1.Ancient and Modern Documentation of Classic Formula Sangjuyin
Xiaofang WANG ; Lyuyuan LIANG ; Jialei CAO ; Ziming XU ; Wangju ZHOU ; Yiping WANG ; Yujie CHANG ; Ruiting SU ; Yihan LI ; Jingwen LI ; Bingqi WEI ; Bingxiang MA ; Wenli SHI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):200-207
Sangjuyin, as a pungent and cooling agent with precise therapeutic effect, is a classic pungent formula for cooling relief of the epidermis, which is highly respected by medical practitioners. This formula is from the Wenbing Tiaobian written by WU Jutong in the Qing dynasty, on the basis of which subsequent medical practitioners have made additions and subtractions to apply it. The authors used the bibliometric method to systematically organize the medical books from the Qing dynasty and the Republic of China and modern literature to analyze the composition, concoction, decoction, efficacy, and previous and modern application of Sangjuyin. After examination, the drug base of this formula is basically clear. Armeniacae Semen Amarum is the dried mature seeds of Armeniaca vulgaris, family Rosaceae. Forsythiae Fructus is the dried fruit of Forsythia suspensa, family Mulleinaceae. Menthae Haplocalycis Herba is the dried above-ground part of Mentha haplocalyx, family Labiatae. Mori Folium is the dried leaves of Morus alba, family Moraceae. Chrysanthemi Flos is the dried head of Chrysanthemum morifolium, family Asteraceae. Platycodonis Radix is the dried root of Eryngium grandiflorum, family Eryngium. Glycyrrhizae Radix et Rhizoma is the dried root and rhizome of Glycyrrhiza uralensis of the Leguminosae family, and Phragmitis Rhizoma is the fresh or dried rhizome of Phragmites communis of the Gramineae family. It is recommended that the eight drugs be used in raw form as medicine. The dosage and method of decoction were converted into a modern single dosage of 7.46 g Armeniacae Semen Amarum, 5.60 g Forsythiae Fructus, 2.98 g Menthae Haplocalycis Herba, 9.33 g Mori Folium, 3.73 g Chrysanthemi Flos, 7.46 g Platycodonis Radix, 2.98 g Glycyrrhizae Radix et Rhizoma, and 11.19 g Phragmitis Rhizoma, with 400 mL water added, and the solution was boiled to obtain 200 mL, taken twice a day. Sangjuyin has the efficacy of dispersing wind and clearing heat, promoting lung and relieving cough, and it is used for treating the initial onset of wind-warmth and the evidence of evil spirits in the lungs and collaterals. Modern research has shown that Sangjuyin is often used in the treatment of cough, pneumonia, rhinitis, and other respiratory diseases, and the results of this study provide a reference for the later development of Sangjuyin.
2.Signal mining of adverse reactions associated with macrolide antibiotics in pediatric patients based on the FAERS database
Zhenpo ZHANG ; Jiaxin HE ; Jingping ZHENG ; Yuting WANG ; Lin MA ; Ling SU
Journal of Pharmaceutical Practice and Service 2026;44(3):160-166
Objective To explore the adverse event signals of children using macrolide drugs (azithromycin, clarithromycin, and erythromycin), and provide reference for rational medicine use in clinical practice. Methods Data from children under 12 years old were extracted from the US FAERS database spanning from the first quarter of 2004 to the second quarter of 2023. The adverse drug reaction (ADR) signal mining for three macrolide antibiotics was conducted using the Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) methods. Special emphasis was placed on analyzing and contrasting the differences in adverse events among the three drugs. Results A total of 1 615 reports for children under 12 years old were retrieved from the FAERS database, including 1 024 reports of azithromycin, 460 reports of clarithromycin, and 131 reports of erythromycin. Among azithromycin and erythromycin, there were more reports from boys than girls, while for clarithromycin, there were more reports from girls than boys. Oral administration was the most common route of administration for all three drugs. Regarding the outcome of adverse events reported, azithromycin and clarithromycin were primarily associated with other serious adverse events, whereas erythromycin was mainly associated with hospitalization and other serious adverse events. The number of adverse events reported decreased with increasing age, with a higher number of reports in the 0-3 age group. Using the ROR and BCPNN methods for signal detection, 86 signals were identified for azithromycin, 91 for clarithromycin, and 34 for erythromycin. These signals involved 22 System Organ Classes (SOCs), with azithromycin mainly concentrated in skin and subcutaneous tissue disorders (n=21), clarithromycin in gastrointestinal disorders (n=15), and erythromycin in gastrointestinal disorders (n=8). Twenty-four signals of moderate to high risk were detected, with 13 for azithromycin, 9 for clarithromycin, and 2 for erythromycin. Conclusion The adverse events induced by the three drugs with different risks in different systems. When clinically treating Mycoplasma pneumoniae pneumonia in children, the risk profiles of drugs in different systems should be considered, and personalized dosing should be implemented.
