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1.
BMJ Case Rep ; 17(6)2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38839414

ABSTRACT

Tamoxifen is a non-steroidal selective oestrogen receptor modulator commonly used in the treatment of breast cancer. It is associated with the development of fatty liver and steatohepatitis however drug-induced liver injury is rare. We report a woman in her 50s who developed malaise with an acute moderate aminotransferase elevation without jaundice 6 months after starting tamoxifen. She was not commenced on any other recent drugs and extensive investigation including infective and autoimmune liver screen, cross-sectional imaging and FibroScan were unremarkable. Liver biopsy revealed moderate lobular hepatitis with hepatocyte drop-out. Tamoxifen was ceased and the liver enzymes showed resolution over the following 3 months and improvement of her symptoms.


Subject(s)
Antineoplastic Agents, Hormonal , Breast Neoplasms , Chemical and Drug Induced Liver Injury , Tamoxifen , Humans , Tamoxifen/adverse effects , Female , Chemical and Drug Induced Liver Injury/etiology , Chemical and Drug Induced Liver Injury/diagnosis , Middle Aged , Breast Neoplasms/drug therapy , Antineoplastic Agents, Hormonal/adverse effects , Liver/pathology , Liver/drug effects
2.
Am Soc Clin Oncol Educ Book ; 44(3): e433126, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38788186

ABSTRACT

Androgen-deprivation therapy (ADT) is well established as the standard of care in metastatic prostate cancer (PCa) management; however, ADT has significant adverse effects (AEs) that must be addressed. This review aims to highlight opportunities to mitigate AEs of ADT and explore alternatives in PCa management. Specifically, we discuss behavioral and pharmacologic strategies for mitigating ADT AEs as well as ADT-sparing approaches for hormone-sensitive and castration-resistant PCa. Equipped with effective mitigation strategies and possible alternatives, clinicians and researchers can optimize health-related quality of life for patients currently receiving ADT for PCa and consider treatments that spare patients from AEs of ADT.


Subject(s)
Androgen Antagonists , Prostatic Neoplasms , Quality of Life , Humans , Male , Androgen Antagonists/therapeutic use , Androgen Antagonists/adverse effects , Prostatic Neoplasms/drug therapy , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Disease Management
3.
Sci Rep ; 14(1): 11367, 2024 05 18.
Article in English | MEDLINE | ID: mdl-38762547

ABSTRACT

Fulvestrant, as the first selective estrogen receptor degrader, is widely used in the endocrine treatment of breast cancer. However, in the real world, there is a lack of relevant reports on adverse reaction data mining for fulvestrant. To perform data mining on adverse events (AEs) associated with fulvestrant and explore the risk factors contributing to severe AEs, providing a reference for the rational use of fulvestrant in clinical practice. Retrieved adverse event report information associated with fulvestrant from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database, covering the period from market introduction to September 30, 2023. Suspicious AEs were screened using the reporting odds ratio (ROR) and proportional reporting ratio methods based on disproportionality analysis. Univariate and multivariate logistic regression analyses were conducted on severe AEs to explore the risk factors associated with fulvestrant-induced severe AEs. A total of 6947 reports related to AEs associated with fulvestrant were obtained, including 5924 reports of severe AEs and 1023 reports of non-severe AEs. Using the disproportionality analysis method, a total of 210 valid AEs were identified for fulvestrant, with 45 AEs (21.43%) not listed in the product labeling, involving 11 systems and organs. The AEs associated with fulvestrant were sorted by frequency of occurrence, with neutropenia (325 cases) having the highest number of reports. By signal strength, injection site pruritus showed the strongest signal (ROR = 658.43). The results of the logistic regression analysis showed that concurrent use of medications with extremely high protein binding (≥ 98%) is an independent risk factor for severe AEs associated with fulvestrant. Age served as a protective factor for fulvestrant-related AEs. The co-administration of fulvestrant with CYP3A4 enzyme inhibitors did not show statistically significant correlation with the occurrence of severe AEs. Co-administration of drugs with extremely high protein binding (≥ 98%) may increase the risk of severe adverse reactions of fulvestrant. Meanwhile, age (60-74 years) may reduce the risk of severe AEs of fulvestrant. However, further clinical research is still needed to explore and verify whether there is interaction between fulvestrant and drugs with high protein binding through more clinical studies.


