内容紹介
Summary
The criteria for biological postmenopause have not been clearly defined, although determining the menopausal status is crucial for selecting agents for adjuvant endocrine therapy for patients with breast cancer. The long-term effects of adjuvant toremifene(TOR)and anastrozole(ANA)on serum follicle-stimulating hormone(FSH)and estradiol(E2)levels in Japanese women were examined using data from a prospective randomized study that mainly studied serum lipids and bone metabolism for 2 years. The study medications were administered orally daily at 40 mg and 1 mg for TOR and ANA, respectively. Sixty-nine patients were randomly assigned to the TOR group(n=36)or ANA group(n=33). FSH and E2 levels were measured using chemiluminescent immunoassay. The mean ages of the patients in the TOR and ANA groups were 62.5 and 60.0 years, respectively. None of the patients experienced menstruation during the course of the study. The baseline serum FSH level in the TOR group(69.6 mIU/mL)decreased to 59.2%, 54.6%, and 50.0% at 6, 12, and 24 months, respectively, after therapy commencement. The FSH levels ranged from 8.6 to 68.1 mIU/mL and were<20 mIU/mL in 2 patients(9.5%;8.6 and 14.4 mIU/mL). The serum FSH levels in the ANA group did not change markedly over 24 months. The baseline serum E2 level in the ANA group(11.6 pg/mL)decreased to 72.4%, 70.7%, and 61.2% at 6, 12, and 24 months, respectively, after therapy commencement. The serum E2 level in the TOR group did not change markedly over 24 months. When switching to other endocrine agents as adjuvant therapy for patients with breast cancer treated with TOR, the serum FSH level decreased to half of the preinitiation level, and one-tenth of the FSH levels was<20 mIU/mL, while the postmenopausal serum E2 level was maintained.
要旨
閉経後乳癌術後療法患者におけるトレミフェン(TOR),アナストロゾール(ANA)投与の血中卵胞刺激ホルモン(FSH)とエストラジオール(E2)への影響を検討した。無作為化比較試験で脂質・骨代謝マーカーと同時に測定したFSHとE2の値を遡及的に解析した。測定は化学発光免疫測定法を用いた。69人が登録され36人がTOR群,33人がANA群に割り付けられた。平均年齢はTOR群で62.5歳,ANA群で60.0歳。FSH値はTOR群において投与前値69.6 mIU/mLが,投与後6か月後59.2%,12か月後54.6%,24か月後に50.0%へ低下した。24か月後のFSH値の範囲は8.6～68.1 mIU/mLで,20.0 mIU/mL以下が2人(9.5%; 8.6と14.4 mIU/mL)であった。ANA群では変化を認めなかった。E2値はANA群において投与前値(11.6 pg/mL)は6か月後72.4%,12か月後70.7%,24か月後に61.2%へ低下した。TOR群では変化を認めなかった。TOR投与中にアロマターゼ阻害剤へのスイッチを検討する局面には,血中FSH値はTOR投与で約50%低下し,その約10%は20 mIU/mL以下であることを念頭に置き,閉経の判定は総合的に行うことが必要である。
目次
The criteria for biological postmenopause have not been clearly defined, although determining the menopausal status is crucial for selecting agents for adjuvant endocrine therapy for patients with breast cancer. The long-term effects of adjuvant toremifene(TOR)and anastrozole(ANA)on serum follicle-stimulating hormone(FSH)and estradiol(E2)levels in Japanese women were examined using data from a prospective randomized study that mainly studied serum lipids and bone metabolism for 2 years. The study medications were administered orally daily at 40 mg and 1 mg for TOR and ANA, respectively. Sixty-nine patients were randomly assigned to the TOR group(n=36)or ANA group(n=33). FSH and E2 levels were measured using chemiluminescent immunoassay. The mean ages of the patients in the TOR and ANA groups were 62.5 and 60.0 years, respectively. None of the patients experienced menstruation during the course of the study. The baseline serum FSH level in the TOR group(69.6 mIU/mL)decreased to 59.2%, 54.6%, and 50.0% at 6, 12, and 24 months, respectively, after therapy commencement. The FSH levels ranged from 8.6 to 68.1 mIU/mL and were<20 mIU/mL in 2 patients(9.5%;8.6 and 14.4 mIU/mL). The serum FSH levels in the ANA group did not change markedly over 24 months. The baseline serum E2 level in the ANA group(11.6 pg/mL)decreased to 72.4%, 70.7%, and 61.2% at 6, 12, and 24 months, respectively, after therapy commencement. The serum E2 level in the TOR group did not change markedly over 24 months. When switching to other endocrine agents as adjuvant therapy for patients with breast cancer treated with TOR, the serum FSH level decreased to half of the preinitiation level, and one-tenth of the FSH levels was<20 mIU/mL, while the postmenopausal serum E2 level was maintained.
要旨
閉経後乳癌術後療法患者におけるトレミフェン(TOR),アナストロゾール(ANA)投与の血中卵胞刺激ホルモン(FSH)とエストラジオール(E2)への影響を検討した。無作為化比較試験で脂質・骨代謝マーカーと同時に測定したFSHとE2の値を遡及的に解析した。測定は化学発光免疫測定法を用いた。69人が登録され36人がTOR群,33人がANA群に割り付けられた。平均年齢はTOR群で62.5歳,ANA群で60.0歳。FSH値はTOR群において投与前値69.6 mIU/mLが,投与後6か月後59.2%,12か月後54.6%,24か月後に50.0%へ低下した。24か月後のFSH値の範囲は8.6～68.1 mIU/mLで,20.0 mIU/mL以下が2人(9.5%; 8.6と14.4 mIU/mL)であった。ANA群では変化を認めなかった。E2値はANA群において投与前値(11.6 pg/mL)は6か月後72.4%,12か月後70.7%,24か月後に61.2%へ低下した。TOR群では変化を認めなかった。TOR投与中にアロマターゼ阻害剤へのスイッチを検討する局面には,血中FSH値はTOR投与で約50%低下し,その約10%は20 mIU/mL以下であることを念頭に置き,閉経の判定は総合的に行うことが必要である。