Trial reportCancer medicine2021
A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.
Trial report in Cancer medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02216916 (Phase II Trial of HM781-36B in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma), which is not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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.
Phase II Trial of HM781-36B in Patients With Metastatic/Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC) After Failure of or Unfit for Platinum-containing Therapy
Who cites it
9 citing papers in PubMed, 11 citations in OpenAlex.
- A phase II study of poziotinib in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.Cancer medicine · 2021Trial
- Exploring the Therapeutic Implications of Co-Targeting the EGFR and Spindle Assembly Checkpoint Pathways in Oral Cancer.Pharmaceutics · 2024Review
- Enhancing drug and cell line representations via contrastive learning for improved anti-cancer drug prioritization.NPJ precision oncology · 2024Article
- Targeted radionuclide therapy for head and neck squamous cell carcinoma: a review.Frontiers in oncology · 2024Review
- Inhibitory effect of Schisandrin on the pharmacokinetics of poziotinib in vivo and in vitro by UPLC-MS/MS.Thoracic cancer · 2023Article
- Targeted therapy for head and neck cancer: signaling pathways and clinical studies.Signal transduction and targeted therapy · 2023Review
- Recent findings on the impact of ErbB receptors status on prognosis and therapy of head and neck squamous cell carcinoma.Frontiers in medicine · 2023Review
- Molecular Basis and Rationale for the Use of Targeted Agents and Immunotherapy in Sinonasal Cancers.Journal of clinical medicine · 2022Review
- Emerging tyrosine kinase inhibitors for head and neck cancer.Expert opinion on emerging drugs · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn phase I studies, poziotinib has shown meaningful efficacy against various types of cancers. This phase 2 study aimed to investigate the efficacy and safety of poziotinib in recurrent and/or metastatic head and neck squamous cell carcinoma (R/M-HNSCC).
methodsOverall, 49 patients were enrolled (median age, 62 years; age range, 21-78 years). Patients received a median of two prior treatments including chemotherapy and others and received 12 mg poziotinib orally once daily as part of a 28-day cycle. The primary endpoint was objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS). Targeted capture sequencing was performed using available tissues to identify translational biomarkers related to clinical response.
resultsORR was 22.4%, median PFS was 4.0 months (95% confidence interval [CI], 1.8-6.2 months), and median OS was 7.6 months (95% CI, 4.4-10.8 months). The most common treatment-related adverse events were acneiform rash (85%) and mucositis (77%). A grade 3 or higher adverse event was acneiform rash (3%). Targeted capture sequencing was performed in 30 tissue samples. TP53 and PIK3CA were the most frequently mutated genes (43%), followed by CCND1 (33%) and EGFR (30%). Mutations in ERBB2, ERBB3, and ERBB4, which are HER family genes, were observed in 17%, 13%, and 10% samples, respectively. There was no difference in the frequency of somatic mutations in the HER family genes between the clinically benefitted and non-benefitted groups.
conclusionCompared to other pan-HER inhibitors, poziotinib showed clinically meaningful efficacy in heavily treated R/M-HNSCC. CLINICAL TRIAL REGISTRATION NUMBER: NCT02216916.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.