Preliminary results of a phase I/II trial of paclitaxel in patients with relapsed or cisplatin-refractory testicular cancer
Preliminary results of a phase I/II trial of paclitaxel in patients with relapsed or cisplatin-refractory testicular cancer
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紫杉醇治疗复发性或顺铂难治性睾丸癌患者的 I/II 期试验的初步结果
DOI：
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发表时间：
2005
影响因子：
3.6
通讯作者：
R. Souchon
中科院分区：
文献类型：
--
作者：
C. Bokemeyer;H. Schmoll;F. Natt;M. Knoche;J. Beyer;R. Souchon
紫杉醇是一种新的抗肿瘤药物，对顺铂敏感的肿瘤，特别是卵巢癌具有明显的活性。此外，在顺铂耐药的卵巢癌患者中也观察到了紫杉醇的反应。到目前为止，紫杉醇在治疗睾丸癌中的作用还没有被探索。尽管转移性睾丸癌患者的治愈率普遍很高，但复发的患者对以铂为基础的挽救化疗没有反应，预后极差。在I/II期试验中，10名复发的顺铂耐药的恶性生殖细胞肿瘤患者接受紫杉醇6小时输注(8名患者)或3小时输注(2名患者)的治疗，剂量从135 mg/m2到310 mg/m2，间隔3周。三名患者对紫杉醇有反应，但分别在两个和四个疗程后不久，两名患者的疾病复发。1例标志物阴性的部分应答持续5个月以上。紫杉醇的毒性在135 mg/m2至225 mg/m2的剂量范围内是可耐受的。所有患者均出现粒细胞减少，WHO分级为3级和4级，但持续时间较短(中位数为3天；范围：2-7天)。其他毒性如粘膜炎(5例1级)、神经毒性(1例1级、1例2级)、感染(1例3级)和腹泻(1例2级)没有剂量限制。无过敏反应，但有1例患者在紫杉醇治疗过程中出现严重肌痛。6例顺铂耐药患者在紫杉醇治疗后再次接受以顺铂为基础的化疗，其中4例获得3、4、5个月和5个月以上的肿瘤缓解。为了探索紫杉醇在复发和/或顺铂耐药的睾丸癌中的作用，由德国睾丸癌研究小组进行的一项II期研究正在进行中，该研究使用225 mg/m2紫杉醇每3周3小时输注一次。
Paclitaxel represents a novel antitumour agent with demonstrated activity in cisplatin-sensitive tumours, particularly ovarian cancer. In addition, responses to pacliaxel have been observed in patients with cisplatin-refractory ovarian cancer. The role of paclitaxel in the treatment of testicular cancer has not been explored so far. Despite the generally high cure rates in patients with metastatic testicular cancer, patients with relapsed disease not responding to platin-based salvage chemotherapy have an extremely poor prognosis. In a phase I/II trial 10 patients with relapsed, cisplatin-refractory malignant germ-cell tumours were treated with paclitaxes as 6-h infusions (8 patients) or 3-h infusions (2 patients) at doses from 135 mg/m2 to 310 mg/m2 at 3-week intervals. Three patients achieved a response to paclitaxel, but disease recurred shortly in two patients after two and four cycles of therapy, respectively. One patient has remained in marker-negative partial reponse for more than 5 months. The toxicity of paclitaxel was tolerable for a dose range from 135 mg/m2 to 225 mg/m2. Granulocytopenia, WHO grades 3 and 4, occurred in all patients but was of short duration (median 3 days; range: 2–7 days). Other toxicities such as mucositis (5 patients grade 1), neurotoxicity (1 patient grade 1, 1 patients grade 2), infection (1 patient grade 3) and diarrhoea (1 patient grade 2) were not dose-limiting. There were no hypersensitivity reactions, but 1 patient developed severe myalgias during therapy with paclitaxel. Six patients with documented cisplatin-refractory disease were retreated with cisplatin-based chemotherapy after paclitaxel treatment and, in 4 of these, tumour responses of 3, 4, 5 and more than 5 months duration were achieved. In order to explore the role of paclitaxel in relapsed and/or cisplatin-refractory testicular cancer a phase II study using a 3-h infusion of 225 mg/m2 paclitaxel every 3 weeks, conducted by the German Testicular Cancer Study Group, is ongoing.
影响因子：
45.3
作者：
BROWN, T;HAVLIN, K;VONHOFF, D
通讯作者：
VONHOFF, D