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
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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 -