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.Interpretation of guideline for breast cancer screening in Chinese women
Yubei HUANG ; Zhongsheng TONG ; Kexin CHEN ; Ying WANG ; Peifang LIU ; Lin GU ; Juntian LIU ; Jinpu YU ; Fengju SONG ; Wenhua ZHAO ; Yehui SHI ; Hui LI ; Huaiyuan XIAO ; Xishan HAO
Chinese Journal of Clinical Oncology 2019;46(9):433-441
Breast cancer is the most common cancer for Chinese women. Early screening is the best way to improve the rates of early diagnosis and early treatment of breast cancer. The peak ages of breast cancer in Chinese women are obviously different from those in the European and American countries. It is imperative to develop a guideline for breast cancer screening that is suitable for Chinese women. Based on the analysis and summary of breast cancer screening data in China, and the latest guidelines and consensus on breast cancer screening in Europe, the United States and East Asia, China Anti-Cancer Association and National Clinical Research Center for Cancer (Tianjin Medical University Cancer Institute and Hospital) has developed a population-based guideline for breast cancer screening in Chinese women. This guideline has provided detailed recommendations on the screening starting age, screening modalities, and screening interval in Chinese women with average risk and high risk of breast cancer, respectively. This article aims to interpret the above guideline, providing references for professionals in breast cancer screening.
5.Acupuncture combined with auricular point sticking therapy for post stroke depression:a randomized controlled trial.
Lin ZHANG ; Yan ZHONG ; Shulin QUAN ; Yehui LIU ; Xuehui SHI ; Zhenguang LI ; Jingjing WANG
Chinese Acupuncture & Moxibustion 2017;37(6):581-585
OBJECTIVETo observe the clinical effects of acupuncture combined with auricular point sticking based on the western medication for post stroke depression (PSD).
METHODSSixty patients with PSD were randomly assigned into an acupuncture plus auricular application group (a combination group) and a medication group, 30 cases in each one. 20 mg paroxetine hydrochloride was prescribed orally in the medication group, once a day for continuous 8 weeks. Based on the above treatment, 30-minute acupuncture was used in the combination group for 8 weeks at Baihui (GV 20), Sishencong (EX-HN 1), Shenting (GV 24), Yintang (GV 29), Shenmen (HT 7), Neiguan (PC 6), Taichong (LR 3), Hegu (LI 4), Zusanli (ST 36), Sanyinjiao (SP 6) and Fenglong (ST 40), once the other day and three times a week. Auricular point sticking therapy for 8 weeks was applied at shenmen (TF), pizhixia (AT), xin (CO), and gan (CO), with pressing 3 times a day and once 3-5 days. The total score and each factor scores of Hamilton's depression scale (HAMD) were observed in the two groups before and after treatment, and Asberg's antidepressant side-effect rating scale (SERS) and clinical effect were evaluated.
RESULTSAfter treatment, the total HAMD scores of the two groups decreased compared with those before treatment (both<0.05), with better effect in the combination group (<0.05). The scores of the combination group after treatment were lower than those in the medication group, including the anxiety/somatization factor, sleep disturbance factor, hopelessness factor (all<0.05). The total effective rate of the combination group was 86.7% (26/30), which was better than 66.7% (20/30) of the medication group (<0.05). The SERS score of the combination group was lower than that of the medication group (<0.05).
CONCLUSIONSAcupuncture combined with auricular point sticking can improve the clinical symptoms and are effective and safe for PSD.
6.Effects of human umbilical cord mesenchymal stem cells combined with goserelin on repairing rat ovarian damage
Xiaochen JIA ; Zhenyu LU ; Wenjing MENG ; Yehui SHI
Tianjin Medical Journal 2017;45(1):25-29
Objective To observe the repairing effect of human umbilical cord mesenchymal stem cells (hUC-MSCs) and goserelin on chemotherapy-induced ovarian injury, and the distribution and growth of hUC-MSCs transplanted in rat chemotherapy-induced ovarian injury. Methods A total of 120 SD rats were randomized into group A-E:A normal group, B NS control group, C goserelin group, D hUC-MSCs group and E hUC-MSCs+goserelin group. The rat premature ovarian failure (POF) model was established by given a loading dose of cyclophosphamide (CTX, 50 mg/kg) followed by daily intraperitoneal injection of CTX (8 mg/kg) for consecutive 14-day. The hUC-MSCs were injected through caudal vein, and goserelin was given by subcutaneous injection 4 days before POF model established. The serum level of estrogen was detected and numbers of follicles were counted. After GFP was transfected by lentivirus, the distribution and growth of stem cells transplanted in rats were observed by animal in vivo imaging system. Results At day 46, the serum level of estrogen showed no significant difference between group A and group E (P > 0.05). There were no significant differences in the counted follicles between group A and group E (P>0.05). After tail vein injection of the transfected cells, GFP positive cells were found in injury ovarian. Conclusion There is a repairing effect of hUC-MSCs and goserelin on ovarian injury.
