1.Efficacy and safety of pyrotinib treatment for human epidermal growth factor receptor 2-positive advanced breast cancer: a single-center real-world study
Tianxiao MAO ; Chunhui WANG ; Ying JIANG ; Xiaoyu LI ; Bei XU
Chinese Journal of Clinical Medicine 2026;33(5):772-779
Objective To systematically evaluate the efficacy and safety of pyrotinib-based therapy in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer based on real-world data, and to explore factors associated with prognosis. Methods A total of 102 patients with HER2-positive advanced breast cancer who received pyrotinib at Zhongshan Hospital, Fudan University, were included retrospectively from January 1, 2019, to January 31, 2024, and prospectively from February 1, 2024, to November 30, 2025. Follow-up was conducted until March 31, 2026. Clinical and follow-up data of the patients were collected, and survival analysis was performed by Kaplan-Meier method. Prognostic factors were analyzed through multivariable Cox regression and logistic regression. Results Among the 102 patients, the median follow-up duration was 31.3 months, the median progression-free survival (PFS) was 12.9 months, the median overall survival (OS) has not been reached (estimated to be 64.8 months), and the objective response rate (ORR) was 35.29%. Multivariate Cox regression analysis revealed that lung metastasis (HR=2.562,P=0.006), third-line and subsequent treatment (HR=3.857,P=0.010), and pyrotinib monotherapy (HR=3.682,P=0.015) were associated with shorter PFS. Eastern Cooperative Oncology Group performance status (ECOG PS)≥2 (HR=16.948,P<0.001) and third-line and subsequent treatment (HR=3.958,P=0.034) were associated with shorter OS. No associated factors related to ORR were found. Regarding safety, diarrhea was the most common adverse event, occurring in 74.51% of patients. Conclusions In real-world clinical practice, pyrotinib-based therapy demonstrated clinical efficacy and manageable safety in patients with HER2-positive advanced breast cancer. Lung metastasis, pyrotinib monotherapy, ECOG PS≥2, and pyrotinib administration in multiple lines of therapy may affect patient prognosis.
2.Construction of a prediction model for muscular invasion in upper urinary tract urothelial carcinoma based on preoperative MRI features
Haonan CHEN ; Lingkai CAI ; Hongyuan DING ; Hao JI ; Tianxiao HONG ; Hao YU ; Qikai WU ; Chaoran ZHAO ; Xiao YANG ; Qiang CAO ; Xiancheng ZHAO ; Pengchao LI ; Qiang LYU
Chinese Journal of Urology 2025;46(9):661-668
Objective:To construct a nomogram based on preoperative MRI imaging features for the prediction of muscle-invasive upper urinary tract urothelial carcinoma(UTUC)and evaluate its performance.Methods:This retrospective cohort study analyzed the clinical data of 99 UTUC patients treated at the First Affiliated Hospital of Nanjing Medical University from April 2018 to May 2024. Among them,69(69.7%)were male and 30(30.3%)were female,with a median age of 67.0 years. All patients underwent preoperative MRI and radical nephroureterectomy. According to postoperative pathology,tumors staged ≥ T 2 were assigned to the muscle-invasive group,and those staged ≤ T 1 were assigned to the non-muscle-invasive group. Baseline data,pathological information,and imaging characteristics were collected and compared between the two groups. Logistic regression analysis was performed to identify risk factors for muscle-invasive UTUC,and a nomogram was constructed. The diagnostic performance of the model was assessed using receiver operating characteristic(ROC)curves,calibration curves,and decision curve analysis(DCA). Results:Among the 99 patients,70(70.7%)were diagnosed with muscle-invasive UTUC,and 29(29.3%)with non-muscle-invasive UTUC. The muscle-invasive group had significantly larger tumor size[4.5(2.8,7.0)cm vs. 3.0(2.3,4.5)cm, P = 0.029],a higher incidence of multifocal tumors[37.1%(26/70)vs. 3.5%(1/29), P < 0.001],patchy tumors[30.0%(21/70)vs. 6.9%(2/29), P = 