Search Results (315)

Background/Objectives: Endocrine therapy (ET) is a common treatment for hormone-dependent breast cancer and is associated with a significant reduction in recurrence and mortality rates. However, the decision to initiate endocrine therapy is a critical and often distressing juncture for patients. The need to weigh its survival benefits against the potential burden of side effects, including mood changes, pain, muscle stiffness, and fatigue, can render this decision-making phase a source of significant distress. The present systematic review aimed to identify and synthesize the sociodemographic and psychosocial predictors of the decision-making process related to ET adherence among women with breast cancer. Methods: A systematic literature search was conducted in three electronic databases—PubMed Central, ProQuest, and Scopus—to identify studies examining the association between sociodemographic and psychosocial factors and the decision-making process regarding ET among women with breast cancer. Inclusion criteria encompassed cross-sectional studies published between 2000 and 2025. Data were extracted and analyzed to identify recurring predictors across studies. The findings were synthesized through a narrative synthesis. Results: Twelve cross-sectional studies met the inclusion criteria, comprising a total of 8510 women diagnosed with breast cancer and undergoing ET. Ten studies (83%) identified sociodemographic variables—such as age, marital status, educational level, and ethnicity—as significant predictors of decision-making. Moreover, nine studies (75%) reported psychosocial factors, including quality of life (QoL), fear of progression, infertility concerns, and social support, as influential in the decision to initiate or continue ET. Specifically, the decision to adhere to ET is generally supported by younger age, higher education, better perceived quality of life, and greater social support. Conversely, it is hindered by lower income, lower education, fertility concerns related to marital status, and diminished quality of life. Conclusions: The findings of this review indicate that both sociodemographic and psychosocial factors play key roles in shaping women’s decisions regarding adherence to ET. Understanding these predictors can facilitate decision-making and inform the development of targeted interventions aimed at improving treatment adherence and supporting patient-centered care in breast cancer treatment. The focus on decision-making processes, rather than on adherence rates, is what distinguishes this review from other systematic reviews. Full article

Background: Patients with primary central nervous system (CNS) tumors often experience fatigue and sleep disturbances, significantly impacting their quality of life. Exercise has been shown to improve these symptoms in various cancer populations. The aim of this study is to evaluate the effects of different types of exercise on fatigue and sleep in less-investigated CNS tumor patients. Methods: A literature search was conducted in PubMed, Scopus, Cochrane Library, and CINAHL. Eligible randomized and non-randomized studies evaluating exercise interventions in patients diagnosed with primary brain tumors were systematically reviewed, primarily using a narrative synthesis approach. Cancer-related fatigue and sleep-related outcomes were extracted as variables of interest. Where possible [≥2 Randomized Control Trials (RCTs) available for glioma patients], meta-analyses were conducted to assess the overall effects of physical therapy on the above-mentioned outcomes. Results: A total of 15 relevant intervention studies were identified, either RCTs or other types of studies, such as prospective feasibility cohort studies and case studies. A total of 448 participants were enrolled, with the majority diagnosed with glioma. There were single reports on pituitary adenoma after surgery and meningioma patients. In glioma patients, the overall effect of various modality exercise interventions on fatigue was non-significant, reflecting the heterogeneous characteristics of studies with diverse outcomes. However, meta-analysis focusing on combined exercise interventions (aerobic and resistance training) showed a positive effect on reducing fatigue in these patients [Standardized Mean Difference (SMD) = 0.866, p = 0.03]. Fatigue in glioma patients may also improve through yoga and Pilates. Aerobic but not strength exercise seems to improve sleep in glioma patients (SMD = 1.14, p = 0.02). Sleep quality may also improve through yoga and combined exercise. Conclusions: Certain types of exercise appear to effectively reduce fatigue and improve sleep in patients with CNS tumors. Future, well–controlled, multi-arm, larger-scale studies are necessary to resolve discrepancies, as well as to explore long-term outcomes and define factors influencing individualized exercise responses. Full article