7.Histone deacetylase inhibitor down-regulated the expression of HER-2 in breast cancer through the changes in miRNA
Yehui SHI ; Weipeng ZHAO ; Xingyu CHEN ; Juping ZHANG ; Shuai LI ; Yongsheng JIA ; Zhongsheng TONG
Chinese Journal of Clinical Oncology 2017;44(13):644-648
Objective:To investigate the mechanism of histone deacetylase (HDAC) inhibitor in down-regulating the expression of HER-2 in breast cancer cells and to provide an innovative therapeutic option to overcome the disadvantages of anti-HER-2 therapy. Meth-ods:HER-2-positive breast cell lines were treated with HDAC inhibitors. The changes in the gene and protein levels of HER-2 were de-tected by qPCR and Western blot. MiRNA microarray was used to identify the HDAC inhibitors, whereas qPCR was used to verify the miRNA expression. Results:In vitro cell experiments confirmed that the HDAC inhibitors TSA and SAHA can down-regulate the expres-sion of HER-2 in breast cancer cell lines. TSA can down-regulate the expression of HER-2 gene in BT474 and decrease the concentra-tions of 100 nmol by 10.7%and 200 nmol by 38.9%(P<0.05). TSA had no effect on the primary cells. The expression of HER-2 gene of BT474 was down-regulated by 93.9%(P<0.05) in the 5μmol/L group but not in the 1μmol/L group. SAHA significantly affected the pri-mary cells at a concentration of 1μmol/L and reduced the cells at 87.1%at a concentration of 5μmol/L. Seven miRNAs were identified from the miRNA microarray. MiR-762 was used as a basis to identify the changes in miRNA. The miRNA sputum identified by miRNA microarray and qPCR may be associated with the down-regulation of HER-2 by HDAC inhibitors. Conclusion: HDAC inhibitors may down-regulate the expression of HER-2 in breast cancer cells by changing some miRNAs.
8.Clinical efficacy of apatinib in treating refractory triple-negative advanced breast cancer
Xiaorui WANG ; Xu WANG ; Yehui SHI ; Chen WANG ; Zhongsheng TONG
Chinese Journal of Clinical Oncology 2017;44(15):769-772
Objective:To evaluate the effectiveness and safety of using apatinib in the treatment of refractory triple-negative advanced breast cancer. Methods:Eight cases of advanced triple-negative breast cancer patients confirmed via histopathology, who were previously treated with anthracycline, taxane, gemcitabine, capecitabine, and 500 mg/d apatinib in our hospital from July 2015 to November 2016, were retrospectively analyzed. The time of disease progress, effective rate, clinical benefits, and side effects were observed. Results:Eight patients were administrated with an average of 4 treatment cycles, and the effects were evaluated after 2 weeks. Four patients exhibited partial remission, 3 had a stable disease, and 1 had a progressive disease. The disease control rate was 87.5%, and the median progression free survival was 4.2 months. The main side effects were hand-foot syndrome (3/8), bone marrow arrest (4/8), hypertension (2/8), proteinuria (3/8), hemoptysis (1/8), nausea (2/8), and fatigue (2/8). Most of these side effects were tolerable. Conclusion:Apatinib can effectively and tolerably prolong survival time and improve the quality of life of patients with advanced triple-negative breast cancer.
9.Clinical analysis of 40 patients with multiple primary carcinomas using multidisci-plinary consultation for palliative treatment
Haiyan SUN ; Zhanyu PAN ; Xinwei ZHANG ; Lujun ZHAO ; Jianyu XIAO ; Yehui SHI ; Fang LIU ; Wenge XING ; Jie ZHANG
Chinese Journal of Clinical Oncology 2016;43(15):674-678
Objective:The implementation of a multidisciplinary team (MDT) approach for palliative treatment of patients with multi-ple primary carcinomas (MPCs) was evaluated in Tianjin Medical University Cancer Institute and Hospital. Methods:A total of 40 pa-tients with MPCs who attended the consultation by MDT in our hospital from January 1, 2014 to April 21, 2016 were analyzed retro-spectively. Clinical data of the 40 cancer patients were reviewed. The essential characteristics and results of MDT treatment decisions were summarized and expected outcomes were evaluated. Results:A total of 40 cases with MPCs were included in MDT assessment, accounting for 6.4%of the 629 patients who were handled by the MDT. A total of 39 MDT decisions were followed up successfully. Among these MDT decisions, 26 (65%) were fully implemented, 7 (17.5%) were partially implemented, and 6 (15.0%) were unimple-mented. Expected outcomes were achieved in 25 (96.2%) patients of the fully implemented concordant group, 4 (57.1%) patients of the partially concordant group, and 1 (16.7%) patient from the unimplemented group. Conclusion:MDT specializing on palliative treat-ment can provide recommendations for standardized individualized comprehensive treatment of patients with MPCs. MDT modality should be further improved and widely used for palliative treatment.
10.Clinical decision on a patient with esthesioneuroblastoma
Chunhua SHE ; Wenliang LI ; Qiongli ZHAI ; Bohan XIAO ; Peiguo WANG ; Xiuyu SONG ; Jie YAN ; Yehui SHI
Chinese Journal of Clinical Oncology 2015;(17):871-875
Olfactory neuroblastoma is a rare malignant tumor. Although multiple therapeutic modalities including surgery, radio-therapy, or chemotherapy could be used in patients with olfactory neuroblastoma, no standardized treatment has been achieved. This re-view introduces a case of adult olfactory neuroblastoma treated by a multiple disciplinary team in Tianjin Medical University Cancer In-stitute and Hospital. This review also aims to explore a complete set of diagnostic and treatment practices for the benefit of future pa-tients.

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