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卡铂联合每周紫杉醇和异环磷酰胺治疗晚期头颈部癌症:一项Ⅰ期布朗大学肿瘤学组剂量递增研究(HN-93)。

Carboplatin with weekly docetaxel and ifosfamide in advanced head and neck cancers: a phase I Brown University Oncology Group dose escalation study (HN-93).

机构信息

Division of Hematology/Oncology, Roger Williams Hospital, 825 Chalkstone Avenue, Providence, RI 02908, USA.

出版信息

Cancer Chemother Pharmacol. 2010 Nov;66(6):1013-7. doi: 10.1007/s00280-010-1251-y. Epub 2010 Feb 4.

DOI:10.1007/s00280-010-1251-y
PMID:20130878
Abstract

PURPOSE

A phase I study was performed to determine the maximally tolerated dose of carboplatin, ifosfamide, and docetaxel in advanced head and neck cancers.

METHODS

Carboplatin (week 1) was administered with weekly docetaxel and ifosfamide for 3 weeks in an every 4-week cycle. Restaging was done after two cycles, while dose level escalation was done in cohorts of three patients.

RESULTS

Fifteen patients (recurrent/metastatic disease, n = 8; bulky locally advanced disease, n = 7) were enrolled. No dose-limiting toxicities were observed. Toxicities included grade 3 neutropenia and anemia (n = 2, each), and grade 2 thrombocytopenia (n = 3). The final level of carboplatin AUC = 6 (week 1) with docetaxel 30 mg/m(2) per week and ifosfamide 1,000 mg/m(2) per week was chosen for further evaluation.

CONCLUSIONS

This novel regimen of carboplatin with weekly docetaxel and ifosfamide has a favorable toxicity profile and is active in this setting. Phase II study results are awaited.

摘要

目的

进行了一项 I 期研究,以确定晚期头颈部癌症患者中卡铂、异环磷酰胺和多西他赛的最大耐受剂量。

方法

在每 4 周的周期中,卡铂(第 1 周)与每周多西他赛和异环磷酰胺联合使用 3 周。在两个周期后进行重新分期,而剂量递增则在 3 名患者的队列中进行。

结果

共纳入 15 名患者(复发性/转移性疾病,n = 8;局部晚期大肿块疾病,n = 7)。未观察到剂量限制毒性。毒性包括 3 级中性粒细胞减少症和贫血(各 2 例),以及 2 级血小板减少症(3 例)。最终选择卡铂 AUC = 6(第 1 周)与每周 30 mg/m2 多西他赛和每周 1,000 mg/m2 异环磷酰胺联合用于进一步评估。

结论

这种新型卡铂联合每周多西他赛和异环磷酰胺的方案具有良好的毒性特征,在这种情况下具有活性。正在等待 II 期研究结果。

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