Subject(s)
Adverse Drug Reaction Reporting Systems , Data Mining , Databases, Factual , Fulvestrant , United States Food and Drug Administration , Fulvestrant/adverse effects , Humans , Female , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Middle Aged , Adult , Aged , United States , Breast Neoplasms/drug therapy , Risk Factors , Antineoplastic Agents, Hormonal/adverse effects , Adolescent , Drug-Related Side Effects and Adverse Reactions/epidemiology , Young Adult
5.
Breast ; 75: 103731, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38599048

ABSTRACT

BACKGROUND: When taken as prescribed, endocrine therapy is effective in reducing risk of recurrence and mortality in the treatment of patients with breast cancer. However, treatment side effects can act as a barrier to medication adherence. Existing research has not identified any specific side effects as consistent predictors of nonadherence. Our aim was to explore the influence of symptom clusters on self-reported adherence in patients with breast cancer. METHODS: A cross-sectional online survey was conducted, including patients with breast cancer currently or previously prescribed endocrine therapy (N = 1051). This included measures of self-reported endocrine therapy adherence and common symptoms among this population (insomnia, depression, anxiety, fatigue, musculoskeletal, and vasomotor symptoms). RESULTS: Unintentional nonadherence was higher than intentional nonadherence (50.8 % vs 31.01 %). The most troublesome symptom was insomnia (73.83 % displayed probable insomnia disorder). K-means cluster analysis identified 2 symptom clusters: overall High symptoms, and overall Low symptoms. Participants in the Low symptoms cluster were significantly more likely to be classed as adherent based on unintentional and intentional items. CONCLUSIONS: Nonadherence was high in the current sample, and significantly more likely in participants reporting overall severe symptoms. Clinicians should be aware of the scale of common side effects and facilitate open conversation about potential barriers to adherence. Follow-up care should include assessment of common symptoms and signpost patients to appropriate support or treatment when required. Future research should explore potential for a central symptom to act as a target for intervention, to relieve overall side effect burden and facilitate better medication adherence.


Subject(s)
Antineoplastic Agents, Hormonal , Breast Neoplasms , Medication Adherence , Sleep Initiation and Maintenance Disorders , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/psychology , Medication Adherence/statistics & numerical data , Medication Adherence/psychology , Middle Aged , Cross-Sectional Studies , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Sleep Initiation and Maintenance Disorders/chemically induced , Adult , Aged , Self Report , Depression , Fatigue/chemically induced , Surveys and Questionnaires , Anxiety , Cluster Analysis , Hot Flashes/chemically induced
6.
Expert Opin Pharmacother ; 25(3): 325-334, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38588537

ABSTRACT

BACKGROUND: Hormone therapy with aromatase inhibitors (AIs) for estrogen receptor-dependent breast cancer may expose patients to an increased osteoporosis risk. This study was performed to estimate fracture risk in women with breast cancer to whom AIs were prescribed in Japan. METHODS: This retrospective study used data from the Japanese Medical Data Vision database. Women with breast cancer prescribed AIs over a 12-month period were identified and matched to women not prescribed AIs using a propensity score. Fracture rates were estimated by a cumulative incidence function and compared using a cause-specific Cox hazard model. The proportion of women undergoing bone density tests was retrieved. RESULTS: For all fractures sites combined, cumulative fracture incidence at 10 years was 0.19 [95%CI: 0.16-0.22] in women prescribed AIs and 0.18 [95%CI: 0.15-0.21] without AIs. AI prescription was not associated with any changes in risk (adjusted hazard ratio: 1.08 [95%CI: 0.99-1.17] p = 0.08). Women prescribed AI more frequently underwent bone density testing (31.9% [95% CI: 31.2%; 32.6%] versus 2.2% [95% CI: 2.0%; 2.4%]). CONCLUSIONS: The anticipated association between AI exposure and osteoporotic fracture risk in Japanese women with breast cancer was not seen clearly.


