PURPOSE: To determine the biologic effect of granulocyte-macrophage colony-stimulating factor (sangramostim, GM-CSF; Immunex Corporation, Seattle, WA) as measured by prostate-specific antigen (PSA) kinetics in patients with serologic progression of prostate cancer after definitive local therapy. PATIENTS AND METHODS: Patients with prostate cancer who had undergone previous definitive surgical or radiation therapy with nonmetastatic, recurrent disease as manifested by a rising PSA between 0.4 ng/mL and 6.0 ng/mL were enrolled on this phase II trial. Patients received 250 micro g/m(2)/day of subcutaneous GM-CSF on days 1 through 14 of a 28-day cycle. PSA was measured at day 1 of each cycle. RESULTS: Thirty patients with serologic progression of prostate cancer were treated. The median pretreatment PSA was 2.9 ng/mL. Of the 29 evaluable patients, three patients (10%; 95% confidence interval, 2% to 27%) achieved a 50% reduction in PSA. For the patients (n = 26) in whom the on-treatment PSA doubling time could be calculated, the median PSA doubling time increased from 8.4 months to 15 months (P =.001), and the median slope of the PSA versus time curve decreased with treatment (P =.004). Therapy was well tolerated by all patients, with an average treatment duration of 16.5 cycles (range, 5 to 33). CONCLUSION: GM-CSF has a biologic effect in patients with serologic progression of prostate cancer after definitive local therapy, as measured by PSA declines and modulation of PSA kinetics.
PURPOSE: To determine the biologic effect of granulocyte-macrophage colony-stimulating factor (sangramostim, GM-CSF; Immunex Corporation, Seattle, WA) as measured by prostate-specific antigen (PSA) kinetics in patients with serologic progression of prostate cancer after definitive local therapy. PATIENTS AND METHODS: Patients with prostate cancer who had undergone previous definitive surgical or radiation therapy with nonmetastatic, recurrent disease as manifested by a rising PSA between 0.4 ng/mL and 6.0 ng/mL were enrolled on this phase II trial. Patients received 250 micro g/m(2)/day of subcutaneous GM-CSF on days 1 through 14 of a 28-day cycle. PSA was measured at day 1 of each cycle. RESULTS: Thirty patients with serologic progression of prostate cancer were treated. The median pretreatment PSA was 2.9 ng/mL. Of the 29 evaluable patients, three patients (10%; 95% confidence interval, 2% to 27%) achieved a 50% reduction in PSA. For the patients (n = 26) in whom the on-treatment PSA doubling time could be calculated, the median PSA doubling time increased from 8.4 months to 15 months (P =.001), and the median slope of the PSA versus time curve decreased with treatment (P =.004). Therapy was well tolerated by all patients, with an average treatment duration of 16.5 cycles (range, 5 to 33). CONCLUSION:GM-CSF has a biologic effect in patients with serologic progression of prostate cancer after definitive local therapy, as measured by PSA declines and modulation of PSA kinetics.
Authors: Jianqing Lin; Tingting Zhan; Danielle Duffy; Jean Hoffman-Censits; Deborah Kilpatrick; Edouard J Trabulsi; Costas D Lallas; Inna Chervoneva; Kimberly Limentani; Brooke Kennedy; Sarah Kessler; Leonard Gomella; Emmanuel S Antonarakis; Michael A Carducci; Thomas Force; Wm Kevin Kelly Journal: Am J Cancer Ther Pharmacol Date: 2014-09-07
Authors: Guru Sonpavde; Mingjun Wang; Leif E Peterson; Helen Y Wang; Teresa Joe; Martha P Mims; Dov Kadmon; Michael M Ittmann; Thomas M Wheeler; Adrian P Gee; Rong-Fu Wang; Teresa G Hayes Journal: Invest New Drugs Date: 2013-04-23 Impact factor: 3.850
Authors: Xiao X Wei; Stephen Chan; Serena Kwek; Jera Lewis; Vinh Dao; Li Zhang; Matthew R Cooperberg; Charles J Ryan; Amy M Lin; Terence W Friedlander; Brian Rini; Christopher Kane; Jeffry P Simko; Peter R Carroll; Eric J Small; Lawrence Fong Journal: Cancer Immunol Res Date: 2016-09-29 Impact factor: 11.151