Ulsan College

Axillary surgery for patients with ipsilateral breast tumor recurrence (IBTR) is feasible, but its necessity and impact on oncologic outcomes remain unclear. This study evaluated the role of axillary surgery for patients with clinically node-negative invasive IBTR. The study identified breast cancer patients who had undergone breast-conserving surgery (BCS) at Asan Medical Center between 1990 and 2017 and later experienced invasive ipsilateral breast tumor recurrence (IBTR) as the first recurrence event. Cases with clinically node-positive disease or distant metastasis at recurrence were excluded from the analysis. Clinicopathologic features were compared using the chi-square test. Recurrence-free survival (RFS) after IBTR (second RFS) was analyzed using the Kaplan-Meier method and log-rank test in accordance with the axillary surgery status. Among the 200 enrolled IBTR patients in the study, 60 (30%) underwent axillary surgery. The median time from primary diagnosis to recurrence was 35.5months (range, 2-278months), and the follow-up period after IBTR was 56.5 months (range, 1-229months). Axillary surgery at recurrence was more frequent for patients who had not undergone axillary surgery previously and for patients undergoing salvage mastectomy. No significant difference was observed in second RFS based on whether axillary surgery was performed (5year second RFS 61.0% with axillary surgery vs 68.4% without axillary surgery; P = 0.308). Adjuvant treatments after recurrence were similar regardless of axillary surgery. Oncologic outcomes did not differ based on whether axillary surgery was performed for IBTR patients. The omission of axillary surgery could therefore be considered in cases with clinically node-negative IBTR.

RET fusions appear in 1%-2% of non-small cell lung cancers (NSCLCs). The results from the ARROW study (ClinicalTrials.gov identifier: NCT03037385) supported US Food and Drug Administration approval of pralsetinib, an oral selective RET inhibitor, for metastatic RET-altered NSCLC and RET fusion-positive thyroid cancers. ARROW was a phase I/II open-label study of pralsetinib 400 mg once daily in RET fusion-positive NSCLCs. Coprimary end points were overall response rate (ORR) and safety. Key secondary end points included duration of response, progression-free survival, and overall survival (OS). At data lock (May 20, 2024), 281 patients initiated pralsetinib (median treatment duration, 15.0 months). ORR (measurable disease patients; n = 259) was 78% (95% CI, 69 to 86) for treatment-naïve patients and 63% (95% CI, 54 to 71) for prior platinum-based chemotherapy patients. Median OS was 44.3 months (95% CI, 30.9 to 53.1), 50.1 months (95% CI, 28.3 to not reached) in treatment-naïve patients, and 39.7 months (95% CI, 27.8 to 53.2) in prior platinum patients. Common grade ≥3 treatment-related adverse events were anemia (21%), hypertension (15%), and decreased neutrophils (13%). Three treatment-related deaths occurred (pneumonia, n = 2; interstitial lung disease and rhabdomyolysis, n = 1 each). Safety was consistent with previous ARROW reports; no hypersensitivity was reported in patients receiving prior immunotherapies. Pralsetinib produced robust, durable responses with manageable safety in treatment-naïve and previously treated patients with RET fusion-positive NSCLCs, confirming previous findings with longer follow-up.

The kidney plays a vital role in eliminating gadolinium-based contrast agents (GBCAs), and renal function may contribute to various GBCA-associated adverse drug reactions (ADRs), particularly acute kidney injury (AKI). The objective of the study is to investigate whether GBCA administration elevates AKI risk and explore the correlation between renal function and the incidence of GBCA-associated acute ADRs. Adult patients who underwent MRI examinations between January 2015 and June 2021 at the inpatient department of a single tertiary general hospital were retrospectively examined. Baseline estimated glomerular filtration rate (eGFR) before MRI examination, serum creatinine levels of the nearest timepoint before and after MRI examinations, and symptoms of GBCA-associated acute ADRs were retrospectively reviewed. AKI was diagnosed based on the Kidney Disease: Improving Global Outcomes guideline. Propensity score matching and inverse probability of treatment weighting were used to adjust for selection bias. The rates of GBCA-associated acute ADRs and AKI were compared using generalized estimating equation (GEE) for total data and randomly sampled one patient-one examination data. This study included 35,197 MRI examinations with available serum creatinine levels, and AKI was diagnosed in 569 cases (1.62%; 95% CI: 1.48%-1.75%). Logistic regression with GEE after propensity score matching revealed a significantly lower AKI incidence in examinations with GBCA enhancement (OR, 0.59; 95% CI: 0.46-0.77; P < 0.001); this finding was consistent across patient groups with both eGFR of >60mL/min/1.73 m 2 (OR, 0.53; 95% CI: 0.34-0.84; P = 0.007) and eGFR between 30 and 60mL/min/1.73 m 2 (OR, 0.49; 95% CI: 0.32-0.74; P < 0.001). The rates of GBCA-associated acute allergic-like reactions (adjusted OR, 1.01; 95% CI: 1.00-1.02; P = 0.125) and physiological reactions (adjusted OR, 1.00; 95% CI: 0.98-1.02; P = 0.997) showed no significant association with baseline eGFRs. In this large retrospective study, the administration of GBCAs was not associated with higher rates of AKI, which remained consistent across varying levels of baseline renal function. Furthermore, no significant increase in GBCA-associated acute ADRs was observed in patients with impaired renal function. These findings suggest that GBCA administration is generally well-tolerated across a wide spectrum of renal function, without increasing the risk of AKI or GBCA-associated acute ADRs.

Background: (1,3)--D-Glucan (BDG) is an adjunctive biomarker for invasive fungal infections, but its analytical variability and lack of external quality assessment (EQA) programs limit assay reliability.This study evaluated BDG stability under practical storage conditions and explored the feasibility of a split-sample procedure as an alternative quality-assurance approach.Methods: The reliability of BDG assay results was assessed through three experiments addressing pre-analytical handling, storage stability, and interlaboratory comparability.To examine the effect of freeze-thaw stress, samples with low, moderate, and high BDG concentrations were repeatedly frozen and thawed.Short-term stability was then evaluated using pooled samples at near-cutoff, weak-positive, and strong-positive levels stored at different temperatures for up to 72 hours, with triplicate testing at predefined intervals.In addition, seven serum samples were aliquoted and analyzed in parallel at two institutions to assess interlaboratory agreement.Results: Repeated freeze-thaw cycles resulted in a marked reduction in BDG concentrations, whereas values remained largely stable for up to 72 hours under both refrigerated and frozen storage.Variability was the greatest near the assay cutoff.Interlaboratory comparison showed acceptable agreement in six of seven samples, with one discrepant result likely attributable to specimen-specific or handling-related factors.Conclusions: BDG assays remain stable under short-term refrigerated or frozen storage but are susceptible to repeated freeze-thaw cycles and variability near the cutoff range.The split-sample procedure offers a practical interim approach when EQA is unavailable and may serve as a foundation for standardized quality-assurance frameworks for BDG testing.