每两周一次吉西他滨联合紫杉醇治疗复发性或转移性头颈部鳞状细胞癌的II期试验：西南肿瘤学组S0329研究
Phase II trial of biweekly gemcitabine and paclitaxel with recurrent or metastatic squamous cell carcinoma of the head and neck: Southwest Oncology Group study S0329.
作者信息
Malhotra Binu, Moon James, Kucuk Omar, Clark Joseph I, Urba Susan G, Wolf Gregory T, Worden Francis P
机构信息
Department of Hematology Oncology, University of Michigan, Ann Arbor, Michigan.
出版信息
Head Neck. 2014 Dec;36(12):1712-7. doi: 10.1002/hed.23522. Epub 2014 Jan 29.
BACKGROUND
A phase I study and an institutional pilot study in patients with metastatic/recurrent squamous cell carcinoma of the head and neck (SCCHN) utilizing biweekly gemcitabine and paclitaxel (GEMTAX), showed an overall response rate of 53%. 1 This phase II trial was conducted to determine the feasibility, tolerability, and efficacy of this combination.
METHODS
Patients with metastatic/recurrent SCCHN were treated with gemcitabine (3000 mg/m2) and paclitaxel (150 mg/m2) on days 1 and 15 of every 28-day cycle.
RESULTS
In 57 patients with measurable disease, median progression-free survival (PFS) was 4 months and median overall survival (OS) was 8 months. Overall response rate of 28% and disease stabilization in 19% were seen. There were no treatment-related deaths with grade 3/4 hematologic toxicity seen in 20% of the patients.
CONCLUSION
Biweekly GEMTAX is feasible, well tolerated, and demonstrated reasonable efficacy. This may be an alternative for patients who are not candidates for platinum-based chemotherapy.
背景
一项针对转移性/复发性头颈部鳞状细胞癌（SCCHN）患者的I期研究和一项机构试点研究，采用每两周一次的吉西他滨和紫杉醇（GEMTAX）方案，总缓解率为53%。1 本II期试验旨在确定该联合方案的可行性、耐受性和疗效。
方法
转移性/复发性SCCHN患者在每28天周期的第1天和第15天接受吉西他滨（3000 mg/m2）和紫杉醇（150 mg/m2）治疗。
结果
在57例可测量疾病的患者中，中位无进展生存期（PFS）为4个月，中位总生存期（OS）为8个月。总缓解率为28%，疾病稳定率为19%。20%的患者出现3/4级血液学毒性，但无治疗相关死亡。
结论
每两周一次的GEMTAX方案可行，耐受性良好，并显示出合理的疗效。这可能是不适合铂类化疗的患者的一种替代方案。
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