Posner M R, Lefebvre J L
Head and Neck Oncology Program, Dana-Farber Cancer Institute, SW430H, 44 Binney street, Boston, MA 02115, USA.
Br J Cancer. 2003 Jan 13;88(1):11-7. doi: 10.1038/sj.bjc.6600685.
Patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) are often treated with induction chemotherapy or chemoradiotherapy, but to date without major impact on survival. The combination of cisplatin-5-fluorouracil (5-FU) (PF) has been used as standard induction therapy; however, poor patient survival has stimulated investigation into new agents with potential activity in SCCHN. Docetaxel has significant single-agent activity in SCCHN and has been investigated in combination with PF regimens as induction therapy. The results of six phase II studies of docetaxel-PF regimens (TPF) as induction in locally advanced SCCHN patients are reviewed and reported. Consistently, high 2-year survival rates and overall response rates were demonstrated across the phase II trials in the range 42-82 and 71-100%, respectively. The toxicity profile seen with TPF-based regimens was acceptable. The primary toxicity was neutropenia, which together with gastrointestinal complaints accounted for the majority of adverse events. Given the encouraging phase II experience with TPF-based regimens, two large-scale phase III studies comparing TPF-based regimens with standard PF regimens are underway. The results have significant potential for validating the findings of the phase II studies, demonstrating improved survival and overall response of patients treated with docetaxel-based induction chemotherapy.
局部晚期头颈部鳞状细胞癌(SCCHN)患者通常接受诱导化疗或放化疗,但迄今为止对生存率并无重大影响。顺铂-5-氟尿嘧啶(5-FU)(PF)联合方案一直被用作标准诱导治疗;然而,患者生存率较低促使人们对在SCCHN中具有潜在活性的新药展开研究。多西他赛在SCCHN中具有显著的单药活性,并已被研究用于与PF方案联合作为诱导治疗。本文回顾并报告了六项多西他赛-PF方案(TPF)作为局部晚期SCCHN患者诱导治疗的II期研究结果。在各项II期试验中,一致显示出较高的2年生存率和总缓解率,分别在42%-82%和71%-100%范围内。基于TPF的方案所观察到的毒性特征是可接受的。主要毒性为中性粒细胞减少,其与胃肠道不适一起构成了大多数不良事件。鉴于基于TPF的方案在II期试验中的令人鼓舞的经验,两项比较基于TPF的方案与标准PF方案的大规模III期研究正在进行中。这些结果极有可能验证II期研究的结果,证明接受基于多西他赛的诱导化疗的患者生存率和总缓解率有所提高。