Phase II evaluation of Taxol in advanced head and neck cancer: an Eastern Cooperative Oncology group trial.
Phase II evaluation of Taxol in advanced head and neck cancer: an Eastern Cooperative Oncology group trial.
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发表时间：
1993
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通讯作者：
A. Forastiere;D. Neuberg;S. Taylor;R. Deconti;G. Adams
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作者：
A. Forastiere;D. Neuberg;S. Taylor;R. Deconti;G. Adams
东方合作肿瘤学组织(ECOG)正在对组织学证实的晚期头颈部鳞状细胞癌患者进行紫杉醇的II期试验。到目前为止，参与这项研究的患者要么有复发的疾病，要么新诊断出患有无法治愈的局部区域疾病或远处转移。之前的化疗仅限于在进入研究前至少12个月进行诱导或辅助化疗。所有患者的脑电地形图表现状态均为0或1，且病情可测。治疗方案为紫杉醇250 mg/m2，24小时持续静脉滴注，随后皮下注射r-MET-HU粒细胞集落刺激因子5微克/公斤/天，第3~15天或直至中性粒细胞绝对值>1500。每3周重复一次周期。截至1992年9月1日，该研究登记了27名患者。在这些患者中，有三名患者被确定为不合格，三名患者的评估为时过早。有两人过早死亡，一人肯定死亡，另一人可能与毒品有关。观察到两个完全响应和五个部分响应。接受83个疗程的23名患者的毒性是可评估的。骨髓抑制是观察到的主要毒性反应，17例(74%)患者出现3级或4级白细胞减少，20例(87%)患者出现3级或4级中性粒细胞减少，持续时间平均为2天(范围1-4)。发生周围神经病变9例(1级5例，2级3例，3级1例)。其他少见的毒性包括口腔炎、恶心和呕吐以及肌痛。这项试验将继续进行，直到获得30名符合条件的患者。
The Eastern Cooperative Oncology Group (ECOG) is conducting a phase II trial of Taxol in patients with histologically confirmed, advanced squamous cell carcinoma of the head and neck. Patients entered in the study to date either had recurrent disease or were newly diagnosed with incurable local-regional disease or distant metastases. Prior chemotherapy was limited to induction or adjuvant chemotherapy at least 12 months prior to entry in the study. All patients had an ECOG performance status of 0 or 1 and measurable disease. The treatment schedule was Taxol 250 mg/m2 by 24-hour continuous intravenous infusion followed by r-met Hu granulocyte-colony stimulating factor 5 micrograms/kg/day subcutaneous injection day 3 to 15 or until the absolute neutrophil count was greater than 1500. Cycles were repeated every 3 weeks. As of September 1, 1992, 27 patients were registered in the study. Of these, three patients were determined to be ineligible, and three were too early to evaluate. There were two early deaths, one definitely and one possibly drug related. Two complete and five partial responses have been observed. Twenty-three patients receiving 83 courses were evaluable for toxicity. Myelosuppression was the primary toxicity observed with 17 (74%) patients experiencing grade 3 or 4 leukopenia and with 20 (87%) patients experiencing grade 3 or 4 neutropenia lasting an average of 2 days (range, 1-4). Peripheral neuropathy occurred in nine patients (grade 1, five patients; grade 2, three patients; grade 3, one patient). Other infrequent toxicities were stomatitis, nausea and vomiting, and myalgias. This trial will continue until 30 eligible patients are accrued.(ABSTRACT TRUNCATED AT 250 WORDS)