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Randomized phase II/III clinical trial of elpamotide for patients with advanced pancreatic cancer: PEGASUS-PC Study.

Yamaue H, Tsunoda T, Tani M, Miyazawa M, Yamao K, Mizuno N, Okusaka T, Ueno H, Boku N, Fukutomi A, Ishii H, Ohkawa S, Furukawa M, Maguchi H, Ikeda M, Togashi Y, Nishio K, Ohashi Y - Cancer Sci. (2015)

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.

View Article: PubMed Central - PubMed

Affiliation: Second Department of Surgery Wakayama Medical University, Wakayama, Japan.

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Kaplan–Meier estimates of overall survival (a) and progression-free survival (b) in pancreatic cancer patients treated with gemcitabine and elpamotide (Active group) or gemcitabine and placebo (Placebo group), according to treatment group. CI, confidence interval; H-F, Harrington–Fleming test; MST, median survival time.
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fig02: Kaplan–Meier estimates of overall survival (a) and progression-free survival (b) in pancreatic cancer patients treated with gemcitabine and elpamotide (Active group) or gemcitabine and placebo (Placebo group), according to treatment group. CI, confidence interval; H-F, Harrington–Fleming test; MST, median survival time.

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.


Randomized phase II/III clinical trial of elpamotide for patients with advanced pancreatic cancer: PEGASUS-PC Study.

Yamaue H, Tsunoda T, Tani M, Miyazawa M, Yamao K, Mizuno N, Okusaka T, Ueno H, Boku N, Fukutomi A, Ishii H, Ohkawa S, Furukawa M, Maguchi H, Ikeda M, Togashi Y, Nishio K, Ohashi Y - Cancer Sci. (2015)

Kaplan–Meier estimates of overall survival (a) and progression-free survival (b) in pancreatic cancer patients treated with gemcitabine and elpamotide (Active group) or gemcitabine and placebo (Placebo group), according to treatment group. CI, confidence interval; H-F, Harrington–Fleming test; MST, median survival time.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4520640&req=5

fig02: Kaplan–Meier estimates of overall survival (a) and progression-free survival (b) in pancreatic cancer patients treated with gemcitabine and elpamotide (Active group) or gemcitabine and placebo (Placebo group), according to treatment group. CI, confidence interval; H-F, Harrington–Fleming test; MST, median survival time.
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.

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.

View Article: PubMed Central - PubMed

Affiliation: Second Department of Surgery Wakayama Medical University, Wakayama, Japan.

Show MeSH
Related in: MedlinePlus