Rick O, Braun T, Siegert W, Beyer J
Klinikum Reinhardshöhe, Fachklinik für Onkologische Rehabilitation, Quellenstrasse 8-12, 34527 Bad Wildungen, Germany.
Eur J Cancer. 2006 Aug;42(12):1775-9. doi: 10.1016/j.ejca.2006.03.013. Epub 2006 Jun 9.
The aim of this study was assess the activity of thalidomide in patients with progressive relapsed or platinum-refractory germ-cell tumours (GCT). Between April 2002 and January 2003, 15 patients with inoperable progressive GCT were treated with escalated daily doses of 200-600 mg thalidomide. All patients had failed first-line and salvage chemotherapy with a median of 6 (range 4-12) cisplatin-based treatment cycles, 13/15 (87%) patients had received high-dose chemotherapy (HDCT) and 8/15 (53%) patients were considered platinum-refractory or absolute refractory; 8/15 (53%) patients had previously received other palliative chemotherapy regimens. No patient achieved a complete remission (CR) or partial remission (PR). However, 5/15 (33%) patients achieved serological PR and 1 additional patient had stable disease for 3 months. The median duration of remissions was 3 months (range 2-12 months) including 2 patients with a progression-free survival of 9 and 12 months. Responses occurred mainly in patients with a low tumour burden, slow disease progression and alpha-foetoprotein (AFP) elevations. Responses to thalidomide were independent from platinum-sensitivity. Toxicity was mild, with lethargy and constipation in the majority of patients. Skin rash grade II developed in 2 patients and peripheral neurotoxicity grade II/III developed in 4 patients. One responding patient died suddenly from an unknown cause. It is concluded that thalidomide shows single-agent activity in patients with heavily pre-treated GCT, AFP elevations and slowly progressive disease.
本研究的目的是评估沙利度胺对进展性复发或铂类难治性生殖细胞肿瘤（GCT）患者的疗效。2002年4月至2003年1月期间，15例无法手术的进展性GCT患者接受了逐步递增的沙利度胺每日剂量治疗，剂量为200 - 600mg。所有患者一线和挽救性化疗均失败，接受以顺铂为基础的治疗周期中位数为6个（范围4 - 12个），13/15（87%）的患者接受过高剂量化疗（HDCT），8/15（53%）的患者被认为对铂类耐药或绝对耐药；8/15（53%）的患者先前接受过其他姑息性化疗方案。没有患者达到完全缓解（CR）或部分缓解（PR）。然而，5/15（33%）的患者达到血清学PR，另有1例患者疾病稳定3个月。缓解的中位持续时间为3个月（范围2 - 12个月），其中2例患者无进展生存期为9个月和12个月。反应主要发生在肿瘤负荷低、疾病进展缓慢且甲胎蛋白（AFP）升高的患者中。对沙利度胺的反应与铂类敏感性无关。毒性较轻，大多数患者出现嗜睡和便秘。2例患者出现II级皮疹，4例患者出现II/III级周围神经毒性。1例有反应的患者突然不明原因死亡。结论是沙利度胺对预处理严重、AFP升高且疾病进展缓慢的GCT患者显示出单药活性。