0.019],spiculated tumor margins[52.9%(37/70)vs. 17.2%(5/29), P = 0.001],tumor compression on renal parenchyma or periureteral/peripelvic fat[68.6%(48/70)vs. 10.3%(3/29), P < 0.001],high-grade pathology[92.9%(65/70)vs. 75.9%(22/29), P = 0.043],lymph node metastasis[28.6%(20/70)vs. 0, P = 0.001],and lymphovascular invasion[42.9%(30/70)vs. 10.3%(3/29), P=0.002]. The apparent diffusion coefficient(ADC)values[0.9(0.8,1.1)× 10 -3 mm2/s vs. 1.1(1.0,1.4)× 10 -3 mm2/s, P < 0.001]and normalized ADC(NADC)values[0.8(0.7,1.0)vs. 0.9(0.8,1.1), P = 0.002]were significantly lower in the muscle-invasive group. Univariate logistic regression identified multifocality,patchy tumor patterns,spiculated tumor margins,tumor compression on renal parenchyma or periureteral/peripelvic fat,and low NADC values as risk factors for muscle-invasive UTUC(all P < 0.05). Multivariate analysis revealed multifocality( OR = 17.903,95% CI 1.650 - 194.253, P = 0.018),tumor compression on renal parenchyma or perirenal / ureteral fat( OR = 14.690,95% CI 3.069 - 70.323, P < 0.001),and low NADC value( OR = 0.016,95% CI 0.001 - 0.471, P = 0.017)as independent risk factors. A nomogram was constructed based on these factors. The area under the ROC curve(AUC)of the model was 0.898(95% CI 0.838 - 0.957),with an optimal cutoff value of 0.639. The model showed an accuracy of 83.8%,sensitivity of 81.4%,and specificity of 89.7%. Calibration curves indicated good calibration,and DCA showed that the model provided substantial clinical net benefit. Conclusions:This study constructed a nomogram based on preoperative MRI features,including tumor multifocality,compression on renal parenchyma or periureteral/peripelvic fat and NADC value,which demonstrates good predictive performances for muscle-invasive UTUC.
3.A case report of high-burden bladder tumor within an inguinal bladder hernia
Zihan XUE ; Liliang LI ; Yunkai QIE ; Guodong SONG ; Tianxiao ZHANG ; Rongjiang LI ; Changli WU ; Hailong HU
Chinese Journal of Urology 2025;46(5):392-394
Bladder tumor within inguinal bladder hernia is rare. This article reports a case of a male patient who was admitted to hospital due to gross hematuria,accompanied by lower abdominal pain when straining to urinate for two months. Physical examination revealed a irreducible mass in the left inguinal region. Ultrasound and MRI examinations suggested an inguinal bladder hernia complicated by multiple bladder lesions. Cystoscopy revealed extensive tumors,and pathological examination indicated high-grade urothelial carcinoma with carcinoma in situ. PET-CT confirmed pelvic lymph node metastasis. The patient underwent three cycles of neoadjuvant therapy followed by laparoscopic radical cystectomy combined with hernia repair. There was no evidence of recurrence of the hernia or tumor after one year of follow-up.
4.Preprocedural evaluation for endovascular treatment in non-acute symptomatic intracranial artery occlusion:current status and future perspectives
Yingkun HE ; Zhengpeng ZHU ; Yanyan HE ; Tianxiao LI
Chinese Journal of Cerebrovascular Diseases 2025;22(10):659-664
Non-acute symptomatic intracranial artery occlusion carries a high risk of stroke recurrence and can lead to severe neurological deficits.Although endovascular treatment is a pivotal treatment modality,optimal surgical patient selection criteria remain controversial and as its postoperative outcome varies substantially among individuals.This article addressed these critical issues by exploring imaging-based strategies to identify patients who may benefit from endovascular revascularization,analyzing factors influencing technical success and procedural risks and emphasizing the necessity of individualized treatment approaches.Furthermore,this article discussed the current limitations in endovascular treatment and proposed future research directions to standardize and optimize the clinical application of this technology for non-acute symptomatic intracranial artery occlusion.