3.Short-term results of transcatheter aortic valve replacement using Venus A-Plus valve delivery system in patients with severe aortic stenosis: A retrospective cohort study
Hang ZHANG ; Huajun WANG ; Fengwu SHI ; Su LIU ; Qianli MA ; Jinghui AN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(03):438-443
Objective To evaluate the short-term efficacy of transcatheter aortic valve replacement (TAVR) using Venus A-Plus valve delivery system in patients with severe aortic stenosis. Methods The clinical data of patients undergoing TAVR in our hospital from August 2018 to March 2022 were collected and they were divided into a Venus A-Plus and a Venus A group according to the type of valve delivery system used. The perioperative data of the two groups were compared. Results A total of 121 patients were included, including 70 patients in the Venus A-Plus group [45 males and 25 females with a mean age of (67.81±6.62) years], and 51 patients in the Venus A group [33 males and 18 females with a mean age of (68.25±7.01) years]. All patients underwent TAVR, and the postoperative hemodynamic features (left ventricular ejection fraction, mean cross-valve pressure difference, peak flow rate) were significantly improved (P<0.05). There was no statistical difference in surgical success rate, all-cause mortality, conversion to thorax opening, valve-in-valve placement, moderate or above perivalvular regurgitation, new left bundle branch block or new right bundle branch block between the two groups (P>0.05). Conclusion TAVR with Venus A-Plus valve delivery system in patients with severe aortic stenosis shows comparable efficacy to the first-generation Venus A system and is satisfactory, safe and reliable.
4.Mechanism of Ruyan Neixiao Cream in Promoting Ferroptosis in Breast Precancerous Lesion Cells by Regulating Nrf2/SLC7A11/GPX4 Signaling Pathway
Haotian ZHANG ; Yebei QIU ; Ran SU ; Xianxin YAN ; Min MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):98-107
ObjectiveTo explore the mechanism by which Ruyan Neixiao cream (RUC) induces ferroptosis in breast precancerous lesion (BPL) cells, and to enrich the theoretical foundation for its use in the treatment of BPL. MethodsThe inhibition of cell proliferation by 1%, 2%, and 4% concentrations of Ruyanneixiao Cream transdermal solution (RUT) was assessed using cell counting kit-8 (CCK-8) and a colony formation assay. Reactive oxygen species (ROS) were measured using the DCFH-DA probe, and the levels of ferrous ions (Fe2+), glutathione (GSH), and malondialdehyde (MDA) were determined using appropriate kits. Lipid peroxidation was detected with the C11-BODIPY581/591 fluorescent probe. The expression of nuclear factor E2-related factor 2 (Nrf2), solute carrier family 7 member 11 (SLC7A11), and glutathione peroxidase 4 (GPX4) proteins was analyzed by Western blot. The BPL rat model was constructed using 2,2′-bis(hydroxymethyl)butyric acid (DMBA) combined with estrogen and progesterone, and the rats were treated with RUC for external application. After the 12th cycle, the rats were euthanized, and histopathological changes in breast tissue were observed by hematoxylin-eosin (HE) staining. Fe2+ and MDA levels in breast tissue were measured using corresponding kits. The expression of Nrf2, SLC7A11, and GPX4 proteins in BPL rat breast tissue was detected by immunohistochemistry (IHC) and Western blot. ResultsCompared with the matrix group, the cell viability of MCF-10AT cells in the 1%, 2%, and 4% RUT groups was significantly reduced (P<0.05) in a concentration-dependent manner, with the 24-hour half inhibitory concentration (IC50) being 2.23%. Compared with the 4% RUT group, cell viability in the RUT + Fer-1 group was significantly increased (P<0.05). Compared with the matrix group, the colony formation rates of MCF-10AT cells in the 1%, 2%, and 4% RUT groups were significantly decreased (P<0.05). Compared with the 4% RUT group, the cell colony formation rate of the RUT + Fer-1 group was significantly increased (P<0.05). Compared with the matrix group, the levels of ROS and Fe2+ in the 1%, 2%, and 4% RUT groups were significantly increased (P<0.05), while GSH levels were significantly decreased (P<0.05), and MDA and lipid peroxidation levels were significantly increased (P<0.05). Compared with the 4% RUT group, ROS and Fe2+ levels in the RUT + Fer-1 group were significantly reduced (P<0.05), while GSH levels were significantly increased (P<0.05), and MDA and lipid peroxidation levels were significantly reduced (P<0.05). Compared with the matrix group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the 1%, 2%, and 4% RUT groups were significantly decreased (P<0.05). Compared with the 4% RUT group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the RUT + Fer-1 group were significantly increased (P<0.05). In the in vivo experiment, compared with the matrix group, the breast tissue histopathological status of the BPL rats in the RUC group was effectively improved, with less dilatation of the mammary ducts and more orderly duct arrangement. No pathological morphology indicative of invasive cancer was observed. Compared with the matrix group, Fe2+ and MDA levels in the mammary tissue of the RUC group were significantly increased (P<0.05). Compared with the matrix group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the mammary tissue of the RUC group were significantly reduced (P<0.05). ConclusionRUC may induce ferroptosis in BPL cells by inhibiting the Nrf2/SLC7A11/GPX4 signaling pathway, increasing Fe2+ accumulation, and promoting lipid peroxidation.
