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PubMed2003

[Clinical evaluation of hot flushes developing during endocrine therapy for prostate carcinoma].

OBJECTIVE: There are few clinical investigations on the hot flushes that develop during endocrine therapy for prostate cancer in Japan, although there are many reports in the Western countries. Therefore, we evaluated the incidence of hot flushes and the association between hot flushes and clinical characteristics of prostate cancer patients receiving endocrine therapy. PATIENTS AND METHODS: Sixty-eight prostate cancer patients receiving endocrine therapy (LH-RH analog (group LH-RHA); 22 patients, LH-RHA + non-steroidal antiandrogen (group LH-RHA + NSAA); 20 patients, LH-RHA + steroidal antiandrogen (group LH-RHA + SAA); 8 patients, LH-RHA + estramustine phosphate (group LH-RHA + EP); 1 patient, bilateral orchiectomy (group O); 5 patients, O + non-steroidal antiandrogen (group O + NSAA); 11 patients, and O + steroidal antiandrogen (group O + SAA); 1 patient) were evaluated by a fixed questionnaire. The incidence of the hot flush, the association between hot flushes and the clinical factors, as well as the therapy of hot flushes including SAA and Kampo therapy were analyzed. RESULTS: The overall incidence of hot flushes was 37% (36% in group LH-RHA, 45% in group LH-RHA + NSAA, 13% in group LH-RHA + SAA, 0% in group LH-RHA + EP, 20% in group O, 45% in group O + NSAA, 100% in group O + SAA). No significant association between the hot flushes and the clinical factors of the patients was observed. On the other hand, in 3 of 4 patients treated by SAA, hot flushes improved after 4 weeks. In 2 of 3 patients treated by Kampo, hot flushes improved after 4 weeks. CONCLUSION: Hot flushes are the major side effect of endocrine therapy for Japanese prostate cancer patients. SAA and Kampo are thought to be effective for treatment of hot flushes.

Aged↗
PubMed1996

[Treatment of clinically localized prostatic cancer--endocrine therapy].

We assessed the actuarial survival of 28 patients with localized prostate cancer who were treated with endocrine therapy in comparison with that of 19 patients who had radical prostatectomy between 1972 and 1995. There were no significant differences among the cause-specific curves and clinical disease-free survival of patients treated with endocrine therapy and radical prostatectomy but the all-cause survival curves favored the surgery group. The results of endocrine therapy alone were unsatisfactory for the patients with high grade tumors. In conclusion, the patients with localized prostate cancer at high risk of death from other complications are reasonable candidates for endocrine therapy.

Actuarial Analysis↗
PubMed2004

Endocrine therapy with or without radical prostatectomy for T1b-T3N0M0 prostate cancer.

BACKGROUND: We retrospectively compared the 5-year survival rates of T1b-T3N0M0 prostate cancer patients treated either by endocrine therapy plus radical prostatectomy or endocrine therapy alone. METHODS: Clinical T1b-T3N0M0 prostate cancer patients were enrolled at 104 institutions in Japan. They were assigned to study 1 (n = 176), if they were indicated to prostatectomy, if not indicated, they were assigned to study 2 (n = 151). The indication of prostatectomy was based on the clinical judgement of physicians and/or patients. Those assigned to study 1 underwent prostatectomy and adjuvant endocrine therapy with or without preoperative androgen deprivation. Those assigned to study 2 were treated with leuprorelin acetate with or without chlormadinone acetate. They were followed-up every 3 months until death or for 5 years and over. RESULTS: Those assigned to study 1 were younger (mean age 67.2 vs 75.7 years), less advanced in clinical stage, and had lower prostate specific antigen levels (mean 43.8 vs 103.6 ng/mL). Death for any reason was observed less frequently in study 1 (n = 29, 16%) than study 2 (n = 50, 33%), and the 5-year overall survival rate was higher in study 1 (87 vs. 68%). However, prostate cancer deaths were comparatively seldom (9% in study 1 and 7% in study 2), resulting in the identical 5-year cause specific survival rate in both study groups (91%). In both study groups the overall survival was almost equal to the natural survival of age-matched men. CONCLUSIONS: Endocrine therapy offers a reasonable survival rate in T1b-T3 prostate cancer patients within a 5-year follow-up. Observation will be extended to determine 10-year outcomes.

