1.Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study
Chunfang HAO ; Xu WANG ; Yehui SHI ; Zhongsheng TONG ; Shufen LI ; Xiaodong LIU ; Lan ZHANG ; Jie ZHANG ; Wenjing MENG ; Li ZHANG
Cancer Research and Treatment 2025;57(2):434-442
Purpose:
Approximately 50%-74% of patients with metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
Materials and Methods:
In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400 mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
Results:
From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cutoff date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% confidence interval [CI], 8.3 to 18.5). With all patients evaluated, an ORR of 38.9% (95% CI, 23.1 to 56.5) and a DCR of 83.3% (95% CI, 67.2 to 93.6) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
Conclusion
Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
2.Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study
Chunfang HAO ; Xu WANG ; Yehui SHI ; Zhongsheng TONG ; Shufen LI ; Xiaodong LIU ; Lan ZHANG ; Jie ZHANG ; Wenjing MENG ; Li ZHANG
Cancer Research and Treatment 2025;57(2):434-442
Purpose:
Approximately 50%-74% of patients with metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
Materials and Methods:
In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400 mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
Results:
From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cutoff date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% confidence interval [CI], 8.3 to 18.5). With all patients evaluated, an ORR of 38.9% (95% CI, 23.1 to 56.5) and a DCR of 83.3% (95% CI, 67.2 to 93.6) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
Conclusion
Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
3.Combination Therapy of Pyrotinib and Metronomic Vinorelbine in HER2+ Advanced Breast Cancer after Trastuzumab Failure (PROVE): A Prospective Phase 2 Study
Chunfang HAO ; Xu WANG ; Yehui SHI ; Zhongsheng TONG ; Shufen LI ; Xiaodong LIU ; Lan ZHANG ; Jie ZHANG ; Wenjing MENG ; Li ZHANG
Cancer Research and Treatment 2025;57(2):434-442
Purpose:
Approximately 50%-74% of patients with metastatic human epidermal growth factor receptor 2 (HER2)–positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
Materials and Methods:
In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400 mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
Results:
From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cutoff date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% confidence interval [CI], 8.3 to 18.5). With all patients evaluated, an ORR of 38.9% (95% CI, 23.1 to 56.5) and a DCR of 83.3% (95% CI, 67.2 to 93.6) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
Conclusion
Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
4.Clinicopathological analysis and literature review of Burkitt-like lymphoma with 11q aberration
Honglan ZHANG ; Chunmei YANG ; Congying YANG ; Chunfang ZHANG ; Yanhong NIE ; Yanling HE ; Qian WANG ; Wanneng HE ; Chang ZHANG ; Hao CHEN
Clinical Medicine of China 2022;38(3):222-227
Objective:To investigate the clinicopathological features,differential diagnosis,treatment and prognosis of Burkitt-like lymphoma with 11q aberration (BLL-11q).Methods:The clinical manifestations,histological morphology,immunophenotype and molecular genetic changes of 2 cases of BLL-11q admitted to the department of pathology of The First People's Hospital of Lianyungang in 2020 and 2021 were analyzed retrospectively,and the relevant literatures were reviewed.Results:Patients were found with right neck masses inadvertently and grew rapidly. They presented with localized disease with Ann Arbor stages IA and IIA. Microscopically, the normal structure of the lymph node disappeared and was replaced by a diffuse proliferation of lymphocytes, with consistent morphology and medium size. And the presence of "star-sky" phenomenon was obvious, the morphological characteristics were similar to Burkitt lymphoma. Immunophenotypically, tumor cells were diffusely positive for CD20, CD79α, PAX5, CD10 and Bcl-6, partly moderately positive for C-MYC and MUM-1, however, CD3, Bcl-2, CD30 and TDT were negative,Ki-67 positive index was more than 95%, and EBER was negative. FISH detection showed that MYC, Bcl-2, and Bcl-6 were negative. Both cases had the 11q23.3 gain and 11q24.3 loss. Both patients were treated with chemotherapy and followed up for 10-22 months,and achieved complete remission and disease-free survival.Conclusion:BLL-11q is a rare germinal center B-cell lymphoma with abnormal long arm of chromosome 11 and lack of MYC gene rearrangement. It should be distinguished from Burkitt lymphoma, diffuse large B-cell lymphoma, B-lymphoblastic lymphoma, large B-cell lymphoma with IRF4 rearrangement and high-grade B-cell lymphoma. On the basis of morphology and immunophenotype, the diagnosis depends on genetic detection. There may be a better prognosis.
