatin 12 mg/m(2) + 5-FU 600 mg/m(2) per day) or a high dose (cisplatin 15 mg/m(2) + 5-FU 750 mg/m(2) per day). Both were administered as a 5-day continuous infusion in week 1 and week 5 during radiotherapy.
With a median follow-up of 44 months, the overall survival and disease-free survival were 35 months and 22 months (n = 67) for the low-dose group and 36 months and 33 months for the high-dose group (n = 96). The 2-year locoregional control rate was 67.2% for the low-dose and 66.8% for the high-dose group. No statistically significant differences were demonstrated in the treatment efficacy end points. The high-dose regimen resulted in significantly more grade 3?4 neutropenia (31.5% vs 10.9%, p = 0.003) and a trend towards more mucositis (62.1% vs 49.3%, p = 0.066).
低剂量方案导致的3/4级中性粒细胞减少和黏膜炎较少，且治疗效果相似。应在前瞻性随机临床试验中进一步研究以证实其有效性和耐受性。
本非随机研究比较了两种剂量水平的顺铂/5-氟尿嘧啶（5-FU）作为头颈部局部晚期鳞状细胞癌放化疗方案的疗效和毒性特征。
同步化疗包括两种剂量水平：低剂量（顺铂12mg/m² + 5-FU 600mg/m² 每日）或高剂量（顺铂15mg/m² + 5-FU 750mg/m² 每日）。两者均在放疗的第1周和第5周进行为期5天的持续输注。
中位随访44个月，低剂量组的总生存期和无病生存期分别为35个月和22个月（n = 67），高剂量组为36个月和33个月（n = 96）。低剂量组和高剂量组的2年局部区域控制率分别为67.2%和66.8%。治疗效果终点未显示出统计学上的显著差异。高剂量方案导致显著更多的3/4级中性粒细胞减少（31.5%对10.9%，p = 0.003）以及更严重黏膜炎的趋势（62.1%对49.3%，p = 0.066）。