Age Factors↗
PubMed2004

[Controversies in endocrine therapy for breast cancer].

Major advances have been made in the treatment of postmenopausal women with hormone-sensitive breast cancer. Although tamoxifen has been the standard endocrine therapy for the past twenty years, the development of a third generation of aromatase inhibitors (Als), which effectively inhibit estrogen synthesis in extragonadal sites, gives us a wider range of choices in endocrine therapy. However, many questions remain with respect to the optimal use of Als. Differences between Als and tamoxifen as well as non-steroidal and steroidal Als in their long-term adverse effects on bone demineralization and lipid metabolism are only starting to emerge. The preferable orders for use of non-steroidal and steroidal Als, Als and pure anti-estrogen in patients with metastatic disease are emerging subjects to be examined, following several studies that showed non-cross reactivity between these types of drug. Neo-adjuvant endocrine therapy is now attempting to apply breast conserving surgery in larger numbers of elderly patients who are not suitable for neo-adjuvant chemotherapy. Moreover, many investigators are currently searching for surrogate markers in neo-adjuvant endocrine treatment that can predict the responsiveness and prognosis with adjuvant endocrine therapy. Further research concomitant with clinical trials may lead to a more reliable endocrine therapy modality in the treatment of breast cancer.

Anastrozole↗
PubMed2002

[Developments in endocrine therapy for breast cancer].

After the usefulness of ovariectomy in breast cancer patients was demonstrated, endocrine therapy has been one of the most effective treatments of breast cancer. Thereafter, it became clear that estrogen receptors (ERs) existed in the cells of breast cancer. After it was found that ERs could be used as a predictive factor of endocrine therapy for breast cancer, the validity of endocrine therapy has became more certain. Tamoxifen, a major selective estrogen receptor modulator, is the first agent which has shown evidence of improving survival time and disease-free survival time in the treatment of breast cancer, and is the standard treatment, widely used in the treatment of breast cancer all over the world. LH-RH analogue, commonly used in ablation treatment among premenopausal women, produces the same effect as ovariectomy, and recently has shown good results equivalent to chemotherapy in premenopausal breast cancer treatment. Furthermore, aromatase inhibitors as a form of ablation treatment of postmenopausal women have been used recently. In comparison with tamoxifen, aromatase inhibitors have revealed the same or more effective result in postmenopausal breast cancer treatment. In the near future, endocrine mechanisms in the body and the molecular mechanisms of transcription by ER will be more clearly elucidated, and then new kinds of agent and combined therapies for the endocrine treatment of breast cancer will be developed. Currently, many clinical randomized trials are being conducted to examine the effectiveness of new endocrine treatment. Significant changes are occurring in the endocrine treatment of breast cancer.

Antineoplastic Agents, Hormonal↗
PubMed1996

[Neoadjuvant endocrine therapy in patients with locally advanced prostate cancer].

Recently, there has been an increasing interest in the application of preoperative endocrine therapy prior to radical prostatectomy. The main purpose of this treatment modality is to enhance surgical curability and increase survival. Endocrine therapy was performed before radical prostatectomy on 40 patients between 1986 and 1993; 15 had stage B2 and 25 had stage C disease. The median duration of preoperative endocrine therapy was 3.8 months. All patients subsequently underwent radical prostatectomy, pelvic lymphadenectomy and castration. There was on average a 25.5% (0-71.8%) decrease in maximal cross-sectional area of prostate gland as determined by transrectal ultrasonography. Treatment-related histological effects, divided into three grades were as follows; excellent in 17, moderate in 11 and poor or no regression in 12. Pathological downstaging of disease status from the diagnosis made at the initial clinical examination was seen in 13 of the 40 patients (33%). At a median follow-up of 50 months (19-118 months), 36 of the 40 patients are disease-free and two died of cancer 43 and 50 months postoperatively. These findings suggest that preoperative endocrine therapy plays an important role in the management of locally advanced prostatic cancer.

