A Multicenter Open-Label Randomized Controlled Trial of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer

作者：Saito Tomotaka; Nakai Yousuke; Isayama Hiroyuki; Hirano Kenji; Ishigaki Kazunaga; Hakuta Ryunosuke; Takeda Tsuyoshi; Saito Kei; Umefune Gyotane; Akiyama Dai; Watanabe Takeo; Takagi Kaoru; Takahara Naminatsu; Hamada Tsuyoshi; Uchino Rie; Mizuno Suguru; Mouri Dai; Yagioka Hiroshi; Kogure Hirofumi; Togawa Osamu; Matsubara Saburo; Ito Yukiko; Yamamoto Natsuyo; Tada Minoru; Koike Kazuhiko

来源：Pancreas, 2018, 47(7): 800-806.

DOI：10.1097/MPA.0000000000001079

• pancreatic cancer
• pancrelipase
• pancreatic exocrine insufficiency
• chemotherapy
• pancreatic enzyme replacement therapy
• nutritional status

Objective Exocrine pancreatic insufficiency may impair the nutritional status in pancreatic cancer (PC), but the role of pancreatic enzyme replacement therapy (PERT) is not fully evaluated. Therefore, we conducted this multicenter open-label randomized controlled trial to evaluate the role of PERT in PC patients.
Methods Patients with unresectable PC receiving chemotherapy were randomly assigned to pancrelipase and nonpancrelipase groups. Patients in the pancrelipase group took oral pancrelipase of 48,000 lipase units per meal. N-benzoyl-tryrosyl para-aminobenzoic acid (NBT-PABA) test was performed at baseline. Our primary endpoint was change in body mass index (BMI) at 8 weeks. Secondary endpoints were change in other nutritional status at 8 weeks and overall survival.
Results A total of 88 patients were enrolled between May 2014 and May 2016. The NBT-PABA test was lower than the normal range in 90%. There were no significant differences in change in BMI at 8 weeks: 0.975 and 0.980 in the pancrelipase and the nonpancrelipase groups, respectively (P = 0.780). The other nutritional markers were also comparable. The median overall survival was 19.0 and 12.0 months (P = 0.070).
Conclusions In this randomized controlled trial, pancrelipase failed to improve the change in BMI at 8 weeks in PC patients receiving chemotherapy.

• 出版日期2018-8