González-Larriba J L, Garcia Carbonero I, Sastre Valera J, Perez Segura P, Diaz-Rubio E
Division of Medical Oncology, Hospital Universitario San Carlos, Universidad Complutense, Madrid, Spain.
Oncology (Williston Park). 1997 Sep;11(9 Suppl 10):90-7.
This study compared the activity and toxicity of fluorouracil (5-FU)/ cisplatin with the combination tegafur and uracil (UFT)/cisplatin in the neoadjuvant treatment of locally advanced-stage III or IV (MO)-head and neck cancer. A total of 67 patients were randomly assigned to treatment with cisplatin 100 mg/m2 on day 1 followed by either a continuous infusion of 5-FU 1,000 mg/m2/day on days 2 through 6 (group 1) or oral administration of UFT 300 mg/m2/day on days 2 through 20 (group 2). Both treatments were repeated every 21 days for four cycles. Responding patients received locoregional standard radiotherapy (50 to 70 Gy) after chemotherapy. Group 1 was comprised of 34 patients, 30 of whom were men, with a median age of 57.5 years; 79% of this group had a Karnofsky performance status of 90% to 100%; 70% had a squamous and 29% an undifferentiated histology. The majority (85%) had stage IV disease. Of the 33 patients in group 2, 29 were men. The median age was 56 years. Most (88%) had a performance status of 90% to 100%. More patients had a squamous than an undifferentiated histology (82% vs 18%) and most (88%) had stage IV disease. Overall response in group 1 was 73% (21% complete) compared with 79% (18% complete) in group 2. At a median follow-up of 84 months, no significant differences have emerged in overall survival, 15 vs 37 months, or time to progression, 8.5 vs 14.5 months, for groups 1 and 2, respectively. Toxicity was also similar, except for phlebitis, which occurred significantly more often in group 1 (71% vs 9%). Cisplatin/UFT was as effective as the classic cisplatin/5-FU regimen and has the advantages of outpatient oral administration and a lower incidence of phlebitis.
本研究比较了氟尿嘧啶（5-FU）/顺铂与替加氟尿嘧啶（替加氟/尿嘧啶，UFT）/顺铂联合方案在局部晚期III期或IV期（M0）头颈癌新辅助治疗中的活性和毒性。共有67例患者被随机分配接受治疗，第1天给予顺铂100mg/m²，随后，第2至6天持续输注5-FU 1000mg/m²/天（第1组），或第2至20天口服UFT 300mg/m²/天（第2组）。两种治疗均每21天重复一次，共四个周期。缓解的患者在化疗后接受局部区域标准放疗（50至70Gy）。第1组由34例患者组成，其中30例为男性；中位年龄为57.5岁。该组79%的患者卡氏评分90%至100%；70%为鳞状组织学类型，29%为未分化组织学类型。大多数（85%）为IV期疾病。第2组的33例患者中，29例为男性。中位年龄为56岁。大多数（88%）患者的体能状态为90%至100%。鳞状组织学类型的患者多于未分化组织学类型的患者（82%对18%），大多数（88%）为IV期疾病。第1组的总缓解率为73%（21%为完全缓解），而第2组为79%（18%为完全缓解）。在中位随访84个月时，第1组和第2组的总生存期分别为15个月和37个月，无进展生存期分别为8.5个月和14.5个月，均未出现显著差异。毒性反应也相似，但静脉炎除外，第1组静脉炎的发生率明显更高（71%对9%）。顺铂/UFT与经典的顺铂/5-FU方案疗效相当，具有门诊口服给药的优势，且静脉炎发生率较低。