Aged↗
PubMed2000

[Standards, Options and Recommendations (SOR) for endocrine therapy in patients with non metastatic breast cancer. FNCLCC].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature systematic review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines according to the definitions of Standards, Options and Recommendations for endocrine therapy in patients with non metastatic breast cancer. METHODS: Data have been identified by literature search using Medline, Embase, Cancerlit and Cochrane databases - until july 1999 - and the personal reference lists of the expert group. Once the guidelines were defined, the document was submitted for review to 125 independent reviewers. RESULTS: The main recommendations for the endocrine therapy of patients with non metastatic breast cancer are: 1) Endocrine therapy modalities depend on menopausal status or age of women: ovarian suppression for premenopausal women, antiestrogen drug therapy for postmenopausal women (standard). 2) Tamoxifen (20 mg/d - 5 years) is beneficial to women with positive estrogen receptor tumor (standard, level of evidence A). There is no indication of tamoxifen treatment for women with negative estrogen receptor tumor (standard, level of evidence A). 3) For postmenopausal women with positive estrogen receptor tumor, tamoxifen is the standard adjuvant treatment (level of evidence A). For postmenopausal women with negative estrogen receptor, adjuvant chemotherapy has to be considered (option, level of evidence A). No adjuvant treatment has to be considered for women with poor health condition (option). 4) For premenopausal women with estrogen receptor tumor, results of clinical trials of chemotherapy versus endocrine therapy, suggest a benefit for endocrine therapy. However, there is no sufficient evidence to consider endocrine therapy alone as a standard adjuvant treatment. 5) For premenopausal women, chemotherapy + ovarian suppression or chemotherapy + tamoxifen are not better than chemotherapy alone (level of evidence A). 6) For postmenopausal women, administration of chemotherapy plus adjuvant tamoxifen versus the same tamoxifen alone, is of additional benefit in reducing recurrences but not in prolonging overall survival (standard, level of evidence A). 7) Balance of known benefits (delay to recurrence and death) and risks (side-effects of therapy) for adjuvant chemoendocrine therapy has to be taken into consideration before decision making. Chemoendocrine therapy can be indicated for women at high risk of developing metastatic disease (recommendation, experts agreement).

Antineoplastic Agents, Hormonal↗
PubMed1988

A randomized trial of adjuvant endocrine therapy, chemotherapy, and chemoendocrine therapy for operable breast cancer stratified by estrogen receptors.

Based on estrogen receptor (ER) status and menopausal status, operable breast cancer (International Union Against Cancer [UICC] Stage I, II, and III) patients were randomized for adjuvant endocrine therapy, chemotherapy, and chemoendocrine therapy, and the effects on the disease-free survival (DFS) and overall survival (OS) were compared. Adjuvant endocrine therapy was composed of tamoxifen (TAM) 20 mg/day orally for 2 years in postmenopausal patients. In premenopausal patients, oophorectomy (OVEX) was done before TAM administration. In the chemotherapy arm, the patients were given 0.06 mg/kg of body weight of mitomycin C (MMC) intravenously (IV) and then an oral administration of cyclophosphamide (CPA) 100 mg/body orally in an administration of a 3-month period and a 3-month intermission. This 6-month schedule was repeated four times in 2 years. As the chemoendocrine therapy arm, TAM with MMC + CPA chemotherapy was added. The patients were randomized according to ER and menopausal status. Estrogen receptor-positive (ER+) cancer patients were randomized to three arms: TAM +/- OVEX, MMC + CPA, or MMC + CPA + TAM. For estrogen receptor-negative (ER-) patients, there were two arms: MMC + CPA, or MMC + TAM. The study started in September 1978, and 692 patients entered until the end of 1984 were evaluated. The median follow-up was about 46 months. Totally, a 9.8% rate (68/692) of recurrence was noted, a 7.5% rate (52/692) of mortality. There were no significant differences in DFS or OS among the treatment arms in ER+ or ER- patients. There was significant differences in adverse effects such as bone marrow suppression, gastrointestinal disturbances, cystitis, hair loss between endocrine therapy and chemotherapy or chemoendocrine therapy groups. In this preliminary study, it was concluded that because of less adverse effects of endocrine therapy, it seems rational to select the operable breast cancer patients by the presence or absence of ER, namely, endocrine therapy for ER+ and chemotherapy for ER- cancer patients.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Vascular endothelial growth factor is associated with the efficacy of endocrine therapy in patients with advanced breast carcinoma.

