Raguse Jan Dirk, Gath Hans Joachim, Oettle Helmut, Bier Jürgen
Clinic and Policlinic for Oral and Maxillofacial Surgery, Plastic Surgery, Clinical Navigation and Robotics, Charité Universitätsmedizin Berlin, Campus Virchow Hospital, Augustenburger Platz 1, 13353 Berlin, Germany.
Oral Oncol. 2006 Jul;42(6):614-8. doi: 10.1016/j.oraloncology.2005.11.001. Epub 2006 Feb 20.
The purpose of this phase II trial was to investigate the efficacy and toxicity of oxaliplatin combined with folinic acid (FA) and 5-FU in patients with recurrent squamous cell carcinoma of the head and neck (scchn) in advanced stage of disease. Thirty-six patients with recurrent/metastatic disease with median age of 59 years were enrolled. Patients received oxaliplatin (85mg/m(2)) and FA (200mg/m(2)) followed by 5-FU (2000mg/m(2)) as 24h continuous infusion on day 1 and 15 in a 4-week cycle. On day 8 and 22 FA (200mg/m(2)) and 5-FU (2000mg/m(2)) were administered without oxaliplatin followed by two weeks without cytotoxic treatment. Toxic effects, length of survival and tumour response were assessable in 33/36 patients. The overall response was 60.6% with 7 (21.2%) complete responders (CR) and 13 (39.4%) partial responders (PR). Eight patients (24.2%) showed stable disease (SD) and 5 (15.2%) progressed. The median time to progression (TTP) was 8.1 month (range 2-14) and median overall survival was 10.8 months (range 5-16). The 1-year survival rate was 43.2%. The incidence of haematological toxicity was low but mild paraesthesias occurred in all patients received more then 3 cycles of cytotoxic therapy and dose reduction was necessary in two patients due to diarrhoea grade 3. In this small phase II study the combination of oxaliplatin, FA and 5-FU (OFF) demonstrated relative to the standard regimen of cisplatin and 5-FU a high antitumoural activity in previously treated scchn with favourable toxicity profile.
这项II期试验的目的是研究奥沙利铂联合亚叶酸（FA）和5-氟尿嘧啶（5-FU）对疾病晚期复发性头颈部鳞状细胞癌（scchn）患者的疗效和毒性。入组了36例复发/转移性疾病患者，中位年龄59岁。患者在第1天和第15天接受奥沙利铂（85mg/m²）和FA（200mg/m²），随后接受5-FU（2000mg/m²）持续24小时静脉滴注，每4周为一个周期。在第8天和第22天给予FA（200mg/m²）和5-FU（2000mg/m²），不使用奥沙利铂，随后两周不进行细胞毒性治疗。33/36例患者可评估毒性作用、生存期和肿瘤反应。总缓解率为60.6%，其中7例（21.2%）为完全缓解（CR），13例（39.4%）为部分缓解（PR）。8例患者（24.2%）疾病稳定（SD），5例（15.2%）病情进展。中位疾病进展时间（TTP）为8.1个月（范围2-14个月），中位总生存期为10.8个月（范围5-16个月）。1年生存率为43.2%。血液学毒性发生率较低，但所有接受超过3个周期细胞毒性治疗的患者均出现轻度感觉异常，2例患者因3级腹泻需要降低剂量。在这项小型II期研究中，相对于顺铂和5-FU的标准方案，奥沙利铂、FA和5-FU（OFF）联合方案在先前治疗的scchn中显示出较高的抗肿瘤活性，且毒性特征良好。
