Raloxifene

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First report of malignant mixed mesodermal tumour of the uterus: case report A 64-year-old woman developed malignant mixed mesodermal tumour of the uterus during treatment with raloxifene for osteoporosis. The woman, who had a history of bicornuate uterus, presented with postmenopausal bleeding; she had been prescribed raloxifene [dosage not stated] about 1 year before the symptom onset. Endometrial biopsy findings showed endometrial polyp. About 5 months later, her symptoms had persisted and she underwent transvaginal ultrasonography, which revealed a bicornuate uterus, a right endometrial echo of 4mm and a left endometrial echo of 24mm. Biopsy showed a malignant mixed mesodermal tumour. The woman underwent a total abdominal hysterectomy, pelvic washings, bilateral salpingooophorectomy, appendectomy, and pelvic and paraaortic lymph node dissection. Her uterus measured 5cm from cornu to cornu, 3cm from cervix to fundus and 4.5cm from anterior to posterior. Her right endometrial cavity measured 3.5 × 1 × 0.1cm and was atrophic, whereas her left endometrial cavity measured 5cm long and 3cm across and contained a polypoid mass (3 × 2.5 × 1cm). The tumour had grossly invaded her myometrium. Her ovaries were atrophic. Microscopic examination proved the polypoid tumour to be malignant mixed mesodermal tumour (carcinosarcoma), with a biphasic microscopic appearance. Immunostains for progesterone and estrogen receptor in the tumour were negative, whereas the endometrium in her right endometrial cavity showed weak estrogen effect. She was discharged on postoperative day 4. She subsequently received radiotherapy, ifosfamide and cisplatin, and had no evidence of recurrent disease. Author comment: "The tumor described in our patient may be related to estrogenic stimulation of the uterus by raloxifene because the endometrium in the right uterine horn showed a weak estrogenic effect." Goldman NA, et al. Malignant mixed Mullerian tumor of the uterus in a patient taking raloxifene. Obstetrics and Gynecology 105: 1278-1280, No. 5, Part 2, May 801059589 2005 - USA

» Editorial comment: A search of AdisBase and Medline did not reveal any previous case reports of malignant mixed tumour of the uterus associated with raloxifene. The WHO Adverse Drug Reactions database contained 13 reports of uterine disorder NOS and 15 reports of uterine neoplasm associated with raloxifene.

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Reactions 13 Jan 2007 No. 1134