Ruxolitinib plus capecitabine may improve survival in patients with metastatic pancreatic cancer, according to a study published online ahead of print in the Journal of Clinical Oncology.1
In a double-blind phase 2 study, researchers sought to determine whether patients with advanced pancreatic adenocarcinoma who had treatment failure with gemcitabine would benefit from the JAK1/JAK2 inhibitor ruxolitinib (15 mg twice daily) plus capecitabine (1,000 mg/m2) or placebo plus capecitabine.
In the intent-to-treat population (ruxolitinib, n=64; placebo, n=63) hazard ration was 0.79 (95% CI: 0.53 to 1.18; P=0.25) for overall survival and 0.75 (95% CI: 0.52 to 1.10; P=0.14) for progression-free survival.
A prespecified subgroup analysis of patients with inflammation, defined by serum C-reactive protein levels greater than the study population median (13 mg/L), overall survival was significantly greater with ruxolitinib than with placebo (hazard ratio, 0.47; 95% CI: 0.26-0.85; P = 0.011).
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Prolonged survival in this subgroup was supported by post hoc analyses of overall survival that categorized patients by the modified Glasgow Prognostic Score. Ruxolitinib plus capecitabine was generally well tolerated.
In regard to safety, grade 3 or greater adverse events were observed with similar frequency in the ruxolitinib (74.6%) and placebo (81.7%) groups. Grade 3 or greater anemia was more frequent with ruxolitinib (15.3%; placebo, 1.7%).
- Hurwitz HI, Uppal N, Wagner SA, et al. Randomized, double-blind phase II study of ruxolitinib or placebo in combination with capecitabine in patients with metastatic pancreatic cancer for whom therapy with gemcitabine has failed. [published online ahead of print September 8, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.61.4578.