Background: Radspherin^® is a novel α-emitting radiopharmaceutical administered intraperitoneally following complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for peritoneal metastases. It delivers short-range radiation aimed at eliminating residual microscopic disease. This qualitative study explored how participants with colorectal cancer experienced participating in an early-phase clinical trial involving CRS-HIPEC followed by Radspherin^®. Materials and Methods: Semi-structured interviews were conducted with ten participants enrolled in a phase 1/2a trial involving CRS-HIPEC and intraperitoneal Radspherin^®. The analysis was guided by a phenomenological and interpretive approach using reflexive thematic analysis. Results: Participants expressed a strong sense of motivation and hope tied specifically to receiving Radspherin^®, which they perceived as an opportunity to improve their prognosis. Many also viewed participation as a contribution to future cancer research. None attributed complications or side effects to Radspherin^®. Clear and supportive verbal communication from healthcare professionals was highly valued, while the written information was described as overwhelming. Despite fears of recurrence, most participants remained optimistic about regaining a meaningful life. While experiences with Radspherin^® were largely positive, participants also described pain, fatigue, and prolonged recovery related to CRS-HIPEC, including ongoing functional and psychosocial challenges. Conclusions: Participants associated Radspherin^® with hope and a therapeutic benefit but did not link it to their adverse events. Their willingness to participate in experimental treatment was shaped by trust in clinicians, clear communication, and a desire for extended survival. However, the burden of CRS-HIPEC-related side effects underscores the importance of tailored follow-up and support. Full article

Background/Objectives: Recent preclinical studies suggest that acute exercise induces immune modulation, enhances tumor blood perfusion, and is associated with reduced tumor growth. Adding exercise to immunochemotherapy treatment (ICT) has been proposed as a strategy to increase treatment effectiveness. The ERICA trial (NCT04676009) aimed to assess the feasibility of acute aerobic exercise performed immediately before the administration of ICT in patients with metastatic non-small cell lung cancer (mNSCLC) and to explore hypothesis-generating outcomes related to physical fitness and patient-reported outcomes. Methods: Newly diagnosed mNSCLC patients were randomly assigned (2:1) to the exercise or control group. The exercise intervention included supervised acute exercise before each of four ICT cycles plus a 3-month home-based walking program with an activity tracker and step goals. The feasibility of the exercise protocol was assessed through adherence, acceptability, tolerability, and safety. Clinical, physical, and patient-reported outcomes were assessed at baseline and after 3 months. Results: Twenty-six patients (mean age 60.6 years; SD 10.65) participated, with an 87.5% acceptance rate. In the exercise group (n = 17), 80.9% of participants completed the acute exercise sessions, with a median interval of 38 min [IQR, 20–60] between exercise and ICT. No exercise-related adverse effects were reported. After 3 months, 60% of participants in the exercise group were classified as active and maintained their step goals. Self-reported measures suggest that maintaining physical fitness is favorable for reducing fatigue and insomnia, and therefore improving quality of life. Conclusions: Acute exercise performed immediately before each ICT administration in patients with mNSCLC appears feasible and safe. Full article

Background/Objectives: Obesity is a common comorbidity but there remains limited understanding on how higher obesity rates in rural areas may impact physical function decline and other health domains among cancer patients. This study addresses this gap by examining the association between body mass index (BMI) and physical function among a cohort of rural advanced cancer patients. Methods: This cross-sectional analysis uses baseline data from the Nurse AMIE trial (NCT04673019). Individuals were categorized as ‘normal weight’ (BMI ≤ 25 kg/m²), ‘overweight’ (BMI > 25 to 30 kg/m²), and ‘obese’ (BMI > 30 kg/m²). Objective physical function was measured by the Short Physical Performance Battery (SPPB) and subjective physical function and health domains were measured using surveys (PROMIS; SF-36). Results: Of 348 patients included, 88 (25.3%) were classified as ‘normal weight’, 107 (30.7%) as ‘overweight’, and 153 (44.0%) as ‘obese’. Average age was 64.8 years (SD = 12.2), 46% (n = 160) were female, 95% were white (n = 331), and 52% (n = 182) were Stage 4. Total SPPB scores revealed poorer functioning with higher BMI (M ± SD: BMI ≤ 25 kg/m²: 9.1 ± 2.3; BMI > 25–30 kg/m²: 8.3 ± 3.1; BMI > 30 kg/m²: 8.1 ± 2.8; p = 0.04). Similarly, scores from the SF-36 revealed subjective physical function was lower with higher BMI (BMI ≤ 25 kg/m²: 57.9 ± 29.1; BMI > 25–30 kg/m²: 53.7 ± 28.0; BMI > 30 kg/m²: 47.6 ± 27.6; p = 0.004). Participants reported lower levels of energy and greater fatigue with higher BMI (BMI ≤ 25 kg/m²: 49.8 ± 26.1; BMI > 25–30 kg/m²: 45.1 ± 24.6; BMI > 30 kg/m²: 40.7 ± 22.6; p = 0.01). Conclusions: Higher BMI is associated with poorer physical function and increased fatigue among rural advanced cancer patients, highlighting the need for supportive care related to physical function in this at-risk group. Full article

