Abstract
16019 Background: Chemotherapy options after docetaxel based regimens for HRPC are needed. The multi-targeted anti-folate, pemetrexed (P), is a broadly active cytotoxic that may benefit this group of patients. Methods: HRPC patients with progressive disease after docetaxel with a Karnofsky performance status (KPS) of at least 70 were treated with P 500 mg/m2 iv d1 with vitamin support on a q21d cycle. The primary endpoint was PSA response per consensus criteria. A two-stage simon design was employed. A pharmacogenetic analysis of reduced folate carrier-1 gene (RFC1) was performed. Results: 49patients were enrolled with a median age of 68 (53–83) and a median KPS of 90 (70–100). A median of 3 cycles (1–20) were administered. 9 patients (19.4%) experienced grade 3/4 hematologic toxicity (neutropenic fever - 2 pts) and 17 patients (34.7%) experienced grade 3 non-hematologic toxicity (fatigue - 6 pts, infection - 4 pts, bone pain/arthralgia/dyspnea/liver function abnormalities - 3 pts each). Best PSA response was: confirmed > 50% decline in 4 patients (8.2%, 95% CI 0.5–15.8%), stable disease lasting at least 12 weeks in 10 patients (20.4%, 95% CI 9.1–31.7%), and progressive disease in 32 patients (65.3%, 95% CI 52.0–78.6%). Among 26 patients with measurable disease by RECIST, 2 patients (7.7%) demonstrated a partial response and 10 patients (38.5%) has confirmed stable disease at 12 weeks. The median time to PSA progression, objective progression, and overall survival were 2.0, 4.4, and 14.0 months respectively. 12 patients (24.5%) had improvement from their baseline pain scores. Pharmacogenetic analyses of the RFC1 G80A wild-type (G/G), heterozygous (G/A), and mutated (A/A) genotype frequencies did not show a relationship between genotypes and time to PSA progression, objective progression and overall survival. Conclusions: Pemetrexed treatment for HRPC patients with progression after docetaxel therapy was associated with 25% of patients having disease control at 12 weeks. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly Eli Lilly
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