Asan Medical Center

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.

There is no proven treatment to alleviate symptoms of postacute sequelae of SARS-CoV-2 infection (PASC), despite its substantial public health burden. To evaluate the efficacy of metformin and ursodeoxycholic acid (UDCA) in improving PASC symptoms in adults. Double-blind, placebo-controlled, randomized clinical trial. (Clinical Research Information Service: KCT0009342). Two tertiary hospitals in South Korea, July 2024 to April 2025. Of 666 adults screened, 396 with a PASC index score of 12 or greater were randomly assigned. Oral metformin (uptitrated to 1500 mg/d), UDCA (900 mg once daily), or double placebo for 14 days (1:1:1). Proportion of participants achieving PASC recovery (index score <12) at 8 weeks. Among 396 randomized participants (median age, 36 years [IQR, 28 to 49 years]; 72% women), 132 received metformin, 132 received UDCA, and 132 received placebo. The mean interval from SARS-CoV-2 infection was 9.8 months (SD, 7.5). The mean baseline PASC score was 19.3 (SD, 5.7). Recovery occurred in 63.6% (84 of 132) with metformin, 68.2% (90 of 132) with UDCA, and 68.2% (90 of 132) with placebo. Mean changes in PASC scores from baseline to week 8 were -10.05 (95% CI, -11.35 to -8.76) with metformin and -10.62 (CI, -11.79 to -9.45) with UDCA, compared with -10.43 (CI, -11.69 to -9.18) with placebo. Findings may not be generalizable to patients with more severe or persistent long COVID. A 2-week course of metformin or UDCA did not significantly improve recovery from PASC. National Institute of Infectious Diseases, National Institute of Health, South Korea.