Masitinib plus gemcitabine may be effective in the treatment of specific subgroups of patients with advanced pancreatic ductal adenocarcinoma (PDAC), according to a recent study published in the Annals of Oncology.
Researchers led by Gaël Deplanque, MD, of the Saint Joseph Hospital in Paris looked at 353 patients with inoperable, chemotherapy-naïve PDAC who were randomized to either gemcitabine in combination with masitinib or placebo.
Primary endpoint was overall survival in a modified intent-to-treat population, with secondary analyses intended to define subgroups with poor survival when receiving single-agent gemcitabine with subsequent evaluation of masitinib.
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Two specific subgroups that were noted for having a significantly poor survival rate when receiving single-agent gemcitabine were those with an overexpression of acyl-CoA oxidase-1 (ACOX1) in the blood, and those with a baseline pain intensity threshold (VAS greater than 20 mm).
The researchers found that median overall survival was similar between the treatment arms for the overall population.
However, they found a significant treatment effect in the aforementioned subgroups treated with masitinib, with a median overall survival of 11.7 months in those with ACOX1 overexpression, and 8.0 months in the subgroup with a lower threshold for pain.
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While they noted higher rate of toxicities in patients treated with masitinib, they stated that these side effects were manageable.
“The present data warrant initiation of a confirmatory study that may support the use of masitinib plus gemcitabine for treatment of PDAC patients with overexpression of ACOX1 or baseline pain,” they concluded.
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