BACKGROUND: Vascular endothelial growth factor (VEGF) is a mediator of angiogenesis and is associated with a poor prognosis in patients with primary breast carcinoma. In the current study, the authors investigated whether there was an association between VEGF levels in tumor tissues and response rates to first-line, systemic therapy in patients with advanced breast carcinoma. METHODS: In 172 tumors from patients with primary breast carcinoma who developed distant metastases during follow-up, cytosolic levels of VEGF were measured using a quantitative enzyme-linked immunosorbent assay. Patients received either endocrine therapy (n = 96) or chemotherapy (n = 76) as first-line treatment after they were diagnosed with advanced disease. RESULTS: In univariate logistic regression analysis for response to endocrine therapy in 96 patients, an increasing level of VEGF, as a log-transformed, continuous variable, was correlated with a poor rate of response (P = 0.043). In multivariate analysis, a significantly lower rate of response to first-line endocrine therapy was found for patients who had high VEGF levels compared with patients who had low VEGF levels (P = 0.025). Similar results were found for the subgroup of 82 patients who received tamoxifen (P = 0.011). An association of VEGF with response to first-line endocrine therapy was found in addition to a predictive impact for estrogen receptor/progesterone receptor status (P = 0.027). VEGF levels did not predict the rate of response to first-line chemotherapy. CONCLUSIONS: The results demonstrated that the level of VEGF affects response to endocrine therapy independent of steroid hormone receptor status and may help to refine further the indication for this treatment in individual patients. Further studies are warranted to explain this underlying resistance to endocrine therapy.

Adult↗
PubMed1987

[Synergistic effect of cell kinetics-directed chemo-endocrine therapy on experimental mammary tumors].

We tried to demonstrate that the cell kinetics-directed chemoendocrine therapy is more effective on hormone dependent breast cancer than empirical combination of the endocrine therapy and chemotherapy. Cell kinetics of each tumor was measured by flow cytometric analysis. Estrogen dependent human breast cancer cell line MCF-7 was used in vitro. In vivo, androgen dependent SC-115 carcinoma was transplanted to DDS mice. In vitro, tamoxifen was administered as the endocrine therapy. In vivo, we carried out testectomy on DDS mice. Effect of the endocrine therapy on the cell kinetics of the tumor was thought to be G1-S depression. High density 5FU was administered as the chemotherapeutic agents, whose content was 1 microgram/ml in vitro and 40 mg/kg in vivo. 5FU brought temporary decrease of cells in S phase. Only anteceding 5FU administration had synergistic effect in combination of 5FU and the endocrine therapy. 5FU was convinced to act more effectively on cells in S phase, so it was shown that cell kinetics-directed schedule was superior to the empirical treatment schedule in chemoendocrine therapy.

Androgens↗
PubMed1989

Endocrine therapy of human breast cancer cells: the role of secreted polypeptide growth factors.

Endocrine therapy is an important modality in the treatment of breast cancer. However, the precise molecular mechanisms underlying the growth inhibitory effect of endocrine therapy are unknown. Recently, it has been shown that breast cancer cells express and secrete polypeptide growth factors that can regulate the growth of the cells through autocrine and/or paracrine pathways. These growth factors are thought to be involved in the response to endocrine therapy. Three different mechanisms have been suggested: (1) stimulation of growth inhibitory peptides; (2) repression of mitogenic peptides; and (3) stimulation of mitogenic growth factors in cells overexpressing the corresponding receptor. This article reviews the scientific evidence on which these hypotheses are based.

