RECOMBINANT KERATINOCYTE GROWTH FACTOR IN HEAD & NECK CANCER

在放射+/-化疗的最终治疗期间，粘膜炎会导致相当高的发病率和经常不受欢迎的治疗中断。重组角质形成细胞生长因子(KGF)的I/II期研究被提出，试图克服严重的粘膜炎。初步信息包括在人类志愿者中测试重组角质形成细胞生长因子及其与治疗剂的相互作用。符合条件的局部晚期头颈癌患者将在一项随机、双盲、安慰剂控制的剂量递增研究中接受明确的放射+化疗。计划在放疗/化疗前启动生长因子的三个剂量水平，并每周重复。患者将在治疗后最多2个月接受急性反应评估，并在1年内评估挥之不去的口干症、其他晚期影响和生活质量。未来的研究将确定头颈部癌症患者使用KGF的最佳剂量和时机，并将这种药物应用于也受粘膜炎影响的其他部位(肺和食道)的治疗。

Mucositis results in considerable morbidity and often undesired treatment interruption during definitive treatment for head and neck cancer with radiation +/- chemotherapy. A Phase I/II study of recombinant keratinocyte growth factor (KGF) is proposed in an attempt to overcome severe mucositis. Preliminary information including testing of recombinant keratinocyte growth factor in human volunteers and its interaction with therapeutic agents has been accomplished. Eligible patients with locally advanced head and neck cancer will receive definitive radiation + chemotherapy in a randomized, double-blind, placebo-controlled dose escalation study. Three dose levels are planned with the initiation of growth factor prior to radiation/chemotherapy and repeated weekly. Patients will be evaluated for acute effects up to 2 months after therapy and for lingering xerostomia, other late effects and quality of life for 1 year. Future studies would define the optimal dose and timing of KGF for head and neck cancer patients and adapt this agent for treatment of other sites (lung and esophagus) which are also affected by mucositis.