5.Safety and efficacy of the Neuroform EZ stent in treating severe symptomatic intracranial atherosclerotic stenosis
Ziang CHEN ; Wenbo LIU ; Dehua GUO ; Yanyan HE ; Mengyue LIU ; Yang ZHAO ; Yukuan PANG ; Tianxiao LI ; Yingkun HE
Chinese Journal of Cerebrovascular Diseases 2025;22(10):721-730
Objective To evaluate the safety and efficacy of the Neuroform EZ self expanding stent for severe symptomatic intracranial atherosclerotic stenosis(sICAS).Methods Retrospectively enrolled consecutive patients with severe sICAS who underwent percutaneous transluminal angioplasty and stenting(PTAS)with a Neuroform EZ stent in the Department of Cerebrovascular Disease,Henan Provincial People's Hospital,from March 2020 to December 2022.Baseline demographic and clinical data were collected,including age,sex,hypertension,diabetes mellitus,coronary artery disease,dyslipidemia,hyperhomocysteinemia,transient ischemic attack(TIA)and ischemic stroke,smoking history,modified Rankin scale(mRS)score at admission,and National Institutes of Health stroke scale(NIHSS)score.Preoperative imaging data included target vessel(basilar artery,intracranial segment of the internal carotid artery,middle cerebral artery,and intracranial vertebral artery),lesion length,degree of stenosis,and vascular morphology according to the Mori classification(type A,lesion length<5 mm with concentric or moderately eccentric stenosis;type B,lesion length<10 mm with severely eccentric stenosis;type C,lesion length>10 mm or arterial angulation>90°).Technical success was defined as accurate delivery and deployment of the stent with complete coverage of the target lesion and immediate post deployment residual stenosis<50%.Postoperative head CT was performed to detect intracranial hemorrhage.Periprocedural complications were recorded,including intracranial hemorrhage,arterial dissection,in stent thrombosis,and perforator occlusion occurring intraoperatively within 72 hours after the procedure.At one-month post-operation,patients were seen through outpatient follow-up for TIA,hemorrhagic or ischemic stroke,and all cause death.At 6 months after surgery,DSA or CT angiography(CTA)was performed to assess in stent restenosis(ISR,defined as>50%stenosis within the stent or within5mm of its edges,or>20%luminal loss).At 1 and 2 years postoperatively,ipsilateral ischemic stroke or TIA recurrence was assessed by outpatient visit or telephone follow up.Results A total of 76 patients with severe sICAS underwent PTAS with a Neuroform EZ stent(56 males,20 females,age 47-80 years,with a mean age of[61±10]years).(1)Within all patients enrolled,40 had middle cerebral artery,16 with basilar artery,6 with intracranial vertebral artery and 14 with intracranial internal carotid artery.The preprocedural lesion length was 2-15 mm,with a mean length of(6.2±2.5)mm,and stenosis severity was70%-99%,the mean severity was(83.2±6.9)%,with Mori type B being the most common type(57.9%[44/76]).(2)PTAS was successfully completed on all patients(technical success 100%).Pre dilation with a conventional balloon was performed in all cases(using balloon with diameter of 1.5-3.5mm,and stent with diameter of 2.5-4.5 mm and length of 15-30 mm).Immediate post procedural residual stenosis was(17.4±9.0)%,significantly lower than baseline(t=52.9,P<0.05),with a mean difference of 65.8%(95%CI63.3%-68.3%).(3)Among all 76patients,one patient developed a flow limiting dissection post balloon angioplasty,which recovered after stent deployment.One patient with basilar artery stenosis experienced recurrent ischemic stroke at 5-day postoperatively,presenting with right sided weakness and coughing on liquids.Imaging showed an acute infarct in the left pons,considered perforator occlusion.The overall periprocedural complication rate was 2.6%(2/76).(4)No deaths occurred within 30 days after surgery.Sixty nine patients(90.8%)underwent 6 month imaging follow up with DSA(52 cases)or CTA(17 cases).ISR occurred in 12 patients(17.4%),including 6 asymptomatic and 6symptomatic cases.The ipsilateral ischemic stroke recurrence rate was 6.6%(5/76)at1 year and13.2%(10/76)at2years.Conclusions Neuroform EZstent assisted PTASappears safe and feasible for the treatment of severe sICAS.The long term effectiveness requires confirmation in large,multicenter,prospective studies.
