title: Brief report: phase II multicenter study of temozolomide in patients with cisplatin-resistant germ cell tumors.
abstract: OBJECTIVE
  To determine the activity and toxicity of temozolomide in a phase II multicenter trial in patients diagnosed with relapsed or cisplatin-refractory germ cell tumors.
  
  
  METHODS
  During a recruitment period of 30 months, 20 patients received temozolomide 150 mg/m(2)/day p.o. for 5 days every 4 weeks, escalating to 200 mg/m(2)/day if grade II toxicity was not observed in the first cycle. Eligibility criteria were tumor progression or relapse after previous cisplatin and ifosfamide-containing chemotherapy, creatinine clearance of >40 ml/min, and a performance status of 0-2.
  
  
  RESULTS
  The median age was 38 years (range 27-56). Seventeen patients had nonseminomatous tumors, and 3 had seminomatous tumors. Six of the patients had extragonadal primary tumors (3 retroperitoneal and 3 mediastinal). The median number of prior cisplatin-containing cycles was 11 (range 7-20). Eight patients received prior high-dose chemotherapy and 14 were refractory or absolutely refractory to cisplatin. A total of 45 cycles were administered. Two partial responses lasting 9 and 3.5 months (overall response rate 10%, 95% CI 1.2-31.7) were observed. One of these responses was seen in a patient with a cisplatin-refractory tumor that had previously been treated with high-dose chemotherapy. The median time to progression and the median overall survival were 1.5 and 3.1 months, respectively. Grade III hematological toxicity consisted of thrombocytopenia in 2 patients and anemia in 1 patient. No grade IV toxicity was observed.
  
  
  CONCLUSIONS
  Temozolomide had some activity in heavily pretreated patients resistant to cisplatin-based chemotherapy.
authors: Hospital Sant Pau, Barcelona, Spain. jmaroto @ santpau.cat
authors: P
authors: P
authors: Maroto
authors: R
authors: R
authors: Huddart
authors: X
authors: X
authors: Garcia del Muro
authors: A
authors: A
authors: Horwich
authors: L
authors: L
authors: Paz Ares
authors: J
authors: J
authors: Aparicio
authors: J R
authors: JR
authors: Germa-Lluch
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000627:therapeutic use*; D003606:Dacarbazine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy*; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D000077204:Temozolomide; D013736:Testicular Neoplasms / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003606:Dacarbazine; D002945:Cisplatin; D000077204:Temozolomide