Division of Clinical Oncology, Department of Internal Medicine I & Comprehensive Cancer Center, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Department of Pathology, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.
Med Oncol. 2018 Feb 7;35(3):32. doi: 10.1007/s12032-018-1087-6.
Three weekly high-dose chemotherapy regimens in combination with weekly cetuximab are the treatment of choice for patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (SCCHN), although the majority of patients suffer from severe side effects. Thus, we investigated the efficacy and safety of an alternative, more convenient and less toxic biweekly modified cisplatin, docetaxel plus cetuximab (TPEx) regimen in this retrospective analysis. Thirty-eight patients receiving off-protocol cisplatin (50 mg/m) in combination with docetaxel (50 mg/m) plus cetuximab (500 mg/m) every other week were included. Data collection included baseline demographic, response rate (ORR) and toxicity data as well as disease control rate, overall survival (OS) and progression-free survival (PFS). The median age was 60 years, and the majority of patients suffered from oral cavity carcinomas (44.7%) followed by oropharyngeal (28.9%) and laryngeal (17.9%) carcinomas. The ORR was 50%, and four (10.5%) patients achieved a complete response, while 15 (39.5%) patients had a partial response. The OS and PFS were 10.8 months (95% CI 6.7-14.2) and 6.3 months (95% CI 5.7-6.8), respectively. The one-year survival rate was 44.7%. The therapy was well tolerated, and the most common grade 3/4 adverse events were myelosuppression (13.2%), hypomagnesaemia (23.7%) and acne-like rash (13.1%). In conclusion, modified biweekly TPEx is of comparable efficacy with conventional TPEx and represents a well-tolerated regimen in R/M SCCHN patients. Further evaluation of this protocol in prospective clinical trials is warranted.
三种每周高剂量化疗方案联合每周西妥昔单抗是复发性/转移性（R/M）头颈部鳞状细胞癌（SCCHN）患者的首选治疗方法，尽管大多数患者都有严重的副作用。因此，我们在这项回顾性分析中研究了替代方案的疗效和安全性，即更方便、毒性更小的每两周一次的改良顺铂、多西他赛加西妥昔单抗（TPEx）方案。纳入了 38 例接受非方案顺铂（50mg/m）联合多西他赛（50mg/m）和西妥昔单抗（500mg/m）每两周一次治疗的患者。数据收集包括基线人口统计学、客观缓解率（ORR）和毒性数据，以及疾病控制率、总生存期（OS）和无进展生存期（PFS）。中位年龄为 60 岁，大多数患者患有口腔癌（44.7%），其次是口咽癌（28.9%）和喉癌（17.9%）。ORR 为 50%，4 例（10.5%）患者完全缓解，15 例（39.5%）患者部分缓解。OS 和 PFS 分别为 10.8 个月（95%CI 6.7-14.2）和 6.3 个月（95%CI 5.7-6.8）。一年生存率为 44.7%。该治疗方案耐受性良好，最常见的 3/4 级不良事件为骨髓抑制（13.2%）、低镁血症（23.7%）和痤疮样皮疹（13.1%）。总之，改良的每两周一次的 TPEx 与常规的 TPEx 具有相当的疗效，是 R/M SCCHN 患者耐受良好的方案。需要进一步在前瞻性临床试验中评估该方案。