Subject(s)
Aromatase Inhibitors , Bone Density , Breast Neoplasms , Databases, Factual , Osteoporotic Fractures , Humans , Female , Aromatase Inhibitors/adverse effects , Aromatase Inhibitors/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Japan/epidemiology , Retrospective Studies , Osteoporotic Fractures/epidemiology , Osteoporotic Fractures/prevention & control , Osteoporotic Fractures/chemically induced , Middle Aged , Aged , Bone Density/drug effects , Incidence , Osteoporosis/epidemiology , Osteoporosis/drug therapy , Osteoporosis/chemically induced , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Aged, 80 and over , Adult
7.
Bull Cancer ; 111(4): 356-362, 2024 Apr.
Article in French | MEDLINE | ID: mdl-38453587

ABSTRACT

INTRODUCTION: Evaluating the benefits and risks of prolonged hormonal treatment with aromatase inhibitors (AIs) for treating hormone-dependent breast cancer. METHODS: A systematic review and meta-analysis was conducted. Studies reporting on randomized clinical trials concerning prolongating hormonal therapy with AIs as compared to a placebo or no prolongation, after an initial five years of hormonal therapy, were eligible. RESULTS: Seven clinical trials were included. Prolonged AI therapy was associated with a statistically significant improvement in disease-free survival (RR=0.70, 95% CI 0.60 to 0.80). A statistically significant increase was observed for osteoporosis (RR=1.17, 95% CI 1.03 to 1.33), hot flushes/flashes (RR=1.27, 95% CI 1.08 to 1.49), myalgia (RR=1.23, 95% CI 1.09 to 1.39), fractures (RR=1.26, 95% CI 1.09 to 1.45) and arthralgia (RR=1.17, 95% CI 1.10 to 1.25). However, no statistically significant association was observed between prolonged AI therapy and overall survival, cardiovascular events, and bone pain. DISCUSSION: Prolonged AI therapy has significant benefits in terms of disease-free survival in women with hormone-dependent breast cancer. However, adverse effects and a lack of evidence for a benefit on overall survival must be considered in the decision-making process regarding adjuvant hormone therapy extension.


Subject(s)
Breast Neoplasms , Female , Humans , Breast Neoplasms/drug therapy , Aromatase Inhibitors/adverse effects , Combined Modality Therapy , Chemotherapy, Adjuvant/adverse effects , Adjuvants, Immunologic/therapeutic use , Hormones/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Tamoxifen/adverse effects
8.
Eur J Endocrinol ; 190(4): G15-G24, 2024 Mar 30.
Article in English | MEDLINE | ID: mdl-38552173

ABSTRACT

OBJECTIVE: Mitotane is an important cornerstone in the treatment of pediatric adrenal cortical tumors (pACC), but experience with the drug in the pediatric age group is still limited and current practice is not guided by robust evidence. Therefore, we have compiled international consensus statements from pACC experts on mitotane indications, therapy, and management of adverse effects. METHODS: A Delphi method with 3 rounds of questionnaires within the pACC expert consortium of the international network groups European Network for the Study of Adrenal Tumors pediatric working group (ENSAT-PACT) and International Consortium of pediatric adrenocortical tumors (ICPACT) was used to create 21 final consensus statements. RESULTS: We divided the statements into 4 groups: environment, indications, therapy, and adverse effects. We reached a clear consensus for mitotane treatment for advanced pACC with stages III and IV and with incomplete resection/tumor spillage. For stage II patients, mitotane is not generally indicated. The timing of initiating mitotane therapy depends on the clinical condition of the patient and the setting of the planned therapy. We recommend a starting dose of 50 mg/kg/d (1500 mg/m²/d) which can be increased up to 4000 mg/m2/d. Blood levels should range between 14 and 20 mg/L. Duration of mitotane treatment depends on the clinical risk profile and tolerability. Mitotane treatment causes adrenal insufficiency in virtually all patients requiring glucocorticoid replacement shortly after beginning. As the spectrum of adverse effects of mitotane is wide-ranging and can be life-threatening, frequent clinical and neurological examinations (every 2-4 weeks), along with evaluation and assessment of laboratory values, are required. CONCLUSIONS: The Delphi method enabled us to propose an expert consensus statement, which may guide clinicians, further adapted by local norms and the individual patient setting. In order to generate evidence, well-constructed studies should be the focus of future efforts.


