OBJECTIVES:To evaluate the prevalence of European Association of Urology-defined combination and platinum eligibility at first-line treatment initiation, and to assess their impact on conventional treatment sequence and overall survival in a real-world Japanese cohort. METHODS:We retrospectively analyzed 148 patients with metastatic urothelial carcinoma who initiated systemic chemotherapy between 2018 and 2024 at a single institution in Japan. Cisplatin eligibility was assessed according to the Galsky criteria. Combination therapy eligibility and platinum eligibility were defined according to the European Association of Urology guideline. RESULTS:Among the 148 patients, 128 (86.5%) were combination-eligible and 20 (13.5%) ineligible. Among combination-eligible patients, 70 (54.7%) were cisplatin-eligible, 47 (36.7%) cisplatin-ineligible but platinum-eligible, and 11 (8.6%) platinum-ineligible. Median overall survival was significantly longer in combination-eligible patients than in combination-ineligible patients (25 vs. 16 months, p = 0.019, HR 2.46, 95% CI 1.16-5.23). Within the combination-eligible group, cisplatin-eligible patients tended to show superior median overall survival (not reached) compared with cisplatin-ineligible/platinum-eligible (25 months) and platinum-ineligible (15 months, p = 0.11 and p = 0.082, respectively). Only 25.0% (32/128) of combination-eligible patients received the chemotherapy-immune checkpoint inhibitor-enfortumab vedotin sequence, while 20.0% (4/20) of combination-ineligible patients also completed this sequence. CONCLUSIONS:European Association of Urology-defined combination and platinum eligibility were associated with survival outcomes and treatment sequence capability in a real-world setting. These findings highlight the prognostic value but practical limitations of eligibility criteria, emphasizing the need to develop more practical classification frameworks that ensure broader access to effective therapy.

Background/Objectives: Penile malignant tumors are rare neoplasms, and both clinicopathologic features and prognoses remain unclear in Japanese patients. Here, we investigated the prognoses of penile malignant tumors in Japan using the nationwide hospital-based cancer registry (HBCR) database. Methods: The 2015 HBCR database cohort was queried to identify patients with penile malignant tumors. Moreover, we investigated age, pathology, tumor-node-metastases classification, first-course treatment, and overall survival in these patients. Results: A total of 269 patients were analyzed from the 2015 cohort (149 squamous cell carcinoma [SCC] patients and 56 extramammary Paget disease [EMPD] patients). The median ages at diagnosis in both SCC and EMPD patients were 76.0 and 76.5 years. The median observation period was 53 months in the present study. The 5-year overall survival (OS) rates of SCC and EMPD were 56.8% and 78.5%. The 5-year OS rates of clinical stages 0-I, II, III, and IV were (respectively) 68.0%, 70.1%, 38.5%, and 11.9% in SCC patients and (respectively) 83.7%, 83.3%, not evaluated, and 0% in patients with EMPD. Conclusions: We revealed the OS of Japanese patients with penile SCC and EMPD in a large population-based study for the first time. Patients with clinical stage IV penile SCC and EMPD had extremely poor prognoses, highlighting a need for improved disease management in these patients.

Abstract Pretreatment immune profiles associated with immune-related adverse events (irAEs) may inform individualized management strategies, including enhanced monitoring and early toxicity intervention, in patients with metastatic renal cell carcinoma (mRCC) treated with nivolumab plus ipilimumab. In this cohort (n = 51), we analyzed pretreatment peripheral blood parameters and whole-blood transcriptomic profiles. Higher lymphocyte and monocyte counts (odds ratios [ORs] 14.36 and 9.90, respectively) were significantly associated with an increased risk of irAEs, whereas higher neutrophil counts and C-reactive protein levels (ORs 0.08 and 0.27, respectively) were associated with a decreased risk. To characterize immune pathways associated with irAE development, we performed whole-blood transcriptomic analyses. Gene set enrichment analysis revealed upregulation of lymphocyte- and humoral immunity-related pathways and downregulation of neutrophil- and inflammatory-related pathways in patients who developed irAEs. CIBERSORTx demonstrated reduced neutrophil fractions and increased proportions of CD8⁺ T cells and activated memory CD4⁺ T cells, indicating an adaptive immune-dominant profile. Exploratory analysis identified five candidate genes (ANAPC1, CDK4, MCM6, GRAP2, and BST2) that may contribute to the immune features associated with irAE development. Collectively, these findings suggest that irAE development is associated with a distinct systemic immune profile characterized by enhanced lymphocyte-related and reduced neutrophil-related immune activity.