5.Research progress in therapeutic resistance mechanism and therapeutic strategy of cancer stem cells
Weidong LI ; Shuling WANG ; Chunfang HAO ; Xiaojing GUO
International Journal of Biomedical Engineering 2022;45(4):328-334
Cancer stem cells (CSCs) are a class of cells with self-renewal, differentiation, and tumorigenic potential in tumors. It is currently believed that the resistance of CSCs to chemotherapy and radiotherapy is an important cause of tumor recurrence and metastasis. Researchers have found that related factors in many signaling pathways endow CSCs with the ability to adapt to changes in the microenvironment, including inflammatory factors, hypoxia, low pH, and a lack of nutrients. In recent years, the mechanism of CSCs' resistance to therapy has been studied, mainly including the drug efflux mediated by the ATP-binding cassette transporter, the effect of aldehyde dehydrogenase 1 (ALDH1) activity on tumor stem cells, the enhancement of DNA damage repair and degradation of reactive oxygen species, autophagy, activation of development-related pathways, stimulation of the microenvironment, and EMT. The targeting strategies for CSCs include targeting signaling pathway inhibitors, targeting multidrug resistance, DNA damage repair, ALDH, targeting the tumor microenvironment, immunotherapy, etc. In this review, the research progress in CSCs treatment resistance and related treatment strategies was reviewed.
6.Research progress in endocrine clinical treatment of HR +/HER2 - metastatic breast cancer
Shuling WANG ; Chunfang HAO ; Weidong LI ; Zhongsheng TONG
International Journal of Biomedical Engineering 2022;45(5):430-436
Breast cancer, as a heterogeneous disease, has different molecular subtypes. The most common molecular subtype is hormone receptor positive (HR +). Endocrine therapy is the predominant treatment for this subtype. The main treatment modality for HR +/human epidermal growth factor receptor 2-negative (HER2 -) metastatic breast cancer (MBC) is novel targeted agents combined with endocrine therapy. In this review, researches in endocrine clinical treatment of HR +/HER2 - MBC was reviewed to provide a new targeted therapy, including CDK4/6 inhibitors combined with endocrine therapy, the debate between CDK4/6 inhibitors combined with endocrine therapy and chemotherapy, new directions of CDK4/6 inhibitor combination, exploration of multiple treatment strategies after CDK4/6 inhibitor therapy progresses, histone deacetylase inhibitor combined with endocrine therapy, PI3K/Akt/mTOR pathway targeting drugs in combination with endocrine therapy, polyadenosine diphosphate ribose polymerase (PARP) inhibitors for gBRCA1/2 mutated breast cancer, novel targeted drugs, and multi-target/multi-combination therapy model.
7.Clinical efficacy of Da Vinci robot-assisted iliofemoral vein bypass grafting
Rongjie ZHANG ; Long SUN ; Shiwei YANG ; Wei SUN ; Ping LIU ; Chunfang HU ; Yingxue HAO
Chinese Journal of Digestive Surgery 2019;18(4):380-386
Objective To explore the clinical efficacy of Da Vinci robot-assisted iliofemoral vein bypass grafting.Methods The retrospective descriptive study was conducted.The clinical data of one 66-year-old male patient who underwent Da Vinci robot-assisted iliofemoral vein bypass grafting in the First Affiliated Hospital of Army Military Medical University in March 2019 were collected.The patient was failed to recanalize iliofemoral vein stent thrombosis by endovascular measures and underwent Da Vinci robot-assisted iliofemoral vein bypass grafting after balloon occlusion preset in the common iliac vein.Observation indicators:(1) intra-and postoperative situations;(2) follow-up and survival situations.Follow-up using outpatient examination was performed to detect the patient's postoperative survival and swelling reduction of affected extremity up to April 2019.Results (1) Intra-and post-operative situations:the patient underwent Da Vinci robot-assisted iliofemoral vein bypass grafting successfully.The operation time of balloon occlusion preset by digital subtraction angiography was 35 minutes.The operation time of Da Vinci robot-assisted iliofemoral vein bypass grafting was 502 minutes (50 minutes of exposure time of femoral vein,80 minutes of exposure time of iliac vein,40 minutes of great saphenous vein harvesting time,70 minutes of end to side anastomosis between autogenous great saphenous vein and femoral vein,10 minutes of subcutaneous tunnel construction,90 minutes of end to side anastomosis between autogenous great saphenous vein and iliac vein,60 minutes of suturing except vessel closure,102 minutes of preparation time,check and washing time).The volume of intraoperative blood loss was 500 mL and no intraoperative complications occurred.The autogenous great saphenous vein graft was well filled and no bleeding was found at both proximal and distal anastomoses after iliofemoral vein bypass grafting.There were 4 abdominal Trocar holes including 2 of 1.2 cm and 2 of 0.8 cm.The incisional length of right groin and left great saphenous vein harvesting region was 5.0 cm and 15.0 cm,respectively.At the discharge time,the patient had swelling subsided partially at right lower extremity and skin tesion reduced significantly compared with the admission.The perimeters at 15 cm above right knee joint and left knee joint were 53.5 cm and 48.0 cm.The maximum perimeters of right calf and left calf were 41.0 cm and 38.0 cm.No postoperative complications occurred.Duration of hospital stay after surgery was 3 days.(2) Follow-up and survival situations:the patient was followed up for 1 month,with good survival.The patient had swelling subsided of affected extremity.The perimeters at 15 cm above right and left knee joint were 52.0 cm and 48.0 cm.The maximum perimeters of right calf and left calf were 40.0 cm and 38.0 cm.Conclusion The Da Vinci robot-assisted iliofemoral vein bypass grafting is safe and feasible,with good short-term outcomes.
