Trial reportCancer2017
Double-blind, randomized phase 3 trial of low-dose 13-cis retinoic acid in the prevention of second primaries in head and neck cancer: Long-term follow-up of a trial of the Eastern Cooperative Oncology Group-ACRIN Cancer Research Group (C0590).
Trial report in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Interventions for head and neck cancer survivors: Systematic review.Head & neck · 2022Pooled it
- Retinoids in cancer chemoprevention and therapy: Meta-analysis of randomized controlled trials.Frontiers in genetics · 2022Pooled it
- Article
- Perceptions of chemoprevention among individuals at high risk of oral cancer: qualitative study within the UK-based SAVER trial.BMJ open · 2025Article
- Chemoprevention of Head and Neck Cancer: A Review of Current Approaches and Future Perspectives.Cancer prevention research (Philadelphia, Pa.) · 2024Review
- Review
- Mutagen sensitivity and risk of second cancer in younger adults with head and neck squamous cell cancer: 15-year results.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2022Article
- A risk factor for newly diagnosed secondary cancer in patients with early-stage laryngeal, oropharyngeal, or hypopharyngeal cancer: sub-analysis of a prospective observation study.International journal of clinical oncology · 2022Article
- Retinol binding protein 1-dependent activation of NF- κB signaling enhances the malignancy of non-glioblastomatous diffuse gliomas.Cancer science · 2022Article
- The incidence of newly diagnosed secondary cancer; sub-analysis the prospective study of the second-look procedure for transoral surgery in patients with T1 and T2 head and neck cancer.International journal of clinical oncology · 2021Article
- Leukoplakia and Immunology: New Chemoprevention Landscapes?International journal of molecular sciences · 2020Review
- Second primary tumors in proliferative verrucous leukoplakia: a series of 33 cases.Clinical oral investigations · 2020Article
- Association between Dietary Vitamin A and HPV Infection in American Women: Data from NHANES 2003-2016.BioMed research international · 2020Article
- A subtype of oral, laryngeal, esophageal, and lung, squamous cell carcinoma with high levels of TrkB-T1 neurotrophin receptor mRNA.BMC cancer · 2019Article
- AllergoOncology: Microbiota in allergy and cancer-A European Academy for Allergy and Clinical Immunology position paper.Allergy · 2019Article
- CRBP-1 over-expression is associated with poor prognosis in tongue squamous cell carcinoma.BMC cancer · 2018Article
- Chemoprevention of Head and Neck Cancers: Does It Have Only One Face?BioMed research international · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 13 institutions in 2 countries.
Funding
Abstract
background13-Cis retinoic acid (13-CRA) is a synthetic vitamin A derivative. High-dose 13-CRA in patients with squamous cell cancers of the head and neck (SCCHNs) reduces the incidence of second primary tumors (SPTs). The authors report long-term results from a phase 3 randomized trial that compared treatment with low-dose 13-CRA versus placebo for patients who had early stage SCCHN, with a focus on the development of SPTs and overall survival (OS).
methodsIn total, 176 patients who received treatment for stage I/II SCCHN were randomized to receive either low-dose 13-CRA (weight-based dose of 7.5 mg or 10 mg) or placebo for 2 years. A competing-risk approach and the log-rank test were used to compare the time to SPT and OS, respectively, between groups.
results13-CRA neither significantly reduced the cumulative incidence of SPT (P = .61) nor improved the time to SPT (hazard ratio [HR] for 13-CRA/placebo; 0.86; P = .61). Despite limited power, there was a trend toward improved OS for the 13-CRA arm (HR, 0.75; P = .14), particularly among patients whose index tumor was surgically excised (N = 26; HR, 0.50; P = .057) and among women (N = 39; HR, 0.44; P = .065) and never/former smokers (N = 129; HR, 0.61; P = .055), with a median follow-up of 16 years. The main 13-CRA related toxicities were dry skin and cheilitis.
conclusionsTreatment with low-dose 13-CRA for 2 years did not decrease the incidence of SPT; subset analysis indicates a potential survival advantage among patients who are women and never/former smokers. More targeted interventions based on clinical risk factors and molecular characterization of tumors may yield greater success in future prevention trials. Cancer 2017;123:4653-4662. © 2017 American Cancer Society.
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