ABSTRACT Background Mesothelioma of the tunica vaginalis testis is a rare neoplasm, accounting for less than 1% of all mesothelioma cases. Due to the rarity of this disease, a standard treatment has not been established. Clinical management is generally adapted from the strategies used for pleural mesothelioma. Although immune checkpoint inhibitors (ICIs) have demonstrated efficacy in treating pleural mesothelioma, their role in mesothelioma of the tunica vaginalis testis remains uncharacterized due to a lack of evidence. This is the first report documenting a clinical response to nivolumab in chemoresistant mesothelioma of the tunica vaginalis testis. Case A 71‐year‐old man presented with painless left scrotal swelling and was initially diagnosed with a hydrocele at the referring hospital. One year later, hydrocelectomy revealed partial thickening of the tunica without malignancy. A subsequent magnetic resonance imaging analysis revealed a new intratesticular nodule. Orchiectomy was performed, and the pathological findings revealed an epithelioid mesothelioma. He was referred to Tsukuba University Hospital for further treatment. He also had a history of Self‐Defense Force service, which suggested possible asbestos exposure. Imaging revealed pelvic lymphadenopathy with fluorodeoxyglucose uptake in the right external iliac lymph nodes. He received four cycles of cisplatin and pemetrexed every 3 weeks, resulting in stable disease. Bilateral pelvic lymph node dissection was performed and confirmed the presence of metastatic mesothelioma. Nine months after the surgery, bilateral inguinal lymph node recurrence occurred, and he received cisplatin monotherapy because of renal impairment. Despite four additional cycles of cisplatin monotherapy, the disease progressed. Therefore, chemotherapy was discontinued, and nivolumab was administered. Nivolumab resulted in sustained tumor shrinkage. However, after 3 months of treatment, he developed immune‐related encephalitis requiring corticosteroid therapy and nivolumab discontinuation. After 16 months of nivolumab initiation, he was dead from the disease. Conclusion This is the first report documenting the clinical response of a chemoresistant mesothelioma of the tunica vaginalis testis to nivolumab. ICIs are a promising treatment option for this rare and challenging disease.

Horseshoe kidney (HSK) with ureteropelvic junction obstruction (UPJO) is a rare clinical condition. For successful pyeloplasty in these patients, preoperative anatomic mapping is crucial. Therefore, we investigated the utility of three-dimensional (3D) image reconstruction technology for accurate preoperative and intraoperative procedure planning. We retrospectively investigated the surgical outcomes of 6 patients who underwent laparoscopic pyeloplasty (LP) for HSK-associated UPJO at our hospital between October 2017 and October 2019. Next, we examined the concordance between intraoperative findings and 3D images reconstructed with SYNAPSE VINCENT® software. Preoperative 3D-CT imaging clearly visualized the unique anatomy of HSK, including arteries and veins, and the vessels crossing the UPJ anteriorly could be detected before surgery in 5 of 6 patients. Importantly, these images completely coincided with intraoperative findings. In fact, no intraoperative complications or conversions to open surgery were needed. Moreover, all patients are currently asymptomatic and have no major sequelae at a mean follow-up of 29.9 months (range 15.4 to 39.7). The present study suggests the potential utility of 3D image reconstruction technology in performing LP through detailed preoperative mapping of complex renal anatomies, such as in HSK.

