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AbstractObjectiveTo investigate the incidence and characteristics of breast cancer in transgender people in the Netherlands compared with the general Dutch population.DesignRetrospective, nationwide cohort study.SettingSpecialised tertiary gender clinic in Amsterdam, the Netherlands.Participants2260 adult trans women (male sex assigned at birth, female gender identity) and 1229 adult trans men (female sex assigned at birth, male gender identity) who received gender affirming hormone treatment.Main outcome measuresIncidence and characteristics (eg, histology, hormone receptor status) of breast cancer in transgender people.ResultsThe total person time in this cohort was 33 991 years for trans women and 14 883 years for trans men. In the 2260 trans women in the cohort, 15 cases of invasive breast cancer were identified (median duration of hormone treatment 18 years, range 7-37 years). This was 46-fold higher than in cisgender men (standardised incidence ratio 46.7, 95% confidence interval 27.2 to 75.4) but lower than in cisgender women (0.3, 0.2 to 0.4). Most tumours were of ductal origin and oestrogen and progesterone receptor positive, and 8.3% were human epidermal growth factor 2 (HER2) positive. In 1229 trans men, four cases of invasive breast cancer were identified (median duration of hormone treatment 15 years, range 2-17 years). This was lower than expected compared with cisgender women (standardised incidence ratio 0.2, 95% confidence interval 0.1 to 0.5).ConclusionsThis study showed an increased risk of breast cancer in trans women compared with cisgender men, and a lower risk in trans men compared with cisgender women. In trans women, the risk of breast cancer increased during a relatively short duration of hormone treatment and the characteristics of the breast cancer resembled a more female pattern. These results suggest that breast cancer screening guidelines for cisgender people are sufficient for transgender people using hormone treatment.

Cardiovascular risk is increased in transgender persons using gender-affirming hormone therapy. To gain insight into the mechanism by which sex hormones affect cardiovascular risk in transgender persons, we investigated the effect of hormone therapy on markers of inflammation and hemostasis. In this exploratory study, 48 trans women using estradiol patches plus cyproterone acetate (CPA) and 47 trans men using testosterone gel were included. They were between 18 and 50 years old and did not have a history of cardiovascular events. Measurements were performed before and after 3 and 12 months of hormone therapy. After 12 months, in trans women, systemic and endothelial inflammatory markers decreased (hs-CRP -66%, (95% CI -76; -53), VCAM-1-12%, (95% CI -16; -8)), while platelet activation markers increased (PF-4 +17%, (95% CI 4; 32), β-thromboglobulin +13%, (95% CI 2; 24)). The coagulation marker fibrinogen increased transiently, after 3 months (+15%, (95% CI 1; 32)). In trans men, hs-CRP increased (+71%, (95% CI 19; 145)); platelet activation and coagulation markers were not altered. In both trans women and trans men, leptin and adiponectin changed towards reference values of the experienced gender. Platelet activation and coagulation marker concentrations increased in trans women using transdermal estradiol plus CPA, but not in trans men using testosterone. Also, concentrations of inflammatory markers decreased in trans women, while hs-CRP increased in trans men. Our results indicate that hormone therapy may affect hemostasis in transgender persons, which could be an underlying mechanism explaining the increased cardiovascular risk in this population.

Abstract Context The impact of gender-affirming hormone therapy (HT) on cardiometabolic parameters is largely unknown. Objective The effects of 1 year of treatment with oral or transdermal administration of estrogen (plus cyproterone) and transdermal or IM application of testosterone on serum lipid levels and blood pressure (BP) were assessed in transgender persons. Design and Methods In this prospective, observational substudy of the European Network for the Investigation of Gender Incongruence, measurements were performed before and after 12 months of HT in 242 transwomen and 188 transmen from 2010 to 2017. Results Mean values are reported. In transmen, HT increased diastolic BP (2.5%; 95% CI, 0.6 to 4.4) and levels of total cholesterol (TC; 4.1%; 95% CI, 1.5 to 6.6), low-density lipoprotein–cholesterol (LDL-C; 13.0%; 95% CI, 9.2 to 16.8), and triglycerides (36.9%; 95% CI, 29.8 to 44.1); high-density lipoprotein–cholesterol levels decreased (HDL-C; 10.8%; 95% CI, −14.0 to −7.6). In transwomen, HT slightly decreased BP (systolic BP, −2.6%, 95% CI, −4.2 to −1.0; diastolic BP, −2.2%, 95% CI, −4.0 to −0.4) and decreased levels of TC (−9.7%; 95% CI, −11.3 to −8.1), LDL-C (−6.0%; 95% CI, −8.6 to 3.6), HDL-C (−9.3%; 95% CI, −11.4 to −7.3), and triglycerides (−10.2%; 95% CI, −14.5 to −5.9). Conclusion Unfavorable changes in lipid profile were observed in transmen; a favorable effect was noted in transwomen. HT effects on BP were negligible. Long-term studies are warranted to assess whether and to what extent HT in trans individuals results in a differential effect on cardiovascular disease outcomes. In this prospective observational study, favorable lipid changes were found in transwomen and unfavorable lipid changes found in transmen after 12 months of gender-affirming hormone therapy.