5.Mechanism of Ruyan Neixiao Cream in Promoting Ferroptosis in Breast Precancerous Lesion Cells by Regulating Nrf2/SLC7A11/GPX4 Signaling Pathway
Haotian ZHANG ; Yebei QIU ; Ran SU ; Xianxin YAN ; Min MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):98-107
ObjectiveTo explore the mechanism by which Ruyan Neixiao cream (RUC) induces ferroptosis in breast precancerous lesion (BPL) cells, and to enrich the theoretical foundation for its use in the treatment of BPL. MethodsThe inhibition of cell proliferation by 1%, 2%, and 4% concentrations of Ruyanneixiao Cream transdermal solution (RUT) was assessed using cell counting kit-8 (CCK-8) and a colony formation assay. Reactive oxygen species (ROS) were measured using the DCFH-DA probe, and the levels of ferrous ions (Fe2+), glutathione (GSH), and malondialdehyde (MDA) were determined using appropriate kits. Lipid peroxidation was detected with the C11-BODIPY581/591 fluorescent probe. The expression of nuclear factor E2-related factor 2 (Nrf2), solute carrier family 7 member 11 (SLC7A11), and glutathione peroxidase 4 (GPX4) proteins was analyzed by Western blot. The BPL rat model was constructed using 2,2′-bis(hydroxymethyl)butyric acid (DMBA) combined with estrogen and progesterone, and the rats were treated with RUC for external application. After the 12th cycle, the rats were euthanized, and histopathological changes in breast tissue were observed by hematoxylin-eosin (HE) staining. Fe2+ and MDA levels in breast tissue were measured using corresponding kits. The expression of Nrf2, SLC7A11, and GPX4 proteins in BPL rat breast tissue was detected by immunohistochemistry (IHC) and Western blot. ResultsCompared with the matrix group, the cell viability of MCF-10AT cells in the 1%, 2%, and 4% RUT groups was significantly reduced (P<0.05) in a concentration-dependent manner, with the 24-hour half inhibitory concentration (IC50) being 2.23%. Compared with the 4% RUT group, cell viability in the RUT + Fer-1 group was significantly increased (P<0.05). Compared with the matrix group, the colony formation rates of MCF-10AT cells in the 1%, 2%, and 4% RUT groups were significantly decreased (P<0.05). Compared with the 4% RUT group, the cell colony formation rate of the RUT + Fer-1 group was significantly increased (P<0.05). Compared with the matrix group, the levels of ROS and Fe2+ in the 1%, 2%, and 4% RUT groups were significantly increased (P<0.05), while GSH levels were significantly decreased (P<0.05), and MDA and lipid peroxidation levels were significantly increased (P<0.05). Compared with the 4% RUT group, ROS and Fe2+ levels in the RUT + Fer-1 group were significantly reduced (P<0.05), while GSH levels were significantly increased (P<0.05), and MDA and lipid peroxidation levels were significantly reduced (P<0.05). Compared with the matrix group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the 1%, 2%, and 4% RUT groups were significantly decreased (P<0.05). Compared with the 4% RUT group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the RUT + Fer-1 group were significantly increased (P<0.05). In the in vivo experiment, compared with the matrix group, the breast tissue histopathological status of the BPL rats in the RUC group was effectively improved, with less dilatation of the mammary ducts and more orderly duct arrangement. No pathological morphology indicative of invasive cancer was observed. Compared with the matrix group, Fe2+ and MDA levels in the mammary tissue of the RUC group were significantly increased (P<0.05). Compared with the matrix group, the protein expression levels of Nrf2, SLC7A11, and GPX4 in the mammary tissue of the RUC group were significantly reduced (P<0.05). ConclusionRUC may induce ferroptosis in BPL cells by inhibiting the Nrf2/SLC7A11/GPX4 signaling pathway, increasing Fe2+ accumulation, and promoting lipid peroxidation.
