Baghi Mehran, Hambek Markus, May Angelika, Radeloff Andreas, Gstoettner Wolfgang, Knecht Rainald
Department for ENT-Surgery, University of Frankfurt am Main, Germany.
Anticancer Res. 2006 Jan-Feb;26(1B):559-63.
In this phase II study, the efficacy and toxicity of a triple chemotherapy with docetaxel, cisplatin and 5- Fluorouracil (TPF) was evaluated in the adjuvant therapy of locoregionally advanced cancer of the head and neck. This represented the first use of polychemotherapy as single adjuvant therapy after surgery.
Twenty patients with stage II-IV (UICC) squamous cell carcinoma of the head and neck (SCCHN) were treated by surgery of the primary and the regional lymph nodes. Four weeks after surgery, all patients received polychemotherapy consisting of docetaxel 75 mg/m2 day 1, cisplatin 100 mg/m2 day 1 and 5- Fluorouracil (5- FU) 1000 mg/m2 days 1 through 4 (total dose 4000 mg/m2), on days 1, 22 and 43 for a maximum of 3 cycles. The performance status of all patients at the beginning of the chemotherapy was 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
Fifty-eight cycles were administered to the 20 patients. The major acute toxicities were mucositis (2 patients) and febrile neutropenia (4 patients). One patient dropped out after the first cycle because of severe mucositis. After a median follow-up of 16.5 months (range, 1-41 months), the median time to progression was 20 months (range, 16-22 months). The estimated overall survival according to Kaplan-Meier at the median time of follow-up was 90%. No distant metastases were detectable after the adjuvant chemotherapy with TPF in locally advanced SCCHN, neither were late effects observed.
TPF was tolerated, with an acceptable toxicity profile, in patients with a good performance status. The preliminary results appear to justify further investigations to evaluate the efficacy of this modality in the adjuvant setting.
在这项II期研究中，评估了多西他赛、顺铂和5-氟尿嘧啶（TPF）三联化疗在局部晚期头颈癌辅助治疗中的疗效和毒性。这是首次将多药化疗作为手术后的单一辅助治疗方法。
20例II-IV期（国际抗癌联盟[UICC]）头颈鳞状细胞癌（SCCHN）患者接受了原发灶和区域淋巴结手术。术后4周，所有患者接受多药化疗，具体方案为：多西他赛75mg/m²，第1天；顺铂100mg/m²，第1天；5-氟尿嘧啶（5-FU）1000mg/m²，第1至4天（总剂量4000mg/m²），在第1、22和43天给药，最多3个周期。根据东部肿瘤协作组（ECOG）标准，所有患者化疗开始时的体能状态评分为0-1分。
20例患者共接受了58个周期的化疗。主要急性毒性反应为黏膜炎（2例患者）和发热性中性粒细胞减少（4例患者）。1例患者因严重黏膜炎在第1个周期后退出研究。中位随访16.5个月（范围1-41个月），中位疾病进展时间为20个月（范围16-22个月）。根据Kaplan-Meier法估计，随访中位时间时的总生存率为90%。局部晚期SCCHN患者接受TPF辅助化疗后未发现远处转移，也未观察到晚期效应。
对于体能状态良好的患者，TPF耐受性良好，毒性反应可接受。初步结果似乎证明有必要进一步研究以评估这种治疗方式在辅助治疗中的疗效。
