Docetaxel/cisplatin as first-line chemotherapy in patients with head and neck carcinoma - A phase II trial
Docetaxel/cisplatin as first-line chemotherapy in patients with head and neck carcinoma - A phase II trial
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DOI：
10.1002/cncr.10574
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发表时间：
2002-06-01
期刊：
影响因子：
6.2
通讯作者：
Dittrich, C
中科院分区：
文献类型：
--
作者：
Baur, M;Kienzer, HR;Dittrich, C
背景这项II期研究的目的是评估阿替卡韦（D）和顺铂（P）在局部晚期不可切除、转移性或复发性头颈部鳞状细胞癌（SCCHN）患者中的临床活性和毒性。在34例患者中，30例有资格接受第1天D 80 mg/m2和第2天P 70 mg/m2的治疗。每3周重复治疗。化疗开始时，肿瘤有以下扩展：局部15例，远处转移2例，复发13例。总体而言，基于意向治疗分析，所有合格患者人群的客观缓解率为53%，95%置信区间（CI; 34.33-71.66%）。2例患者完全疾病缓解（病理学），4例患者完全疾病缓解（临床），10例患者部分疾病缓解，3例患者疾病状态无变化，7例患者疾病进展。客观缓解的持续时间中位数为5+个月（范围3-8+个月）。11例患者（37%）发生4级粒细胞减少症，3例患者（10%）发生3级粒细胞减少症（分级基于加拿大国家癌症研究所-常见毒性标准的分类）。6例患者死于败血症。总体而言，D和P的组合代表了用于治疗SCCHN患者的高度活性的化疗方案。然而，由于该方案的高毒性，预防性给予抗生素和造血生长因子是必不可少的，因为这是一个为期三天的皮质类固醇前驱用药方案。最重要的是，这种药物组合不推荐用于治疗世界卫生组织体能状态> 1的患者。癌症2002;94：2953- 8. (C)2002年美国癌症协会。
BACKGROUND. The objective of this Phase II study was to assess the clinical activity and toxicity of docetaxei (D) and cisplatin (P) in patients with locally advanced unresectable, metastatic, or recurrent squamous cell carcinoma of the head and neck (SCCHN).PATIENTS. Of 34 patients, 30 were eligible for treatment with D 80 mg/m(2) on Day 1 and P 70 mg/m(2) on Day 2. Therapy was repeated every 3 weeks. At the start of chemotherapy, the tumors had the following extensions: locoregional, n = 15; distant metastatic, n = 2; and relapse, n = 13.RESULTS. Overall, the rate of objective responses in the population of all eligible patients based on an intention-to-treat analysis was 53%, with a 95% confidence interval (CI; 34.33-71.66%). Two patients had complete disease remission (pathologic), 4 patients had complete disease remission (clinical), 10 patients had partial disease remission, 3 patients had no change in disease status, and 7 patients had disease progression. The duration of objective response was median 5+ months (range 3-8+ months). Eleven patients (37%) had Grade 4 granulocytopenia and three patients (10%) had Grade 3 granulocytopenia (grades were based on the classification of the National Cancer Institute of Canada-Common Toxicity Criteria). Six patients died of septicemia.CONCLUSIONS. Overall, the combination of D and P represents a highly active chemotherapeutic regimen for the treatment of patients with SCCHN. However, because of the high toxicity of this regimen, prophylactic administration of antibiotics and hematopoietic growth factors is essential as is a three-day corticosteroid premedication regimen. Above all, this combination of drugs is not recommended for treatment of patients with a World Health Organization performance status of > 1. Cancer 2002;94:2953- 8. (C) 2002 American Cancer Society.