BACKGROUND: LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer. METHODS: We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels. RESULTS: On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]). CONCLUSION: LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile. TRIAL REGISTRATION ClinicalTrials.gov, NCT04563936.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

PURPOSE: The purpose of this study was to investigate relationships among menopausal symptoms, functional status, and distress and to identify factors influencing distress in premenopausal breast cancer patients who had been on endocrine therapy. METHODS: A descriptive correlational study was conducted. Data were collected using questionnaires from 140 patients with breast cancer undergoing endocrine therapy at a general hospital. Data were analyzed using descriptive statistics, t-test, ANOVA, Tukey HSD test, Pearson's correlation analysis and hierarchical regression analysis. RESULTS: The mean scores for menopausal symptom, functional status, and distress were 19.65±7.86, 2.67±0.33 and 3.69±2.19, respectively. The menopausal symptoms and distress were positively correlated (r=.76, p<.001). The menopausal symptoms and functional status (r=−.43, p<.001) and functional status and distress (r=−.31, p<.001) were negatively correlated. The most influential factor for distress was menopausal symptoms (β=.79, p<.001). CONCLUSION: Based on the findings of this study, developing nursing intervention programs focusing on decreasing menopausal symptoms and distress are recommended.
Activities of Daily Living ; Antineoplastic Agents, Hormonal ; Breast Neoplasms ; Breast ; Female ; Hospitals, General ; Humans ; Menopause ; Nursing ; Stress, Psychological

This study investigated the clinical activity of abiraterone plus prednisone in docetaxel-naïve and docetaxel-resistant Chinese patients with metastatic castration-resistant prostate cancer (mCRPC). A total of 146 patients with docetaxel-naïve group (103 cases) and docetaxel-resistant group (43 cases) were enrolled from the Shanghai Cancer Center (Shanghai, China) in this retrospective cohort study. The efficacy endpoints were prostate-specific antigen response rate, prostate-specific antigen progression-free survival, clinical/radiographic progression-free survival, and overall survival in response to abiraterone plus prednisone. Significantly higher prostate-specific antigen response rate was found in docetaxel-naïve group (54.4%, 56/103) compared to docetaxel-resistant group (34.9%, 15/43) (P = 0.047). In addition, significantly higher median prostate-specific antigen progression-free survival (14.0 vs 7.7 months, P = 0.005), clinical or radiographic progression-free survival (17.0 vs 12.5 months, P = 0.003), and overall survival (27.0 vs 18.0 months, P = 0.016) were found in docetaxel-naïve group compared to docetaxel-resistant group, respectively. The univariate and multivariate analyses indicated that lower albumin and visceral metastases were independent significant predictors for shorter overall survival. To sum up, our data suggested that abiraterone plus prednisone was efficient in both docetaxel-naïve and docetaxel-resistant Chinese patients. Moreover, higher PSA response rate and longer overall survival were observed in the docetaxel-naïve group, which suggested that abiraterone was more effective for docetaxel- naïve patients than for docetaxel failures.
Aged ; Aged, 80 and over ; Androstenes/therapeutic use* ; Antineoplastic Agents, Hormonal/therapeutic use* ; China ; Disease Progression ; Disease-Free Survival ; Drug Therapy, Combination ; Humans ; Male ; Middle Aged ; Prednisone/therapeutic use* ; Prostatic Neoplasms, Castration-Resistant/mortality* ; Retrospective Studies ; Survival Rate ; Treatment Outcome

We aimed to evaluate the current nationwide trend, efficacy, safety, and quality of life (QoL) profiles of hormone treatment in real-world practice settings for prostate cancer (PCa) patients in Korea. A total of 292 men with any biopsy-proven PCa (TanyNanyMany) from 12 institutions in Korea were included in this multi-institutional, observational study of prospectively collected data. All luteinizing hormone-releasing hormone (LHRH) agonists were allowed to be investigational drugs. Efficacy was defined as (1) the rate of castration (serum testosterone ≤50 ng dl^-1) at 4-week visit and (2) breakthrough (serum testosterone >50 ng dl^-1 after castration). Safety assessments included routine examinations for potential adverse events, laboratory tests, blood pressure, body weight, and bone mineral density (BMD, at baseline and at the last follow-up visit). QoL was assessed using the Expanded Prostate Cancer Index Composite-26 (EPIC-26). The most common initial therapeutic regimen was LHRH agonist with anti-androgen (78.0%), and the most commonly used LHRH agonist for combination and monotherapy was leuprolide (64.0% for combination and 58.0% for monotherapy). The castration and breakthrough rates were 78.4% and 6.6%, respectively. The laboratory results related to dyslipidemia worsened after 4 weeks of hormone treatment. In addition, the mean BMD T-score was significantly lower at the last follow-up (mean: -1.950) compared to baseline (mean: -0.195). The mean total EPIC-26 score decreased from 84.8 (standard deviation [s.d.]: 12.2) to 78.3 (s.d.: 8.1), with significant deterioration only in the urinary domain (mean: 23.5 at baseline and 21.9 at the 4-week visit). These findings demonstrate the nationwide trend of current practice settings in hormone treatment for PCa in Korea.
Aged ; Androgen Antagonists/therapeutic use* ; Antineoplastic Agents, Hormonal/therapeutic use* ; Cholesterol/blood* ; Drug Therapy, Combination ; Humans ; Leuprolide/therapeutic use* ; Male ; Middle Aged ; Prostatic Neoplasms/pathology* ; Quality of Life ; Receptors, LHRH/agonists* ; Republic of Korea ; Testosterone/blood* ; Treatment Outcome ; Triglycerides/blood*

