Huber M H, Lippman S M, Benner S E, Shirinian M, Dimery I W, Dunnington J S, Hong W K
Department of Thoracic/Head & Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
Am J Clin Oncol. 1996 Aug;19(4):379-82. doi: 10.1097/00000421-199608000-00012.
Chemotherapy has not significantly altered the overall survival of patients with recurrent squamous cell carcinoma of the head and neck; therefore, the development of new agents is essential. The purpose of the current phase II study was to define the efficacy of ifosfamide in the treatment of recurrent squamous cell carcinoma of the head and neck. All patients were required to have squamous cell carcinoma of the head and neck that had recurred following surgery or radiotherapy or both. Patients may have received prior chemotherapy. Patients were initially treated with ifosfamide 2 g/m2/day for 4 days (dose level 0). Dose level-1 was 2 g/m2/day for 3 days, and dose level-2 was 2 g/m2/day for 2 days. All patients received mesna 400 mg/m2/day prior to and 1,200 mg/m2/day as a continuous infusion after ifosfamide. Thirty-eight patients were enrolled in the study. Five patients were inevaluable for toxicity or response. Overall, the regimen was well tolerated, with grade 4 granulocytopenia the only significant toxicity occurring in 16 patients. Overall, eight of 31 evaluable patients (25.8%) had a major response. Only one of the 10 patients (10%) with prior chemotherapy responded, but seven of the 21 patients (33.3%) with no prior chemotherapy had major responses. Ifosfamide is an active agent in recurrent squamous cell carcinoma of the head and neck. Further studies of ifosfamide in combination with other agents, particularly as induction therapy in patients with locally advanced disease, are warranted.
化疗并未显著改变复发性头颈部鳞状细胞癌患者的总生存期；因此，研发新型药物至关重要。本II期研究的目的是确定异环磷酰胺治疗复发性头颈部鳞状细胞癌的疗效。所有患者均需患有头颈部鳞状细胞癌，且该癌症在手术或放疗或两者之后复发。患者可能曾接受过化疗。患者最初接受异环磷酰胺2 g/m²/天，共4天（剂量水平0）。剂量水平1为2 g/m²/天，共3天，剂量水平2为2 g/m²/天，共2天。所有患者在异环磷酰胺给药前接受美司钠400 mg/m²/天，并在异环磷酰胺给药后以1200 mg/m²/天的剂量持续输注。38名患者入组本研究。5名患者因毒性或反应而无法评估。总体而言，该方案耐受性良好，16名患者出现的唯一显著毒性为4级粒细胞减少。总体而言，31名可评估患者中有8名（25.8%）有主要反应。10名曾接受化疗的患者中只有1名（10%）有反应，但21名未接受过化疗的患者中有7名（33.3%）有主要反应。异环磷酰胺是复发性头颈部鳞状细胞癌的一种有效药物。有必要进一步研究异环磷酰胺与其他药物联合使用的情况，特别是作为局部晚期疾病患者的诱导治疗。
