Phase III Randomized Trial of Toremifene vs Tamoxifen in Hormonodependant Advanced Breast Cancer

Milla-Santos, A.; Milla, L.; Rallo, L.; Solano, V.

doi:10.1023/a:1006440802709

Cited by 54 publications

(21 citation statements)

References 20 publications

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“…A Spanish double-blind, randomized study in 217 postmenopausal women with advanced breast cancer reported a somewhat higher response rate with toremifene 60 mg than with tamoxifen 40 mg (64% vs 52%), although the difference did not achieve statistical significance [34] . Time to progression and overall survival rates were similar in the two groups.…”

Section: Followup Treatment Resultsmentioning

confidence: 97%

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Toremifene in the treatment of breast cancer

Mustonen¹

2014

WJCO

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Core tip: Toremifene is safe and effective in the treatment of breast cancer. Toremifene and tamoxifen are equivalently effective in the treatment of breast cancer, although some studies show an advantage for toremifene. Safety and tolerability is also broadly equivalent, although toremifene may cause fewer uterine neoplasms, serious vascular adverse events and has a more beneficial effect on plasma lipids than does tamoxifen.Mustonen MVJ, Pyrhönen S, Kellokumpu-Lehtinen PL. Toremifene in the treatment of breast cancer.

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Section: Followup Treatment Resultsmentioning

confidence: 97%

“…There have been ten randomized controlled studies comparing toremifene with tamoxifen [29][30][31][32][33][34][35][36][37][38] . Collectively, these studies, which include a total of more than 5500 patients show rather clearly that toremifene is not less effective than tamoxifen.…”

Section: Randomized Studies With Toremifenementioning

confidence: 99%

Toremifene in the treatment of breast cancer

Mustonen¹

2014

WJCO

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“…Consequently, alternative SERMs were developed and entered clinical use in the 1990s. Toremifene and idoxifene were closely related to tamoxifen and Phase III trials showed postmenopausal women with advanced breast cancer treated with these agents produced similar objective response rates to tamoxifen [33][34][35]. Structurally distinct SERMs ('fixed-ring' derivates), such as raloxifene ( Figure 2) and arzoxifene, were then introduced.…”

Section: Selective Estrogen Receptor Modulatorsmentioning

confidence: 99%

Endocrine therapy – current benefits and limitations

Nicholson

Johnston

2005

Breast Cancer Res Treat

116

107

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Endocrine therapy is a valuable option for the treatment of postmenopausal women with estrogen receptor (ER)-positive breast cancer due to its demonstrated efficacy and favorable safety profile. Although tamoxifen has been the established treatment for more than 20 years its long-term use is associated with several tolerability concerns and may lead to increased risk of endometrial cancer and thromboembolic complications. In addition, many patients who initially respond to treatment with endocrine agents such as tamoxifen eventually relapse with resistant disease. Sequential use of endocrine therapies is often used in patients as resistance to individual agents develops. Several endocrine approaches have been developed that deprive the tumor of estrogen stimulation, either by directly modulating the ER-signaling pathway or by lowering serum or tumor concentrations of estrogen. In the classic pathway of estrogen signal transduction, the steroid hormone binds to its intracellular ER, triggering a cascade of events that ultimately leads to altered gene transcription. More recently, it has become apparent that ER activation can also occur via estrogen-independent receptor activation or by non-nuclear action through cell surface receptors. Consequently, molecular cross-talk exists between the ER and growth factor signaling cascades, which is a key factor in de novo and acquired resistance to endocrine therapy. Inappropriate activation of growth factor signaling can readily promote endocrine therapy failure in breast cancer cells, either by overriding the growth-inhibitory properties of antiestrogenic drugs or by establishment of a new self-propagating autocrine loop that efficiently drives resistant cell growth. Fulvestrant is a new type of ER antagonist with no agonist effects that binds, blocks and causes degradation of the ER. As multiple signaling pathways are involved in the activation of ER, the use of agents such as fulvestrant that directly target the ER and lead to both degradation of the receptor and abrogation of ER signaling may prevent or delay the development of absolute endocrine resistance. In addition, combining antiestrogenic drugs with inhibitors of cell signaling molecules to target both the ER and growth factor signaling pathways is likely to provide a means of delaying endocrine therapy resistance, leading the way to more effective breast cancer treatment.

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“…Results of this trial were presented recently at the 2006 American Society of Clinical Oncology meeting. Toremifene (TOR) is an oral, non-steroidal estrogen receptor blocker approved for first-line hormonal therapy of postmenopausal patients with advanced breast cancer [5,6]. It has also shown anti-tumor activity in patients who had failed prior tamoxifen therapy.…”

Section: Introductionmentioning

confidence: 99%

The effects of atamestane and toremifene alone and in combination compared with letrozole on bone, serum lipids and the uterus in an ovariectomized rat model

Goss

et al. 2006

Breast Cancer Res Treat

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We compared the effects of atamestane (ATA) and toremifene (TOR) alone and in combination, with letrozole (LET) on bone, serum lipids and the uterus in ovariectomized (OVX) rats after 16 weeks of treatment. Compared to OVX controls lumbar vertebral and femoral BMD as well as mechanical strength and trabecular bone volume were significantly greater in animals given ATA, TOR or ATA + TOR. The effects of ATA were not reversed by the androgen receptor blocker, flutamide (FLT). Serum cholesterol, low-density lipoprotein cholesterol and triglycerides were reduced by TOR and ATA + TOR whereas they remained unchanged in animals receiving ATA, ATA + FLT, and LET. The uterine epithelium in OVX animals was equally stimulated by TOR and ATA + TOR and unaffected by ATA or LET. Intact animals had significant atrophy of the uterine epithelium when receiving ATA. In summary, TOR alone or in combination with ATA had a predictable stimulatory effect on bone and the uterine epithelium while reducing key parameters of lipid metabolism. In contrast, ATA but not LET had an unexpected stimulatory effect on the OVX rat's bone and this was not reversed by the anti-androgen FLT leaving this finding unexplained for now. ATA is distinct from LET on end-organ function and this favorable profile makes clinical testing of this steroidal aromatase inhibitor of interest in the clinical setting.

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Phase III Randomized Trial of Toremifene vs Tamoxifen in Hormonodependant Advanced Breast Cancer

Cited by 54 publications

References 20 publications

Toremifene in the treatment of breast cancer

Toremifene in the treatment of breast cancer

Endocrine therapy – current benefits and limitations

The effects of atamestane and toremifene alone and in combination compared with letrozole on bone, serum lipids and the uterus in an ovariectomized rat model

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