BackgroundConventional semen analysis does not fully capture male reproductive potential. The sperm DNA fragmentation index (DFI) may detect latent infertility, although the sperm chromatin structure assay (SCSA) is costly and technically demanding. Image-based analysis of semen microscopy, including artificial intelligence (AI), may enable lower-cost noninvasive assessment. However, progress is limited by a lack of standardized multimodal datasets linking sperm images with the DFI and relevant covariates. ObjectiveThis protocol describes the initial phase of the Nippon Semen and Environmental Exposure Database (N-SEED) initiative. The study aims to (1) establish standardized acquisition and quality control procedures for sperm microscopy/video and DFI measurement; (2) evaluate the feasibility and magnitude of associations between predefined image-/video-derived variables and the DFI; and (3) characterize clinical, environmental, physical, and lifestyle factors that may act as candidate correlates or confounders for subsequent image-based fertility research. MethodsThis multi-institutional cross-sectional study centralized clinical assessment and specimen collection at a single site in Japan. The prespecified group-specific enrollment targets were 25 for group 1 (a relatively homogeneous low-risk cohort for DFI quality control) and 100 for group 2 (apparently healthy community-based adult volunteers for exploratory association analyses). Microscopic sperm videos, automated semen parameters, and sperm oxidative stress data were obtained at collection. SCSA-based DFI assays are currently being performed sequentially. Group 2 participants additionally provided fasting blood and early-morning urine samples for endocrine, metabolic, environmental chemical, and elemental assays. They also underwent physical measurements and completed structured questionnaires/interviews on lifestyle, nutrition, sleep, psychological status, sexual function, and collection conditions. The primary outcome measure is the continuous DFI assessed with SCSA. Group 1 data will be used to evaluate intraday, interday, and interfacility variability and to fix flow cytometry gating settings. In groups 1 and 2, predefined image-/video-derived summary variables after standardized preprocessing will be analyzed against the continuous DFI using correlation analyses and simple linear regression to assess whether sperm microscopy data contain information relevant to sperm DNA integrity. Exploratory categorical DFI analyses will use simple logistic regression. Secondary exploratory analyses will examine candidate covariates and data completeness, including sensitivity analyses. ResultsThe study was registered in the University Hospital Medical Information Network Clinical Trials Registry on January 18, 2026. Between January 18 and February 21, 2026, 124 unique participants were recruited (group 1: n=25; group 2: n=103; both groups: n=4). Sample and data collection were completed on February 21, 2026. Biospecimen assays and primary association analyses are expected to be completed by March 2028. ConclusionsThis initial N-SEED phase will deliver a standardized, quality-controlled multimodal resource linking sperm microscopy/video data with the DFI and broader physiological and environmental measures. Its immediate contribution is not to provide an immediately deployable clinical AI tool but rather to support feasibility assessment, confounder identification, and planning for subsequent database expansion and external validation of image-based male fertility assessment methods. Trial RegistrationUMIN Clinical Trials Registry UMIN000060395; https://tinyurl.com/mryfymw5 International Registered Report Identifier (IRRID)DERR1-10.2196/93803

BACKGROUND:Enfortumab vedotin (EV) has demonstrated clinical benefits as a third-line monotherapy after chemotherapy and immune checkpoint inhibitors and is currently established, in combination with pembrolizumab, as a first-line standard therapy for metastatic urothelial carcinoma (mUC). However, dermatologic adverse events (DAEs) are common and may necessitate treatment interruption. While EV rechallenge is often considered, evidence regarding the recurrence and management of DAEs after rechallenge is limited. AIMS:To analyze the incidence, timing, and severity of DAEs following EV rechallenge and assess the impact of dose modifications and initial inpatient versus outpatient management on clinical outcomes. METHODS AND RESULTS:This retrospective observational study included patients with mUC who received EV at a single institution between January 2022 and December 2024. Of the 48 patients treated with EV, 36 (75.0%) developed DAEs, with a median onset of 11 days. Twenty patients resumed EV after interruption due to DAEs; 13 (65%) experienced recurrence. Recurrent DAEs tended to be of lower grade than the initial events and to be similar to the initial episode in terms of the type of DAEs. Early-onset (≤ 7 days) DAEs were more likely to progress to grade ≥ 3. Although inpatient management enabled earlier detection and intervention, it did not reduce the incidence of severe toxicity compared to outpatient care. CONCLUSION:DAEs frequently recur after EV rechallenge but are typically less severe than the initial episode. Early-onset DAEs may predict severe toxicity, underscoring the need for close monitoring and proactive management. Prospective studies are warranted to optimize rechallenge strategies and improve the safety of EV therapy.

