Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019
A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer.
Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.
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The trial behind it
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
21 citing papers in PubMed.
- HER2-targeted therapies beyond breast cancer - an update.Nature reviews. Clinical oncology · 2024Review
- Targeted radionuclide therapy for head and neck squamous cell carcinoma: a review.Frontiers in oncology · 2024Review
- Assessments of CYP‑inhibition‑based drug-drug interaction between vonoprazan and poziotinibPharmaceutical biology · 2023Article
- The History and Development of HER2 Inhibitors.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Article
- History and Future of HER2-Targeted Therapy for Advanced Gastric Cancer.Journal of clinical medicine · 2023Review
- Inhibitory effect of Schisandrin on the pharmacokinetics of poziotinib in vivo and in vitro by UPLC-MS/MS.Thoracic cancer · 2023Article
- Deviating HER2 test results in gastric cancer: analysis from the prospective multicenter VARIANZ study.Journal of cancer research and clinical oncology · 2023Article
- Small molecule inhibitors targeting the cancers.MedComm · 2022Review
- HER2-targeted advanced metastatic gastric/gastroesophageal junction adenocarcinoma: treatment landscape and future perspectives.Biomarker research · 2022Review
- Effects of dacomitinib on the pharmacokinetics of poziotinibPharmaceutical biology · 2021Article
- Review
- Human epidermal growth factor receptor 2 (HER2) in advanced gastric cancer: where do we stand?Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021Review
- HER2 Expression, Test Deviations, and Their Impact on Survival in Metastatic Gastric Cancer: Results From the Prospective Multicenter VARIANZ Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021Article
- Tumor microenvironment characterization in stage IV gastric cancer.Bioscience reports · 2021Article
- Article
- Emerging agents that target signaling pathways in cancer stem cells.Journal of hematology & oncology · 2020Review
- Contrast-Enhanced CT Parameters of Gastric Adenocarcinoma: Can Radiomic Features Be Surrogate Biomarkers for HER2 Over-Expression Status?Cancer management and research · 2020Article
- Inhibition and Induction by Poziotinib of Different Rat Cytochrome P450 EnzymesFrontiers in pharmacology · 2020Article
- Tyrosine Kinase Inhibitors in the Combination Therapy of HER2 Positive Breast Cancer.Technology in cancer research & treatmentArticle
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPoziotinib (HM781-36B) is an irreversible pan-HER tyrosine kinase inhibitor which targets EGFR, HER2, and HER4. This prospective, multicenter, open-label, phase I/II study determined the maximum tolerated dose (MTD) and evaluated the safety and efficacy of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer (GC).
methodsPatients with HER2-positive GC previously treated with one line of chemotherapy received oral poziotinib (8 mg or 12 mg) once daily for 14 days, followed by 7 days off. Paclitaxel (175 mg/m
resultsIn the phase I part, 12 patients were enrolled (7 at dose level 1, 5 at dose level 2). One patient receiving poziotinib 8 mg and 2 receiving poziotinib 12 mg had dose-limiting toxicities (DLTs); all DLTs were grade 4 neutropenia, one with fever. The most common poziotinib-related adverse events were diarrhea, rash, stomatitis, pruritus and loss of appetite. The MTD of poziotinib was determined to be 8 mg/day and this was used in the phase II part which enrolled 32 patients. Two patients (6.3%) had complete responses and 5 (15.6%) had partial responses (objective response rate 21.9%). Median progression-free survival and overall survival were 13.0 weeks (95% CI 9.8-21.9) and 29.5 weeks (95% CI 17.9-59.2), respectively.
conclusionsThe MTD of poziotinib combined with paclitaxel and trastuzumab was 8 mg/day. This combination yielded promising anti-tumor efficacy with manageable toxicity in previously treated patients with HER2-positive GC.
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