title: Retrospective analysis of satraplatin in patients with metastatic urothelial cancer refractory to standard platinum-based chemotherapy.
abstract: Satraplatin is a novel platinum agent with favorable clinical attributes including oral bioavailability and lack of significant treatment-associated neuropathy and nephropathy. Furthermore, preclinical studies have shown that satraplatin is active is cisplatin-resistant tumors. We retrospectively evaluated the activity of satraplatin in patients with cisplatin or carboplatin-refractory urothelial carcinoma and demonstrated lack of significant antitumor activity in this population.
  
  
  BACKGROUND
  Satraplatin is an oral platinum analogue with antitumor activity in cisplatin-resistant cells lines. The activity of satraplatin in patients with metastatic cancers of the urothelial tract refractory to standard platinum agents has not previously been reported.
  
  
  METHODS
  We previously reported a phase I study of the safety and pharmacokinetics of satraplatin in patients with refractory solid tumors and varying degrees of renal impairment. Given that the majority of patients enrolled in the study had metastatic cancers of the urothelial tract, and all patients were treated with a uniform dose and schedule, we performed a retrospective analysis to describe the activity of satraplatin in this cohort.
  
  
  RESULTS
  A total of 12 patients with metastatic cancers of the urothelial tract were enrolled. The majority (83%) had transitional cell carcinomas, whereas 2 patients (17%) had adenocarcinomas. All patients were treated previously with platinum agents; 6 patients (50%) had previously received cisplatin and 8 patients (67%) had previously received carboplatin. Patients were treated with a median of 1.5 cycles of satraplatin (range, 1-4). There were no objective responses; 1/12 (8%) patients experienced transient stable disease and 11/12 (92%) experienced disease progression as best response.
  
  
  CONCLUSIONS
  Treatment with satraplatin in patients with metastatic cancers of the urothelial tract who had progressed on standard platinum-based chemotherapy resulted in negligible antitumor activity. These conclusions are limited by the retrospective nature of the analysis and the phase I population from which the data were derived. The activity of satraplatin in patients with metastatic cancers of the urothelial tract who have been less heavily pretreated is unknown.
authors.affiliation: Mount Sinai School of Medicine/Tisch Cancer Institute, New York, NY 10029, USA. matthew.galsky@mssm.edu
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Galsky
authors.forename: Sonia
authors.initials: S
authors.lastname: Seng
authors.forename: Luis H
authors.initials: LH
authors.lastname: Camacho
authors.forename: Elena G
authors.initials: EG
authors.lastname: Chiorean
authors.forename: Daniel
authors.initials: D
authors.lastname: Mulkerin
authors.forename: David S
authors.initials: DS
authors.lastname: Hong
authors.forename: William K
authors.initials: WK
authors.lastname: Oh
authors.forename: Dean F
authors.initials: DF
authors.lastname: Bajorin
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000494:pharmacology / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000494:pharmacology / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D017211:Treatment Failure; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D019459:Urothelium / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; D009944:Organoplatinum Compounds; C081294:satraplatin; D016190:Carboplatin; D002945:Cisplatin