Trial reportJournal of the National Comprehensive Cancer Network : JNCCN2012
A randomized phase II study of cetuximab every 2 weeks at either 500 or 750 mg/m2 for patients with recurrent or metastatic head and neck squamous cell cancer.
Trial report in Journal of the National Comprehensive Cancer Network : JNCCN, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06332092 (A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma), which is not on this map. Cited by 20 papers, 2 of them syntheses 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.
A Phase 2, Randomized, Multicenter, Open-label, Study of FID-007 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma
Who cites it
20 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Evidence-based guideline diagnosis, treatment, prevention and aftercare of oropharyngeal and hypopharyngeal carcinoma.German medical science : GMS e-journal · 2025Guideline
- Radiotherapy and Receptor Tyrosine Kinase Inhibition for Solid Cancers (ROCKIT): A Meta-Analysis of 13 Studies.JNCI cancer spectrum · 2021Pooled it
- Multi-agent chemotherapy for refractory head and neck cancer.Journal of the Chinese Medical Association : JCMA · 2026Article
- Molecular imaging predicts trastuzumab-deruxtecan (T-DXd) response in head and neck cancer xenograft models.Molecular oncology · 2025Article
- Review of Current and Future Medical Treatments in Head and Neck Squamous Cell Carcinoma.Cancers · 2024Review
- Exploring the Therapeutic Implications of Co-Targeting the EGFR and Spindle Assembly Checkpoint Pathways in Oral Cancer.Pharmaceutics · 2024Review
- Review
- A phase 1 study of concurrent cabozantinib and cetuximab in recurrent or metastatic head and neck squamous cell cancer.Oral oncology · 2024Article
- Targeting Epidermal Growth Factor Receptor for Cancer Treatment: Abolishing Both Kinase-Dependent and Kinase-Independent Functions of the Receptor.Pharmacological reviews · 2023Review
- Biweekly administration of cetuximab in Japanese patients with recurrent or metastatic head and neck cancer.International journal of clinical oncology · 2022Article
- Multidisciplinary management of locally advanced and metastatic cutaneous squamous cell carcinoma.Current oncology (Toronto, Ont.) · 2020Review
- Phase I Study of Ficlatuzumab and Cetuximab in Cetuximab-Resistant, Recurrent/Metastatic Head and Neck Cancer.Cancers · 2020Article
- Nimotuzumab plus platinum-based chemotherapyTherapeutic advances in medical oncology · 2020Article
- A retrospective paired study: efficacy and toxicity of nimotuzumab versus cisplatin concurrent with radiotherapy in nasopharyngeal carcinoma.BMC cancer · 2016Article
- Second-line treatment of recurrent HNSCC: tumor debulking in combination with high-dose-rate brachytherapy and a simultaneous cetuximab-paclitaxel protocol.Radiation oncology (London, England) · 2016Article
- Molecularly targeted therapy for the treatment of head and neck cancer: a review of the ErbB family inhibitors.OncoTargets and therapy · 2016Review
- Balancing Safety and Efficacy of Epidermal Growth Factor Receptor Inhibitors in Patients With Squamous Cell Carcinoma of the Head and Neck.The oncologist · 2015Review
- Tumor and stromal-based contributions to head and neck squamous cell carcinoma invasion.Cancers · 2015Review
- Recent multidisciplinary approach with molecular targeted drugs for advanced head and neck cancer.International journal of clinical oncology · 2014Review
- Cetuximab: its unique place in head and neck cancer treatment.Biologics : targets & therapy · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors.
Funding
Abstract
Cetuximab is typically administered on a weekly schedule for patients with recurrent or metastatic head and neck squamous cell cancer (HNSCC). This study explores cetuximab administered every 2 weeks (q2w). In this multicenter randomized prospective phase II study, eligible patients (≤2 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease; ECOG performance status ≤2) were randomized to receive cetuximab q2w at 500 mg/m(2) (Group A) or 750 mg/m(2) (Group B). The primary end point was response rate (RECIST 1.0). Sixty-one patients were enrolled: 35 in Group A and 26 in Group B, which was closed early for lack of efficacy. Confirmed partial response rates were 11% for Group A (4/35) and 8% for Group B (2/26) according to intention to treat analysis. Partial responses occurred only among patients whose primary tumors were in the oral cavity or larynx. Median progression-free survival (PFS) and median overall survival (OS) were similar for both groups (PFS, 2.2 and 2.0 months; OS, 7.0 and 9.4 months; Groups A and B, respectively). The most common cetuximab-related adverse events (all grades) among treated subjects included rash, fatigue, and hypomagnesemia. Cetuximab, 500 mg/m(2), q2w achieves similar efficacy as conventional dosing for patients with recurrent or metastatic HNSCC. Escalating the dose to 750 mg/m(2) q2w offers no obvious therapeutic advantage.
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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.