8.Clinicopathological analysis of nongestational choriocarcinoma in 4 cases
Yuan ZHAO ; Chunfang ZHANG ; Hao CHEN
Chongqing Medicine 2017;46(1):75-77
Objective To investigate the clinical manifestations,pathological features,treatment and prognosis of nongesta-tional choriocarcinomas.Methods The clinicopathological data in 4 cases of nongestational choriocarcinoma were retrospectively analyzed and the relevant literatures were reviewed.Results All 4 patients had no confirmed diagnosis at first visit to hospital.All patients received the operative therapy and postoperative bleomycin,etoposide and cis-platinum (BEP)regimen chemotherapy.The followed up lasted for 3-32 months.One case died at postoperative 26 months due to pulmonary metastasis;one case was loss of follow up;two cases had relatively favorable condition.Conclusion Nongestational choriocarcinoma is a rare and highly invasive trophoblastic neoplasm,and is prone for early distant metastasis.The treatment is recommended to adopt operation combined with postoperative combined chemotherapy of multiple drugs.
9.Carriage and homology of carbapenemase genes of multidrug-resistant Acinetobacter baumannii in Wuj iang
Xiaoyan NI ; Hao SHEN ; Chunfang MA
Chinese Journal of Infection Control 2016;15(12):913-916,933
Objective To investigate the carriage and homology of carbapenemase genes of multidrug-resistant Acinetobacterbaumannii (MDRAB)in Wujiang area.Methods A total of 44 non-duplicated MDRAB isolated from patients in 3 general hospitals in Wujiang area from January 2010 to December 2013 were collected. Minimum inhibitory concentrations (MICs)were detected,carbapenemase genes OXA-51,OXA-23,OXA-24,OXA-58, IMP,TEM,SHV,and GES were amplified with polymerase chain reaction(PCR),homology of strains was detec-ted with pulsed-field gel electrophoresis (PFGE).Results 44 MDRAB strains were mainly collected from sputum (93.18% ),mainly distributed in intensive care unit (ICU),department of respiratory diseases,and department of neurosurgery,accounting for 45.45% ,27.27% ,and 13.64% respectively;MDRAB were both sensitive to minocy-cline and polymyxin B,resistance rates to piperacillin,ampicillin/sulbactam,ceftazidime,gentamicin,amikacin, and ciprofloxacin were all 100.00% ,resistance rates to imipenem and meropenem were both 97.73% . 44 MDRAB strains were all detected OXA-51,OXA-23 and TEM genes,12 strains were positive for GES gene,1 strain was positive for OXA-58 and SHV respectively,OXA-24 and IMP genes were not found ;MDRAB were divided into 7 types of G-A,which included 19,3,9,3,1,4,and 5 strains respectively,type A was mainly from two large gen-eral hospitals in Wujiang area (Wujiang First People’s Hospital and Shengze Hospital),type B,D and E strains were not detected in Wujiang First People’s Hospital,type E strain was only 1 isolate and was from Yongding Hos-pital,the other types were sporadically distributed.Conclusion Multidrug resistance of clinically isolated Acineto-bacterbaumannii is serious in Wujiang area,OXA-23 and TEM genes are major causes of multidrug resistance in Acinetobacterbaumannii,the main types are A and C,which present clonal spread.
10.Primary Study on Predicting the Termination of Paroxysmal Atrial Fibrillation Based on a Novel RdR RR Intervals Scatter Plot.
Hongwei LU ; Chenxi ZHANG ; Ying SUN ; Zhidong HAO ; Chunfang WANG ; Jiajia TIAN
Journal of Biomedical Engineering 2015;32(4):763-766
Predicting the termination of paroxysmal atrial fibrillation (AF) may provide a signal to decide whether there is a need to intervene the AF timely. We proposed a novel RdR RR intervals scatter plot in our study. The abscissa of the RdR scatter plot was set to RR intervals and the ordinate was set as the difference between successive RR intervals. The RdR scatter plot includes information of RR intervals and difference between successive RR intervals, which captures more heart rate variability (HRV) information. By RdR scatter plot analysis of one minute RR intervals for 50 segments with non-terminating AF and immediately terminating AF, it was found that the points in RdR scatter plot of non-terminating AF were more decentralized than the ones of immediately terminating AF. By dividing the RdR scatter plot into uniform grids and counting the number of non-empty grids, non-terminating AF and immediately terminating AF segments were differentiated. By utilizing 49 RR intervals, for 20 segments of learning set, 17 segments were correctly detected, and for 30 segments of test set, 20 segments were detected. While utilizing 66 RR intervals, for 18 segments of learning set, 16 segments were correctly detected, and for 28 segments of test set, 20 segments were detected. The results demonstrated that during the last one minute before the termination of paroxysmal AF, the variance of the RR intervals and the difference of the neighboring two RR intervals became smaller. The termination of paroxysmal AF could be successfully predicted by utilizing the RdR scatter plot, while the predicting accuracy should be further improved.
Atrial Fibrillation
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diagnosis
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Computer Systems
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Heart Rate
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Humans
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Machine Learning

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