Background:Very low uptake in workplace semen analysis research is difficult to interpret, particularly in employer-adjacent settings, where nonparticipation may reflect limited recruitment reach, limited understanding of the occupational rationale, low perceived relevance, or procedure-related concerns. Objective:This post hoc formative study described self-reported awareness of a parent workplace semen analysis study as an indicator of effective recruitment reach, reported reasons for nonparticipation under the implemented survey condition, and design issues for exposure-defined workplace reproductive health research. Methods:In April-May 2025, we conducted an anonymous web-based cross-sectional follow-up survey among male employees in Japan who had been eligible for, but had not completed, a parent workplace semen analysis study. The parent study invited approximately 2000 male employees from 3 companies between November 2024 and January 2025; 6 completed the protocol. The follow-up survey invited approximately 900 male employees from 1 company. Part 1 assessed awareness, reasons for nonparticipation, interest in male reproductive health information, and general openness to future related research. Optional Part 2 assessed age, knowledge, concerns, expected reactions, and willingness under simplified conditions. Responses were summarized descriptively using Wilson 95% CIs; no hypothesis testing was performed. Results:We analyzed 108 submitted questionnaires; 83 respondents completed Part 2. Overall, 74/108 (68.5%; 95% CI 59.3-76.5) respondents reported no awareness of the parent study. Among unaware respondents, 68/74 (91.9%; 95% CI 83.4-96.2) selected "did not know the study existed." Among aware nonparticipants, the most frequent reasons were perceived irrelevance and resistance to collecting semen (each 9/34, 26.5%; 95% CI 14.6-43.1), embarrassment or reluctance (8/34, 23.5%; 95% CI 12.4-40), and hassle (7/34, 20.6%; 95% CI 10.3-36.8). In Part 2, anxiety about unfavorable results was reported by 52/83 (62.7%; 95% CI 51.9-72.3) respondents, concerns about collection location or privacy protection by 48/83 (57.8%; 95% CI 47.1-67.9), and self-reported resistance by 42/83 (50.6%; 95% CI 40.1-61.1). Under simplified conditions, 36/83 (43.4%; 95% CI 33.2-54.1) respondents indicated willingness to undergo semen analysis. Conclusions:Very low uptake in this employer-adjacent semen analysis study was not interpretable as a single phenomenon. This post hoc formative process evaluation identified limited awareness, suggesting limited effective recruitment reach under the implemented procedures, and characterized the reason profile among aware nonparticipants, including low perceived relevance and semen collection-related concerns. Rather than identifying primary causal determinants of nonparticipation, the findings support a bounded recruitment-methodological interpretation and highlight recruitment-cascade components for prospective measurement: objective exposure to recruitment materials, information access, understanding of the occupational rationale, voluntary postinformation declination, privacy concerns, logistical burden, and specimen-return completion. Informed acceptability after occupational reproductive-hazard education should be evaluated in future designs that include such education and comprehension assessment.

BACKGROUND:Population-specific, age- and sex-stratified reference intervals (RIs) for many serum trace elements remain limited, constraining the clinical interpretation of inductively coupled plasma mass spectrometry (ICP-MS)-based measurements. OBJECTIVE:To derive age- and sex-stratified serum reference intervals-not previously available for a large Japanese screening cohort-for eight trace elements (Co, As, Se, Rb, Sr, Mo, Ag, and Cs), and to assess between-facility and between-year variation. METHODS:A predefined 17-element panel was measured by ICP-MS in adults participating in an optional screening initiative at 12 sites in Japan (2017-2020). After age and eligibility exclusions, deduplication to one sample per participant, and removal of two sites with fewer than 20 participants, 17,523 individuals from 10 sites were retained for analysis. From the 17-element panel, the eight target analytes were pre-specified for RI derivation. RIs were estimated using a CLSI EP28-A3c-oriented statistical framework with Box-Cox transformation and bootstrap 90% confidence intervals. Pooling decisions were guided by Kruskal-Wallis effect sizes and RI width ratios. RESULTS:All eight elements showed age- and/or sex-related variation. As and Mo were generally higher in older age groups in both sexes, and Ag and Cs also tended to be higher in older groups (non-monotonic patterns), whereas Rb was generally lower in older groups. Se was relatively stable in men but increased up to the 60-69-year age group in women. Co was higher in women than in men, with a higher upper reference limit at ages 20-49. Sr upper reference limits generally increased with age in both sexes, especially in women aged ≥70 years. Between-year and between-site effect sizes were small overall, supporting pooled RI construction. SIGNIFICANCE:This study provides large-scale, age-decade- and sex-stratified descriptive serum RIs for eight trace elements that previously lacked established Japanese reference intervals. These intervals support contextual interpretation of ICP-MS biomonitoring data. IMPACT STATEMENT:This study provides large-scale, age-decade- and sex-stratified, descriptive serum concentration intervals for eight trace elements that lack established age- and sex-stratified serum reference intervals for Japanese adults (Co, As, Se, Rb, Sr, Mo, Ag, Cs). Derived from a multicentre screening population rather than a formally defined healthy cohort, these descriptive intervals support the contextual interpretation of ICP-MS-based biomonitoring data and provide a basis for future toxicological and nutritional assessments.

