Final report of a phase II evaluation of paclitaxel in patients with advanced squamous cell carcinoma of the head and neck - An Eastern Cooperative Oncology Group Trial (PA390)
Final report of a phase II evaluation of paclitaxel in patients with advanced squamous cell carcinoma of the head and neck - An Eastern Cooperative Oncology Group Trial (PA390)
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DOI：
10.1002/(sici)1097-0142(19980601)82:11
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发表时间：
1998-06-01
期刊：
影响因子：
6.2
通讯作者：
Adams, G
中科院分区：
文献类型：
--
作者：
Forastiere, AA;Shank, D;Adams, G
背景。在接受姑息治疗的头颈部癌患者中，已经测试了许多单一药物。一般情况下，15-30%的患者达到持续3-4个月的部分缓解。治疗并没有显示能改变生存率。很明显，需要确定具有潜在更大活性的新药。为此，东方肿瘤合作小组对紫杉醇进行了i期评价。复发、转移或局部晚期、无法治愈的头颈部鳞状细胞癌患者均符合条件。试验的剂量和方案是最大耐受剂量250mg /m(2)，由I期试验确定，采用24小时输注计划和粒细胞集落刺激因子支持。每隔3周进行一次疗程，直到疾病进展得到记录。对血液毒性和神经毒性进行剂量调整。34例患者登记参加研究，其中30例符合条件。严重或危及生命的粒细胞减少是最常见的毒性观察，发生在91%的患者。在反应评估之前，一名患者死于败血症，一名死于心肌梗死。40%的符合条件的患者有反应（4例完全缓解，8例部分缓解）。中位缓解持续时间为4.5个月（范围2-20个月），中位生存期为9.2个月，1年生存率为33%。这些结果表明紫杉醇是治疗头颈部鳞状细胞癌的活性药物。评估替代输注方案和联合方案的研究目前正在进行中。(C) 1998美国癌症协会。
BACKGROUND. A number of single agents have been tested in patients with carcinoma of the head and neck receiving palliative treatment. In general, 15-30% of patients achieve a partial response lasting 3-4 months. Treatment has not been shown to alter survival rates. It is clear that new drugs with potentially greater activity need to be identified. For this purpose, the Eastern Cooperative Oncology Group conducted a Phase LI evaluation of paclitaxel.METHODS. Patients with recurrent, metastatic, or locally advanced, incurable squamous cell carcinoma of the head and neck were eligible. The dose and schedule tested was the maximum tolerable dose of 250 mg/m(2) determined from Phase I trials using a 24-hour infusion schedule and granulocyte-colony stimulating factor support. Courses were given at 3-week intervals until progression of disease was documented. Dose modifications were specified for hematologic toxicity and for neurotoxicity.RESULTS. Thirty-four patients were registered on study and 30 were eligible. Severe or life-threatening granulocytopenia was the most frequent toxicity observed, occurring in 91% of patients. Prior to response evaluation, one patient died of sepsis and one died of a myocardial infarct. Response was observed in 40% of eligible patients (4 complete and 8 partial responses). The median duration of response was 4.5 months (range, 2-20 months), with a median survival of 9.2 months and a 1-year survival rate of 33%.CONCLUSIONS. These results indicate that paclitaxel is an active agent for the treatment of squamous cell carcinoma of the head and neck. Studies evaluating alternative infusion schedules and combination regimens currently are underway. (C) 1998 American Cancer Society.