Subject(s)
Adrenal Cortex Neoplasms , Adrenocortical Carcinoma , Drug-Related Side Effects and Adverse Reactions , Humans , Child , Mitotane/adverse effects , Adrenocortical Carcinoma/drug therapy , Adrenocortical Carcinoma/pathology , Antineoplastic Agents, Hormonal/adverse effects , Adrenal Cortex Neoplasms/drug therapy , Adrenal Cortex Neoplasms/pathology
9.
Drugs ; 84(4): 385-401, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38480629

ABSTRACT

Tamoxifen, a cornerstone in the adjuvant treatment of estrogen receptor-positive breast cancer, significantly reduces breast cancer recurrence and breast cancer mortality; however, its standard adjuvant dose of 20 mg daily presents challenges due to a broad spectrum of adverse effects, contributing to high discontinuation rates. Dose reductions of tamoxifen might be an option to reduce treatment-related toxicity, but large randomized controlled trials investigating the tolerability and, more importantly, efficacy of low-dose tamoxifen in the adjuvant setting are lacking. We conducted an extensive literature search to explore evidence on the tolerability and clinical efficacy of reduced doses of tamoxifen. In this review, we discuss two important topics regarding low-dose tamoxifen: (1) the incidence of adverse effects and quality of life among women using low-dose tamoxifen; and (2) the clinical efficacy of low-dose tamoxifen examined in the preventive setting and evaluated through the measurement of several efficacy derivatives. Moreover, practical tools for tamoxifen dose reductions in the adjuvant setting are provided and further research to establish optimal dosing strategies for individual patients are discussed.


Subject(s)
Antineoplastic Agents, Hormonal , Breast Neoplasms , Dose-Response Relationship, Drug , Quality of Life , Tamoxifen , Tamoxifen/administration & dosage , Tamoxifen/adverse effects , Tamoxifen/therapeutic use , Humans , Breast Neoplasms/drug therapy , Female , Antineoplastic Agents, Hormonal/administration & dosage , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Chemotherapy, Adjuvant , Randomized Controlled Trials as Topic
10.
JAMA Oncol ; 10(5): 594-602, 2024 May 01.
Article in English | MEDLINE | ID: mdl-38451492

ABSTRACT

Importance: Combination androgen deprivation therapy (ADT) with radiotherapy is commonly used for patients with localized and advanced prostate cancer. Objective: To assess the efficacy and safety of the oral gonadotropin-releasing hormone antagonist relugolix with radiotherapy for treating prostate cancer. Design, Setting, and Participants: This multicenter post hoc analysis of patients with localized and advanced prostate cancer receiving radiotherapy in 2 randomized clinical trials (a phase 2 trial of relugolix vs degarelix, and a subset of the phase 3 HERO trial of relugolix vs leuprolide acetate) included men who were receiving radiotherapy and short-term (24 weeks) ADT (n = 103) from 2014 to 2015 and men receiving radiotherapy and longer-term (48 weeks) ADT (n = 157) from 2017 to 2019. The data were analyzed in November 2022. Interventions: Patients receiving short-term ADT received relugolix, 120 mg, orally once daily (320-mg loading dose) or degarelix, 80 mg, 4-week depot (240-mg loading dose) for 24 weeks with 12 weeks of follow-up. Patients receiving longer-term ADT received relugolix, 120 mg, orally once daily (360-mg loading dose) or leuprolide acetate injections every 12 weeks for 48 weeks, with up to 90 days of follow-up. Main Outcomes and Measures: Castration rate (testosterone level <50 ng/dL [to convert to nmol/L, multiply by 0.0347) at all scheduled visits between weeks 5 and 25 for patients receiving short-term ADT and weeks 5 and 49 for patients receiving longer-term ADT. Results: Of 260 patients (38 Asian [14.6%], 23 Black or African American [8.8%], 21 Hispanic [8.1%], and 188 White [72.3%] individuals), 164 (63.1%) received relugolix. Relugolix achieved castration rates of 95% (95% CI, 87.1%-99.0%) and 97% (95% CI, 90.6%-99.0%) among patients receiving short-term and longer-term ADT, respectively. Twelve weeks post-short-term relugolix, 34 (52%) achieved testosterone levels to baseline or more than 280 ng/dL. Ninety days post longer-term ADT, mean (SD) testosterone levels were 310.5 (122.4) (106.7) ng/dL (relugolix; n = 15) vs 53.0 ng/dL (leuprolide acetate; n = 8) among the subset assessed for testosterone recovery. Castration resistance-free survival was not statistically different between the relugolix and leuprolide acetate cohorts (hazard ratio, 0.97; 95% CI, 0.35-2.72; P = .62). Adverse events grade 3 or greater for short-term or longer-term relugolix (headache, hypertension, and atrial fibrillation) were uncommon (less than 5%). Conclusions and Relevance: The results of these 2 randomized clinical trials suggest that relugolix rapidly achieves sustained castration in patients with localized and advanced prostate cancer receiving radiotherapy. No new safety concerns were identified when relugolix was used with radiotherapy.