The Andreotti-Mayer locus is a subset of the moduli space of principally polarized abelian varieties, defined by a condition on the dimension of the singular locus of the theta divisor. It is known that the Jacobian locus in the moduli space is an irreducible component of the Andreotti-Mayer locus. In this paper, we generalize the Andreotti-Mayer locus to the case of the moduli space of abelian varieties with non-principal polarization and prove that the Prym locus of branched double coverings is an irreducible component of the generalized Andreotti-Mayer locus.

BACKGROUND:This analysis utilized a subject-based analysis of data from the prospective single-arm phase III trial (jRCT2061210055) to evaluate the efficacy of photodynamic diagnosis (PDD) when 5-aminolevulinic acid hydrochloride (5-ALA) was administered 4-8 h before transurethral resection of bladder tumors (TURBT). METHODS:This study evaluated 144 patients suspected of having non-muscle invasive bladder cancer (NMIBC), including 127 with NMIBC (38 patients had normal-to-flat-appearing cancer) and 17 without cancer. The diagnostic accuracy and clinical utility of blue light (BL) during TURBT were assessed for each patient and compared with those of white light (WL). RESULTS:Subject-based analysis revealed that WL alone missed tumor lesions in 33.1 % of patients, whereas BL alone missed 3.1 % in a biopsy-based analysis (P < 0.001). WL alone failed to diagnose NMIBC in 4.7 % of patients, while BL missed 1.6 %. Adding BL to WL led to an upgrade of NMIBC risk classification in 12 of 127 patients (9.4 %), including 5 upgraded to high-risk and 4 to highest-risk categories. CONCLUSION:This study is the first to demonstrate that PDD's efficacy is maintained up to 8 h after oral 5-ALA administration and indicates that PDD improves the detection rate of bladder cancer, potentially optimizing risk stratification and offering optimal additional treatment.

Background To investigate variations in diagnostic performance of photodynamic diagnosis (PDD) according to surgical experience. Methods Data were extracted from patients having pT1 or lower primary tumors that underwent PDD-assisted transurethral resection of bladder tumors (TURBT) with orally 5-amibolevulinic acid at our institute. Surgical experience was categorized by urological experience (first-year and second-year) and PDD experience (<10, 10-19, and ≥20 cases). Sensitivity, specificity, and accuracy rates were calculated based on PDD or white light (WL) findings and pathologic diagnosis. The bladder neck, trigone, and prostatic urethra were defined as areas with a high probability of tangential effect. Results A total of 108 patients and 343 specimens were extracted. The second-year surgeons had significantly higher accuracy rates than first-year surgeons (81.5% vs. 69.0%, p=0.013), while PDD experience did not significantly affect accuracy rates (76.5, 75.5, and 69.0%). In addition, the accuracy rate was also significantly lower in tangential effect areas (59.6% vs. 80.8%). Multivariate analysis identified urological experience as a significant factor improving accuracy rate (odds ratio [OR] 2.14) while tangential effects substantially reduced accuracy rate (OR 0.37). Notably, combining both PDD and WL resulted in a sensitivity exceeding 94%, even in first-year urology residents and tangential effect areas. Conclusions Urological experience had a greater impact on diagnostic performance of PDD compared to PDD experience. The combination of PDD and WL findings may improve sensitivity and reduce the possibility of missed diagnoses for less experienced urology residents.

Background To identify the prognosis of Japanese patients with collecting duct carcinoma (CDC). Methods We used a hospital-based cancer registry data in Japan to extract CDC cases that were diagnosed in 2013, histologically confirmed, and determined the first course of treatment. We further investigated treatment modalities and estimated overall survival (OS) by the Kaplan-Meier method. Results A total of 61 CDC patients were identified. The 5-year OS rates for all CDC patients in Japan at 2013 were 23.6% (95% CI: 15.0-37.4), with a median OS of 14 months (95% CI: 12-24). The 5-year OS rate for CDC patients at stages I, III, and IV were 53.0% (95% CI: 29.9-94.0), 35.7% (95% CI: 19.8-64.4), and 3.4% (95% CI: 0.5-23.7), respectively. Noteworthy, the 1-year OS for stage IV patients was 27.6% (95% CI: 0.5-23.7) and the median OS was only 5 months (95% CI: 4-12). We further examined the OS for advanced disease according to treatment modalities. The median OS for chemotherapy alone was significantly shorter than surgery alone (4 months [95% CI: 4-4] vs. 15 months [95% CI: 13-68]; p<0.001). Conclusions Japanese CDC patients face poor prognoses similar to Western countries, especially in advanced cases that receive only chemotherapy. Surgery appears necessary for advanced disease.

