胰腺外分泌替代疗法对不可切除胰腺癌患者疗效的随机试验

Efficacy of pancreatic exocrine replacement therapy for patients with unresectable pancreatic cancer in a randomized trial.

作者信息

Woo Sang Myung, Joo Jungnam, Kim So Young, Park Sang-Jae, Han Sung-Sik, Kim Tae Hyun, Koh Young Hwan, Chung Seung Hyun, Kim Yun-Hee, Moon Hae, Hong Eun Kyung, Lee Woo Jin

机构信息

Center for Liver Cancer, National Cancer Center, Republic of Korea.

Cancer Biostatistics Branch, Research Institute for National Cancer Control and Evaluation, National Cancer Center, Republic of Korea.

出版信息

Pancreatology. 2016 Nov-Dec;16(6):1099-1105. doi: 10.1016/j.pan.2016.09.001. Epub 2016 Sep 4.

DOI:10.1016/j.pan.2016.09.001

PMID:27618657

Abstract

BACKGROUND

Weight loss in pancreatic cancer is associated with maldigestion due to pancreatic duct obstruction. Pancreatic exocrine replacement therapy (PERT) may significantly improve fat and protein absorption.

OBJECTIVES

This prospective, double-blind, randomized, placebo-controlled phase II trial assessed whether PERT could reduce or prevent weight loss in patients with unresectable pancreatic cancer.

METHODS

Sixty seven patients with unresectable pancreatic cancer were randomized to receive enteric coated PERT, consisting of 6-9 capsules of pancreatin (457.7 mg/capsule), or placebo. Patients took two capsules each three times daily during main meals and one capsule each up to three times daily when having between-meal snacks. The primary endpoint was the percentage change in body weight at eight weeks.

RESULTS

The mean percentage change in body weight (1.49% [1.12 kg] vs. 2.99% [1.63 kg], P = 0.381) and the mean percent change in Patient-Generated Subjective Global Assessment (PG-SGA) score (8.85% vs. 15.69%, p = 0.18) did not differ significantly between the PERT and placebo groups. There was no improvement in quality of life and overall survival did not differ significantly between the PERT and placebo groups (5.84 months vs 8.13 months, p = 0.744).

CONCLUSIONS

PERT did not reduce weight loss in patients with unresectable pancreatic cancer. Larger randomized trials are needed to identify those patients who may benefit from PERT.

TRIAL REGISTRATION

ClinicalTrials.gov Number NCT01587534.

摘要

背景

胰腺癌患者体重减轻与胰管阻塞导致的消化功能不良有关。胰腺外分泌替代疗法（PERT）可能显著改善脂肪和蛋白质吸收。

目的

这项前瞻性、双盲、随机、安慰剂对照的II期试验评估了PERT是否能减少或预防无法切除的胰腺癌患者的体重减轻。

方法

67例无法切除的胰腺癌患者被随机分配接受肠溶PERT（由6 - 9粒胰酶胶囊组成，每粒457.7毫克）或安慰剂。患者在正餐时每日三次，每次服用两粒胶囊，在吃零食时每日最多三次，每次服用一粒胶囊。主要终点是八周时体重的百分比变化。

结果

PERT组和安慰剂组之间的体重平均百分比变化（1.49% [1.12千克] 对 2.99% [1.63千克]，P = 0.381）以及患者主观整体评估（PG - SGA）评分的平均百分比变化（8.85% 对 15.69%，p = 0.18）差异均无统计学意义。生活质量没有改善，PERT组和安慰剂组的总生存期差异也无统计学意义（5.84个月对8.13个月，p = 0.744）。