Gemcitabine in patients with relapsed or cisplatin-refractory testicular cancer
Gemcitabine in patients with relapsed or cisplatin-refractory testicular cancer
复制标题
DOI：
10.1200/jco.1999.17.2.512
复制
发表时间：
1999-02-01
影响因子：
45.3
通讯作者：
Kanz, L
中科院分区：
文献类型：
--
作者：
Bokemeyer, C;Gerl, A;Kanz, L
目的：尽管转移性睾丸生殖细胞肿瘤患者的治愈率通常较高，但对顺铂为基础的一线治疗反应不完全或高剂量挽救化疗后疾病复发的患者预后极差。这第二阶段的研究评估吉西他滨在患者中使用密集预处理或顺铂难治性睾丸生殖细胞cancers.Patients和方法：35例患者（中位年龄，33岁）入组; 31例患者完全评估。所有患者均患有转移性非腺瘤性生殖细胞肿瘤; 8例患者患有性腺外原发性肿瘤。20例患者（63%）有肺转移，12例患者（39%）有肝转移。既往以顺铂为基础的化疗周期的中位数为7个; 22例患者（71%）接受了高剂量化疗联合自体干细胞移植，19例患者（61%）接受了紫杉醇治疗。17例患者（54%）被认为是难治性或绝对难治性chemotherapy.Results：6 31评估的患者（19%）反应良好，吉西他滨，11例（35%）显示没有变化，和14例（45%）有疾病进展。至治疗失败的中位时间为4个月（范围：2至9+个月），中位生存期为6个月（范围：2至23个月）。患者接受了中位6次吉西他滨应用。10例患者（32%）需要减少剂量，主要是由于血液学毒性。4例患者（13%）发生3/4级粒细胞减少症，7例患者（22%）发生3/4级血小板减少症。结论：吉西他滨在强化预处理和难治性生殖细胞肿瘤中显示出抗肿瘤活性。在大约20%的患者中观察到了反应，包括22例既往高剂量化疗后的患者中的3例和4例纵隔肿瘤患者中的1例。吉西他滨可能是强化预治疗患者的合理姑息治疗选择，应进一步研究以确定其在生殖细胞肿瘤风险适应性治疗策略中的作用。(C)1999年，美国临床肿瘤学会。
Purpose: Despite generally high cure rates in patients with metastatic testicular germ cell tumors, patients with incomplete response to cisplatin-based first-line therapy or with relapsed disease after high-dose salvage chemotherapy have a very poor prognosis. This phase II study evaluates the use of gemcitabine in patients with intensively pretreated or cisplatin-refractory testicular germ cell cancers.Patients and Methods: Thirty-five patients (median age, 33 years) were enrolled; 31 patients were fully assessable. All patients had metastatic nonseminomatous germ cell tumors; eight patients had extragonadal primary tumors. Twenty patients (63%) had lung metastases, and 12 patients (39%) had liver metastases. The median number of prior cisplatin-based chemotherapy cycles was seven; 22 patients (71%) had received high-dose chemotherapy with autologous stem-cell transplantation, and 19 patients (61%) had received treatment with paclitaxel. Seventeen patients (54%) were considered refractory or absolutely refractory to chemotherapy.Results: Six of 31 assessable patients (19%) responded favorably to gemcitabine, 11 patients (35%) displayed no change, and 14 patients (45%) had disease progression. The median time to treatment failure was 4 months (range, 2 to 9+ months), and the median survival was 6 months (range, 2 to 23 months). Patients received a median of six gemcitabine applications. Ten patients (32%) required dose reductions, mainly owing to hematologic toxicity. Grade 3/4 granulocytopenia occurred in four patients (13%)and grade 3/4 thrombocytopenia in seven patients (22%). One case of severe sepsis was observed.Conclusion: Gemcitabine displays antitumor activity in intensively pretreated and refractory germ cell tumors. Responses were observed in approximately 20% of patients, including three of 22 patients after previous high-dose chemotherapy and one of four patients with mediastinal rumors. Gemcitabine may be a reasonable palliative option for intensively pretreated patients and should be further investigated to define its role in the risk-adapted treatment strategies for germ cell tumors. (C) 1999 by American Society of Clinical Oncology.