BACKGROUND:Inductively coupled plasma mass spectrometry (ICP-MS) is widely used for the accurate measurement of minerals. However, its application to serum essential mineral measurement has not been fully evaluated. The present study aimed to assess the performance of ICP-MS for serum minerals by comparing its measurements to those obtained using standard quantification methods. METHODS:Cross-sectional data were collected from 282 participants from a single facility in Japan. Serum concentrations of eight key minerals, namely sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, and copper, measured via ICP-MS and standard methods were compared using Passing-Bablok regression and Bland-Altman plots. RESULTS:All minerals, except phosphorus, exhibited good agreement with standard methods, with more stable regression coefficients observed for minerals with greater interindividual variability. After systematically filtering outliers, the mean relative errors were approximately -3% for sodium, potassium, calcium, and magnesium; +5% for iron; 0% for zinc; and -19% for copper. The outliers for iron were primarily due to mild hemolysis, whereas those for zinc were largely attributed to nonhemolysis factors. For phosphorus, the serum total phosphorus concentration measured using ICP-MS was approximately 3.5 times higher than the serum inorganic phosphorus concentration measured using standard methods, with a weak correlation observed between the two methods. CONCLUSION:This study provides a practical foundation for future research. Understanding ICP-MS characteristics will facilitate the development of new approaches in clinical diagnostics.

INTRODUCTION:Experience with the Hugo RAS system in robot-assisted colorectal surgery is limited. This is particularly noticeable when focusing on complex procedures, such as total proctocolectomy (TPC). This study aimed to demonstrate the feasibility and safety of using the Hugo RAS system for TPC. CASE PRESENTATION:A 27-year-old woman with multiple colorectal cancers with a background of familial adenomatous polyposis underwent robot-assisted TPC, including lymph node dissection of the entire colorectal region using the Hugo RAS system. The robotic procedure was divided into 3 steps: 1) Trendelenburg position to perform ascending colon complete mesocolic excision (CME) to the hepatic flexure, 2) descending colon CME and total mesorectal excision with D3 lymph node dissection, and 3) flat position to perform central vessel ligation along the superior mesenteric artery. After undocking, the specimen was extracted transanally, and an ileal pouch was constructed from a small laparotomy at the umbilical incision, followed by ileal pouch-anal anastomosis. The operative time was 632 min, and the estimated blood loss was minimal. The postoperative period was uneventful. CONCLUSIONS:Robot-assisted TPC using the Hugo RAS system is safe and feasible. The flexibility of Hugo, which is carried by a modular-type surgical robot with multiple independent arms, enables safe and effective advanced procedures.

OBJECTIVE:To evaluate the incidence and clinical predictors of gastrointestinal and hepatic adverse events following oral administration of 5-aminolevulinic acid hydrochloride (5-ALA) before transurethral resection of bladder tumors (TURBT). METHODS:Safety data were analyzed from 145 patients enrolled in the prospective, single-arm, multicenter phase III SPP2C102 trial who received 5-ALA 4-8 h before TURBT. The incidence and severity of nausea, vomiting, and liver dysfunction, defined by elevations in aspartate aminotransferase, alanine aminotransferase, and/or gamma-glutamyltransferase, were assessed according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Potential risk factors were evaluated using univariable and multivariable logistic regression; results are reported as adjusted odds ratios (aOR) with 95% confidence intervals (CIs). RESULTS:Nausea/vomiting occurred in 28/145 patients (19.3%), all CTCAE grade 1-2. Female sex was independently associated (aOR 3.15, 95% CI 1.17-8.47), and diastolic blood pressure ≥ 80 mmHg showed a borderline association (aOR 2.37, 95% CI 0.99-5.78). Prophylactic antiemetics yielded a numerically lower rate (21.1% vs. 9.1%; p = 0.25). Liver-enzyme elevations similarly occurred in 28/145 patients (19.3%), all CTCAE grade 1-2. Systolic blood pressure ≥ 130 mmHg remained independently associated (aOR 4.73, 95% CI 1.62-13.78), whereas associations for hypertensive comorbidity and BMI ≥ 25 kg/m2 in univariable analyses did not persist after adjustment. CONCLUSION:5-ALA-related nausea, vomiting, and transient liver-enzyme elevations were common but generally mild. Simple bedside variables-particularly sex and blood pressure-may guide selective antiemetic prophylaxis and closer biochemical monitoring in routine practice.