NEW YORK (Reuters Health) Oct 18 - The investigational drug tasquinimod slowed progression and improved survival in men with metastatic castration-resistant prostate cancer (CRPC), researchers report.
In 211 men evaluated at 6 months, progression-free survival was 69% with active treatment vs 37% with placebo (p<0.001). Median progression-free survival (PFS) was 7.6 and 3.3 months with tasquinimod and placebo, respectively.
The new data, published online September 19th in the Journal of Clinical Oncology, are from a phase II study. The drug has since moved on to phase III testing in a similar, but larger, population.
"Tasquinimod is a small molecule with antiangiogenic and immunomodulatory activity," lead author Dr. Roberto Pili told Reuters Health by email. "Its potential mechanism of action makes this agent quite interesting in the current therapeutic options for these patients."
Dr. Pili of Roswell Park Cancer Institute, Buffalo, New York and colleagues randomly assigned chemotherapy-naive men with MRPC and minimal symptoms to oral tasquinimod reaching a dose of 1.0 mg a day or to placebo.
Patients were assessed using the Response Evaluation Criteria in Solid Tumors Group, Prostate Cancer Working Group (PCWG2) standard.
When patients were stratified into prognostic groups based on site of metastasis, PFS duration (with treatment vs placebo, respectively) was 6.1 vs 3.1 months with nodal metastasis, 8.8 vs 3.4 months with bone metastases, and 6.0 vs 3.0 months with visceral metastases.
The rate of grade 3 to 4 adverse events was 40% with tasquinimod vs 10% with placebo. The rate of deep vein thrombosis was 4% in the active treatment group; the problem didn't arise in any placebo patients.
Dr. Pili and colleagues note that currently available options for these men include autologous cellular therapy with sipuleucel-T (Provenge), docetaxel (Taxotere), and cabazitaxel (Jevtana) and secondary hormonal manipulations such as abiraterone acetate (Zytiga).
"If (tasquinimod's) clinical benefit is confirmed in the ongoing phase III clinical trial, we will have an additional tool in our armamentarium to treat recurrent prostate cancer," Dr. Pili said.
Three of the paper's 10 authors are employed by Active Biotech (Lund, Sweden), sponsor of the phase II and phase III studies. Another five receive research support from the company.
SOURCE: http://bit.ly/p0EIGA
J Clin Oncol 2011.
In 211 men evaluated at 6 months, progression-free survival was 69% with active treatment vs 37% with placebo (p<0.001). Median progression-free survival (PFS) was 7.6 and 3.3 months with tasquinimod and placebo, respectively.
The new data, published online September 19th in the Journal of Clinical Oncology, are from a phase II study. The drug has since moved on to phase III testing in a similar, but larger, population.
"Tasquinimod is a small molecule with antiangiogenic and immunomodulatory activity," lead author Dr. Roberto Pili told Reuters Health by email. "Its potential mechanism of action makes this agent quite interesting in the current therapeutic options for these patients."
Dr. Pili of Roswell Park Cancer Institute, Buffalo, New York and colleagues randomly assigned chemotherapy-naive men with MRPC and minimal symptoms to oral tasquinimod reaching a dose of 1.0 mg a day or to placebo.
Patients were assessed using the Response Evaluation Criteria in Solid Tumors Group, Prostate Cancer Working Group (PCWG2) standard.
When patients were stratified into prognostic groups based on site of metastasis, PFS duration (with treatment vs placebo, respectively) was 6.1 vs 3.1 months with nodal metastasis, 8.8 vs 3.4 months with bone metastases, and 6.0 vs 3.0 months with visceral metastases.
The rate of grade 3 to 4 adverse events was 40% with tasquinimod vs 10% with placebo. The rate of deep vein thrombosis was 4% in the active treatment group; the problem didn't arise in any placebo patients.
Dr. Pili and colleagues note that currently available options for these men include autologous cellular therapy with sipuleucel-T (Provenge), docetaxel (Taxotere), and cabazitaxel (Jevtana) and secondary hormonal manipulations such as abiraterone acetate (Zytiga).
"If (tasquinimod's) clinical benefit is confirmed in the ongoing phase III clinical trial, we will have an additional tool in our armamentarium to treat recurrent prostate cancer," Dr. Pili said.
Three of the paper's 10 authors are employed by Active Biotech (Lund, Sweden), sponsor of the phase II and phase III studies. Another five receive research support from the company.
SOURCE: http://bit.ly/p0EIGA
J Clin Oncol 2011.
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