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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
Received April 3, 2024  Accepted August 8, 2024  Published online August 9, 2024  
DOI: https://doi.org/10.4143/crt.2024.340    [Epub ahead of print]
AbstractAbstract PDFPubReaderePub
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.
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Gynecologic cancer
Genomic and Transcriptomic Characterization Revealed the High Sensitivity of Targeted Therapy and Immunotherapy in a Subset of Endometrial Stromal Sarcoma
Nan Kang, Yinli Zhang, Shichao Guo, Ran Chen, Fangzhou Kong, Shuchun Wang, Mingming Yuan, Rongrong Chen, Danhua Shen, Jianliu Wang
Cancer Res Treat. 2023;55(3):978-991.   Published online February 2, 2023
DOI: https://doi.org/10.4143/crt.2022.1647
AbstractAbstract PDFPubReaderePub
Purpose
The unique chromosomal rearrangements of endometrial stromal sarcoma (ESS) make it possible to distinguish high-grade ESS (HGESS) and low-grade ESS (LGESS) from the molecular perspective. Analysis of ESS at the genomic and transcriptomic levels can help us achieve accurate diagnosis of ESS and provide potential therapy options for ESS patients.
Materials and Methods
A total of 36 ESS patients who conducted DNA- and/or RNA-based next-generation sequencing were retrospectively enrolled in this study. The molecular characteristics of ESS at genomic and transcriptomic levels, including mutational spectrum, fusion profiles, gene expression and pathway enrichment analysis and features about immune microenvironment were comprehensively explored.
Results
TP53 and DNMT3A mutations were the most frequent mutations. The classical fusions frequently found in HGESS (ZC3H7B-BCOR and NUTM2B-YWHAE) and LGESS (JAZF1-SUZ12) were detected in our cohort. CCND1 was significantly up-regulated in HGESS, while the expression of GPER1 and PGR encoding estrogen receptor (ER) and progesterone receptor (PR) did not differ significantly between HGESS and LGESS. Actionable mutations enriched in homologous recombination repair, cell cycle, and phosphoinositide 3-kinase/AKT/mammalian target of rapamycin pathways were detected in 60% of HGESS patients. Genes with up-regulated expression in HGESS were significantly enriched in five immune-related pathways. Most HGESS patients (85.7%) had positive predictors of immunotherapy efficacy. Moreover, immune microenvironment analysis showed that HGESS had relatively high immune infiltration. The degree of immune infiltration in HGESS patients with ZC3H7B-BCOR fusion was relatively higher than that of those with NUTM2B-YWHAE fusion.
Conclusion
This study investigated the molecular characteristics of ESS patients at the genomic and transcriptomic levels and revealed the potentially high sensitivity of targeted therapy and immunotherapy in a subset of HGESS with specific molecular features, providing a basis for guiding decision-making of treatment and the design of future clinical trials on precision therapy.