Breast Neoplasms↗
PubMed1989

Histological effects of endocrine therapy for prostatic cancer in relation to clinical course.

In order to evaluate histological changes in cases of prostatic cancer following endocrine therapy, 25 extensive specimens were removed from prostates during periods of local control, and were examined with respect to prognosis. Shortly after the commencement of the endocrine therapy, there were noticeable degenerative changes in the cancer cells as well as structural changes such as desquamation of cells and loss of cancer nests. Later than two months from the start of therapy, stromal changes such as fibrosis and scar formation appeared. Coagulation necrosis of tumor tissue, inflammatory cell infiltration and granulomatous reactions were not as prominent. Within the first two months of treatment, the endocrine therapy uniformly affected the cancer tissues to some extent. After then, some showed relapsing viable cells in a part of the tumor, being judged to be no response. The others continued to respond to the therapy. The response was estimated as marked when such therapeutic changes appeared diffusely and profoundly over the tissues removed. Patients with a marked response had a good prognosis, indicating histological evaluation after endocrine therapy to provide a prognostic factor.

Aged↗
PubMed1995

[Progress in breast cancer chemo-endocrine therapy from the survival standpoint].

The EBCTCG overview in 1992 made, it clear that a substantial percentage of patients treated with adjuvant chemotherapy or endocrine therapy showed prolonged survival. In advanced breast cancer patients, indirect evidence was obtained that chemotherapy as well as endocrine therapy may prolong the survival of patients: changes in the survival of a defined cohort in decades, a comparison of the survival time of all patients randomized to a regimen with a higher response rate and that of patients with a lower response rate, and a comparison of the survival of responders and non-responders. We compared the survival times of advanced breast cancer patients treated with an endocrine therapy with adreno-oophorectomy to chemo-endocrine therapy with FAC. There was longer survival in the former group. In these 371 patients, a Cox's proportional hazard model with the landmark method including the response category for the survival estimation showed that the response has a definitive effect on survival. Selection of patients should be in terms of prognostic factors so as to prolong their survival.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Adjuvant endocrine therapy in postmenopausal breast cancer.

Adjuvant endocrine therapy with tamoxifen has a clearly established benefit in postmenopausal women with resected early breast cancer that expresses the estrogen receptor and/or progesterone receptor. Whereas there is a vast and long experience with tamoxifen, the major focus of clinical trials over the past 6 years has involved the study of the third-generation aromatase inhibitors. Recently published data from the Arimidex, Tamoxifen, Alone or in Combination (ATAC) trial, which involved only postmenopausal women and is the largest adjuvant trial ever conducted, has demonstrated superior efficacy for anastrozole over tamoxifen alone or in combination with anastrozole. These data have engendered a great deal of discussion as to whether they provide a sufficient basis for changing the standard of practice in terms of choice of agent. Currently, a case can be made that further maturation of the ATAC trial is necessary and that tamoxifen should remain the standard of endocrine adjuvant therapy for most women, with anastrozole being used in those with a contraindication or intolerance to tamoxifen. However, close attention must be paid to new information as it develops not only related to efficacy but also to other end organ effects.

Anastrozole↗
PubMed1996

Loss of estrogen receptor in recurrent breast cancer is associated with poor response to endocrine therapy.