Female cancers, including breast and gynecological malignancies, are among the most prevalent oncological conditions worldwide. Advances in screening, diagnosis, and treatment have markedly improved survival, resulting in a growing population of female cancer survivors. Consequently, long-term health and quality of life have become essential aspects of comprehensive cancer care. Among survivorship issues, sleep disturbances—particularly insomnia—are highly prevalent and associated with adverse outcomes including mood and cognitive impairment, fatigue, immune and cardiometabolic dysregulation, and reduced adherence to therapy. Insomnia, defined as difficulty initiating or maintaining sleep or experiencing poor sleep quality with daytime impairment, affects 6–10% of the general population and is more common in women. In cancer survivors, poor sleep quality appears to be three times more frequent, reaching 62% in breast cancer survivors, although these data may be underestimated, especially for other cancer types, due to the small sample size and heterogeneity of the studies. The pathogenesis of insomnia in female cancer patients is multifactorial, involving cancer-related inflammation, hypothalamic–pituitary–adrenal axis dysregulation, neuroimmune alterations, treatment effects, psychological distress, and behavioral factors. Hormonal disruption plays a central role, as oncological treatments are often the cause of iatrogenic menopause, leading to vasomotor symptoms, mood and cognitive disturbances, sexual dysfunction, and genitourinary complaints, all contributing to sleep disruption. Importantly, estrogens and progesterone independently regulate sleep–wake pathways via central mechanisms, influencing sleep quality even in the absence of vasomotor symptoms. Management requires a multidisciplinary approach integrating oncology, gynecology, and sleep medicine. Cognitive Behavioral Therapy for Insomnia (CBT-I) is first-line, while pharmacologic options include benzodiazepines, Z-drugs, SSRIs/SNRIs, melatonin, or new medication like DORAs. Menopausal hormone therapy (MHT) should be considered for premature menopause management in selected women without contraindications, improving both vasomotor symptoms and sleep quality. Emerging neurokinin receptor (NK-R) antagonists show promise, and ongoing trials suggest significant potential even in breast cancer survivors. Full article

Cancer-related fatigue (CRF) is prevalent and onerous for cancer survivors. Not all survivors respond equally to interventions, but the characteristics distinguishing responders and non-responders are often unknown. This secondary analysis study compared baseline characteristics for responders (CRF reduction ≥2 points), non-responders, and those lost to follow-up using data from a two-group pre-test/post-test trial of a four-week exercise intervention compared to usual care. Included were 278 adult cancer survivors, with a mean age of 52.2 ± 11.9, 65% (180/278) female, and 90% (250/278) Caucasian. Of these, 77 (28%) were responders, 153 (55%) were non-responders, and 48 (17%) were lost to follow-up. At baseline, participants completed the 6-item Schwartz Cancer Fatigue Scale, with responses from 1 (not at all) to 5 (extremely fatigued) and a total score ranging 6–30. In the intervention group, 35% (49/141) reported decreased fatigue, 24% (34/141) reported increased fatigue, 25% (35/141) had minimal change, and 16% (23/141) were lost to follow-up. In the control group, 20% (28/137) reported decreased fatigue, 39% (53/137) reported increased fatigue, 23% (31/137) had minimal change, and 18% (25/137) were lost to follow-up. Responders in both groups reported higher baseline fatigue than non-responders, with mean differences of 5.2 (95% CI: 3.6–6.8) and 5.4 (95% CI: 3.4–7.3) for intervention and usual care, respectively. Higher baseline fatigue was found in responders compared to non-responders, regardless of group assignment, suggesting that those with a greater fatigue burden may have derived more benefit from exercise for CRF or a regression to the mean effect. Full article

Erythropoietin (EPO) is a hormone mainly produced by the kidney. EPO stimulates red blood cell production in response to hypoxia. EPO represents one of the most compelling paradoxes in medical oncology. For decades, recombinant EPO has been prescribed as an effective therapy for cancer-related anemia and fatigue, significantly improving patients’ quality of life while reducing their dependence on blood transfusions. Yet, accumulating scientific evidence knowledge has highlighted the complex interactions between EPO and tumor biology that extend well beyond its hematopoietic functions. The putative expression of EPO receptors on tumor cells has raised concerns about a potential role of EPO in promoting tumor progression, although conclusive clinical evidence remains lacking. Recent studies have revealed that EPO may contribute to immunosuppressive mechanisms within the tumor microenvironment, thereby reshaping our understanding of its risk/benefit profile in oncology. This evolving body of evidence calls for an objective reassessment of EPO’s dual nature as both a therapeutic ally and a potential oncological threat, in order to bring more caution around decision-making in the current era of strongly evolving cancer care. Full article