Citations

Citations to this article as recorded by  
  • Integrated Transcriptomic Landscape and Deep Learning Based Survival Prediction in Uterine Sarcomas
    Yaolin Song, Guangqi Li, Zhenqi Zhang, Yinbo Liu, Huiqing Jia, Chao Zhang, Jigang Wang, Yanjiao Hu, Fengyun Hao, Xianglan Liu, Yunxia Xie, Ding Ma, Ganghua Li, Zaixian Tai, Xiaoming Xing
    Cancer Research and Treatment.2025; 57(1): 250.     CrossRef
  • Genomic and T cell repertoire biomarkers associated with malignant mesothelioma survival
    Muwen Nie, Zhao Sun, Ningning Li, Liangrui Zhou, Shuchun Wang, Mingming Yuan, Rongrong Chen, Lin Zhao, Ji Li, Chunmei Bai
    Thoracic Cancer.2024; 15(19): 1502.     CrossRef
  • Single-cell RNA-seq reveals FGF12 as a prognostic biomarker in low-grade endometrial stromal sarcoma
    Yu Miao, Meng Dong, Qiyin Zhou, Julia Thiel, Na Li, Ying Cai, Dan Yuan, Haitao Wang, Su-Han Jin, Hua Yang, Jinjing Wang, Benjamin Frey, Udo S. Gaipl, Hu Ma, Jian-Guo Zhou
    Frontiers in Immunology.2024;[Epub]     CrossRef
  • High-Grade Endometrial Mesenchymal Sarcoma: Current Status and Future Trends
    Zhang Lushuang, Zhao Liubiqi
    Clinical Journal of Obstetrics and Gynecology.2023; 6(3): 132.     CrossRef
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  • 3 Web of Science
  • 4 Crossref
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Pediatric cancer
Effectiveness and Safety of Dabrafenib in the Treatment of 20 Chinese Children with BRAFV600E-Mutated Langerhans Cell Histiocytosis
Ying Yang, Dong Wang, Lei Cui, Hong-Hao Ma, Li Zhang, Hong-Yun Lian, Qing Zhang, Xiao-Xi Zhao, Li-Ping Zhang, Yun-Ze Zhao, Na Li, Tian-You Wang, Zhi-Gang Li, Rui Zhang
Cancer Res Treat. 2021;53(1):261-269.   Published online September 15, 2020
DOI: https://doi.org/10.4143/crt.2020.769
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We sought to investigate the effectiveness and safety of dabrafenib in children with BRAFV600E-mutated Langerhans cell histiocytosis (LCH).
Materials and Methods
A retrospective analysis was performed on 20 children with BRAFV600E-mutated LCH who were treated with dabrafenib.
Results
The median age at which the patients started taking dabrafenib was 2.3 years old (range, 0.6 to 6.5 years). The ratio of boys to girls was 2.3:1. The median follow-up time was 30.8 months (range, 18.9 to 43.6 months). There were 14 patients (70%) in the risk organ (RO)+ group and six patients (30%) in the RO group. All patients were initially treated with traditional chemotherapy and then shifted to targeted therapy due to poor control of LCH or intolerance to chemotherapy. The overall objective response rate and the overall disease control rate were 65% and 75%, respectively. During treatment, circulating levels of cell-free BRAFV600E (cfBRAFV600E) became negative in 60% of the patients within a median period of 3.0 months (range, 1.0 to 9.0 months). Grade 2 or 3 adverse effects occurred in five patients.
Conclusion
Some children with BRAFV600E-mutated LCH may benefit from monotherapy with dabrafenib, especially high-risk patients with concomitant hemophagocytic lymphohistiocytosis and intolerance to chemotherapy. The safety of dabrafenib is notable. A prospective study with a larger sample size is required to determine the optimal dosage and treatment duration.

Citations

Citations to this article as recorded by  
  • Genetic Landscape and Its Prognostic Impact in Children With Langerhans Cell Histiocytosis
