Randomized phase II/III clinical trial of elpamotide for patients with advanced pancreatic cancer: PEGASUS-PC Study.
Bottom Line: No statistically significant differences were found between the two groups in the prolongation of overall survival (Harrington-Fleming P-value, 0.918; log-rank P-value, 0.897; hazard ratio, 0.87, 95% confidence interval [CI], 0.486-1.557).Combination therapy of elpamotide with gemcitabine was well tolerated.Despite the lack of benefit in overall survival, subgroup analysis suggested that the patients who experienced severe injection site reaction, such as ulceration and erosion, might have better survival.
Affiliation: Second Department of Surgery Wakayama Medical University, Wakayama, Japan.Show MeSH
Related in: MedlinePlus
Mentions: The analysis of OS was based on 135 deaths (88.2%) among the 153 patients. Figure2(a) shows the OS of both groups. No statistically significant differences were found between the groups in the prolongation of OS (H-F P-value, 0.918; log–rank P-value, 0.897; HR, 0.87 [95% CI, 0.486–1.557]). Median survival time is 8.36 months (95% CI, 7.46–10.18) in the Active group, and 8.54 months (95% CI, 7.33–10.84) in the Placebo group.
Affiliation: Second Department of Surgery Wakayama Medical University, Wakayama, Japan.