Background Several studies have demonstrated the efficacy of electronic patient-reported outcomes (ePROs) monitoring during chemo(immune)therapy, improving symptom detection and health-related quality of life (HRQoL). However, most existing applications only alert caregivers when patients report severe toxicity and lack real-time, symptom specific feedback for mild to moderate symptoms. This may undermine self-management, missing the opportunity to prevent progression to more severe toxicity. Integration of triage questions in ePRO symptom management enables the generation of tailored severity-based advice and facilitates timely self-directed care, minimising involvement of caregivers for mild symptoms. This study aims to evaluate whether symptom monitoring through the eChemoCoach reduces the occurrence of CTCAE ≥ 3 non-haematological side effects in breast cancer patients undergoing (neo)adjuvant chemo(immune)therapy. Methods This multicentre, non-blinded randomised controlled trial will include patients with invasive breast cancer (stage I-III) starting (neo)adjuvant chemo(immune)therapy. A total of 746 ( n  = 373 intervention, n  = 373 controls) patients will be recruited across 12 Dutch hospitals. In addition to standard care, patients in the intervention arm use the eChemoCoach ePRO-questionnaire via the hospitals’ patient portal of the electronic health record (EHR), enabling daily self-reporting of therapy-related symptoms. The ePRO assesses symptom severity using a patient-adapted version of the Common Terminology Criteria for Adverse Events (CTCAE), supplemented with triage questions. Based on severity, the system provides real-time, tailored self-management advice. Patients in the control arm solely receive standard care. The primary outcome is the incidence of non-haematological CTCAE grade ≥ 3 side effects. Secondary outcomes are the effect of the eChemoCoach ePRO on toxicity patterns, relative dose intensity (RDI), HRQoL, anxiety, distress, patient empowerment, unplanned care and usability. Discussion This is the first RCT to assess an ePRO system fully integrated as a native module within a hospital’s EHR, providing direct access for patients and caregivers, incorporating triage questions to guide symptom assessment, and delivering real-time tailored self-management advice for mild toxicities. This approach may decrease patient burden during chemo(immune)therapy, reduce the occurrence of CTCAE grade ≥ 3 side effects, improve RDI, and reduce clinical workload. Trial registration Prospectively registered at ClinicalTrials.gov, ID NCT06424054, May 2024.

Abstract Context Trans women (male sex assigned at birth, female gender identity) mostly use antiandrogens combined with estrogens and can subsequently undergo vaginoplasty including orchiectomy. Because the prostate remains in situ after this procedure, trans women are still at risk for prostate cancer. Objective To assess the incidence of prostate cancer in trans women using hormone treatment. Design In this nationwide retrospective cohort study, data of participants were linked to the Dutch national pathology database and to Statistics Netherlands to obtain data on prostate cancer diagnosis and mortality. Setting Gender identity clinic. Participants Trans women who visited our clinic between 1972 and 2016 and received hormone treatment were included. Main Outcome Measures Standardized incidence ratios (SIRs) were calculated using the number of observed prostate cancer cases in our cohort and the number of expected cases based on age-specific incidence numbers from the Netherlands Comprehensive Cancer Organization. Results The study population consisted of 2281 trans women with a median follow-up time of 14 years (interquartile range 7-24), and a total follow-up time of 37 117 years. Six prostate cancer cases were identified after a median 17 years of hormone treatment. This resulted in a lower prostate cancer risk in trans women than in Dutch reference males (SIR 0.20, 95% confidence interval 0.08-0.42). Conclusions Trans women receiving androgen deprivation therapy and estrogens have a substantially lower risk for prostate cancer than the general male population. Our results support the hypothesis that androgen deprivation has a preventive effect on the initiation and development of prostate cancer.