    Chan-Juan Wang, Lei Cui, Shuang-Shuang Li, Hong-Hao Ma, Dong Wang, Hong-Yun Lian, Yun-Ze Zhao, Li-Ping Zhang, Wei-Jing Li, Qing Zhang, Xiao-Xi Zhao, Ying Yang, Xiao-Tong Huang, Wei Liu, Yi-Zhuo Wang, Wan-Shui Wu, Tian-You Wang, Rui Zhang, Zhi-Gang Li
    Archives of Pathology & Laboratory Medicine.2025; 149(2): 175.     CrossRef
  • Targeted therapy and immunotherapy for orbital and periorbital tumors: a major review
    Emmanuel Lee Boniao, Richard C. Allen, Gangadhara Sundar
    Orbit.2024; 43(5): 656.     CrossRef
  • Treatment of children with refractory/relapse high risk langerhans cell histiocytosis with the combination of cytarabine, vindesine and prednisone
    Wenqian Wang, Jian Ge, Honghao Ma, Hongyun Lian, Lei Cui, Yunze Zhao, Zhigang Li, Tianyou Wang, Rui Zhang
    BMC Pediatrics.2024;[Epub]     CrossRef
  • Vemurafenib combined with chemotherapy achieved sustained remission in pediatric LCH: a multi-center observational study
    Jiaying Lei, Wenxia Wang, Danna Lin, Chengguang Zhu, Wenguang Jia, Wenjun Weng, Xiaoshan Liu, Yuhan Ma, Zhixuan Wang, Lihua Yang, Xiangling He, Yunyan He, Yang LI
    Journal of Cancer Research and Clinical Oncology.2024;[Epub]     CrossRef
  • Clinical features and treatment outcomes of liver involvement in paediatric Langerhans cell histiocytosis
    Xinshun Ge, Wenxin Ou, Ang Wei, Hongyun Lian, Honghao Ma, Lei Cui, Dong Wang, Liping Zhang, Xiaoman Wang, Lejian He, Rui Zhang, Tianyou Wang
    BMC Pediatrics.2024;[Epub]     CrossRef
  • Refractory juvenile xanthogranuloma of the mastoid bone responsive to trametinib
    Isaac Hauk, Ignacio Gonzalez‐Gomes, Deepak Chellapandian, Jonathan Metts, Peter H. Shaw
    Pediatric Blood & Cancer.2024;[Epub]     CrossRef
  • Advancements in the understanding and management of histiocytic neoplasms
    Kyung-Nam Koh, Su Hyun Yoon, Sung Han Kang, Hyery Kim, Ho Joon Im
    Blood Research.2024;[Epub]     CrossRef
  • Real-world experience with targeted therapy in patients with histiocytic neoplasms in the Netherlands and in Belgium
    Paul G. Kemps, F. J. Sherida H. Woei-A-Jin, Patrick Schöffski, Thomas Tousseyn, Isabelle Vanden Bempt, Friederike A. G. Meyer-Wentrup, Natasja Dors, Natasha K. A. van Eijkelenburg, Marijn A. Scheijde-Vermeulen, Ingrid M. Jazet, Maarten Limper, Margot Jak,
    Blood Neoplasia.2024; 1(3): 100023.     CrossRef
  • The clinical impact of serum soluble CD25 levels in children with Langerhans cell histiocytosis
    Zi-Jing Zhao, Hong-Yun Lian, Wei-Jing Li, Qing Zhang, Hong-Hao Ma, Dong Wang, Yun-Ze Zhao, Ting Zhu, Hua-Lin Li, Xiao-Tong Huang, Tian-You Wang, Rui Zhang, Lei Cui, Zhi-Gang Li
    Jornal de Pediatria.2024;[Epub]     CrossRef
  • Liver transplantation in a child with sclerosing cholangitis due to Langerhans cell histiocytosis: a case report
    Xue-Lian Wang, Chun-Xiao Fang, Min-Xia Chen, Hua-Mei Yang, Lan-Hui She, Yu Gong, Yi Xu, Wei-Qiang Xiao, Jin-Sheng Tian, Bin Ai, Li Huang, Xu-Fang Li
    Frontiers in Pediatrics.2024;[Epub]     CrossRef
  • BRAF V600E gene mutation is present in primary intraosseous Rosai-Dorfman disease
    Lokman Cevik, Swati Satturwar, Dan Jones, Joel Mayerson, Steve Oghumu, O. Hans Iwenofu
    Human Pathology.2024; 154: 105702.     CrossRef
  • Langerhans cell histiocytosis as a clonal disease of mononuclear phagocyte system
    Evgeniy F. Khynku, Maria K. Monaenkova, Olga B. Tamrazova, Alexey V. Taganov, Мarina А. Gureeva, Gayane E. Bagramova, Anton V. Molochkov
    Almanac of Clinical Medicine.2023; 50(7): 428.     CrossRef
  • Lineage switching of the cellular distribution of BRAF V600E in multisystem Langerhans cell histiocytosis
