Trial reportThe oncologist2024
Phase II clinical trial of docetaxel and trastuzumab for HER2-positive advanced extramammary Paget's disease (EMPD-HER2DOC).
Trial report in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed.
- Trial
- Treatment Strategies for Extramammary Paget Disease: A Narrative Review of Current Status and Future Directions.Cancers · 2026Review
- Article
- Preoperative prediction of HER2 expression in gastric cancer based on an enhanced CT radiomics model.Translational cancer research · 2026Article
- Management of Extramammary Paget Disease of the Male Genital Region: A Narrative Review and Two Case Reports.Journal of clinical medicine · 2026Review
- HER2-directed therapy in metastatic vulvar empd-a report of two cases and narrative review.AME case reports · 2026Article
- Metastatic extramammary Paget's disease successfully treated by trastuzumab deruxtecan: a rare case report.Frontiers in medicine · 2026Article
- Trastuzumab deruxtecan treatment for HER2-low metastatic scrotal extramammary Paget's disease with bone marrow involvement: a case report.Frontiers in oncology · 2026Article
- Antibody-drug conjugate (disitamab vedotin) therapy targeting HER2-low or higher advanced extramammary Paget's disease.The oncologist · 2025Article
- Genomic profiling and personalized treatment strategies for skin malignancies: findings from the center for cancer genomics and advanced therapeutics database.International journal of clinical oncology · 2025Review
- Secondary Perianal Paget's Disease Originating From Adenocarcinoma of the Anorectal Junction: A Case Report.Clinical, cosmetic and investigational dermatology · 2025Article
- Review
- Immunotherapy may be more appropriate for ERBB2 low-expressing extramammary paget's disease patients: a prognosis analysis and exploration of targeted therapy and immunotherapy of extramammary paget's disease patients.Cancer immunology, immunotherapy : CII · 2024Article
Corrections and comments
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Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNo consensus has been reached regarding the optimal chemotherapy for metastatic extramammary Paget's disease (EMPD), a rare cutaneous adenocarcinoma, because of the lack of solid evidence from prospective trials. However, the immunohistochemical profile of EMPD reportedly resembles that of breast cancer, particularly in terms of human epidermal growth factor receptor 2 (HER2) expression, suggesting that HER2 is a promising therapeutic target for advanced HER2-positive EMPD.
methodsIn this phase II single-arm trial, 13 Japanese patients received intravenous trastuzumab (loading dose of 8 mg/kg and maintenance dose of 6 mg/kg) and docetaxel (75 mg/m2) every 3 weeks for up to 2 years. The docetaxel dose was reduced or discontinued according to its toxicity. The primary trial endpoints were objective response rate (ORR) after 3 cycles of treatment and safety throughout the study period.
resultsAll 13 patients completed 3 cycles of combination therapy. The median follow-up was 27.9 months. The ORR was 76.9% (n = 10/13; 90% CI, 50.5-93.4). Frequently observed adverse events were neutropenia (100%), hypoalbuminemia (84.6%), and mucocutaneous infection (84.6%), all of which were well tolerated.
conclusionThe combination of docetaxel and trastuzumab demonstrated a favorable clinical effect and acceptable tolerability, which makes it a good treatment option for HER2-positive metastatic EMPD (ClinicalTrials.gov Identifier: UMIN000021311, jRCTs031180073).
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