PURPOSE: Up to 30% to 40% of metastases from hormone receptor-positive primary breast cancer do not respond to endocrine therapy. We studied how often hormone receptor status changes between primary and recurrent tumors and whether such a change might explain unresponsiveness to endocrine therapy. PATIENTS AND METHODS: Primary breast cancer samples and matched asynchronous recurrences were studied from 50 patients who had not received any adjuvant therapy. Estrogen receptor (ER) and progesterone receptor (PR) status was determined immunohistochemically from histologically representative formalin-fixed paraffin-embedded tumor samples. ER status was ascertained by mRNA in situ hybridization. RESULTS: Thirty-five (70%) of 50 primary tumors were positive for ER and 30 (60%) for PR. Hormone receptor status of the recurrent tumor differed from that of the primary tumor in 18 cases (36%). Discordant cases were due to the loss of ER (n = 6), loss of PR (n = 6), or loss of both receptors (n = 6). Receptor-negative primary tumors were always accompanied by receptor-negative recurrences. Among 27 patients with ER-positive primary tumors, loss of ER was a significant predictor (P = .0085) of poor response to subsequent endocrine therapy. Only one of eight patients (12.5%) with lost ER expression responded to tamoxifen therapy, whereas the response rate was 74% (14 of 19) for patients whose recurrent tumors retained ER expression. CONCLUSION: Loss of ER expression in recurrent breast cancer should be considered as a cause for poor response to endocrine therapy in primarily ER-positive patients. We conclude that analysis of recurrent tumor samples may improve the predictive value of ER and PR assays.

Adult↗
PubMed1996

[New development of endocrine therapy in prostate cancer].

Indication and new agents for endocrine therapy in prostate cancer were outlined, and new development of endocrine therapy was reviewed in terms of total androgen blockade (TAB) for advanced disease and localized disease as neoadjuvant setting, and antiandrogen withdrawal syndrome. TAB is considered to be useful in the treatment of patients with advanced prostate cancer, particularly those with minimal disease and good performance status. Neoadjuvant TAB therapy before radical prostatectomy may decrease cancer positive surgical margins. However, long-term follow-up data are required to determine the impact on survival. Antiandrogen withdrawal seems to be therapeutically efficacious for patients with hormone-refractory prostate cancer, with a response rate of about 20%. Therefore, antiandrogen withdrawal should be tried before initiating therapy for hormone-refractory prostate cancer.

Aged↗
PubMed2025

High p62 and ALDH1A3 Reduce the Effectiveness of Endocrine Therapy in Luminal B Breast Cancer.

BACKGROUND/AIM: High expression of p62 and ALDH1A3 indicates a poor clinical outcome in luminal B breast cancer, and p62 is involved in the progression of ALDH1-positive luminal B breast cancer stem cells. However, the association between endocrine therapy and high p62 and ALDH1A3 expression, in luminal B breast cancer remains unclear. MATERIALS AND METHODS: Two datasets with gene expression and clinical data for patients with primary breast cancer (METABRIC, n=2,509; The Cancer Genome Atlas, n=1,084) were downloaded and statistically analyzed. To evaluate the association between the p62 and ALDH1A3 expression levels and endocrine therapy, including tamoxifen and aromatase inhibitor, in patients with luminal B breast cancer, disease-specific survival was examined using Kaplan-Meier and multivariate Cox regression analyses. RESULTS: Patients with p62 high ALDH1A3 high luminal B breast cancer treated with endocrine therapy exhibited a poor prognosis. Moreover, patients with p62 high ALDH1A3 high luminal B breast cancer treated with tamoxifen showed a trend towards a poor prognosis, but those treated with aromatase inhibitors showed a significantly poor prognosis. These results suggest that endocrine therapy, especially aromatase inhibitors, exhibits a reduced effectiveness against p62 high ALDH1A3 high luminal B tumors. CONCLUSION: p62 and ALDH1A3 could be used together as a prognostic biomarker for predicting the efficacy of endocrine therapy for luminal B breast cancer.

ALDH1A3↗
PubMed2005

Endocrinology and hormone therapy in breast cancer: new insight into estrogen receptor-alpha function and its implication for endocrine therapy resistance in breast cancer.

Estrogen and its receptor (ER) are critical for development and progression of breast cancer. This pathway is targeted by endocrine therapies that either block ER functions or deplete ER's estrogen ligand. While endocrine therapies are very effective, de novo and acquired resistance are still common. Laboratory and clinical data now indicate that bidirectional molecular crosstalk between nuclear or membrane ER and growth factor receptor pathways such as HER2/neu is involved in endocrine resistance. Preclinical data suggest that blockade of selected growth factor receptor signaling can overcome this type of resistance, and this strategy is already being tested in clinical trials.

Antineoplastic Agents, Hormonal↗