Efficacy of raloxifene hydrochloride for the prevention of health care problems in patients who undergo surgery for endometrial cancer: a multicenter randomized clinical trial.
作者信息
Nakamura Koji, Sawada Kenjiro, Sugiyama Michiyo, Mabuchi Seiji, Hisamatsu Takeshi, Nishio Yukihiro, Ito Kimihiko, Kimura Tadashi, Kamiura Shoji, Morishige Ken-ichirou
机构信息
*Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Suita, Osaka; †Department of Obstetrics and Gynecology, Gifu University Graduate School of Medicine, Gifu; ‡Department of Obstetrics and Gynecology, Osaka Police Hospital, Osaka; §Department of Obstetrics and Gynecology, Kansai Rosai Hospital, Amagasaki, Hyogo; and ∥Department of Gynecology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
出版信息
Int J Gynecol Cancer. 2015 Feb;25(2):288-95. doi: 10.1097/IGC.0000000000000333.
OBJECTIVE
Removal of the ovaries is common during surgery for endometrial cancer. However, because loss of the ovaries can cause several health problems in patients, strategies for the prevention of such problems need to be established. Hence, we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density (BMD), bone metabolism, and the lipid profile of patients who had undergone surgery for patients with endometrial cancer.
MATERIALS AND METHODS
Patients with endometrial cancer were enrolled after treatment. The participants were randomized into 2 groups: group 1 included 39 women who received alfacalcidol (1 μg/d) alone and group 2 included 37 women who received alfacalcidol and the test drug, raloxifene hydrochloride, at a dose of 60 mg/d. The BMD of lumbar spine and femoral neck, serum bone markers, as well as lipid profile parameters were evaluated at enrollment as well as 6, 12, and 24 months after the enrollment. The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine (L2-L4) and femoral neck BMD.
RESULTS
Sixty-four women completed the 24-month study. At 24 months, the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 (3.5% vs -0.8% and 2.3% vs -2.8%, respectively). In group 2, low-density lipoprotein-cholesterol levels were significantly reduced by 13.6% and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7% and 25.7%, respectively. The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene (5.8% vs 1.9%). Recurrence was detected in 2 (2.6%) patients in group 1. No severe adverse events were noted in any patient during the study period.
CONCLUSIONS
Raloxifene exerts positive effects on BMD, bone metabolism, and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer.
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