6.Current status and prospect of absolute ethanol sclerotherapy for cerebral arteriovenous malformations
Weixing BAI ; Yanyan HE ; Tianxiao LI
Journal of Interventional Radiology 2025;34(3):231-233
Although in the treatment of extracranial vascular malformations the absolute ethanol used as an embolization agent has several advantages(such as low cost,reliable efficacy,no impact on subsequent treatments,etc.)and has already achieved significant progress in clinical practice,it is still regarded as a highly-selective liquid embolization agent in the sclerotherapy or embolization treatment of brain arteriovenous malformation(bAVM).At present,the indications of sclerotherapy and embolization therapy by using absolute ethanol include small AVM(<3 cm)located at brain cortex or at non-eloguent area,and relatively low-flow AVM,in such case,the absolute ethanol acts as an effective supplement to other liquid embolization agents.Further studies are needed so as to improve the radiographic visualization and viscosity of absolute ethanol,to make the injection process more controlled,and to alleviate the edema caused by neurotoxicity and inflammation.
7.Chinese expert consensus on drug-coated balloon for the treatment of symptomatic intracranial atherosclerotic stenosis
Tianxiao LI ; Liqun JIAO ; Zhongrong MIAO ; Jianmin LIU
Chinese Journal of Cerebrovascular Diseases 2025;22(11):794-804
Endovascular interventional angioplasty is an important treatment for symptomatic intracranial atherosclerotic stenosis(sICAS).However,conventional endovascular interventions,such as bare-metal stenting and plain balloon angioplasty,are associated with a high risk of restenosis.Drug-coated balloon(DCB),due to the drug-carrying properties,may reduce the long-term restenosis risk and represent a novel option for the endovascular intervention of sICAS.Presently,DCB for sICAS has been a subject of increasing clinical studies,and its clinical application has progressed to small-scale use.Nevertheless,it's lack of an unified guidelines or consensus to standardize its procedural indications,technical details,and perioperative management.This expert consensus summarized the relevant clinical studies on DCB for sICAS and incorporated the practical experience of specialists from neurointerventional field,aiming to provide reasonable guidance for the current clinical use of DCB in treating sICAS.
8.Economic evaluations of postoperative complications after colorectal cancer surgery
Tianxiao WEI ; Tingfei GU ; Zhouqiao WU ; Fei SHAN ; Ziyu LI ; Jiafu JI
Chinese Journal of Gastrointestinal Surgery 2025;28(1):41-47
Objective:This study aims to analyze the economic impact of postoperative complications after colorectal cancer surgery.Methods:A retrospective cohort study was conducted. Patients with a preoperative pathological diagnosis of colorectal cancer who met surgical indications and underwent surgical treatment were included, while those with incomplete hospitalization cost data were excluded. From March 2017 to March 2022, three hundred and ninety-two colorectal cancer patients treated at Peking University Cancer Hospital and Institute Gastrointestinal Cancer Center I, were enrolled. Descriptive statistics were performed on the incidence of complications, hospitalization costs, and postoperative length of stay. A cohort was established based on the presence of postoperative complications (POC) and absence of postoperative complications (non-POC) to study economic differences. Propensity score matching analysis was employed to reduce potential confounding factors.Results:Among 392 colorectal cancer patients, 90 (23.0%) developed POC (POC group), while 302 were in the non-POC group. Significant statistical differences were found between the two groups in terms of operation duration, extent of resection, and stoma creation (all P < 0.05); other baseline indicators showed no significant differences (all P>0.05). The median hospitalization cost for patients with postoperative anastomotic leakage was 115 973 yuan, an increase of 38 941 yuan (50.5%) over the non-POC group's 77 059 yuan; the median hospitalization cost for patients with mechanical obstruction was 111 477 yuan, an increase of 34 418 yuan (44.7%) over the non-POC group; and the median hospitalization cost for patients with wound infection was 95 860 yuan, an increase of 18 801 yuan (24.4%) over the non-POC group. The median postoperative length of stay for patients with anastomotic leakage, mechanical obstruction, and wound infection was 22.0 days, 22.0 days, and 18.5 days, respectively, compared to 9.0 days in the non-POC group, extending by 13.0 days, 13.0 days, and 9.5 days. After propensity score matching, each group had 68 patients, and there were no statistically significant differences in preoperative and intraoperative observations between the two groups (all P>0.05); compared to the non-POC group, the hospitali- zation costs in the POC group significantly increased (89 165 yuan vs. 75 437 yuan, P<0.001), and the postoperative length of stay also significantly extended (14.0 days vs. 8.0 days, P<0.001). Conclusions:The occurrence of POC after colorectal cancer surgery significantly increases hospitalization costs and length of stay. This study provides specific and accurate reference data for subsequent health economic decision-making. This is the first detailed economic impact analysis of postoperative complications of colorectal cancer with a large sample size, which includes an economic impact analysis for each POC and subgroup.
