A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck.
A phase II study of docetaxel in patients with metastatic squamous cell carcinoma of the head and neck.
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多西他赛对头颈部转移性鳞状细胞癌患者的II期研究。
DOI：
10.1038/sj.bjc.6690715
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发表时间：
1999-10
影响因子：
8.8
通讯作者：
Armand, JP
中科院分区：
文献类型：
--
作者：
Couteau, C;Chouaki, N;Leyvraz, S;Oulid-Aissa, D;Lebecq, A;Domenge, C;Groult, V;Bordessoule, S;Janot, F;De Forni, M;Armand, JP
本研究旨在评价多西他赛（D）在选定的头颈部转移性鳞状细胞癌（SCCHN）人群中的活性、安全性和耐受性。24例既往未接受过姑息治疗的患者入组，接受D 100 mg m−2输注1 h，每3周一次。除两名患者外，所有患者均接受了肺转移部位疗效评价。未预防性给予止吐药或生长因子。在22例患者中进行了药代动力学研究。21例患者可评估反应，24例可评估毒性。给予104个周期，每例患者的中位数为4.5（范围1-9）。中位累积剂量为449 mg m−2。5例患者达到部分缓解，中位持续时间为18.7周（范围13.1-50.3）。总体缓解率为20.8%，中位持续时间为11.0周（范围2.4-52.6）。最常见的副作用是中性粒细胞减少（79.2% IV级），但持续时间短（中位数4天），无发热性中性粒细胞减少。中度/重度液体潴留的发生率为29.2%，有一次治疗中止。其他毒性（所有级别）常见（皮肤75%、虚弱50%、感染29.2%、恶心16.7%、腹泻12.5%、口腔炎16.7%、呕吐8.3%和HSR 8.3%）。在药代动力学分析中发现平均清除率为19.6 l h−1 m−2，曲线下面积为6.00 μg ml−1 h−1。多西他赛在所选的转移性SCCHN人群中具有活性，具有良好的耐受性。© 1999癌症研究运动
This study was designed to evaluate the activity, safety and tolerance of docetaxel (D) in a selected population with metastatic squamous cell carcinoma of the head and neck (SCCHN). Twenty-four patients with no prior palliative therapy were enrolled and received D 100 mg m−2 by 1 h of infusion, every 3 weeks. All but two patients had been evaluated for efficacy on lung metastatic sites. No prophylactic administration of anti-emetics or growth factors was given. A pharmacokinetic study was performed in 22 patients. Twenty-one patients were assessable for response and 24 for toxicity. One hundred and four cycles were administered with a median of 4.5 (range 1–9) per patient. The median cumulative dose was 449 mg m−2. Partial responses were achieved in five patients with a median duration of 18.7 weeks (range 13.1–50.3). The overall response rate was 20.8% with a median duration of 11.0 weeks (range 2.4–52.6). The most frequent side-effect was neutropenia (79.2% grade IV) but with a short duration (median 4 days) and no febrile neutropenia. The incidence of moderate/severe fluid retention was 29.2% with one treatment discontinuation. Other toxicities (all grades) were common (skin 75%, asthenia 50%, infection 29.2%, nausea 16.7%, diarrhoea 12.5%, stomatitis 16.7%, vomiting 8.3% and HSR 8.3%). A mean clearance of 19.6 l h−1 m−2 and an area under the curve of 6.00 μg ml−1 h−1 was found in the pharmacokinetic analysis. Docetaxel is active in this selected population with metastatic SCCHN, with a good tolerance. © 1999 Cancer Research Campaign
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影响因子：
45.3
作者：
Bruno, R;Hille, D;Sheiner, LB
通讯作者：
Sheiner, LB
影响因子：
50.5
作者：
CATIMEL, G;VERMORKEN, JB;KAYE, SB
通讯作者：
KAYE, SB
DOI：
10.1002/hed.2880150103
发表时间：
1993-01-01
影响因子：
2.9
作者：
GANDIA, D;WIBAULT, P;CVITKOVIC, E
通讯作者：
CVITKOVIC, E
影响因子：
254.7
作者：
Landis, SH;Murray, T;Wingo, PA
通讯作者：
Wingo, PA
影响因子：
45.3
作者：
Dreyfuss, AI;Clerk, JR;Posner, MR
通讯作者：
Posner, MR