“In a randomized phase II trial (SWOG S0925) reported in the Journal of Clinical Oncology, Yu et al found that the addition of cixutumumab to androgen-deprivation therapy did not significantly increase the rate of undetectable prostate-specific antigen (PSA) in patients with newly diagnosed metastatic hormone-sensitive prostate cancer. Cixutumumab inhibits the insulin-like growth factor I receptor (IGF-IR).
“In the study, 210 patients from SWOG institutions were randomly assigned between February 2011 and December 2012 within 30 days of starting androgen deprivation to receive bicalutamide daily with a luteinizing hormone-releasing hormone agonist alone (n = 105) or with cixutumumab at 10 mg/kg given intravenously over 1 hour every 2 weeks for seven 28-day cycles. The primary endpoint was rate of undetectable PSA (≤ 0.2 ng/mL) at 28 weeks.
“The cixutumumab and control groups were generally balanced for baseline characteristics, including age (median, 65 and 66 years), PSA level (median, 31 and 37 ng/mL), Gleason score (≥7 in 60% and 78%), race (89% and 84% white), metastasis site (lymph node only in 14% and 9%, bone only in 53% and 60%, both in 18% and 16%, visceral in 14% and 15%), and early-induction androgen deprivation (56% and 62%).”