A PHASE-II STUDY OF GEMCITABINE (LY-188011) IN PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK
A PHASE-II STUDY OF GEMCITABINE (LY-188011) IN PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK
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DOI：
10.1093/oxfordjournals.annonc.a058910
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发表时间：
1994-07-01
影响因子：
50.5
通讯作者：
KAYE, SB
中科院分区：
文献类型：
--
作者：
CATIMEL, G;VERMORKEN, JB;KAYE, SB
背景：吉西他滨是一种新型嘧啶类抗代谢药，具有新的代谢特性和作用机制。I期临床试验已经证明了可接受的毒性和有希望的抗肿瘤活性。这个开放的多中心II期临床试验的目的是确定这种药物在晚期头颈cancer.Patients和方法的患者的疗效和毒性：61例晚期和/或复发性鳞状细胞癌的头部和颈部与吉西他滨治疗作为每周30分钟静脉注射给药连续3周，然后休息一周。47例患者的吉西他滨起始剂量为800 mg/m2/周（大多数患者接受化疗预治疗），14例未经化疗患者的吉西他滨起始剂量随后增加至1250 Mg/M2。剂量调整的基础上，血液学和非血液学toxics.Results：7个部分反应，观察54例可评估的患者，产生的反应率为13%（95%的置信区间：4%-22%）。血液学毒性的发生率较低，3-4级中性粒细胞减少症的发生率低于10%。53%的患者出现肝酶升高，主要为1级或2级。39%的患者报告疲劳，经常与流感样symptoms.Conclusion：吉西他滨是一种药物与记录的抗肿瘤活性在晚期鳞状细胞癌的头部和颈部。
Background: Gemcitabine is a new pyrimidine antimetabolite with novel metabolic properties and mechanism of action. Phase I clinical trials have demonstrated acceptable toxicity and promising antitumor activity. The objectives of this open multicenter phase II trial were to determine the efficacy and toxicity of this agent in patients with advanced head and neck cancer.Patients and methods: Sixty-one patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with Gemcitabine as a weekly 30 minutes i.v. administration for 3 consecutive weeks followed by one week rest. The Gemcitabine starting dose was 800 mg/m2/week in 47 patients (a majority being pre-treated with chemotherapy) and was later increased to 1250 Mg/M2 in 14 chemotherapy-naive patients. Dose adjustements were based on hematologic and non-hematologic toxicities.Results: Seven partial responses were observed among 54 evaluable patients, yielding a response rate of 13% (95% confidence interval: 4%-22%). The incidence of hematologic toxicity was low, with grade 3-4 neutropenia in less than 10% of the courses. Fifty-three percent of the patients experienced an increase in liver enzymes, mainly grade 1 or 2. Fatigue was reported by 39% of the patients, frequently associated with flu-like symptoms.Conclusion: Gemcitabine is a drug with documented antitumor activity in patients with advanced squamous cell carcinoma of the head and neck.