ArticleESMO open2026
A randomized, placebo-controlled, phase II study of docetaxel and platinum with or without erlotinib in recurrent/metastatic head and neck squamous-cell carcinomas.
Article in ESMO open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
purposeWe conducted a randomized phase II trial to evaluate whether adding erlotinib to platinum/docetaxel improves clinical outcomes in the first-line treatment of recurrent or metastatic head and neck squamous-cell carcinomas, building on our previous single-arm phase II trial. PATIENTS AND
methodsThis was a placebo-controlled, double-blind, single-center phase II study. Patients (N = 120) were randomly assigned (1 : 1) to receive platinum (carboplatin area under the curve 6 or cisplatin 75 mg/m
resultsMedian PFS was 6.1 months with erlotinib versus 4.4 months with placebo [hazard ratio (HR) 0.63, 95% confidence interval (CI) 0.42-0.95, P = 0.026]. Median overall survival was 17.0 months in the erlotinib arm compared with 13.7 months in the control arm (HR 0.67, 95% CI 0.43-1.04, P = 0.0718), meeting the prespecified type I error threshold. Subgroup analyses demonstrated numerically favorable PFS HRs across most clinical subgroups, with a more pronounced benefit observed in patients with oropharyngeal and human papillomavirus-related tumors. Development of grade ≥2 rash during the first cycle of erlotinib was associated with significantly improved overall survival (HR 0.40, 95% CI 0.19-0.87, P = 0.021). The addition of erlotinib increased the incidence of grade 2-4 adverse events, particularly gastrointestinal toxicity, rash, fatigue, and dehydration but no unexpected safety signals were observed.
conclusionsThe study met its primary endpoint, supporting the continued relevance of epidermal growth factor receptor (EGFR) inhibition in this disease. Although contemporary immunotherapy-based standards limit direct adoption of this regimen, these results provide clinically meaningful insight into EGFR biology and support further development of modernized, tyrosine kinase inhibitor-based EGFR strategies, including rational combinations and biomarker-driven approaches, to improve outcomes.
Indexed as
Identifiers
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.