Alba E, Sanchez-Chaparro M A, Alonso L, Ribelles N, Ramon Delgado J, Rueda A, Pablo Tenllado P, Solano J, Urquiza R
Department of Oncology, Hospital Clinico Universitario, Malaga, Spain.
Am J Clin Oncol. 1996 Apr;19(2):140-3. doi: 10.1097/00000421-199604000-00010.
For patients with advanced, unresectable head and neck (HN) cancer, surgery and/or radiotherapy are the standard treatments but have poor results. A phase II trial of a continuous infusion of cisplatin, 5-FU, and high dose folinic acid (PFL) as induction chemotherapy in patients with previously untreated, locally advanced HN cancer was performed in an attempt to confirm the encouraging results reported by Dana Farber investigators using an identical regimen. Forty-five consecutive patients with unresectable HN cancer were treated every 28 days with a continuous infusion of cisplatin 25 mg/m(2)/day (days 1-5), 5-FU 800 mg/m(2)/day (days 2-6), and folinic acid 500 mg/m(2)/day (days 1-6). After three courses of chemotherapy, patients were treated with surgery and/or radiotherapy. Objective responses were observed in 26 of 38(69%) evaluable patients with 14(37%) clinical complete responses. Grade III-IV toxicity was important and consisted mainly of mucositis and neutropenia that were found in 47 and 18%, respectively , of patients after the first course. There was one toxic death. PFL is an active, toxic induction regimen for far-advanced HN cancer, yielding a response rate in the range of the widely used cisplatin and 5-FU (PF) schedule; a comparative trial is warranted before concluding that PFL is superior to the latter combination.
对于晚期不可切除的头颈部（HN）癌患者，手术和/或放疗是标准治疗方法，但效果不佳。进行了一项II期试验，对先前未经治疗的局部晚期HN癌患者持续输注顺铂、5-氟尿嘧啶（5-FU）和高剂量亚叶酸（PFL）作为诱导化疗，试图证实达纳法伯研究所的研究人员使用相同方案所报告的令人鼓舞的结果。45例连续的不可切除HN癌患者每28天接受一次持续输注顺铂25mg/m²/天（第1 - 5天）、5-FU 800mg/m²/天（第2 - 6天）和亚叶酸500mg/m²/天（第1 - 6天）的治疗。三个化疗疗程后，患者接受手术和/或放疗。在38例可评估患者中的26例（69%）观察到客观缓解，其中14例（37%）为临床完全缓解。III - IV级毒性较为显著，主要包括黏膜炎和中性粒细胞减少，分别在第一个疗程后的患者中占47%和18%。有1例因毒性死亡。PFL是一种针对极晚期HN癌的有效但有毒性的诱导方案，缓解率与广泛使用的顺铂和5-FU（PF）方案相当；在得出PFL优于后一种联合方案的结论之前，有必要进行一项对比试验。