Subject(s)
Androgen Antagonists , Prostatic Neoplasms , Humans , Male , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/radiotherapy , Prostatic Neoplasms/pathology , Aged , Middle Aged , Androgen Antagonists/therapeutic use , Androgen Antagonists/adverse effects , Treatment Outcome , Leuprolide/therapeutic use , Leuprolide/adverse effects , Leuprolide/administration & dosage , Antineoplastic Agents, Hormonal/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Aged, 80 and over , Oligopeptides/therapeutic use , Oligopeptides/adverse effects , Phenylurea Compounds , Pyrimidinones
12.
Tumori ; 110(3): 174-185, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38462772

ABSTRACT

PURPOSE: Cancer treatment-induced bone loss is a side effect of hormonal therapy that can severely affect patients' quality of life. The aim of this survey was to obtain an updated picture of management of bone health in patients with breast cancer undergoing adjuvant hormonal therapy and in patients with hormone sensitive prostate cancer according to Italian oncologists. METHODS: Our survey was made up of 21 multiple-choice questions: the first part dealt with the respondents' characteristics, while the second with management of bone health in the described setting. An invitation to complete the survey was sent by e-mail to 2336 oncologists, members of Italian Association of Medical Oncology, in October 2022. RESULTS: Overall, 121 (5.2%) Italian oncologists completed the survey. In most cases (57%) the oncologist personally took charge of the management of bone health in patients at risk for cancer treatment-induced bone loss. At the beginning of hormonal therapy, most respondents reported to require bone health diagnostic exams, such as dual-energy X-ray absorptiometry (89%), repeated with different timing. Main reported reasons (not mutually exclusive) for prescribing antiresorptive drugs were modifying fracture risk (87%), densitometry values (75%) or prognosis (34%). Answers about the management of antiresorptive therapy were heterogeneous. CONCLUSION: A heterogeneous approach on the management of cancer treatment-induced bone loss in Italy arises from this survey. This scenario highlights the need for a major consensus of the Italian scientific community on the diagnostic and therapeutic approach of cancer treatment-induced bone loss and for a greater awareness of this topic among Italian oncologists.


Subject(s)
Breast Neoplasms , Prostatic Neoplasms , Humans , Male , Prostatic Neoplasms/drug therapy , Breast Neoplasms/drug therapy , Surveys and Questionnaires , Female , Osteoporosis/chemically induced , Osteoporosis/epidemiology , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Bone Density Conservation Agents/therapeutic use , Bone Density Conservation Agents/adverse effects , Italy/epidemiology , Quality of Life , Middle Aged , Bone Density/drug effects , Absorptiometry, Photon
13.
Cancer ; 130(12): 2120-2138, 2024 Jun 15.
Article in English | MEDLINE | ID: mdl-38306301

ABSTRACT

BACKGROUND: Hormone therapy, which is widely prescribed for prostate cancer, might induce cognitive impairment and affect the autonomy of elderly patients. However, previous studies provided conflicting results. The aim of this systematic review and meta-analysis was to synthesize the longitudinal impact of hormone therapy on objective (cognitive tests) and subjective (questionnaires) cognition. METHODS: A search was performed of the PubMed, Web of Science, and PsycINFO databases. Studies that longitudinally assessed cognition in patients undergoing androgen-deprivation therapy and new-generation hormone therapy were considered. To perform a meta-analysis, available scores were aggregated and classified into six objective domains and one subjective domain. Weighted mean effect sizes were computed using a random effect model. RESULTS: Twenty studies were included in the systematic review (1440 patients), and 15 could be included in the meta-analysis (1093 patients). In the systematic review, 20%-50% of patients had objective cognitive impairment before treatment initiation. The meta-analysis revealed a decline in subjective cognition (g = -0.44; p = .03) with androgen-deprivation therapy and new-generation hormone therapy. All other effect sizes were small (from g = -0.02 to g = 0.18), and none of them indicated a significant decline in objective cognition. Significant heterogeneity was observed in all domains of objective cognition. CONCLUSIONS: This synthesis presents the first meta-analytic evidence of the negative impact of androgen-deprivation therapy and new-generation hormone therapy on subjective cognition. In contrast, there was no conclusive evidence of a decline in objective cognition. The high heterogeneity underscores the need for homogeneous cognitive research on prostate cancer. PLAIN LANGUAGE SUMMARY: There is no consensus on the cognitive impairment induced by hormone therapy for prostate cancer, despite the implications for patients' care and daily life. This synthesis of published studies demonstrated an increase in perceived cognitive difficulties but did not prove a decline in cognitive performance during treatment.


