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. Patients and Methods: Eligible patients had histologically confirmed prostate cancer and a confirmed rising prostate-specific antigen (PSA) ≥ 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 ≥ 50%, and ≥ 5 ng/mL, from the pretreatment value. Treatment comprised oral fenretinide 900 mg/m 2 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% Cl, 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.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 43-50 |
| Number of pages | 8 |
| Journal | Clinical Genitourinary Cancer |
| Volume | 7 |
| Issue number | 1 |
| DOIs | |
| State | Published - 2009 |
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Keywords
- 4-HPR
- Alanine aminotransferase
- Aspartate aminotransferase
- Prostate-specific antigen
ASJC Scopus subject areas
- Oncology
- Urology
Cite this
Oral Fenretinide in biochemically recurrent prostate cancer : A California cancer consortium phase II trial. / Cheung, Eric; Pinski, Jacek; Dorff, Tanya; Groshen, Susan; Quinn, David I.; Reynolds, C. Patrick; Maurer, Barry J.; Lara, Primo N; Tsao-Wei, Denice D.; Twardowski, Przemyslaw; Chatta, Gurkamal; McNamara, Mark; Gandara, David R.
In: Clinical Genitourinary Cancer, Vol. 7, No. 1, 2009, p. 43-50.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Oral Fenretinide in biochemically recurrent prostate cancer
T2 - A California cancer consortium phase II trial
AU - Cheung, Eric
AU - Pinski, Jacek
AU - Dorff, Tanya
AU - Groshen, Susan
AU - Quinn, David I.
AU - Reynolds, C. Patrick
AU - Maurer, Barry J.
AU - Lara, Primo N
AU - Tsao-Wei, Denice D.
AU - Twardowski, Przemyslaw
AU - Chatta, Gurkamal
AU - McNamara, Mark
AU - Gandara, David R
PY - 2009
Y1 - 2009
N2 - 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. Patients and Methods: Eligible patients had histologically confirmed prostate cancer and a confirmed rising prostate-specific antigen (PSA) ≥ 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 ≥ 50%, and ≥ 5 ng/mL, from the pretreatment value. Treatment comprised oral fenretinide 900 mg/m 2 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% Cl, 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.
AB - 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. Patients and Methods: Eligible patients had histologically confirmed prostate cancer and a confirmed rising prostate-specific antigen (PSA) ≥ 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 ≥ 50%, and ≥ 5 ng/mL, from the pretreatment value. Treatment comprised oral fenretinide 900 mg/m 2 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% Cl, 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.
KW - 4-HPR
KW - Alanine aminotransferase
KW - Aspartate aminotransferase
KW - Prostate-specific antigen
UR - http://www.scopus.com/inward/record.url?scp=65249124689&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65249124689&partnerID=8YFLogxK
U2 - 10.3816/CGC.2009.n.008
DO - 10.3816/CGC.2009.n.008
M3 - Article
C2 - 19213668
AN - SCOPUS:65249124689
VL - 7
SP - 43
EP - 50
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
SN - 1558-7673
IS - 1
ER -