6.Forty Cases of Mid-Stage Diabetes Kidney Disease Patients of Blood Stasis Syndrome Treated with Huayu Tongluo Formula (化瘀通络方) as an Adjunct Therapy: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial
Yun MA ; Kaishuang WANG ; Shuang CAO ; Bingwu ZHAO ; Lu BAI ; Su WU ; Yuwei GAO ; Xinghua WANG ; Dong BIAN ; Zhiqiang CHEN
Journal of Traditional Chinese Medicine 2025;66(6):588-595
ObjectiveTo evaluate the clinical efficacy of Huayu Tongluo Formula (化瘀通络方, HTF) in patients with mid-stage diabetic kidney disease of blood stasis syndrome and explore its potential mechanisms. MethodsA multi-center, randomized, double-blind, placebo-controlled clinical trial was conducted. Ninety patients of mid-stage diabetic kidney disease of blood stasis syndrome were divided into a control group of 46 cases and a treatment group of 44 cases. Both groups received conventional western medicine treatment, the treatment group additionally taking HTF, while the control group taking a placebo of the formula. The treatment was administered once daily for 24 weeks. The primary outcomes included 24-hour urine total protein (24 h-UTP), serum albumin (Alb), glycated hemoglobin (HbA1c), and serum creatinine (Scr).The secondary outcomes included changes in levels of endothelin-1 (ET-1), nitric oxide (NO), vascular endothelial growth factor (VEGF), and traditional Chinese medicine (TCM) syndrome scores before and after treatment. Clinical efficacy was evaluated based on TCM syndrome scores and overall disease outcomes. Adverse reactions and endpoint events were recorded. ResultsIn the treatment group after treatment, 24 h-UTP, ET-1, and VEGF levels significantly decreased (P<0.05), Alb and NO levels significantly increased (P<0.05); while the TCM syndrome scores for edema, lumbar pain, numbness of limbs, dark purple lips, dark purple tongue or purpura, and thin, rough pulse all significantly decreased (P<0.05). In the control group, no significant changes were observed in any of the indicators after treatment (P>0.05).Compared with the control group, the treatment group showed significant reductions in 24 h-UTP, ET-1, and VEGF levels, and increases in Alb and NO levels (P<0.05). The TCM syndrome scores for edema, lumbar pain, dark purple tongue or purpura, and thin, rough pulse were all lower in the treatment group than in the control group (P<0.05). The total effective rate of TCM syndrome in the treatment group was 59.09% (26/44), and the overall clinical effective rate was 45.45% (20/44). In the control group, these rates were 15.22% (7/46) and 8.7% (4/46), respectively, with the treatment group showing significantly better outcomes (P<0.05). A total of 7 adverse events occurred across both groups, with no significant difference (P>0.05). No endpoint events occurred during the study. ConclusionOn the basis of conventional treatment of Western medicine, HTF can further reduce urinary protein levels and improve clinical symptoms in patients with mid-stage diabetic kidney disease of blood stasis syndrome. The mechanism may be related to its effects on endothelial function.
