title: Activity of thalidomide in patients with platinum-refractory germ-cell tumours.
abstract: 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.
authors.affiliation: Klinikum Reinhardshöhe, Fachklinik für Onkologische Rehabilitation, Quellenstrasse 8-12, 34527 Bad Wildungen, Germany.
authors.forename: O
authors.initials: O
authors.lastname: Rick
authors.forename: T
authors.initials: T
authors.lastname: Braun
authors.forename: W
authors.initials: W
authors.lastname: Siegert
authors.forename: J
authors.initials: J
authors.lastname: Beyer
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D006058:Gonadal Disorders / Q000188:drug therapy*; D006801:Humans; D008479:Mediastinal Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000209:etiology; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D017671:Platinum Compounds / Q000627:therapeutic use; D013792:Thalidomide / Q000627:therapeutic use*; D014565:Urogenital Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D017671:Platinum Compounds; D013792:Thalidomide