Effect of Tamoxifen and Raloxifene on the Proliferative Activity of the Breast Epithelium in Premenopausal Women

Lucato, Miliana Tostes; Freitas‐Junior, Ruffo; Moreira, Marise Amaral Rebouças; Bernardes-Junior, Júlio R. M.; Pinto, Sebastião Alves; Paulinelli, Régis Resende; Soares, Leonardo Ribeiro

doi:10.4137/cmo.s22456

Cited by 3 publications

(5 citation statements)

References 27 publications

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“…Two of the studies analyzed reported a significant change in the mean Ki-67 expression following treatment with acolbifene ( 53 ) and with raloxifene ( 62 ). Interestingly, while Ki-67 was not measured at the pre-treatment stage in the study carried out by Lucato et al ( 63 ), its post-treatment expression was low and there were no significant differences between the raloxifene and tamoxifen therapies tested. In general, the results of the studies analyzed so far reveal that acolbifene, raloxifene and tamoxifen each produce an important anti-proliferative effect.…”

Section: Discussionmentioning

confidence: 85%

“…The Ki-67 antigen was analyzed before treatment and at the treatment’s end point in just 3 of the 7 studies, obtaining results that reached statistical significance (P<0.001) in only 2 studies. In the study by Lucato et al ( 63 ), the Ki-67 antigen was not measured before treatment, yet the values obtained after treatment were not significantly different between the two groups. Likewise, the results presented in the study by Serrano et al were also not significant (P=0.78), whereas the studies by Eng-Wong et al , Decensi et al and Bramwell et al ( 64 - 66 ) did not evaluate the Ki-67 antigen.…”

Section: Resultsmentioning

confidence: 90%

“…After the final assessment, only 7 studies met the study criteria and were included in the systematic review ( 51 , 53 , 62 - 66 ). Two studies involved the use of two treatments and as each treatment could be analyzed separately, these studies were divided to assess the treatment outcomes with different SERMs independently ( 51 , 63 ). A total of 1,139 participants were involved in the 7 studies examined, in which the number of participants ranged from 14 to 672.…”

Section: Resultsmentioning

confidence: 99%

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Selective estrogen receptor modulators in the prevention of breast cancer in premenopausal women: a review

Oceguera-Basurto¹,

Topete²,

Oceguera‐Villanueva³

et al. 2020

Transl Cancer Res TCR

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The detection of premenopausal women at high risk of breast cancer is key to chemoprevention. Therapy with selective estrogen receptor modulators (SERMs) induces a significant antiproliferative effect in estrogen receptor (ER) positive breast cancer. This review was designed according the guidelines of the 2009 PRISMA statement. Searching different databases, including PubMed, MedlinePlus, PLoS One, Cochrane Breast Cancer Specialized Register, Clinical Trials.gov and American Society of Clinical Oncology. From 168 records screened, 15 full text articles were assessed for eligibility and only 7 studies met the inclusion criteria. Three of the studies included analyzed changes in Ki-67 expression, revealing weaker expression after treatment with acolbifene and raloxifene (P<0.001). Three studies also analyzed the breast volume by magnetic resonance imagining (MRI) and demonstrate a significant difference after 1 year with raloxifene treatment (P=0.0017). Moreover, a 20% reduction in breast density was observed after a 2-year treatment with tamoxifen in premenopausal women. SERMs reduce the risk of developing breast cancer. The studies reviewed here demonstrate the modulation of Ki-67 expression and changes in breast density, suggesting an important preventive role for this group of drugs in prevention for premenopausal women at high risk of developing breast cancer.

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Section: Discussionmentioning

confidence: 85%

Section: Resultsmentioning

confidence: 90%

Section: Resultsmentioning

confidence: 99%

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Selective estrogen receptor modulators in the prevention of breast cancer in premenopausal women: a review

Oceguera-Basurto¹,

Topete²,

Oceguera‐Villanueva³

et al. 2020

Transl Cancer Res TCR

View full text Add to dashboard Cite

show abstract

“…Ki‐67 antibodies are used as a predicting factor for treatment response when evaluating different therapies for breast cancer. The capacity to reduce tumor cell proliferation, as measured by Ki‐67 expression, is considered to be a good marker of the efficacy of the agents studied .…”