7.New-onset conduction block after transcatheter aortic valve replacement: A retrospective analysis in a single center
Hang ZHANG ; Huajun WANG ; Fengwu SHI ; Su LIU ; Qianli MA ; Jinghui AN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(03):372-376
Objective To investigate the new-onset conduction block after transcatheter aortic valve replacement (TAVR) and summarize the relevant experience. Methods The perioperative data of TAVR patients in the Second Hospital of Hebei Medical University from January 2016 to February 2023 were collected, and the new-onset incidence of conduction block after TAVR was analyzed retrospectively. Results Finally 352 patients were included, including 225 males and 127 females, with an average age of (67.2±5.1) years, among whom 256 patients were treated with Venus-A valves, 69 patients with Vita-Flow valves, and 27 patients with J-Valve valves. There were 38 (10.8%) patients of new-onset postoperative block. There were 6 (1.7%) patients of new-onset postoperative grade Ⅲ atrioventricular block, including 5 (2.0%) patients of Venus-A and 1 (1.4%) patient of Vita-Flow. Conduction function was restored in 2 patients within 14 days after surgery, and failed to be restored in 4 patients, who then received permanent pacemaker implantation in the Department of Cardiology. There were 27 (7.7%) patients of new left bundle branch block after surgery, including 22 (8.6%) patients of Venus-A, 4 (5.8%) patients of Vita-Flow and 1 (3.7%) patient of J-Valve; and conduction function was restored within 7 days after surgery in 23 patients, and 5 (1.4%) patients developed new right bundle branch blocks after surgery including 4 (1.5%) patients of Venus-A and 1 (1.4%) patient of Vita-Flow. Conclusion New-onset conduction block is a common complication after TAVR, and the new-onset rate of left bundle branch block is the highest, followed by the grade Ⅲ atrioventricular block. Mastering reasonable methods and applying appropriate strategies can effectively reduce the new-onset rate of postoperative conduction block and improve the overall success rate of TAVR surgery.
8.Precise application of O-arm navigation system in thoracolumbar fractures with developmental pedicle stenosis
Lintao SU ; Jianfeng JIANG ; Jun MA ; Liangliang HUANG ; Changyu LEI ; Yaozheng HAN ; Hui KANG
Chinese Journal of Tissue Engineering Research 2025;29(9):1855-1862
BACKGROUND:For thoracolumbar spine fractures with developmental stenosis of the vertebral arch,accurate nail placement is difficult using traditional fluoroscopy-assisted techniques.O-arm navigation assistance systems offer higher precision in general vertebral arch nail placement,but there is scarce literature on the application of O-arm navigation-assisted nail placement in thoracolumbar spine fractures with developmental stenosis of the vertebral arch both domestically and abroad. OBJECTIVE:To explore the accuracy of percutaneous vertebral arch nail placement assisted by O-arm navigation in patients with thoracolumbar spine fractures complicated by developmental stenosis of the vertebral arch. METHODS:A retrospective analysis was conducted on 53 patients who underwent percutaneous vertebral arch screw fixation surgery at Department of Orthopedics,General Hospital of Central Theater Command of PLA for thoracolumbar spine fractures complicated by developmental stenosis of the vertebral arch from January 2021 to March 2023.Totally 208 cases of vertebral arch developmental stenosis were found(cases with multiple vertebral arch developmental stenosis were counted separately).Based on the surgical approach,the patients were divided into two groups:O-arm navigation group(n=98)and C-arm fluoroscopy group(n=110).Postoperative imaging data were compared between the two groups,including anatomical perforation score,functional perforation score,actual vs.expected nail trajectory in the horizontal plane,and sagittal plane angle differences. RESULTS AND CONCLUSION:(1)There was no significant difference in the narrowest width of the pedicle isthmus(pow)between the two groups of patients(P>0.05).The proportions of different degrees of narrowing(mild:6 mm≤pow<7 mm,moderate:5 mm≤pow<6 mm,severe:pow<5 mm)were also not significantly different between the two groups(P>0.05).(2)The overall grade and scores of anatomical perforation and functional perforation were lower in the O-arm group compared to the C-arm group,and these differences were statistically significant(P<0.001).In terms of the angular deviation between the actual and planned screw trajectories,the O-arm group had smaller deviations,and these differences were statistically significant(P<0.05).(3)In the mild and moderate narrowing groups,the O-arm group showed significant advantages in anatomical perforation,functional perforation,and angular deviation between actual and planned screw trajectories,and these differences were statistically significant(P<0.001).(4)The O-arm group demonstrated better performance in anatomical perforation and functional perforation,especially in the T12-L2 segment,with more significant advantages.Additionally,the O-arm group had better angular deviations in actual and planned screw trajectories in all segments compared to the C-arm group.(5)Therefore,the use of O-arm navigation-assisted percutaneous screw placement for the treatment of thoracolumbar fractures with developmental pedicle isthmal narrowing provides higher accuracy and safer surgery.
