Dreyfuss A I, Clark J R, Norris C M, Rossi R M, Lucarini J W, Busse P M, Poulin M D, Thornhill L, Costello R, Posner M R
Head and Neck Oncology Program, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
J Clin Oncol. 1996 May;14(5):1672-8. doi: 10.1200/JCO.1996.14.5.1672.
We conducted a phase II study designed to evaluate the activity, safety, and tolerability of docetaxel (Taxotere: Rhône-Poulenc Rorer Pharmaceuticals Inc, Collegeville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who had not received prior palliative chemotherapy.
Thirty-one patients with measurable, locoregional, or metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m2 as a 1-hour intravenous (i.v.) infusion once every 21 days on an outpatient basis. All patients were premedicated with dexamethasone, diphenhydramine, and cimetidine. Prophylactic administration of growth factors or antiemetics was not permitted.
Thirty-one patients were treated. Twenty-nine patients were assessable for response and 30 for toxicity. Four of 31 patients (13%) achieved complete response (CR), nine (29%) achieved partial response had stable disease (SD) and seven (23%) experienced progression of disease (PD). The major response rate was 42% (95% confidence interval [CI], 24% to 60%). The median duration of responses was 5 months (range, 2 to 14). The principal toxicity was leukopenia, which occurred with rapid onset and brief duration. Sixteen patients (53%) experienced nadir fever, and 13 required dose reduction. Hypersensitivity reactions occurred in four patients. Grade 3 peripheral neuropathy occurred in two patients; grade 2 or 3 fatigue occurred in six (20%) and 10 (33%), respectively. Minimal edema (grade 1) occurred in five patients (17%). Clinically significant mucositis, diarrhea, or dermatitis were not observed.
Docetaxel has major activity against SCCHN. It appears to be well tolerated in this group of patients and can be safely administered on an outpatient basis. Premedication with dexamethasone, cimetidine, and diphenhydramine is associated with a reduced incidence of significant edema, hypersensitivity reactions, and dermatologic toxicities.
我们开展了一项II期研究，旨在评估多西他赛（泰索帝：罗纳普朗克乐若制药公司，宾夕法尼亚州学院站）对既往未接受过姑息化疗的晚期、无法治愈或复发性头颈部鳞状细胞癌（SCCHN）患者的活性、安全性和耐受性。
31例可测量的局部区域或转移性SCCHN患者接受多西他赛治疗，剂量为100mg/m²，作为1小时静脉输注，每21天门诊给药一次。所有患者均预先使用地塞米松、苯海拉明和西咪替丁进行预处理。不允许预防性使用生长因子或止吐药。
31例患者接受了治疗。29例患者可评估疗效，30例可评估毒性。31例患者中有4例（13%）达到完全缓解（CR），9例（29%）达到部分缓解，10例病情稳定（SD），7例（23%）疾病进展（PD）。主要缓解率为42%（95%置信区间[CI]，24%至60%）。缓解的中位持续时间为5个月（范围，2至14个月）。主要毒性为白细胞减少，起病迅速且持续时间短暂。16例患者（53%）出现最低点发热，13例需要降低剂量。4例患者发生过敏反应。2例患者出现3级周围神经病变；6例（20%）和10例（33%）分别出现2级或3级疲劳。5例患者（17%）出现轻度水肿（1级）。未观察到具有临床意义的粘膜炎、腹泻或皮炎。
多西他赛对SCCHN具有主要活性。在这组患者中似乎耐受性良好，可在门诊安全给药。使用地塞米松、西咪替丁和苯海拉明进行预处理可降低明显水肿、过敏反应和皮肤毒性的发生率。
