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多西他赛三周剂量递减联合顺铂治疗复发性/转移性头颈部鳞状细胞癌:一项多中心 II 期研究。

Triweekly reduced-dose docetaxel combined with cisplatin in recurrent/metastatic head and neck squamous cell carcinoma: a multicenter phase II study.

机构信息

Faculty of Medicine, National Yang-Ming University, Taipei, Taiwan.

出版信息

Cancer Chemother Pharmacol. 2011 Dec;68(6):1477-84. doi: 10.1007/s00280-011-1645-5. Epub 2011 Apr 12.

Abstract

PURPOSE

To test the efficacy and safety of a triweekly reduced-dose docetaxel (60 mg/m(2)) regimen combined with a standard dose of cisplatin in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

PATIENTS AND METHODS

Patients with R/M HNSCC were enrolled. All eligible patients received intravenous docetaxel 60 mg/m(2) combined with cisplatin 75 mg/m(2) on day 1 and then every 3 weeks thereafter. Treatment was continued until disease progression, patient intolerance, or death.

RESULTS

In total, 58 patients were enrolled and 41 patients were evaluated. Among the evaluated population, one patient achieved a complete response (2.4%) and nine patients achieved a partial response (22%), resulting in an overall response rate of 24.4%. Furthermore, 17 patients had stable disease (41.5%), which corresponds to a disease control rate of 65.9%. With a median follow-up of 24 months (1-43 months), progression-free survival was 170 days (95% confidence interval 97.9-242.1) and the median overall survival was 265 days (95% confidence interval 89.0-441.0) in evaluable population. The most common toxicities (≥ grade III) were leucopenia (66.7%) and anemia (33.3%).

CONCLUSIONS

Triweekly reduced-dose docetaxel 60 mg/m(2) combined with cisplatin is effective and feasible for Taiwanese patients with R/M HNSCC. However, the hematologic toxicity of this regimen should be carefully monitored and managed.

摘要

目的

检测三星期一次低剂量多西紫杉醇(60 毫克/平方米)联合标准剂量顺铂治疗复发/转移性(R/M)头颈部鳞状细胞癌(HNSCC)患者的疗效和安全性。

患者和方法

招募 R/M HNSCC 患者。所有符合条件的患者接受静脉注射多西紫杉醇 60 毫克/平方米,联合顺铂 75 毫克/平方米,第 1 天,然后每 3 周 1 次。治疗持续到疾病进展、患者不耐受或死亡。

结果

共纳入 58 例患者,41 例患者可评估。在可评估人群中,1 例患者达到完全缓解(2.4%),9 例患者达到部分缓解(22%),总缓解率为 24.4%。此外,17 例患者病情稳定(41.5%),疾病控制率为 65.9%。中位随访时间为 24 个月(1-43 个月),可评估人群的无进展生存期为 170 天(95%置信区间 97.9-242.1),总生存期为 265 天(95%置信区间 89.0-441.0)。最常见的毒性反应(≥3 级)为白细胞减少(66.7%)和贫血(33.3%)。

结论

三星期一次低剂量多西紫杉醇 60 毫克/平方米联合顺铂对台湾 R/M HNSCC 患者有效且可行。然而,该方案的血液学毒性应仔细监测和管理。

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