    Paul Milne, Simon Bomken, Olga Slater, Ashish Kumar, Adam Nelson, Somak Roy, Jessica Velazquez, Kshitij Mankad, James Nicholson, Dan Yeomanson, Richard Grundy, Ahmed Kamal, Anthony Penn, Jane Pears, Gerard Millen, Bruce Morland, James Hayden, Jason Lam, M
    Blood Advances.2023; 7(10): 2171.     CrossRef
  • Treatment of Langerhans Cell Histiocytosis and Histiocytic Disorders: A Focus on MAPK Pathway Inhibitors
    Ashley V. Geerlinks, Oussama Abla
    Pediatric Drugs.2023; 25(4): 399.     CrossRef
  • Dabrafenib, alone or in combination with trametinib, in BRAF V600–mutated pediatric Langerhans cell histiocytosis
    James A. Whitlock, Birgit Geoerger, Ira J. Dunkel, Michael Roughton, Jeea Choi, Lisa Osterloh, Mark Russo, Darren Hargrave
    Blood Advances.2023; 7(15): 3806.     CrossRef
  • Therapiestrategien bei Kindern und Jugendlichen mit Langerhanszell Histiozytosen
    Anke Elisabeth Barnbrock, Caroline Hutter, Konrad Bochennek, Milen Minkov, Thomas Lehrnbecher
    Klinische Pädiatrie.2023; 235(06): 342.     CrossRef
  • Mutant PIK3CA is a targetable driver alteration in histiocytic neoplasms
    Benjamin H. Durham, Oshrat Hershkovitz-Rokah, Omar Abdel-Wahab, Mariko Yabe, Young Rock Chung, Gilad Itchaki, Maayan Ben-Sasson, Vered A. Asher-Guz, David Groshar, Seyram A. Doe-Tetteh, Tina Alano, David B. Solit, Ofer Shpilberg, Eli L. Diamond, Roei D. M
    Blood Advances.2023; 7(23): 7319.     CrossRef
  • Validation of Liquid Chromatography Coupled with Tandem Mass Spectrometry for the Determination of 12 Tyrosine Kinase Inhibitors (TKIs) and Their Application to Therapeutic Drug Monitoring in Adult and Pediatric Populations
    Marie Bellouard, Jean Donadieu, Pauline Thiebot, Etienne Giroux Leprieur, Philippe Saiag, Isabelle Etting, Pamela Dugues, Emuri Abe, Jean-Claude Alvarez, Islam-Amine Larabi
    Pharmaceutics.2023; 16(1): 5.     CrossRef
  • Langerhans cell histiocytosis: promises and caveats of targeted therapies in high-risk and CNS disease
    Oussama Abla
    Hematology.2023; 2023(1): 386.     CrossRef
  • Characteristics and Treatment Outcomes of Pediatric Langerhans Cell Histiocytosis with Thymic Involvement
    Ja-Feng Yao, Dong Wang, Hong-Hao Ma, Hong-Yun Lian, Li Zhang, Tian-You Wang, Zhi-Gang Li, Jin Jiang, Lei Cui, Rui Zhang
    The Journal of Pediatrics.2022; 244: 194.     CrossRef
  • Clinical features and treatment outcomes of pediatric Langerhans cell histiocytosis with macrophage activation syndrome-hemophagocytic lymphohistiocytosis
    Dong Wang, Xi-Hua Chen, Ang Wei, Chun-Ju Zhou, Xue Zhang, Hong-Hao Ma, Hong-Yun Lian, Li Zhang, Qing Zhang, Xiao-Tong Huang, Chan-Juan Wang, Ying Yang, Wei Liu, Tian-You Wang, Zhi-Gang Li, Lei Cui, Rui Zhang
    Orphanet Journal of Rare Diseases.2022;[Epub]     CrossRef
  • Current perspectives on the role of liver transplantation for Langerhans cell histiocytosis: A narrative review
    Jagadeesh Menon, Ashwin Rammohan, Mukul Vij, Naresh Shanmugam, Mohamed Rela
    World Journal of Gastroenterology.2022; 28(30): 4044.     CrossRef
  • Research Progress of BRAF V600E Gene Mutation in Papillary Thyroid Carcinoma
    延泽 刘
    Advances in Clinical Medicine.2022; 12(09): 8499.     CrossRef
  • Recent advances in the understanding of the molecular pathogenesis and targeted therapy options in Langerhans cell histiocytosis
    Jin Kyung Suh, Sunghan Kang, Hyery Kim, Ho Joon Im, Kyung-Nam Koh
    BLOOD RESEARCH.2021; 56(S1): S65.     CrossRef
  • Improvement in Pituitary Imaging After Targeted Therapy in Three Children with BRAF-Mutated Langerhans Cell Histiocytosis with Pituitary Involvement