Subject(s)
Androgen Antagonists , Cognition , Cognitive Dysfunction , Prostatic Neoplasms , Humans , Male , Prostatic Neoplasms/drug therapy , Prostatic Neoplasms/psychology , Cognition/drug effects , Androgen Antagonists/adverse effects , Androgen Antagonists/therapeutic use , Cognitive Dysfunction/chemically induced , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Aged
14.
Cancer Biol Med ; 20(12)2024 02 05.
Article in English | MEDLINE | ID: mdl-38318809

ABSTRACT

OBJECTIVE: Real-word data on long-acting luteinizing hormone-releasing hormone (LHRH) agonists in Chinese patients with prostate cancer are limited. This study aimed to determine the real-world effectiveness and safety of the LHRH agonist, goserelin, particularly the long-acting 10.8-mg depot formulation, and the follow-up patterns among Chinese prostate cancer patients. METHODS: This was a multicenter, prospective, observational study in hormone treatment-naïve patients with localized or locally advanced prostate cancer who were prescribed goserelin 10.8-mg depot every 12 weeks or 3.6-mg depot every 4 weeks with or without an anti-androgen. The patients had follow-up evaluations for 26 weeks. The primary outcome was the effectiveness of goserelin in reducing serum testosterone and prostate-specific antigen (PSA) levels. The secondary outcomes included testosterone and PSA levels, attainment of chemical castration (serum testosterone <50 ng/dL), and goserelin safety. The exploratory outcome was the monitoring pattern for serum testosterone and PSA. All analyses were descriptive. RESULTS: Between September 2017 and December 2019, a total of 294 eligible patients received ≥ 1 dose of goserelin; 287 patients (97.6%) were treated with goserelin 10.8-mg depot. At week 24 ± 2, the changes from baseline [standard deviation (95% confidence interval)] in serum testosterone (n = 99) and PSA (n = 131) were -401.0 ng/dL [308.4 ng/dL (-462.5, -339.5 ng/dL)] and -35.4 ng/mL [104.4 ng/mL (-53.5, -17.4 ng/mL)], respectively. Of 112 evaluable patients, 100 (90.2%) achieved a serum testosterone level < 50 ng/dL. Treatment-emergent adverse events (TEAEs) and severe TEAEs occurred in 37.1% and 10.2% of patients, respectively. The mean testing frequency (standard deviation) was 1.6 (1.5) for testosterone and 2.2 (1.6) for PSA. CONCLUSIONS: Goserelin 10.8-mg depot effectively achieved and maintained castration and was well-tolerated in Chinese patients with localized and locally advanced prostate cancer.


Subject(s)
Goserelin , Prostatic Neoplasms , Male , Humans , Goserelin/adverse effects , Prostate-Specific Antigen/therapeutic use , Antineoplastic Agents, Hormonal/adverse effects , Prospective Studies , Prostatic Neoplasms/drug therapy , Testosterone/therapeutic use , China
15.
Breast Cancer Res Treat ; 204(3): 599-606, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38225523

ABSTRACT

PURPOSE: Breast cancer is the leading cause of cancer death in Brazil and in many countries around the world. In order to minimize the risk of recurrence and death, adjuvant endocrine therapy (AET) is used in women whose tumors express hormone receptors; however, the therapy is associated with low rates of compliance. Therefore, we sought to evaluate the proportion of patients who are adherent/non-adherent to AET at the beginning of the therapy (1st year) and at its end (5th year). METHODS: Cross-sectional study assessing adherence through the Brief Medication Questionnaire. RESULTS: It was identified that eventual failures in maintaining the correct adherence to the treatment have risen from 23% of patients in the 1st year of treatment to 35% of patients in the 5th year (p = 0.005). In both groups, use of aromatase inhibitors, polypharmacy of at least 3 mediations and the previous diagnosis of diabetes mellitus (DM) or systemic arterial hypertension (SAH) have contributed to low adherence among patients. CONCLUSION: The proportion of patients who are not adherent to AET was high in both cohorts, and the rate of non-adherent patients rises over time. It is essential to incorporate screening methods for lack of compliance to AET, as well as measures to try to reduce non-persistence to the treatment, such as educating the patients on the benefits of the treatment, managing comorbidities through lifestyle changes and, therefore, reducing polypharmacy and, above all, detecting and treating very early the adverse effects of AET that might interfere with its correct use.