Even in the era of novel targeted agents, switching to a second-line nonsteroidal antiandrogen (NSAA) is still widely used in treating metastatic castration-resistant prostate cancer (mCRPC), especially in undeveloped countries. However, whether prior treatment with a second-line NSAA would impact the efficacy of abiraterone acetate (Abi) remains uncertain. In the current study, 87 mCRPC patients treated with Abi were analyzed. Among them, 21 were treated with a second-line NSAA (from bicalutamide to flutamide) before receiving abiraterone, while the remaining 66 received Abi directly. Therapeutic efficacy of Abi was compared between those with and without prior second-line NSAA using Kaplan-Meier curves, log-rank test, and Cox regression models. The therapeutic efficacy of Abi was similar between those with or without the prior switching treatment of flutamide, in terms of either prostate-specific antigen progression-free survival (PSA-PFS, 5.5 vs 5.6 months, P = 0.967), radiographic progression-free survival (rPFS, 12.8 vs 13.4 months, P = 0.508), overall survival (OS, not reached vs 30.6 months, P = 0.606), or PSA-response rate (71.4% [15/21] vs 60.6% [40/66], P = 0.370). This is the first time that the impact of prior switching of treatment to a second-line NSAA on the efficacy of Abi in mCRPC patients has been addressed. Our data support that, use of prior sequential bicalutamide and flutamide does not seem to preclude response to abiraterone, although larger cohort studies and, ideally, a randomized controlled trial are needed. These findings will facilitate doctors' decision-making in the treatment of mCRPC patients, especially for those with previous experience of switching NSAA second-line treatments in the clinic.
Abiraterone Acetate/therapeutic use* ; Aged ; Aged, 80 and over ; Androgen Antagonists/therapeutic use* ; Anilides/therapeutic use* ; Antineoplastic Agents, Hormonal/therapeutic use* ; Disease-Free Survival ; Female ; Flutamide/therapeutic use* ; Humans ; Kaplan-Meier Estimate ; Male ; Nitriles/therapeutic use* ; Nonsteroidal Anti-Androgens/therapeutic use* ; Prostate-Specific Antigen/analysis* ; Prostatic Neoplasms, Castration-Resistant/drug therapy* ; Retrospective Studies ; Survival Analysis ; Tosyl Compounds/therapeutic use* ; Treatment Outcome

PURPOSE: The purpose of this study was to identify the degree of menopause symptoms and associated factors in patients with breast cancer who were receiving hormone therapy. METHODS: Data were collected with questionnaires from 150 patients with breast cancer who had been on hormone therapy at a hospital in Seoul. Data were analyzed with the t-test, ANOVA, and Pearson correlation coefficient to compare the degree of menopause symptoms by demographic, clinical and psychological factors. RESULTS: The mean menopause symptoms score was 13.39±7.97. Most participants reported having hot flushes and sweating (75.3%), physical and mental exhaustion (82.7%) and sexual problems (64.7%). Menopause symptoms and depression were correlated with each other (p < .01). Somato-vegetative symptoms were different significantly by age, menopausal status at time of operation, occupation and tumor. Psychological symptoms were different significantly by marital status, operation type and chemotherapy. Urogenital symptoms were different significantly by prior history of cancer, occupation, operation type and radiation therapy. CONCLUSION: These findings can be used to provide tailored nursing interventions by identifying high risk groups for menopausal symptom among breast cancer patients receiving hormone therapy.
Antineoplastic Agents, Hormonal ; Breast Neoplasms ; Breast ; Depression ; Drug Therapy ; Female ; Humans ; Marital Status ; Medication Adherence ; Menopause ; Nursing ; Occupations ; Psychology ; Seoul ; Sweat ; Sweating