    Ying Yang, Dong Wang, Na Li, Honghao Ma, Hongyun Lian, Lei Cui, Qing Zhang, Xiaoxi Zhao, Liping Zhang, Yunze Zhao, Chanjuan Wang, Li Zhang, Tianyou Wang, Zhigang Li, Rui Zhang
    OncoTargets and Therapy.2020; Volume 13: 12357.     CrossRef
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  • 19 Web of Science
  • 25 Crossref
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Clinicopathologic Characteristics and Prognosis of Tongue Squamous Cell Carcinoma in Patients with and without a History of Radiation for Nasopharyngeal Carcinoma: A Matched Case-Control Study
Peng Zhang, Li Zhang, Hui Liu, Lei Zhao, Yong Li, Jing-Xian Shen, Qing Liu, Meng-Zhong Liu, Mian Xi
Cancer Res Treat. 2017;49(3):695-705.   Published online October 11, 2016
DOI: https://doi.org/10.4143/crt.2016.317
AbstractAbstract PDFPubReaderePub
Purpose
Previous studies reported an association between an increased risk of tongue cancer and radiation treatment for nasopharyngeal carcinoma (NPC). This study compared the clinicopathologic characteristics and outcomes of tongue squamous cell carcinoma (TSCC) in patients with and without a history of radiotherapy for NPC.
Materials and Methods
From 1965 to 2009, a total of 73 patients were diagnosed with TSCC with a history of radiotherapy for NPC. The patients were matched in a 1:3 ratio with patients with sporadic TSCC according to age, sex, and year of the TSCC diagnosis. The primary endpoint was the overall survival.
Results
The median interval from NPC to TSCC was 82 months. The NPC survivors were more likely to be diagnosed with a more advanced T classification, less likely to have lymph node involvement, and more likely to have the tumor located in the dorsum of the tongue than sporadic TSCC. Regarding the histologic characteristics, the NPC survivors were more likely to have a weak lymphocytic host response, low tumor budding, and low risk of a worse pattern of invasion. The sporadic TSCC patients had a better overall survival (hazard ratio, 0.690; p=0.033) than the NPC survivors. In competing risks analysis, the cumulative incidence functions for the competing event (documented non-tongue cancer death) were significantly higher in the NPC survivors (Gray’s test, p=0.001).
Conclusion
TSCC patients with a history of radiotherapy for NPC appear to have particular clinicopathologic features, a poorer survival, and are more likely to die from non-tongue cancer causes than those with sporadic TSCC.

Citations

Citations to this article as recorded by  
  • Radiotherapy upregulated immune checkpoints contribute to the development of second primary OSCC
    Li Wang, Siyu Wang, Jiayu Zhang, Jianmin Peng, Bin Cheng, Huan Li, Qinchao Hu
    Oral Diseases.2024; 30(4): 2188.     CrossRef
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    Sybil T. Sha, Edward Christopher Dee, Matthew Mossanen, Brandon A. Mahal, Cierra Zaslowe-Dude, Trevor J. Royce, Michelle S. Hirsch, Guru Sonpavde, Mark A. Preston, Paul L. Nguyen, Kent W. Mouw, Vinayak Muralidhar
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  • SPP1 and FN1 are significant gene biomarkers of tongue squamous cell carcinoma
    Xiao-Liang Xu, Hui Liu, Ying Zhang, Su-Xin Zhang, Zhong Chen, Yang Bao, Tian-Ke Li
    Oncology Letters.2021;[Epub]     CrossRef
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    Liyuan Dai, Qigen Fang, Peng Li, Junfu Wu, Xu Zhang
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  • 11,333 View
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  • 17 Web of Science
  • 13 Crossref
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