Subject(s)
Breast Neoplasms , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/epidemiology , Antineoplastic Agents, Hormonal/adverse effects , Cross-Sectional Studies , Developing Countries , Medication Adherence , Chemotherapy, Adjuvant
16.
Breast Cancer Res Treat ; 204(3): 547-559, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38231313

ABSTRACT

PURPOSE: Adjuvant endocrine therapy (AET) reduces breast cancer morbidity and mortality; however, adherence is suboptimal. Interventions exist, yet few have improved adherence. Patient characteristics may alter uptake of an intervention to boost adherence. We examined moderators of the effect of a virtual intervention (STRIDE; #NCT03837496) on AET adherence after breast cancer. METHODS: At a large academic medical center, patients taking AET (N = 100; Mage = 56.1, 91% White) were randomized to receive STRIDE versus medication monitoring. All stored their medication in digital pill bottles (MEMS Caps) which captured objective adherence. Participants self-reported adherence (Medication Adherence Report Scale) at 12 weeks post-baseline. Moderators included age, anxiety, and depressive symptoms (Hospital Anxiety and Depression Scale), AET-related symptom distress (Breast Cancer Prevention Trial Symptom Scale), and AET-specific concerns (Beliefs about Medications Questionnaire). We used hierarchical linear modeling (time × condition × moderator) and multiple regression (condition × moderator) to test the interaction effects on adherence. RESULTS: Age (B = 0.05, SE = 0.02, p = 0.003) and AET-related symptom distress (B = -0.04, SE = 0.02, p = 0.02) moderated condition effect on self-reported adherence while anxiety (B = -1.20, SE = 0.53, p = 0.03) and depressive symptoms (B = -1.65, SE = 0.65, p = 0.01) moderated objective adherence effects. AET-specific concerns approached significance (B = 0.91, SE = 0.57, p = 0.12). Participants who received STRIDE and were older or presented with lower anxiety and depressive symptoms or AET-related symptom distress exhibited improved adherence. Post hoc analyses revealed high correlations among most moderators. CONCLUSIONS: A subgroup of patients who received STRIDE exhibited improvements in AET adherence. The interrelatedness of moderators suggests an underlying profile of patients with lower symptom burden who benefitted most from the intervention. STUDY REGISTRATION: NCT03837496.


Subject(s)
Breast Neoplasms , Humans , Middle Aged , Female , Chemotherapy, Adjuvant/adverse effects , Antineoplastic Agents, Hormonal/adverse effects , Medication Adherence , Surveys and Questionnaires
17.
Int J Lab Hematol ; 46(3): 546-554, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38296772

ABSTRACT

BACKGROUND: Estrogen receptor (ER)-positive (ER+) breast cancer accounts for approximately 75% of all breast cancers. Tamoxifen, a selective estrogen receptor modulator, is the standard adjuvant treatment. Although better tolerated than aromatase inhibitors, tamoxifen increases the risk of venous thromboembolism (VTE) 1.4-fold. AIM: To assess the hemostatic imbalance induced by tamoxifen in adjuvant treatment of ER+ breast cancer. METHOD: Twenty-five patients in remission from ER+ breast cancer under tamoxifen were included. One hundred and thirty one age- and BMI-matched healthy controls were included to establish reference ranges of thrombin generation assay (TGA) parameters. TGA was performed in the absence and presence of exogenous activated protein C (APC) to calculate the normalized APC sensitivity ratio (nAPCsr), a marker of APC resistance. RESULTS: All TG parameters except the endogenous thrombin potential (ETP) (-APC) were significantly impacted by tamoxifen (p < 0.001). In absence of APC, regardless of TGA parameters, at least 50% of results were outside the reference ranges except for ETP, which was above the upper reference limit in only two individuals. The most impacted parameter was the Peak Height with 52% (-APC) and 80% (+APC) of results above the upper reference range limit, respectively. The nAPCsr was significantly higher in tamoxifen users (mean ± standard deviation = 3.18 ± 0.91) compared to the control group (2.19 ± 0.92, p < 0.0001). CONCLUSION: This observational study showed that patients in remission from ER+ breast cancer taking tamoxifen had altered thrombin generation, as well as an acquired APC resistance. Moreover, this is the first study using the validated ETP-based APC resistance assay in tamoxifen-treated patients.


