Although glucocorticoid (GC) premedication before chemotherapy are frequently used to prevent nausea and vomiting for continuing comfortable chemotherapy, the side effects of intermittent GCs on bone health have not yet been reported. We previously reported that GC premedication caused the reduction of bone mineral densities at lumbar spine (BMD-LS) and the increase of serum bone alkaline phosphatase (BAP) (ASCO-GI 2016 Abst.523). We now report pre-planed subgroup results about this study (ESPRESSO-01 study).
The eligibility criteria were as the follows: (i) histologically proven gastrointestinal cancer.; (ii) The duration of periodical GC premedication is weekly, biweekly, and triweekly.; (iii) age over 20. The primary endpoint was to investigate the variations of BMD-LS by dual energy x-ray absorptiometry (DXA), serum NTX, and BAP, between baseline and 16 weeks after starting chemotherapy. Secondary endpoints were the influence of GC dose intensity, treatment duration, regimens, primary site, and the WHO Fracture Risk Assessment Tool known as the FRAX® tool (http://www.shef.ac.uk/FRAX).
From June 2013 to April 2015, 98 cases were enrolled, and 74 cases comprised the full analysis set. Not only the levels of BMD-LS but also those of total hip and femoral neck BMD at 16 weeks were decreased compared with baseline and the average percent changes were -1.9% (n = 74, 95% CI: -2.7% to -1.1%, p
We found that periodic GC premedication caused the reduction of BMD and the increase of BAP independent of GC dose intensity, treatment regimens, durations, additive steroid usage, and FRAX® output. Now we plan the further study ESPRESSO-02 to investigate the efficacy of prevention GC induced osteoporosis in using GC premedication.
Clinical trial identification
University Hospital Medical Information Network (UMIN) Clinical Trials Registry (protocol ID UMIN000011054). Date of protocol fixation: May 7, 2013.
Legal entity responsible for the study
Hokkaido Gastrointestinal Cancer Study Group (HGCSG)
Y. Komatsu: Chugai Pharmaceutical Co., Ltd Takeda Pharmaceutical Co., Ltd Pfizer Japan INC., Daiichi Sankyo INC., Yakult Honsha Co., Ltd Taiho Pharmaceutical Co., LTD GlaxoSmithKline Pharmaceutical Co., LTD Novartis Pharmaceutical Japan. All other authors have declared no conflicts of interest.