title: Single agent carboplatin for CS IIA/B testicular seminoma. A phase II study of the German Testicular Cancer Study Group (GTCSG).
abstract: BACKGROUND
  The aim was to investigate the use of single agent carboplatin in patients with seminoma stage IIA/B.
  
  
  METHODS
  In a prospective phase II trial, single agent carboplatin at a dose of AUC 7 mg.min/ml every 4 weeks for three cycles in stage IIA (n=51) or four cycles in stage IIB (n=57) was given to 108 patients with previously untreated seminoma stage IIA/B. Patients with residual masses of >or=3 cm were scheduled to receive secondary surgery.
  
  
  RESULTS
  A complete response (CR) was achieved by 88/108 (81%) patients, 17/108 (16%) achieved a partial response (PR), two of 108 (2%) showed no change, and one patient progressed. In all patients with PR the residual disease was <or=3 cm; yet in two of 17 patients with PR, in two of two patients with NC and in one patient with disease progression residual tumor resection was performed demonstrating vital seminoma. Toxicity was acceptable with grades 3 and 4 myelosuppression, nausea and vomiting in less than 10% of patients each. After a median follow-up of 28 months (range 1-68 months) 14/108 (13%) patients relapsed, all after having achieved a CR. All relapses occurred in the retroperitoneum. One patient died from an unrelated cause. The overall failure rate was 19/108 patients (18%). The overall and disease specific survival was 99% and 100%, respectively.
  
  
  CONCLUSIONS
  Four cycles of single agent carboplatin AUC 7 do not safely eradicate retroperitoneal metastases in patients with stage IIA/B seminoma.
authors.affiliation: University/Medical School, Urology, Essen, Germany. susanne.krege@uni-essen.de
authors.forename: S
authors.initials: S
authors.lastname: Krege
authors.forename: C
authors.initials: C
authors.lastname: Boergermann
authors.forename: R
authors.initials: R
authors.lastname: Baschek
authors.forename: A
authors.initials: A
authors.lastname: Hinke
authors.forename: T
authors.initials: T
authors.lastname: Pottek
authors.forename: S
authors.initials: S
authors.lastname: Kliesch
authors.forename: K-P
authors.initials: KP
authors.lastname: Dieckmann
authors.forename: P
authors.initials: P
authors.lastname: Albers
authors.forename: B
authors.initials: B
authors.lastname: Knutzen
authors.forename: S
authors.initials: S
authors.lastname: Weinknecht
authors.forename: H-J
authors.initials: HJ
authors.lastname: Schmoll
authors.forename: J
authors.initials: J
authors.lastname: Beyer
authors.forename: H
authors.initials: H
authors.lastname: Ruebben
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012008:Recurrence; D018239:Seminoma / Q000188:drug therapy* / Q000517:prevention & control; D016019:Survival Analysis; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000517:prevention & control
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin