https://orcid.org/0000-0003-4480-0029
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Abstract
Background
Pancreatic cancer is often associated with cachexia. It had been reported that eicosapentaenoic acid (EPA) improve cachexia. This study aimed to evaluate the efficacy and safety of gemcitabine with an EPA-enriched oral supplement in patients with advanced pancreatic cancer.
Methods
This open-label phase II study consisted of patients (pts) who were randomly categorized into the EPA group (1,000 mg/m2 gemcitabine was administered on day 1, 8, and 15, every 4 weeks while an EPA-enriched oral supplement (prosure®, EPA 1.056 mg per pack) was taken daily at the maximum of two packs or the gemcitabine monotherapy group with an allocation ratio of 2:1. The primary endpoint was the evaluation of the 1-year survival estimating 10% addition.
Results
Randomized 68 pts were examined (EPA: 45, gemcitabine: 23). The 1-year survival probability of the EPA group was 35% while the gemcitabine group was 19%. The median survival times were 8.2 and 9.7 mo, respectively. The hazard ratio for EPA group was 0.79 [95% CI 0.46–1.37]; (P = 0.40). The toxicities were mild and insignificant in both groups. More beneficial effects of EPA in survival were observed in men, pancreatic body-tail and low C-reactive protein patients.
Conclusion
An EPA-enriched oral supplement may be effective in advanced pancreatic cancer.
Disclosure statement
Makoto Ueno has received honoraria from Abbott Japan LLC and Eli Lilly Japan K.K. All remaining authors have declared no conflicts of interest.
Authors’ contributions
Makoto Ueno, Satoshi Kobayashi, Masataka Taguri and Takeharu Yamanaka conceived and designed the study. Makoto Ueno, Kazuya Sugimori, Shinichi Ohkawa, Satoshi Kobayashi, Haruo Miwa, Takashi Kaneko and Manabu Morimoto performed the experiments. All authors were involved in the writing of the manuscript. Makoto Ueno, Masataka Taguri and Takeharu Yamanaka analyzed the data. All authors read and approved the final version of the manuscript.