9.Comparison of safety and efficacy between drug-coated balloon angioplasty and self-expanding stenting in symptomatic middle cerebral artery stenosis
Tianming XU ; Wenbo LIU ; Tianxiao LI ; Yanyan HE ; Qianhao DING ; Yingkun HE
Chinese Journal of Neuromedicine 2025;24(1):23-28
Objective:To compare the efficacy of drug-coated balloon (DCB) angioplasty and self-expanding stenting in symptomatic middle cerebral artery stenosis (MCAS).Methods:A retrospective study was performed. Patients with symptomatic MCAS admitted to Department of Cerebrovascular Diseases, Interventional Center, He'nan Provincial People's Hospital from January 2020 to December 2022 were chosen from their prospective study database. They were divided into a DCB group and a stent group based on approaches. Baseline data differences between the two groups were eliminated using 1: 1 propensity score matching (PSM). Then, the technical success rate, immediate restenosis rate, and 6-month restenosis rate, and clinical outcomes within 30 days and 1 year of procedure were compared between the two groups.Results:After PSM, 58 patients were included, with 29 in the stent group and 29 in the DCB group. Technical success rate was 93.1% (27/29) in the DCB group and 96.6% (28/29) in the stent group, without significant difference ( P>0.05). The immediate restenosis rate was 6.9% (2/29) in the DCB group and 3.4% (1/29) in the stent group, without significant difference ( P>0.05). In terms of safety, no stroke or death events were noted in the two groups within 30 days of procedure; ischemic stroke incidence in the offending vessel areas within 1 year of procedure in the DCB group and stent group was 3.7% (1/27) and 11.5% (3/26), without significant difference ( P>0.05); no hemorrhagic stroke or death were noted in the two groups within 1 year of procedure. In terms of efficacy, the modified Rankin scale score of the two groups was both 0 (0, 0) at 1 year of follow-up, without significant difference ( P>0.05); 46 patients in the DCB group and stent group had imaging followe-up for 6 months: the restenosis rate was 8.0% (2/25) and 23.8% (5/21), respectively, without significant difference ( P>0.05). Conclusion:DCB angioplasty is comparable in efficacy and safety with self-expanding stenting in symptomatic MCAS.