9.Feasibility and safety of transesophageal endoscopic resection for benign mediastinal tumors
Jia YU ; Liyun MA ; Wei SU ; Shengli LIN ; Quanlin LI ; Pinghong ZHOU ; Pingting GAO
Chinese Journal of Clinical Medicine 2025;32(3):362-368
Objective To explore the feasibility, safety, and efficacy of transesophageal endoscopic surgery for mediastinal tumors. Methods A retrospective analysis was conducted on the clinical data of 17 patients who underwent transesophageal endoscopic resection for benign mediastinal tumors at the Endoscopy Center of Zhongshan Hospital, Fudan University, between January 1, 2016 and December 31, 2024. Epidemiological characteristics, surgical parameters, adverse events, and follow-up outcomes were analyzed. Results Among the 17 patients, there were 9 males and 8 females, with an average age of (42.4±14.5) years and an average tumor size of (2.6±1.6) cm. Pathological types included esophageal duplication cysts (6 cases, 35.3%), bronchogenic cysts (5 cases, 29.4%), gastroenteric cysts (3 cases, 17.6%), schwannomas (2 cases, 11.8%), and lymphangioma (1 case, 5.9%). Fourteen patients (82.4%) underwent submucosal tunneling endoscopic resection (STER), 3 patients (17.6%) underwent natural orifice transluminal endoscopic mediastinal surgery. All surgeries were successfully completed without conversion to open surgery. En bloc resection was achieved in 11 patients (64.7%), with an average operative time of (60.9±32.6) min. No intraoperative bleeding or mucosal injury occurred, and 4 patients (23.5%) experienced minor complications (pneumothorax, fever, recurrent laryngeal nerve injury), all of which resolved with conservative treatment. The average postoperative hospital stay was (3.2±1.5) days, and no recurrence was observed during the follow-up period. Conclusions Transesophageal endoscopic resection of benign mediastinal tumors is a safe, effective, and minimally invasive treatment method. Further validation of its efficacy and safety through large-scale prospective studies is warranted.
10.Evaluating the impact of relative dose intensity on efficacy of trastuzumab deruxtecan for metastatic breast cancer in the real-world clinical setting.
Han Yi LEE ; Vivianne SHIH ; Jack Junjie CHAN ; Shun Zi LIONG ; Ryan Shea Ying Cong TAN ; Jun MA ; Bernard Ji Guang CHUA ; Joshua Zhi Chien TAN ; Chuan Yaw LEE ; Wei Ling TEO ; Su-Ming TAN ; Phyu NITAR ; Yoon Sim YAP ; Mabel WONG ; Rebecca DENT ; Fuh Yong WONG ; Tira J TAN
Annals of the Academy of Medicine, Singapore 2025;54(8):458-466
INTRODUCTION:
Trastuzumab deruxtecan (T-DXd) has revolutionised treatment for metastatic breast cancer (MBC). While effective, its high cost and toxicities, such as fatigue and nausea, pose challenges.
METHOD:
Medical records from the Joint Breast Cancer Registry in Singapore were used to study MBC patients treated with T-DXd (February 2021-June 2024). This study was conducted to address whether reducing dose intensity and density may have an adverse effect on treatment outcomes.
RESULTS:
Eighty-seven MBC patients were treated with T-DXd, with a median age of 59 years. At the time of data cutoff, 32.1% of patients were still receiving T-DXd. Over half (54%) of the patients received treatment with an initial relative dose intensity (RDI) of <;85%. Overall median real-world progression-free survival (rwPFS) was 8.1 months. rwPFS was similar between RDI groups (<85%: 8.7 months, <85%: 8.1 months, P=0.62). However, human epidermal growth receptor 2 (HER2)-positive patients showed significantly better rwPFS outcomes compared to HER2-low patients (8.8 versus 2.5 months, P<0.001). Only 16% with central nervous system (CNS) involvement had CNS progressive disease on treatment. No significant progression-free survival (PFS) differences were found between patients with or without CNS disease, regardless of RDI groups. Five patients (5.7%) developed interstitial lung disease (ILD), with 3 (3.4%) having grade 3 events. Two required high-dose steroids and none were rechallenged after ILD. There were no fatalities.
CONCLUSION
Our study demonstrated that reduced dose intensity and density had no significant impact on rwPFS or treatment-related toxicities. Furthermore, only 5.7% of patients developed ILD. T-Dxd provided good control of CNS disease, with 82% of patients achieving CNS disease control.
Humans
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Female
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Breast Neoplasms/mortality*
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Middle Aged
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Trastuzumab/adverse effects*
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Aged
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Adult
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Singapore/epidemiology*
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Antineoplastic Agents, Immunological/adverse effects*
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Camptothecin/adverse effects*
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Immunoconjugates/adverse effects*
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Retrospective Studies
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Progression-Free Survival
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Receptor, ErbB-2/metabolism*
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Neoplasm Metastasis
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Dose-Response Relationship, Drug
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Treatment Outcome
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Registries

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