Trial reportBJU international2018
First-line therapy with dacomitinib, an orally available pan-HER tyrosine kinase inhibitor, for locally advanced or metastatic penile squamous cell carcinoma: results of an open-label, single-arm, single-centre, phase 2 study.
Trial report in BJU international, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01728233 (Phase II Study of the Pan-HER Inhibitor Dacomitinib), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.
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 Study of the Pan-HER Inhibitor Dacomitinib (PF-00299804) for Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Penis.
Who cites it
44 citing papers in PubMed, 1 synthesis or guideline pooled it, 98 citations in OpenAlex.
- Penile cancer: ESMO-EURACAN Clinical Practice Guideline for diagnosis, treatment and follow-up.ESMO open · 2024Guideline
- First-in-human trial exploring safety, antitumor activity, and pharmacokinetics of Sym013, a recombinant pan-HER antibody mixture, in advanced epithelial malignancies.Investigational new drugs · 2022Trial
- VinCaP: a phase II trial of vinflunine in locally advanced and metastatic squamous carcinoma of the penis.British journal of cancer · 2022Trial
- The Impact of Cancer Treatment On Oral Structures and the Facial Part of the Skull - Implications for Prosthetic Treatment and Oncological Risk.Current oncology reports · 2026Review
- Article
- Neoadjuvant Treatment for Penile Cancer: A Systematic Review of Contemporary Evidence.Cancers · 2026Review
- Penile cancer and lymph node management: a call for standardization.International urology and nephrology · 2026Review
- [Current diagnostics and treatment of penile cancer].Urologie (Heidelberg, Germany) · 2026Review
- Prediction of distant metastases in penile squamous cell carcinoma: a SEER population-based study.International urology and nephrology · 2026Article
- Systemic Chemotherapy in Penile Squamous Cell Carcinoma: Mechanisms, Clinical Applications, and Evidence-Based Regimens.Cancers · 2025Review
- [Personalized systemic therapy of penile cancer: molecular targets and new therapeutic horizons].Urologie (Heidelberg, Germany) · 2025Review
- Review
- [Innovative systemic treatment approaches for advanced penile cancer].Urologie (Heidelberg, Germany) · 2025Article
- Molecular characterization of metastatic penile squamous cell carcinoma in developing countries and its impact on clinical outcomes: LACOG 2018 translational study.The oncologist · 2025Article
- New Therapeutic Horizons for Advanced or Metastatic Penile Cancer.The Urologic clinics of North America · 2024Review
- Review
- Structured Literature Review to Identify Human Papillomavirus's Natural History Parameters for Dynamic Population Models of Vaccine Impacts.Infectious diseases and therapy · 2024Review
- Recruitment of hexahydroquinoline as anticancer scaffold targeting inhibition of wild and mutants EGFR (EGFRJournal of enzyme inhibition and medicinal chemistry · 2023Article
- Genomic Profiles and Clinical Outcomes of Penile Squamous Cell Carcinoma With Elevated Tumor Mutational Burden.JAMA network open · 2023Article
- Metastatic Penile Squamous Cell Carcinoma Responsive to Enfortumab Vedotin.International journal of molecular sciences · 2023Article
Corrections and comments
- Commented on by
Authors and funding
19 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo harness the frontline therapy in advanced penile squamous cell carcinoma (PSCC), for which chemotherapy exerts moderate activity but poor efficacy. Dacomitinib is an irreversible, pan-epidermal growth factor receptor (HER) inhibitor. PATIENTS AND
methodsIn a phase 2 study (NCT01728233), patients received dacomitinib 45 mg/day, orally, continuously. Inclusion criteria were SCC histology, clinical stage N
resultsFrom June 2013 to October 2016, 28 patients were treated. Eight (28.6%) had visceral metastases, 14 (50%) had pelvic and 17 (60.7%) clinically involved bilateral lymph nodes. One complete and eight partial responses were obtained (ORR 32.1%, 80% credibility interval 21.0-43.0%). The median (interquartile range [IQR]) follow-up duration was 19.8 (6.3-25.7) months; 12-month progression-free survival was 26.2% (95% confidence interval [CI] 13.2-51.9); 12-month overall survival (OS) was 54.9% (95% CI 36.4-82.8). The median (IQR) OS of locally advanced patients was 20 (11.1-not reached) months. The Bayesian PP of exceeding the 20% ORR target was 92.3%. Grade 3 adverse events (skin rash) were seen in three patients (10.7%). Tissue samples from 25 patients were analysed. Only two patients had high-risk human papillomavirus-positive tumours. Epidermal growth factor receptor (EGFR) amplification was found in four patients (equally responders and non-responders) and it was confirmed in all post-dacomitinib samples. Telomerase reverse transcriptase (TERT) mutations were found in responders only (60%), and phosphatidylinositol 3-kinase/mammalian target of rapamycin (PI3K/mTOR) pathway gene mutations were found in 42.9% of responders vs 8.3% of non-responders.
conclusionDacomitinib was active and well tolerated in patients with advanced PSCC and may represent an option when combined chemotherapy cannot be administered. Mutations in downstream effectors of EGFR signalling in relation to dacomitinib activity deserve further studies.
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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.