Trial reportOral oncology2015
A randomized phase II efficacy and correlative studies of cetuximab with or without sorafenib in recurrent and/or metastatic head and neck squamous cell carcinoma.
Trial report in Oral oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- Angiogenesis Inhibitors for Head and Neck Squamous Cell Carcinoma Treatment: Is There Still Hope?Frontiers in oncology · 2021Pooled it
- A phase II study evaluating axitinib in patients with unresectable, recurrent or metastatic head and neck cancer.Investigational new drugs · 2015Trial
- Window-of-Opportunity Study Utilizing Preoperative Cetuximab in Patients with Head and Neck Cancer.Cancer research communications · 2026Article
- Inhibition of autophagy increases head and neck cancer sensitivity to cetuximab and radiation therapy.Scientific reports · 2026Article
- Radiomics-based model for prediction of TGF-β1 expression in head and neck squamous cell carcinoma.American journal of nuclear medicine and molecular imaging · 2024Article
- Combination Therapy as a Promising Way to Fight Oral Cancer.Pharmaceutics · 2023Review
- Critical review of the current and future prospects of VEGF-TKIs in the management of squamous cell carcinoma of head and neck.Frontiers in oncology · 2023Review
- Review
- Emerging tyrosine kinase inhibitors for head and neck cancer.Expert opinion on emerging drugs · 2022Review
- Review
- Bleeding complications in patients with squamous cell carcinoma of the head and neck.Head & neck · 2021Review
- Vascular Endothelial Growth Factor: A Translational View in Oral Non-Communicable Diseases.Biomolecules · 2021Review
- The Optimal Second-Line Systemic Treatment Model for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: A Bayesian Network Meta-Analysis.Frontiers in immunology · 2021Article
- Bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in advanced squamous cell carcinoma of the head and neck: results from a phase I cohort.Journal for immunotherapy of cancer · 2020Article
- A Driver Never Works Alone-Interplay Networks of Mutant p53, MYC, RAS, and Other Universal Oncogenic Drivers in Human Cancer.Cancers · 2020Review
- HPV Involvement in the Tumor Microenvironment and Immune Treatment in Head and Neck Squamous Cell Carcinomas.Cancers · 2020Review
- An update on angiogenesis targeting in head and neck squamous cell carcinoma.Cancers of the head & neck · 2020Review
- Clinical Development of Molecular Targeted Therapy in Head and Neck Squamous Cell Carcinoma.JNCI cancer spectrum · 2019Article
- PTEN loss is associated with resistance to cetuximab in patients with head and neck squamous cell carcinoma.Oral oncology · 2019Article
- Investigational multitargeted kinase inhibitors in development for head and neck neoplasms.Expert opinion on investigational drugs · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 7 institutions in 1 country.
Funding
Abstract
introductionA combination of cetuximab and sorafenib in patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) were assessed for potential benefit. MATERIAL AND
methodsIn a randomized phase II study, R/M HNSCC patients were treated with cetuximab 400mg/m(2) IV on day 1 followed by 250mg/m(2) IV weekly (Arm A), or cetuximab at the same dose/schedule plus sorafenib 400mg PO twice-a-day (Arm B). Each cycle was 21days. Tumor p16 and HPV status, and plasma immunomodulatory cytokine levels were assessed.
resultsOf 55 patients enrolled (Arm A-27, Arm B-28), 52 patients received assigned treatments and 43 were evaluable for response. Overall response rate was 8% for both arms. Median overall survival (OS) and progression-free survival (PFS) were 9.0 and 3.0months in Arm A, and 5.7 and 3.2months in Arm B, respectively. Forty-four patients had tumors available for p16 staining (35-negative, 9-positive). Three of nine p16-positive tumors were also HPV positive. The p16-negative patients had significantly better PFS compared to the p16-positive patients (3.7 vs. 1.6months; p-value: 0.03), regardless of study arms. Twenty-four plasma samples were tested for 12 cytokine levels and patients with higher TGFβ1 levels had inferior PFS compared to lower levels (1.9 vs. 4.7months; adjusted p-value: 0.015), regardless of study arms.
conclusionsA subset of R/M patients with p16-negative tumors or lower plasma TGFβ1 levels had longer PFS given the cetuximab-based therapy. However, both arms showed only modest response and sorafenib given with cetuximab did not demonstrate clinical benefit.
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What OpenQuestion holds
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.