Abstract | BACKGROUND: PATIENTS AND 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. CONCLUSION: 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.
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Authors | Eric Cheung, Jacek Pinski, Tanya Dorff, Susan Groshen, David I Quinn, C Patrick Reynolds, Barry J Maurer, Primo N Lara Jr, Denice D Tsao-Wei, Przemyslaw Twardowski, Gurkamal Chatta, Mark McNamara, David R Gandara |
Journal | Clinical genitourinary cancer
(Clin Genitourin Cancer)
Vol. 7
Issue 1
Pg. 43-50
(Jan 2009)
ISSN: 1558-7673 [Print] United States |
PMID | 19213668
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Chemical References |
- Androgen Antagonists
- Antineoplastic Agents
- Fenretinide
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Topics |
- Adenocarcinoma
(drug therapy, secondary, surgery)
- Aged
- Aged, 80 and over
- Androgen Antagonists
(therapeutic use)
- Antineoplastic Agents
(therapeutic use)
- Disease Progression
- Fenretinide
(therapeutic use)
- Humans
- Male
- Middle Aged
- Neoplasm Recurrence, Local
(drug therapy, pathology, surgery)
- Neoplasm Staging
- Prostatectomy
- Prostatic Neoplasms
(drug therapy, pathology, surgery)
- Treatment Outcome
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