Delays disease progression, ups progression-free survival with acceptable adverse event profile
TUESDAY, Sept. 20 (HealthDay News) -- In men with castration-resistant prostate cancer (CRPC), treatment with tasquinimod (TASQ) significantly delays disease progression and improves progression-free survival (PFS) with an acceptable adverse event (AE) profile, according to a study published online Sept. 19 in the Journal of Clinical Oncology.
Roberto Pili, M.D., from the Roswell Park Cancer Institute in Buffalo, N.Y., and colleagues investigated the activity of TASQ in 201 men with metastatic CRPC with minimal symptoms. A total of 134 participants were randomly assigned to oral once-daily TASQ, and 67 to placebo. The proportion of patients without disease progression at six months, evaluated by the Response Evaluation Criteria in Solid Tumors Group, Prostate Cancer Working Group (PCWG2), or pain criteria (excluding prostate-specific antigen [PSA]) was the primary end point.
The investigators found that the six-month progression-free proportions were 69 and 37 percent for the TASQ and placebo groups, respectively; and median PFS was 7.6 and 3.3 months, respectively. Based on PCWG2 CRPC clinical subgroups classified according to metastasis localization, PFS was 6.1 versus 3.1 months for nodal metastases, 8.8 versus 3.4 months for bone metastases, and 6.0 versus 3.0 months for visceral metastases, respectively, for those receiving TASQ or placebo. The TASQ group showed stable bone alkaline phosphatase levels, but the impact on PSA kinetics was less marked. AEs, and grade 3 to 4 AEs, including asymptomatic elevations of laboratory parameters and deep vein thrombosis, occurred more frequently in the intervention than the placebo group.
"TASQ significantly slowed progression and improved PFS in patients with metastatic CRPC with an acceptable AE profile," the authors write.
Several authors disclosed financial relationships with pharmaceutical companies, including Active Biotech, manufacturer of tasquinimod.
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