654P - A randomized phase II study of pancrelipase in patients with gastrectomy to assess the prevention of weight loss

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Presenter Shigeyuki Tamura
Citation Annals of Oncology (2016) 27 (6): 207-242. 10.1093/annonc/mdw371
Authors S. Tamura1, H. Taniguchi2, A. Takeno3, K. Murakami3, Y. Katsura3, Y. Ohmura3, A. Naito3, Y. Kagawa3, Y. Takeda3, T. Kato3
  • 1Surgery, Kansai Rosai Hospital, 660-8511 - Amagasaki/JP
  • 2Surgery, Minoh City Hospital, Minoh/JP
  • 3Surgery, Kansai Rosai Hospital, Amagasaki/JP

Abstract

Background

Gastrectomy for gastric cancer is associated with weight loss, which could lead to deterioration of quality of life and even prognosis of patients. Pancrelipase (PL) is pharmaceutical preparation of extracted pancreatic enzyme (pancreatin) with high density from pancreas of the pig. We conducted a randomized phase II single-center study was performed, in which the effects of pancrelipase for the suppression of weight loss and the improvement of nutrition after gastrectomy wrre assessed.

Methods

Patients were randomly divided to receive the PL or not. The PL group received 1800mg/day for 6 months and more after surgery, starting from the day the patients took normal diets. The primary endpoint was the percentage of body weight loss (%BWL) from the presurgical weight to that 6 months after surgery. Body composition, BT-PABA(PFD) test and various blood test results were evalutated at 3, 6 and 12 months after surgery.

Results

172 patients (distal gastrectomy in 128 patients, total gastrectomy in 44 patients) were enrolled from July 2012 through March 2015. 88 patients were PL group and 84 patients were non-PL group. The % BWL after total gastrectomy in 6 months were significantly higher than that after distal gastrectomy (15.2% vs 7.9%). The % BWL of PL group was lower than that of non-PL group, but which was not statistically significant (8.3% vs 10.6%: p = 0.06). The % of reduction of the lean body mass was lower in PL group than that in non-PL group (p = 0.09), whereas the % of fat mass were not difference in two groups.

Conclusions

Administration of PL might be lessened postoperative BWL by means of keeping lean body mass.

Clinical trial identification

Legal entity responsible for the study

N/A

Funding

N/A

Disclosure

All authors have declared no conflicts of interest.