Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma
Phase II evaluation of paclitaxel by short intravenous infusion in metastatic melanoma
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DOI：
10.1097/00008390-200402000-00010
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发表时间：
2004-02
影响因子：
2.2
通讯作者：
A. Bedikian;C. Plager;N. Papadopoulos;O. Eton;J. Ellerhorst;T. Smith
中科院分区：
文献类型：
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作者：
A. Bedikian;C. Plager;N. Papadopoulos;O. Eton;J. Ellerhorst;T. Smith
在四项针对大多数未经化疗的转移性黑色素瘤患者的临床试验中，紫杉醇被发现有效，缓解率为16%。体外研究表明，癌细胞暴露于紫杉醇1小时后，对紫杉醇重复剂量的敏感性在48 - 72小时显著降低，并在120小时恢复。在这项II期研究中，我们评估了紫杉醇的疗效，剂量为90 mg/m2/天，每3周一次，第1、5和9天静脉给药80分钟以上，最初在两组14例转移性脉络膜和非脉络膜黑色素瘤患者中进行。非脉络膜黑色素瘤组中有1例患者确认缓解，因此该组增加了23例患者。(One患者在治疗开始后一周内撤回治疗同意书。认为该患者接受的治疗不足，并登记了更换。）共52例中位年龄为55岁（范围21 - 79岁）的患者接受了治疗。44例患者完成了两个或两个以上疗程的紫杉醇治疗，并可评价反应。我们在6名患者中观察到> 50%的肿瘤消退。除1例外，所有缓解均在32例可评价的非脉络膜黑色素瘤患者中。本组有效率为15.6%。在219个疗程的紫杉醇治疗中，副作用轻微，可控制，大多数是可逆的。未观察到3级急性过敏反应。通过短时间静脉输注给予的紫杉醇对先前治疗的非脉络膜黑色素瘤有轻微活性。
In four clinical trials in mostly chemotherapy-naive patients with metastatic melanoma, paclitaxel was found to be effective with a response rate of 16%. In vitro studies have shown that following exposure of cancer cells to paclitaxel for 1 h, sensitivity to repeat paclitaxel doses decreased markedly at 48–72 h and returned at 120 h. In this phase II study we assessed the efficacy of paclitaxel at a dose of 90 mg/m2 per day given intravenously over 80 min on days 1, 5 and 9 every 3 weeks, initially in two groups of 14 patients with metastatic choroidal and non-choroidal melanoma. One patient in the non-choroidal melanoma group had a confirmed response, and 23 additional patients were therefore accrued to this group. (One patient withdrew consent for treatment within a week from start of therapy. The patient was considered to have received inadequate treatment and a replacement was registered.) A total of 52 patients with a median age of 55 years (range 21–79 years) were treated. Forty-four patients completed two or more courses of paclitaxel and were evaluable for response. We observed >50% tumour regression in six patients. All the responses except one were amongst the 32 evaluable patients with non-choroidal melanoma. The response rate in this group was 15.6%. During the 219 courses of paclitaxel delivered, the side effects were mild, manageable and mostly reversible. No grade 3 acute allergic reactions were observed. Paclitaxel given by short intravenous infusion is marginally active against previously treated non-choroidal melanoma.