10.Paclitaxel induces immunogenic cell death in vascular smooth muscle cells
Chenming SI ; Yanyan HE ; Tianxiao LI ; Jia LIANG ; Yao LIU ; Yang LIU ; Chenqing LI ; Chi MA ; Hui Ferdinand K ; Yingkun HE
Chinese Journal of Neuromedicine 2025;24(2):119-130
Objective:To investigate whether paclitaxel (PTX) can induce immunogenic cell death (ICD) in vascular smooth muscle cells (VSMCs), and explore the new molecular mechanism of PTX-coated balloon angioplasty in intracranial atherosclerotic stenosis.Methods:(1) Cell culture and identification: VSMCs were induced into synthetic vascular smooth muscle cells (sVSMCs); the mRNA and protein expressions of smooth muscle protein 22-α (SM22-α) and α-smooth muscle actin (α-SMA) in VSMCsS and sVSMCs were detected by real-time fluorescent quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) and Western blotting, respectively. Human acute monocytic leukemia cell line THP-1 was induced into dendritic cells (DCs); the CD86 and CD83 expressions in THP-1 and DCs were detected by flow cytometry. (2) Cell viability detection: cell counting kit-8 (CCK-8) assay was used to detect the cell viability of sVSMCs after 0, 0.01, 0.05, 0.5, 5, 10, 50, and 100 μmol/L PTX or under 0, 50, 100, 200, 400, and 600 mmHg (1 mmHg=0.133 kPa) pressures. (3) ICD marker detection: sVSMCs were collected and divided into blank-control group, dimethyl sulfoxide (DMSO) group and PTX group (cultured with 3.2 μmol/L PTX) at normal state and pressure procedure (188 mmHg), respectively; calreticulin (CRT) expression was detected by immunofluorescent staining; adenosine triphosphate (ATP) expression was detected by luciferase assay, and high mobility group protein B1 (HMGB1) expression was detected by enzyme-linked immunosorbent assay (ELISA). (4) ICD-related immune activation assay detection: sVSMCs and DCs were collected and divided into DCs group, PTX+DCs group (cultured with 3.2 μmol/L PTX), DCs+sVSMCs group, and PTX+DCs+sVSMCs group (cultured with 3.2 μmol/L PTX); CD86 and CD83 expressions were detected by flow cytometry; interleukin (IL)-2, IL-10 and interferon-γ (IFN-γ) levels were detected by ELISA. The sVSMCs, DCs and CD8 +T cells were collected and divided into sVSMCs group, sVSMCs+DCs group, sVSMCs+CD8 +T cell group, sVSMCs+DCs+CD8 +T cell group, PTX+sVSMCs group (cultured with 3.2 μmol/L PTX), and PTX+sVSMCs+DCs+CD8 +T cell group (cultured with 3.2 μmol/L PTX); proliferation of these cells was detected by cell clone formation assay. Results:(1) The SM22-α and α-SMA mRNA and protein expressions in the sVSMCs group were significantly lower than those in the VSMCs group ( P<0.05); rate of double-positive CD83 and CD86 in the DCs group was significantly higher than that in the THP-1 group ( P<0.05). (2) The sVSMCs viability decreased in a concentration-dependent manner after PTX treatment at concentrations of 0, 0.01, 0.05, 0.5, 5, 10, 50, and 100 μmol/L, respectively, with significant differences ( P<0.05); half maximal inhibitory concentration (IC 50) of PTX on sVSMCs was 3.2 μmol/L; no significant difference in sVSMCs viability after 3.2 μmol/L PTX treatment was noted under 0, 50, 100, 200, 400, and 600 mmHg pressures ( P>0.05). (3) Under normal state and pressure procedure, CRT fluorescent intensity of sVSMCs in the PTX group (42.00±3.50, 24.19±2.41) was significantly higher than that in the blank-control group (8.60±1.8, 8.42±1.7) and DMSO group (10.23±1.47, 9.71±1.01), ATP luminescence intensity (17 399.33±2 035.58, 17 445.67±2 449.34) was significantly higher than that in the blank-control group (9 021.33±726.84, 10 271.33±2 194.22) and DMSO group (11 977.33±960.91, 11 683.33±419.50), and HMGB1 concentration ([3 258.31±502.08] pg/mL, [3 265.27±246.06] pg/mL) was significantly higher than that in the blank-control group ([1 156.48±184.96] pg/mL, [1 205.20±196.36] pg/mL) and DMSO group ([1 309.59±75.03] pg/mL, [1 265.51±14.52] pg/mL, P<0.05). (4) The PTX+DCs+sVSMCs group had significantly higher CD83, CD86, IFN-γ and IL-2 expressions and lower IL-10 expression than the DCs group, PTX+DCs group, and DCs+sVSMCs group ( P<0.05); the PTX+sVSMCs group and PTX+sVSMCs+DCs+CD8 +T cell group had significantly lower clone formation rate compared with the sVSMCs group, sVSMCs+DCs group, sVSMCs+CD8 +T cell group, and sVSMCs+DCs+CD8 +T cell group ( P<0.05). Conclusion:PTX can promote ICD in VSMCs by promoting DCs activation and enhancing CD8 +T cell toxicity.

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