Background: Hepatocellular carcinoma (HCC) is a leading cause of cancer-related mortality. Atezolizumab plus bevacizumab (Atezo/Bev) has emerged as a first-line therapy for unresectable HCC (uHCC), improving overall and progression-free survival (OS, overall survival and PFS, progression-free survival) in IMbrave150. This study evaluates the real-world efficacy and safety of Atezo/Bev in uHCC. Methods: A retrospective analysis was performed on 87 patients (median age 68 years) treated with Atezo/Bev at Houston Methodist Hospital between January 2020 and June 2023. Demographics, treatment patterns, radiological response, OS, PFS, and toxicities were reviewed. Atezo/Bev was administered per FDA guidelines (atezolizumab 1200 mg plus bevacizumab 15 mg/kg every 3 weeks). Results: Of 87 patients, 78% were male, 71% White, and 70% had BCLC stage C disease. Most (60%) had Child–Pugh class A liver function, and 62% had viral hepatitis. Median OS was 15.1 months (95% CI: 10.57–25.97) and PFS was 9.1 months (95% CI: 7.4–21.07). Objective response rate was 31.3% (CR 7.2%, PR 25%, SD 52%, PD 16%). OS was longer in CP A versus CP B patients (21.2 vs. 5.2 months, p < 0.001) and in those receiving post-Atezo/Bev locoregional therapy (21.2 vs. 10.4 months, p = 0.043). Discontinuation due to toxicity occurred in 14%, mainly gastrointestinal bleeding and fatigue. Conclusions: Atezo/Bev demonstrated favorable real-world efficacy and manageable toxicity in uHCC, particularly in patients with preserved liver function or multimodal therapy. Full article

Objective: The primary objective of this pilot randomized clinical trial was to determine the effect of adding a supervised resistance exercise programme to a home-based physical activity plan on health-related quality of life in patients with colorectal cancer undergoing active treatment. The secondary objectives were to evaluate its effects on anxiety, depression, sleep quality, and inflammatory parameters. Methods: This is a pilot randomized clinical trial with parallel groups. Patients with CRC were recruited through the Oncology Department at the Salamanca University Health Care Complex in Spain. They were randomly allocated to receive either a home-based physical activity plus a supervised resistance training programme, or the home-based physical activity plan only. The primary outcome was health-related quality of life measures and the secondary outcomes included anxiety, depression and sleep quality evaluations. The supervised training lasted 8 weeks for each patient. Results: A total of 40 patients were recruited, 20 for each group. Adding a supervised resistance exercise programme to the home-based activity plan improved symptoms related to quality of life, such as fatigue (p = 0.040) and constipation (p = 0.015). However, no significant effect was found with regard to other health-related quality of life, anxiety, depression or sleep variables. Conclusions: Fatigue and constipation in patients with CRC receiving chemo- and/or immunotherapy may benefit from the introduction of supervised resistance exercise training programmes. Full article

Background: Physical activity provides substantial survival and quality-of-life benefits for cancer survivors, yet participation remains suboptimal globally, particularly in the Middle East and North Africa (MENA) regions. This study represents the first comprehensive examination of physical activity barriers and facilitators among Tunisian cancer survivors. Methods: This cross-sectional study recruited 120 cancer survivors ≥3 months post-chemotherapy completion from University Hospital Farhat Hached, Sousse, Tunisia (October–December 2024). Participants completed validated questionnaires via structured telephone interviews: the International Physical Activity Questionnaire Short Form (IPAQ-SF), the Physical Activity Barriers After Cancer scale (PABAC), the Fatigue Assessment Scale (FAS), and the Patient Activation Measure (PAM-13). Statistical analyses included descriptive statistics, receiver operating characteristic (ROC) analysis, correlation analyses, and multivariable regression modeling with Bonferroni correction for multiple comparisons. Results: Participants (mean age 51.89 ± 10.2 years, 73.9% female) demonstrated significant physical activity declines post-chemotherapy: moderate activity decreased from 31.1% to 1.7% (p < 0.001), median intensity declined from 297 to 44 MET-min/week (p < 0.001). Mean PABAC score was 29.72 ± 5.13, with cognitive barriers predominating (2.85 ± 0.58). Fatigue was universal (100%), with 21% reporting severe fatigue (FAS ≥ 35). Only 26.1% received exercise guidance from healthcare professionals. PABAC demonstrated excellent predictive performance for physical inactivity (AUC = 0.805, 95%CI: 0.724–0.887). Independent predictors of higher barriers included fatigue severity (β = 0.466, p < 0.001), low patient activation (β = −0.091, p = 0.010), and advanced cancer stage (β = 1.932, p = 0.008). Conclusions: Tunisian cancer survivors experience substantial, multidimensional barriers to physical activity, with inadequate healthcare guidance representing a critical system-level gap. Findings support the development of culturally adapted, multidisciplinary interventions that target modifiable cognitive and symptom-related barriers, while enhancing patient activation and healthcare provider engagement. Full article