Several studies have demonstrated the efficacy of electronic patient-reported outcomes (ePROs) monitoring during chemo(immune)therapy, improving symptom detection and health-related quality of life (HRQoL). However, most existing applications only alert caregivers when patients report severe toxicity and lack real-time, symptom specific feedback for mild to moderate symptoms. This may undermine self-management, missing the opportunity to prevent progression to more severe toxicity. Integration of triage questions in ePRO symptom management enables the generation of tailored severity-based advice and facilitates timely self-directed care, minimising involvement of caregivers for mild symptoms. This study aims to evaluate whether symptom monitoring through the eChemoCoach reduces the occurrence of CTCAE [greater than or equal to] 3 non-haematological side effects in breast cancer patients undergoing (neo)adjuvant chemo(immune)therapy. This multicentre, non-blinded randomised controlled trial will include patients with invasive breast cancer (stage I-III) starting (neo)adjuvant chemo(immune)therapy. A total of 746 (n = 373 intervention, n = 373 controls) patients will be recruited across 12 Dutch hospitals. In addition to standard care, patients in the intervention arm use the eChemoCoach ePRO-questionnaire via the hospitals' patient portal of the electronic health record (EHR), enabling daily self-reporting of therapy-related symptoms. The ePRO assesses symptom severity using a patient-adapted version of the Common Terminology Criteria for Adverse Events (CTCAE), supplemented with triage questions. Based on severity, the system provides real-time, tailored self-management advice. Patients in the control arm solely receive standard care. The primary outcome is the incidence of non-haematological CTCAE grade [greater than or equal to] 3 side effects. Secondary outcomes are the effect of the eChemoCoach ePRO on toxicity patterns, relative dose intensity (RDI), HRQoL, anxiety, distress, patient empowerment, unplanned care and usability. This is the first RCT to assess an ePRO system fully integrated as a native module within a hospital's EHR, providing direct access for patients and caregivers, incorporating triage questions to guide symptom assessment, and delivering real-time tailored self-management advice for mild toxicities. This approach may decrease patient burden during chemo(immune)therapy, reduce the occurrence of CTCAE grade [greater than or equal to] 3 side effects, improve RDI, and reduce clinical workload.

BackgroundCardiovascular risk is increased in transgender persons using gender-affirming hormone therapy. To gain insight into the mechanism by which sex hormones affect cardiovascular risk in transgender persons, we investigated the effect of hormone therapy on markers of inflammation and hemostasis.MethodsIn this exploratory study, 48 trans women using estradiol patches plus cyproterone acetate (CPA) and 47 trans men using testosterone gel were included. They were between 18 and 50 years old and did not have a history of cardiovascular events. Measurements were performed before and after 3 and 12 months of hormone therapy.ResultsAfter 12 months, in trans women, systemic and endothelial inflammatory markers decreased (hs-CRP -66%, (95% CI -76; -53), VCAM-1-12%, (95% CI -16; -8)), while platelet activation markers increased (PF-4 +17%, (95% CI 4; 32), β-thromboglobulin +13%, (95% CI 2; 24)). The coagulation marker fibrinogen increased transiently, after 3 months (+15%, (95% CI 1; 32)). In trans men, hs-CRP increased (+71%, (95% CI 19; 145)); platelet activation and coagulation markers were not altered. In both trans women and trans men, leptin and adiponectin changed towards reference values of the experienced gender.ConclusionsPlatelet activation and coagulation marker concentrations increased in trans women using transdermal estradiol plus CPA, but not in trans men using testosterone. Also, concentrations of inflammatory markers decreased in trans women, while hs-CRP increased in trans men. Our results indicate that hormone therapy may affect hemostasis in transgender persons, which could be an underlying mechanism explaining the increased cardiovascular risk in this population.