title: Oral fenretinide in biochemically recurrent prostate cancer: a California cancer consortium phase II trial.
abstract: BACKGROUND
  Fenretinide is a synthetic retinoid that is cytotoxic to a variety of cancers. We conducted a phase II trial of oral fenretinide in patients with biochemically recurrent prostate cancer.
  
  
  METHODS
  Eligible patients had histologically confirmed prostate cancer and a confirmed rising prostate-specific antigen (PSA) >or= 2 ng/mL following either radical prostatectomy and/or pelvic radiation therapy, without clinical or radiographic evidence of metastasis. The primary endpoint was PSA response, which was defined as a confirmed decrease by >or=50%, and >or=5 ng/mL, from the pretreatment value. Treatment comprised oral fenretinide 900 mg/m2 twice daily for 1 week, every 3 weeks, for 1 year.
  
  
  RESULTS
  After a median follow-up of 17.7 months, out of 23 patients, 7 (30%) patients had PSA stable disease (SD), 11 (48%) patients had PSA progression within 3 months, 4 patients had minimal increases over 3 months that did not qualify as SD or progression (17%), and one patient (4%) was not evaluable. Median time to PSA progression was 4.6 months (95% CI, 3.2-8.2 months). Observed grade 3 toxicities included fatigue, pain, hypermagnesemia, a rise in lipase, and nyctalopia.
  
  
  CONCLUSIONS
  Although well-tolerated, oral fenretinide did not meet prespecified PSA criteria for response in biochemically recurrent prostate cancer; however, 30% of patients had SD, which suggests modest single-agent clinical activity. The role of different formulations of fenretinide, which might allow for higher serum concentrations of the drug, is currently under investigation.
authors.affiliation: University of Southern California/Norris Comprehensive Cancer Center, Los Angeles, CA 90089, USA.
authors.forename: Eric
authors.initials: E
authors.lastname: Cheung
authors.forename: Jacek
authors.initials: J
authors.lastname: Pinski
authors.forename: Tanya
authors.initials: T
authors.lastname: Dorff
authors.forename: Susan
authors.initials: S
authors.lastname: Groshen
authors.forename: David I
authors.initials: DI
authors.lastname: Quinn
authors.forename: C Patrick
authors.initials: CP
authors.lastname: Reynolds
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Maurer
authors.forename: Primo N
authors.initials: PN
authors.lastname: Lara
authors.forename: Denice D
authors.initials: DD
authors.lastname: Tsao-Wei
authors.forename: Przemyslaw
authors.initials: P
authors.lastname: Twardowski
authors.forename: Gurkamal
authors.initials: G
authors.lastname: Chatta
authors.forename: Mark
authors.initials: M
authors.lastname: McNamara
authors.forename: David R
authors.initials: DR
authors.lastname: Gandara
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D017313:Fenretinide / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D009367:Neoplasm Staging; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D017313:Fenretinide