Docetaxel: An active drug for squamous cell carcinoma of the head and neck
Docetaxel: An active drug for squamous cell carcinoma of the head and neck
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DOI：
10.1200/jco.1996.14.5.1672
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发表时间：
1996-05-01
影响因子：
45.3
通讯作者：
Posner, MR
中科院分区：
文献类型：
--
作者：
Dreyfuss, AI;Clerk, JR;Posner, MR
目的：我们进行了一项 II 期研究，旨在评估多西紫杉醇（泰索帝：Rhone-Poulene Rorer Pharmaceuticals Inc，Collegeville，PA）在未接受过姑息性化疗的晚期、无法治愈或复发性头颈鳞状细胞癌 (SCCHN) 患者中的活性、安全性和耐受性。 患者和方法： 31 名患有可测量的局部转移性 SCCHN 的患者接受了治疗。在门诊接受多西紫杉醇治疗，剂量为 100 mg/m(2)，每 21 天一次 1 小时静脉 (IV) 输注。所有患者均预先服用地塞米松、苯海拉明和西咪替丁。不允许预防性施用生长因子或止吐药。结果：31 名患者接受治疗。二十九名患者；可评估反应，30 可评估毒性。 31 名患者中有 4 名 (13%) 获得完全缓解 (CR)，9 名 (29%) 获得部分缓解 (PR)，9 名 (29%) 疾病稳定 (SD)，7 名 (23%) 经历疾病进展 (PD)。主要缓解率为 42%（95% 置信区间 [CI]，24% 至 60%），中位缓解持续时间为 5 个月（范围：2 至 14）。主要毒性是白细胞减少，起效快且持续时间短。 16 名患者 (53%) 出现最低热，其中 13 名患者需要减少剂量。 4 名患者出现过敏反应。两名患者出现 3 级周围神经病变； 2 级或 3 级疲劳分别发生在 6 名（20%）和 10 名（33%）。 5 名患者 (17%) 出现轻微水肿（1 级）。未观察到有临床意义的粘膜炎、腹泻或皮炎。结论：多西紫杉醇对SCCHN具有显着活性。该药物在这组患者中似乎具有良好的耐受性，并且可以在门诊安全地给药。术前使用地塞米松、西咪替丁和苯海拉明可降低严重水肿、过敏反应和皮肤毒性的发生率。 (C) 1996 年，美国临床肿瘤学会。
Purpose: We conducted a phase II study designed to evaluate activity, safety, and tolerability of docetaxel (Taxotere: Rhone-Poulene Rorer Pharmaceuticals Inc, Collegeville, PA) in patients with advanced, incurable, or recurrent squamous cell carcinoma of the head and neck (SCCHN) who herd not received prior palliative chemotherapy.Patients and Methods: Thirty-one patients with measurable, locoregional, of metastatic SCCHN were treated with docetaxel, administered at a dose of 100 mg/m(2) as a 1-hour intravenous (IV) 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.Results: 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 (PR), nine (29%) 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.Conclusion: 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. (C) 1996 by American Society of Clinical Oncology.