Section: Discussionmentioning

confidence: 99%

Effect of Ki-67 on Immunohistochemical Classification of Luminal A to Luminal B Subtypes of Breast Carcinoma

et al. 2015

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It has recently been proposed to include an immunohistochemical marker of cell proliferation, Ki-67, as an element with which to classify the molecular subtypes of breast cancer. The objective of this study was to evaluate the effect of the introduction of the Ki-67 marker on the molecular classification of breast cancer by immunohistochemistry. This study was performed on 234 cases of invasive ductal carcinoma of the breast submitted to two immunohistochemical classification panels, one including Ki-67 and the other not. The data obtained with the two classifications were correlated with well-established prognostic factors such as histologic grade, the number of lymph nodes affected and tumor size. The molecular classification without Ki-67 identified: 136 cases of luminal A (58.1%), 19 cases of luminal B (8.1%), 27 cases of human epidermal growth-factor receptor 2 overexpressing (11.5%), 27 cases of basal-like (11.5%), and 25 cases of nonbasal-like triple-negative tumors (10.7%). When Ki-67 was included, this situation changed significantly, with the following cases being identified: 72 cases of luminal A (30.8%) and 83 cases of luminal B tumors (35.5%), resulting in a Kappa score of 0.216. Evaluation of correlations between the luminal A and luminal B tumor subtypes and the selected prognostic factors showed a statistically significant difference only when Ki-67 was included and only with respect to histologic grade (p < 0.001). The new classification with Ki-67 significantly altered the prevalence of the luminal A and luminal B subtypes and improved correlation with the histologic grade.

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“…However, uptake and adherence to daily oral TMX are relatively low [ 5 ]. Raloxifene (RLX), another SERM like TMX, was originally developed to treat osteoporosis in postmenopausal women [ 5 ], but in 2007, the US Food and Drug Administration (FDA) approved the use of RLX to reduce invasive BC risk in postmenopausal women with osteoporosis and/or at high risk for BC [ 9 , 10 ]. Compared to TMX, RLX has a preferable safety profile with no increased risk for endometrial cancer and less risk for thromboembolism [ 5 ], making it an ideal first-line drug to use in a sustained delivery platform for chemoprophylaxis.…”

Section: Introductionmentioning

confidence: 99%

Formulation Development for Transdermal Delivery of Raloxifene, a Chemoprophylactic Agent against Breast Cancer

et al. 2022

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Raloxifene (RLX) is a second-generation selective estrogen receptor modulator approved for the prevention of invasive breast cancer in women. Oral therapy of RLX requires daily intake and is associated with side effects that may lead to low adherence. We developed a weekly transdermal delivery system (TDS) for the sustained delivery of RLX to enhance the therapeutic effectiveness, increase adherence, and reduce side effects. We evaluated the weekly transdermal administration of RLX using passive permeation, chemical enhancers, physical enhancement techniques, and matrix- and reservoir-type systems, including polymeric gels. In vitro permeation studies were conducted using vertical Franz diffusion cells across dermatomed human skin or human epidermis. Oleic acid was selected as a chemical enhancer based on yielding the highest drug delivery amongst the various enhancers screened and was incorporated in the formulation of TDSs and polymeric gels. Based on in vitro results, both Eudragit- and colloidal silicon dioxide-based transdermal gels of RLX exceeded the target flux of 24 μg/cm2/day for 7 days. An infinite dose of these gels delivered 326.23 ± 107.58 µg/ cm2 and 498.81 ± 14.26 µg/ cm2 of RLX in 7 days, respectively, successfully exceeding the required target flux. These in vitro results confirm the potential of reservoir-based polymeric gels as a TDS for the weekly administration of RLX.

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Effect of Tamoxifen and Raloxifene on the Proliferative Activity of the Breast Epithelium in Premenopausal Women

Cited by 3 publications

References 27 publications

Selective estrogen receptor modulators in the prevention of breast cancer in premenopausal women: a review

Selective estrogen receptor modulators in the prevention of breast cancer in premenopausal women: a review

Effect of Ki-67 on Immunohistochemical Classification of Luminal A to Luminal B Subtypes of Breast Carcinoma

Formulation Development for Transdermal Delivery of Raloxifene, a Chemoprophylactic Agent against Breast Cancer

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