Objective: Merkel cell carcinoma (MCC) is a rare and aggressive form of skin cancer. Although immunotherapy has transformed MCC management, published data remain limited. This comprehensive review evaluates current evidence on immune checkpoint inhibitors (ICIs) in MCC, in relation to other treatment modalities such as surgery and radiotherapy. Methods: Peer-reviewed articles published between January 2000 and August 2025 were searched manually in four databases: Scopus, ScienceDirect, PubMed and MEDLINE, using the keywords “Merkel cell carcinoma” AND “immunotherapy” AND “immune checkpoint inhibitors”. The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) methodology was employed. Results: ICIs can be given in different settings: (A) Neoadjuvant: The CheckMate 358 trial reported a 54.5% response rate among 33 radiologically evaluable patients treated with nivolumab, each showing over 30% tumor reduction. (B) Adjuvant: (1) The ADMEC-O phase II trial demonstrated improved disease-free survival with adjuvant nivolumab. (2) The ADAM phase III trial evaluates adjuvant avelumab in node-positive patients post-surgery/radiation, with common side effects including nausea, fatigue, and itching. (3) STAMP, a phase III trial, investigates pembrolizumab in stage I–III MCC. Both ADAM and STAMP have completed accrual and results are pending. (C) Primary therapy: KEYNOTE-017 and JAVELIN trials reported a 60% overall response rate and ~40% 3-year progression-free survival with first-line pembrolizumab or avelumab. Both agents also show promise as salvage therapies. Conclusions: ICIs demonstrate encouraging outcomes in MCC across various treatment stages. Continued research is essential to optimize treatment timing and integrate multimodal therapies. Full article

Background: Anthracycline-based chemotherapy, while highly effective for breast cancer, poses a significant risk for chemotherapy-related cardiac dysfunction (CTRCD), mainly determined by left ventricular ejection fraction (LVEF) reduction. Objectives: We aimed to evaluate the diagnostic utility of speckle tracking analysis (STA) and Diastolic Stress Test Echocardiography (DSTE) for the early detection of cardiac dysfunction either CTRCD or heart failure with preserved ejection fraction (HFpEF) in women undergoing chemotherapy for breast cancer and developed exertional dyspnea and/or fatigue during follow-up. Methods: In this prospective case–control study, 133 women receiving anthracycline-based chemotherapy (with or without anti-HER2 therapy) (chemotherapy group-CTG) and 65 age-matched healthy women as the control group (CG) underwent resting echocardiographic assessment, including LVEF, global longitudinal strain (GLS), myocardial work indices, biomarkers assay (NT-proBNP, troponin, galectin-3) and DSTE at baseline. That assessment was repeated after 12 months in CTG. Results: In this prospective case—control study, 133 women receiving anthracycline-based chemotherapy (with or without anti-HER2 therapy) were included. Based on the presence of CTRCD, they were further subdivided into a CTRCD subgroup (n = 37) and a CTRCD-free subgroup (n = 88). At the end of this study, CTG showed worse values of LVEF, GLS, myocardial work indices than baseline and CG (p < 0.05). Subgroup comparison (CTRCD vs. CTRCD-free) showed significant impairment in LVEF (53.60% vs. 62.60%, p < 0.001), GLS (–16.68% vs. −20.31%, p < 0.001), DSTE-derived tricuspid regurgitation maximum velocity (TRVmax) (3.05 vs. 2.31 m/s, p < 0.001) and elevated biomarkers (NT-proBNP: 200.06 vs. 61.49 pg/mL; troponin: 12.42 vs. 3.95 ng/L, p < 0.001) in the former subgroup. Regression analysis identified GLS, NT-proBNP, troponin, and TRVmax as independent predictors of CTRCD. Notably, a subgroup of CTRCD-free patients (n = 16) showed a high probability for HFpEF based on the HFA-PEFF score, with elevated GLS, NT-proBNP and DSTE-derived TRVmax compared to the rest of CTRCD-free patients and the CG (p < 0.001). Conclusions: STA and DSTE significantly outperform conventional LVEF in detecting subclinical cardiac dysfunction among women with breast cancer receiving chemotherapy. The combination of novel echocardiographic techniques and biomarkers may enable the detection of early CTRCD, including the under-estimated presence of HFpEF among breast cancer women with HF symptoms. Full article

