Toremifene, a selective estrogen receptor modulator, significantly improved biochemical recurrence in bone metastatic prostate cancer: A randomized controlled phase II a trial

BMC Cancer

Volumn 15, Issue 1, 2015, Pages

  Fujimura, Tetsuya ^a   Takahashi, Satoru ^b   Kume, Haruki ^a   Urano, Tomohiko ^a   Takayama, Kenichi ^a   Yamada, Yuta ^a   Suzuki, Motofumi ^a   Fukuhara, Hiroshi ^a   Nakagawa, Tohru ^a   Inoue, Satoshi ^a   Homma, Yukio ^a  

^a UNIVERSITY OF TOKYO   (Japan)

^b NIHON UNIVERSITY   (Japan)

Author keywords

Androgen deprivation therapy; Biochemical recurrence; Prostate cancer; Raloxifene; Toremifene

Indexed keywords

ACETYLSALICYLIC ACID; ANDROGEN RECEPTOR; BICALUTAMIDE; ESTROGEN RECEPTOR ALPHA; ESTROGEN RECEPTOR BETA; GONADORELIN AGONIST; PROSTATE SPECIFIC ANTIGEN; RALOXIFENE; TOREMIFENE; ANTIANDROGEN;

AGED; ANDROGEN DEPRIVATION THERAPY; ANTIBODY SPECIFICITY; ANTIGEN DETECTION; ARTICLE; BIOCHEMICAL RECURRENCE; BIOCHEMICAL RECURRENCE FREE SURVIVAL; BONE METASTASIS; CANCER GRADING; CANCER RECURRENCE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FUNCTIONAL ASSESSMENT; HEADACHE; HOT FLUSH; HUMAN; HUMAN TISSUE; IMMUNOHISTOCHEMISTRY; IMMUNOREACTIVITY; MALE; ORCHIECTOMY; PHASE 2 CLINICAL TRIAL; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; VISUAL ANALOG SCALE; ANTAGONISTS AND INHIBITORS; BLOOD; BONE NEOPLASMS; CLINICAL TRIAL; PATHOLOGY; PROSTATIC NEOPLASMS; SECONDARY; TUMOR RECURRENCE; VERY ELDERLY;

AGED; AGED, 80 AND OVER; ANDROGEN ANTAGONISTS; BONE NEOPLASMS; ESTROGEN RECEPTOR ALPHA; HUMANS; MALE; NEOPLASM RECURRENCE, LOCAL; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS; TOREMIFENE;

EID: 84959253260     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/s12885-015-1871-z     Document Type: Article

References (31)

