Toremifene, a selective estrogen receptor modulator, significantly improved biochemical recurrence in bone metastatic prostate cancer: a randomized controlled phase II a trial. Issue 1 (December 2015)

• Record Type: Journal Article
• Authors: Fujimura, Tetsuya; Takahashi, Satoru; Kume, Haruki; Urano, Tomohiko; Takayama, Kenichi; Yamada, Yuta; Suzuki, Motofumi; Fukuhara, Hiroshi; Nakagawa, Tohru; Inoue, Satoshi; Homma, Yukio
• Is Part Of: BMC cancer. Volume 15:Issue 1(2015)
• Page Start: 1
• Page End: 8
• Publication Date: 2015-12
• Subjects: Toremifene -- Raloxifene -- Androgen deprivation therapy -- Biochemical recurrence -- Prostate cancer; Cancer -- Periodicals; 616.994005
• DOI: 10.1186/s12885-015-1871-z
• Languages: English
• ISSNs: 1471-2407

Abstract

Abstract Backgrounds Durability of androgen-deprivation therapy (ADT) for prostate cancer (PC) is limited. Additional selective estrogen receptor modulators (SERMs) may prolong the durability of ADT, because androgen and estrogen signaling drive PC progression. Methods Men with treatment-naïve bone metastatic PC were randomly assigned in 1:1:1 fashion to receive ADT, toremifene 60 mg plus ADT (TOPADT), or raloxifene 60 mg plus ADT (RAPADT). The primary endpoint was the biochemical recurrence (BCR) rate, and secondary endpoints were changes of scores of the visual analogue scale (VAS) and the functional assessment of cancer therapy (FACT). Results A total of 15 men, 5 each, were allocated to one of the three treatment arms. The basal serum prostate-specific antigen (PSA) level was 198 ng/mL (median, range; 30–8428). Bone metastases were graded as 1 (n = 11), 2 (n = 3), and 3 (n = 1) by the extent of disease. During the median follow-up period of 1370 days (range; 431–1983), BCR occurred in 3, 0 and 2 men in ADT, TOPADT and RAPADT group, respectively. The 5-year BCR-free rate was 30, 100 and 53 %, in ADT, TOPADT and RAPADT group, respectively (p = 0.04, ADT v.s. TOPADT, p = 0.48, ADT v.s. RAPADT andp = 0.12, TOPADT v.s. RAPADT). Scores of VAS improved in all groups and remained stable throughout the study. This analysis is limited as a preliminary result in a single center. Conclusions Toremifene with conventional ADT significantly improved the BCR rate in treatment-naïve bone metastatic PC. Further clinical trials are warranted to confirm the promising clinical efficacy of this combination therapy. Trial registration The protocol was registered at the University Hospital Medical Information Network (UMIN ID;0, 000, 064, 000 ) in Sep 25, 2011.