Background/Objectives: Many cancer survivors continue to experience persistent symptoms such as pain, fatigue, and depression. Exercise and increasing physical activity (PA) are recommended as methods that can help alleviate these symptoms. However, maintaining regular exercise can be difficult due to the challenge of maintaining motivation. This secondary analysis uses data from a randomized controlled pilot study that examines the feasibility of the technology-enhanced combined exercise and other nonpharmacological interventions, such as the TEHEplus program, in managing symptoms. The program used mobile technologies and sent weekly physical performance reports to maintain engagement. In this study, we aimed to examine the impact of weekly physical performance reports on daily symptoms and PA and explored characteristics as moderators. Methods: This secondary analysis included participants who completed the 12-week TEHEplus program. Daily data of steps (PA), sleep duration, and symptoms (rated on a 4-point scale) were collected for 84 days. Mixed-effects and lagged regression models were used to assess the impact of weekly physical performance reports and the moderating effects of baseline characteristics. Results: Seventy-seven survivors of solid tumor cancer (mean age, 59.79, SD = 12.17) were analyzed. During this 84-day period, participants reported a reduction in low energy (B = −0.003, p = 0.004). Step counts increased by an average of 141 steps immediately after each weekly report (B = 140.857, p = 0.027). An increase of 5000 steps on the prior day was related to decreasing pain (B = −0.047, p < 0.001) and fatigue/low energy (B = −0.082, p < 0.001). Two additional hours of prior-night sleep worsened pain (B = 0.029, p = 0.001) and fatigue/low energy (B = 0.027, p = 0.002). Gender, employment, race, caregiver, and type of treatments moderate the relationship between daily PA, sleep (B = −0.131~0.078, p_s < 0.05). Conclusions: Weekly physical performance reports promoted PA, which possibly led to self-reported improvement of symptoms. Higher PA was associated with better self-report symptoms, but longer sleep duration was associated with worsened symptoms, suggesting the need for future studies. The moderating effects suggested that tailoring interventions to individual profiles may enhance the program’s effectiveness. Full article

Background/objectives: Multiple systemic treatments are available for metastatic castration-resistant prostate cancer (mCRPC), with unclear safety profiles. This study seeks to describe the safety determined in randomized clinical trials of a systemic treatment for mCRPC and whether safety differs by age. Methods: We utilized individual patient data from industry-funded phase 2/3 trials in mCRPC on abiraterone acetate (AA). Vivli, a clinical trial repository site, was used. One investigator independently performed screening. Relative effects of treatment were assessed with frequencies and odds of serious adverse events (SAEs). The Preferred Reporting Items for Systematic Reviews and Meta-analyses guideline was used. Subgroup analysis measured odds of SAEs as modified by age. Results: We identified 14 trials with 4296 patients. The median age of participants was 69 years. Nearly all participants experienced at least one adverse event (98.4% abiraterone, 97.3% standard of care [SOC]). More serious adverse events (grade 3 or 4) and deaths (grade 5) occurred in those receiving SOC (71.8%) compared to abiraterone (64.1%). The most frequent adverse event category was “Musculoskeletal and Connective Tissue Disorders”. The most frequent event types included anemia, back pain, hypertension, fatigue, hypokalemia, and bone pain. The odds of all events were lower in those receiving abiraterone compared to SOC. Odds of a serious musculoskeletal event were lower in older subjects by 22% (OR 0.78; 95% CI 0.63, 0.96). Conclusions: In this IPD meta-analysis, abiraterone acetate provides no greater risk of SAE in those receiving abiraterone than those receiving SOCs. Patients in the RCTs are younger and healthier than those in the general population; consequently, the results of RCTS might not be applied to the general population, especially those under-represented in the RCTs. There is a need to further evaluate abiraterone-related fractures and neuromuscular toxicities (NMTs) as key outcomes to gain insight into risk factors related to these adverse events. A real-world prospective study is warranted to examine the overall risks and benefits associated with treatment. Full article