1. Huggins C, Hodges CV. Studies on prostatic cancer. The effect of castration, of estrogen and of androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Cancer Res. 1941;1:293-7.
2. Cookson MS, Lowrance WT, Murad MH, Kibel AS. American Urological Association. Castration-resistant prostate cancer: AUA guideline amendment. J Urol. 2015;193:491-9.
3. Tannock IF, de Witt R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-12.
4. Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, et al. compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-20.
5. Gravis G, Fizazi K, Joly F, Oudard S, Priou F, Esterni B, et al. Androgen-deprivation therapy alone or with or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU15): a randomized, open-label, phase 3 trial. Lancet Oncol 2013;14:149-158.
6. Tammela T. Endocrine treatment of prostate cancer. J Steroid Biochem Mol Biol 2004;92:287-295.
7. Culig Z, Steiner H, Bartsch G, Hobisch A. Mechanism of endocrine therapy-responsive and -unresponsive prostate tumors. Endocr Relat Cancer. 2005;12:229-244.
8. Takizawa I, Lawrence MG, Balanathan P, Robello R, Pearson HB, Garg E, et al. Estrogen receptor alpha drives proliferation in PTEN-deficient prostate carcinoma by stimulating survival signaling, MYC expression and altering glucose sensitivity. Oncotarget 2014;6:604-616.
9. Fujimura T, Takahashi S, Urano T, Ogawa S, Ouchi Y, Kitamura T, et al. Differential expression of estrogen receptor beta (ERbeta) and its C-terminal truncated splice variant ERbetacx as prognostic predictors in human prostatic cancer. Biochem Biophys Res Commun 2001;289:692-699.
10. Taneja S, Smith MR, Dalton JT, Raghow S, Barnette G, Steiner M, et al. Toremifene-a promising therapy for the prevention of prostate cancer and complications of androgen deprivation therapy. Expert Opin Investig Drugs 2006;15:293-305.
11. Price D, Stein B, Sieber P, Tutrone R, Bailen J, Goluboff E, et al. Toremifene for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia: results of a double-blind, placebo controlled, phase IIB trial. J Urol 2006;176:965-971.
12. Riggs BL, Hartman LC. Selective estrogen-receptor modulators-mechanisms of action and application to clinical practice. N Engl J Med 2003; 348: 618-629.
13. Shazer RL, Jain A, Galkin AV, Cinman N, Nguyen KN, Natale RB, et al. Raloxifene, an oestrogen-receptor-β targeted therapy, inhibits androgen-independent prostate cancer growth: results from preclinical studies and a pilot phase II clinical trial. BJU Int 2006;97:691-697.
14. Soloway MS, Hardeman SW, Hickey D, Raymond J, Todd B, Soloway S, et al. Stratification of patients with metastatic prostate cancer based on disease on initial bone scan. Cancer 1988;61;195-202.
15. Cooperberg MR, Hinotsu S, Namiki M, Ito K, Broering J, Carroll PR, et al. Risk assessment among prostate cancer patients receiving primary androgen deprivation therapy. J Clin Oncol 2009;27:4306-4313.
16. Mottet N, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, et al. EAU guidelines on prostate cancer. Part II: treatment of advanced, relapsing, and castration-resistant prostate cancer. Eur Urol. 2011;59:572-583.
17. Hinotsu A, Niimi M, Akaza H, et al. Development of Japanese version of QOL questionnaire for bladder and prostate cancer patients using FACT-Bl and P: Pilot study. Gan To Kagaku Ryoho 1999;26:657-666 (In Japanese).
18. Fujimura T, Takahashi S, Urano T, Takayama K, Sugihara T, Obinata D, et al. Expression of androgen and estrogen signaling components and stem cell markers to predict cancer progression and cancer-specific survival in patients with metastatic prostate cancer. Clin Cancer Res 2014;20:4625-4635.
19. Hussain M, Tangen CM, Higano C, Schelhammer PF, Faulkner J, Crawford ED, et al. Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from southwest oncology group trial 9346 (INT-0162). J Clin Oncol. 2006;24:3984-90.
20. Kawashima H, Nakatani T. Involvement of estrogen receptors in prostatic tissues. Int J Urol. 2012;19:512-22.
21. Turo R, Smolski M, Esler R, Kujawa ML, Bromage SJ, Oakley N, et al. Diethylstilboestrol for the treatment of prostate cancer: past, present and future. Scand J Urol. 2014;48:4-14.
22. Lonard DM, Smith CL. Molecular perspectives on selective estrogen receptors (SERMs): progress in understanding their tissue-specific agonist and antagonist actions. Steroids. 2002;67:15-24.
23. Raghow S, Hooshdaran MZ, Katiyar S, Steiner MS. Toremifene prevents prostate cancer in transgenic adenocarcinoma of mouse prostate model. Cancer Res. 2002;62:1370-6.
24. Smith MR, Malkowicz SB, Chu F, Forrest J, Price D, Sieber P, et al. Toremifene increase bone mineral density in men receiving androgen deprivation therapy for prostate cancer: Interim analysis of multicenter phase 3 clinical study. J Urol. 2008;179:152-5.
25. Smith MR, Malkowicz SB, Chu F, Forrest J, Sieber P, Barnette KG, et al. Toremifene improves lipid profiles in men receiving androgen deprivation therapy for prostate cancer: Interim analysis of multicenter phase 3 clinical study. J Clin Oncol. 2008;26:1824-9.
26. Dutertre M, Smith CL. Molecular mechanisms of selective estrogen receptors (SERM) action. J Pharmacol Exp Ther. 2000;295:431-7.
27. Draper MW, Flowers DE, Huster WJ, Neild JA, Harper KD, Arnaud C. A controlled trial of raloxifene (LY139481) HCI: impact on bone turnover and serum lipid profile in healthy postmenopausal women. J Bone Miner Res. 1996;11:835-42.
28. Kangas L. Review of the pharmacological properties of toremifene. J Steroid Biochem. 1990;36:191-5.
29. Megas G, Chrisofos M, Anastasiou I, Tsitlidou A, Choreftaki T, Deliveliotis C Estrogen receptor (α and β) but not androgen receptor expression is correlated with recurrence, progression and survival in post prostatectomy T3N0M0 locally advanced prostate cancer. Asian J Androl. 2015;17:98-105.
30. Nakajima Y, Akaogi K, Suzuki T, Osakabe A, Yamaguchi C, Sunahara N, et al. Estrogen regulates tumor growth through a nonclassical pathway that includes the transcription factors ERβ and KLF5. Sci Signal. 2011;4:1-12.
31. Chadaha MK, Ashraf U, Lawrence D, Tian L, Levine E, Silliman C, et al. Phase II study of fulvestrant (Faslodex) in castration resistant prostate cancer. Prostate. 2008;68:1461-6.