Objective: To evaluate the role of the serum testosterone level as an independent predictor of bone metastasis of prostate cancer. METHODS: This study included 165 male patients with prostate cancer confirmed by biopsy. The patients were aged 58－78 (66.6±5.3) years and none had received androgen-deprivation therapy, chemotherapy or radiotherapy previously. We obtained the baseline clinical data from the patients, including prostate biopsy Gleason scores and the levels of serum prostate-specific antigen (PSA), total testosterone (TT), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2), alkaline phosphatase (ALP) and prolactin. According to the results of bone scanning, we divided the patients into a bone metastasis and a non-bone metastasis group and screened out the differential factors by univariate analysis and the independent predictor of bone metastasis using the multivariate non-conditional logistic regression model. RESULTS: Univariate analysis showed no statistically significant differences between the bone metastasis and non-bone metastasis groups in age (P = 0.126) or the levels of serum LH (P = 0.930), FSH (P = 0.763) and E2 (P = 0.256), but that the former had remarkably higher Gleason scores (P < 0.01), total PSA (P <0.01) and ALP (P <0.01) but a lower TT level than the latter (P = 0.013). According to the results of multivariate logistic regression analysis, serum ALP (P <0.01, OR = 1.018 ［1.011－1.026］) and total PSA (P <0.01, OR = 1.029 ［1.015－1.044］) could be regarded as independent predictors of bone metastasis of prostate cancer but not low serum TT (P = 0.531, OR = 0.999 ［0.996－1.002］) or biopsy Gleason score (P = 0.898, OR = 0.787 ［0.412－1.9559］). CONCLUSIONS The low level of serum testosterone is closely associated with but not an independent predictor of bone metastasis of prostate cancer.
Aged ; Alkaline Phosphatase ; blood ; Antineoplastic Agents, Hormonal ; Biopsy ; Bone Neoplasms ; secondary ; Estradiol ; blood ; Follicle Stimulating Hormone ; blood ; Humans ; Logistic Models ; Luteinizing Hormone ; blood ; Male ; Middle Aged ; Neoplasm Grading ; Prolactin ; blood ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms ; blood ; pathology ; Retrospective Studies ; Testosterone ; blood ; deficiency

Objective: To explore the feasibility, safety and clinical effect of mid-frequency transcutaneous electrical acupoint stimulation (TEAS) combined with oral tamoxifen (TAM) in the treatment of oligoasthenozoospermia. METHODS: We randomly and equally assigned 120 patients with idiopathic oligoasthenozoospermia to receive oral TAM, mid-frequency TEAS, or TAM+TEAS, all for 8 weeks. Before and after treatment, we recorded the semen volume, total sperm count, sperm concentration, sperm motility, percentage of progressively motile sperm (PMS), and the levels of follicle-stimulating hormone (FSH), luteotrophic hormone (LH) and testosterone (T) in the peripheral serum and compared these parameters among the three groups of patients. RESULTS: Compared with the baseline, none of the patients showed significant improvement in the semen volume (P >0.05) but all exhibited remarkably elevated levels of serum FSH, LH and T after treatment (P <0.05); TAM significantly improved the total sperm count (［25.16 ± 2.05］ vs ［42.65 ± 5.78］ ×106, P <0.05) and sperm concentration (［12.15 ± 2.51］ vs ［24.31 ± 2.59］ ×10⁶/ml, P <0.05), but not total sperm motility (［21.78 ± 8.81］ vs ［22.61 ± 5.75］ %, P >0.05) or PMS (［15.87 ± 7.81］ vs ［16.76 ± 5.86］ %, P >0.05); TEAS markedly increased total sperm motility (［24.81 ± 8.27］ vs ［32.43 ± 4.97］ %, P <0.05) and PMS (［19.71 ± 9.15］ vs ［27.17 ± 5.09］%, P <0.05), but not the total sperm count (［23.23 ± 3.14］ vs ［25.87 ± 4.96］ ×106, P >0.05) or sperm concentration (［11.27 ± 2.24］ vs ［14.12 ± 2.47］ ×10⁶/ml, P >0.05); TAM+TEAS, however, improved not only the total sperm count (［26.17 ± 5.05］ vs ［ 51.14 ± 3.69］×106, P <0.05) and sperm concentration (［12.78 ± 2.41］ vs ［27.28 ± 1.98］ ×10⁶/ml, P <0.05), but also total sperm motility (［23.89 ± 9.05］ vs ［37.12 ± 5.33］%, P <0.05) and PMS (［17.14 ± 8.04］ vs ［31.09 ± 7.12］%, P <0.05). The total effectiveness rate was significantly higher in the TAM+TEAS group than in the TAM and TEAS groups (97.5% vs 72.5% and 75.0%, P <0.05). CONCLUSIONS Mid-frequency TEAS combined with tamoxifen can significantly improve semen quality and increase sex hormone levels in patients with idiopathic oligoasthenozoospermia.
Acupuncture Points ; Antineoplastic Agents, Hormonal ; administration & dosage ; therapeutic use ; Asthenozoospermia ; blood ; therapy ; Combined Modality Therapy ; methods ; Electroacupuncture ; methods ; Feasibility Studies ; Follicle Stimulating Hormone ; blood ; Humans ; Male ; Oligospermia ; blood ; therapy ; Prolactin ; blood ; Semen Analysis ; Sperm Count ; Sperm Motility ; Tamoxifen ; administration & dosage ; therapeutic use ; Testosterone ; blood