Subject(s)
Breast Neoplasms , Receptors, Estrogen , Tamoxifen , Humans , Tamoxifen/therapeutic use , Tamoxifen/adverse effects , Breast Neoplasms/drug therapy , Breast Neoplasms/metabolism , Female , Middle Aged , Receptors, Estrogen/metabolism , Adult , Aged , Hemostasis/drug effects , Thrombin/metabolism , Thrombin/biosynthesis , Antineoplastic Agents, Hormonal/adverse effects , Antineoplastic Agents, Hormonal/therapeutic use , Case-Control Studies
18.
R I Med J (2013) ; 107(2): 7-9, 2024 Feb 01.
Article in English | MEDLINE | ID: mdl-38285742

ABSTRACT

Pituitary apoplexy is a rare but potentially life-threatening complication of androgen deprivation therapy for prostate cancer. We present a case of a 70-year-old African American male with prostate cancer who developed symptoms of pituitary apoplexy, including hot flashes, nausea, vomiting, and cranial nerve III palsy, following the initiation of leuprolide therapy. Imaging revealed a pituitary adenoma with hemorrhage, and prompt multidisciplinary management was initiated. The patient was managed conservatively with improvement in symptoms. This case highlights the importance of recognizing the potential for pituitary apoplexy in patients receiving GnRH agonist therapy. We discuss the clinical presentation of GnRH agonist induced pituitary apoplexy, emphasizing that clinicians should maintain a high index of suspicion and promptly investigate any new neuro- ophthalmic symptoms in this group of patients. Ultimately, prompt diagnosis and treatment are crucial to mitigate the severity of this complication in patients with prostate cancer undergoing androgen deprivation therapy.


Subject(s)
Pituitary Apoplexy , Prostatic Neoplasms , Humans , Male , Aged , Prostatic Neoplasms/drug therapy , Leuprolide/adverse effects , Pituitary Apoplexy/chemically induced , Pituitary Apoplexy/diagnosis , Pituitary Apoplexy/drug therapy , Antineoplastic Agents, Hormonal/adverse effects , Androgen Antagonists/adverse effects , Androgens/therapeutic use
19.
Anticancer Drugs ; 35(4): 371-376, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38241197

ABSTRACT

To investigate the effects of tamoxifen (TAM) and toremifene (TOR) on hepatic function and serum lipid levels in breast cancer patients receiving adjuvant endocrine therapy. The clinical data of 597 early breast cancer patients treated at the First Affiliated Hospital of Nanjing Medical University between January 2016 and December 2022 were collected. All the patients received standard adjuvant endocrine therapy with TAM or TOR after chemotherapy. Hepatic function and serum lipid data of all patients before and at 6 months and 1, 2, and 3 years after the treatment were collected retrospectively and analyzed statistically. There: no negative effect on hepatic function was observed in patients treated with either TAM or TOR. The triglyceride levels in both groups increased during treatment, and the effect of TAM on improving total cholesterol levels was stronger. Total cholesterol levels were not affected by time or treatment regimen. The low-density lipoprotein cholesterol levels decreased in both groups, and the effect was similar between groups. TAM can decrease the high-density lipoprotein cholesterol levels, whereas TOR can increase the high-density lipoprotein cholesterol levels, and there was a significant difference between groups. In the postoperative adjuvant endocrine therapy, TOR and TAM will not negatively impact the hepatic function of breast cancer patients, and TOR is better than TAM in the management of serum lipids; therefore, it may be a better choice for clinical medication.


Subject(s)
Breast Neoplasms , Toremifene , Humans , Female , Toremifene/therapeutic use , Toremifene/pharmacology , Tamoxifen/pharmacology , Retrospective Studies , Antineoplastic Agents, Hormonal/adverse effects , Chemotherapy, Adjuvant , Adjuvants, Immunologic , Lipids/therapeutic use , Cholesterol , Lipoproteins, HDL/therapeutic use
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