Objective: To investigate the clinical effects of integrated traditional Chinese and Western medicine in the treatment of castration-resistant prostate cancer (CRPC). METHODS: A total of 54 CRPC patients were randomly divided into a control and a trial group, all treated by endocrine therapy (oral Bicalutamide at 50 mg per d plus subcutaneous injection of Goserelin at 3.6 mg once every 4 wk) and chemotherapy (intravenous injection of Docetaxel at 75 mg/m2 once every 3 wk plus oral Prednisone at 5 mg bid), while the latter group by Fuyang Huayu Prescription (a Traditional Chinese Medicine ［TCM］ prescription for tonifying yang and dispersing blood stasis) in addition, for a course of 24 weeks. Comparisons were made between the two groups of patients in the level of serum prostate-specific antigen (PSA), Karnofsky physical condition scores, function assessment of cancer therapy-prostate (FACT-P) scores, and TCM symptoms scores before and after 12 or 24 weeks of treatment. RESULTS: Compared with the baseline, the serum PSA level was significantly decreased after 12 weeks of treatment both in the control (［25.9 ± 39.3］ vs ［20.0 ± 21.1］ μg/L, P <0.05) and in the trial group (［22.1 ± 33.9］ vs ［17.9 ± 19.1］ μg/L, P <0.05), with no statistically significant differences between the two groups (P >0.05). At 24 weeks, however, the PSA levels in the control and trial groups were slightly increased to (23.1 ± 28.4) and (19.6 ± 23.5) μg/L, respectively, with no statistically significant differences in between (P >0.05). Karnofsky, FACT-P and TCM symptoms scores were all markedly improved in the trial group after 12 weeks of treatment (P <0.05) and remained stable at 24 weeks, but not in the control group either at 12 or at 24 weeks (P >0.05). CONCLUSIONS TCM Fuyang Huayu Prescription combined with endocrine therapy and chemotherapy is effective for CRPC.
Anilides ; administration & dosage ; Antineoplastic Agents, Hormonal ; therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; therapeutic use ; Docetaxel ; Drug Administration Schedule ; Goserelin ; administration & dosage ; Humans ; Male ; Nitriles ; administration & dosage ; Prednisone ; administration & dosage ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms, Castration-Resistant ; blood ; drug therapy ; Taxoids ; administration & dosage ; Tosyl Compounds ; administration & dosage ; Treatment Outcome

Endometrial hyperplasia (EH) comprises a spectrum of changes in the endometrium ranging from a slightly disordered pattern that exaggerates the alterations seen in the late proliferative phase of the menstrual cycle to irregular, hyperchromatic lesions that are similar to endometrioid adenocarcinoma. Generally, EH is caused by continuous exposure of estrogen unopposed by progesterone, polycystic ovary syndrome, tamoxifen, or hormone replacement therapy. Since it can progress, or often occur coincidentally with endometrial carcinoma, EH is of clinical importance, and the reversion of hyperplasia to normal endometrium represents the key conservative treatment for prevention of the development of adenocarcinoma. Presently, cyclic progestin or hysterectomy constitutes the major treatment option for EH without or with atypia, respectively. However, clinical trials of hormonal therapies and definitive standard treatments remain to be established for the management of EH. Moreover, therapeutic options for EH patients who wish to preserve fertility are challenging and require nonsurgical management. Therefore, future studies should focus on evaluation of new treatment strategies and novel compounds that could simultaneously target pathways involved in the pathogenesis of estradiol-induced EH. Novel therapeutic agents precisely targeting the inhibition of estrogen receptor, growth factor receptors, and signal transduction pathways are likely to constitute an optimal approach for treatment of EH.
Antineoplastic Agents, Hormonal/adverse effects ; Disease Management ; Disease Progression ; Endometrial Hyperplasia/classification/etiology/*therapy ; Female ; Gonadotropin-Releasing Hormone/therapeutic use ; Humans ; Hysterectomy ; Molecular Targeted Therapy/methods ; Progesterone Congeners/therapeutic use ; Risk Factors ; Tamoxifen/adverse effects