Trial reportHead & neck2011
Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer.
Trial report in Head & neck, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 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.
A Phase 2, Open-label Trial of the Safety and Biological Effect of Subcutaneous IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and Neck
A Randomized Phase 2 Trial of Neoadjuvant and Adjuvant Therapy With the IRX 2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it, 54 citations in OpenAlex.
- Interventions for the treatment of oral and oropharyngeal cancers: targeted therapy and immunotherapy.The Cochrane database of systematic reviews · 2015Pooled it
- Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen.Cancer immunology, immunotherapy : CII · 2012Trial
- A short course of neoadjuvant IRX-2 induces changes in peripheral blood lymphocyte subsets of patients with head and neck squamous cell carcinoma.Cancer immunology, immunotherapy : CII · 2012Trial
- Identification of pyroptosis and hypoxia related molecular subtypes and a prognostic signature in colorectal cancer.Discover oncology · 2026Article
- Ferroptosis and oral squamous cell carcinoma: connecting the dots to move forward.Frontiers in oral health · 2024Review
- Head and Neck Squamous Cell Carcinoma Vaccine: Current Landscape and Perspectives.Current issues in molecular biology · 2023Review
- Oral squamous cell carcinomas: state of the field and emerging directions.International journal of oral science · 2023Review
- Global research trends in immunotherapy for head and neck neoplasms: A scientometric study.Heliyon · 2023Article
- Review
- Implications and Emerging Therapeutic Avenues of Inflammatory Response in HPV+ Head and Neck Squamous Cell Carcinoma.Cancers · 2022Review
- Multiplex immunofluorescence to measure dynamic changes in tumor-infiltrating lymphocytes and PD-L1 in early-stage breast cancer.Breast cancer research : BCR · 2021Article
- Defining the Role of Immunotherapy in the Curative Treatment of Locoregionally Advanced Head and Neck Cancer: Promises, Challenges, and Opportunities.Frontiers in oncology · 2021Review
- Preoperative Immunotherapy in the Multidisciplinary Management of Oral Cavity Cancer.Frontiers in oncology · 2021Review
- Neoadjuvant immunotherapy in resectable head and neck cancer: oral cavity carcinoma as a potential research model.Therapeutic advances in medical oncology · 2021Review
- Discordant Responses Between Primary Head and Neck Tumors and Nodal Metastases Treated With Neoadjuvant Nivolumab: Correlation of Radiographic and Pathologic Treatment Effect.Frontiers in oncology · 2020Article
- The Tumor Microenvironment and Immunotherapy of Oropharyngeal Squamous Cell Carcinoma.Frontiers in oncology · 2020Review
- Window of opportunity trials in head and neck cancer.Journal of cancer metastasis and treatment · 2019Article
- Window Studies in Squamous Cell Carcinoma of the Head and Neck: Values and Limits.Current treatment options in oncology · 2018Review
- Therapeutic vaccines for high-risk HPV-associated diseases.Papillomavirus research (Amsterdam, Netherlands) · 2018Review
- Head and Neck Carcinoma Immunotherapy: Facts and Hopes.Clinical cancer research : an official journal of the American Association for Cancer Research · 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
16 authors at 9 institutions in 1 country.
Funding
Abstract
backgroundCellular immune suppression is observed in head and neck squamous cell cancer (HNSCC) and contributes to poor prognosis. Restoration of immune homeostasis may require primary cell-derived cytokines at physiologic doses. An immunotherapy regimen containing a biologic, with multiple-active cytokine components, and administered with cytoxan, zinc, and indomethacin was developed to modulate cellular immunity.
methodsStudy methods were designed to determine the safety and efficacy of a 21-day neoadjuvant immunotherapy regimen in a phase 2 trial that enrolled 27 therapy-naïve patients with stage II to IVa HNSCC. Methods included safety, clinical and radiologic tumor response, disease-free survival (DFS), overall survival (OS), and tumor lymphocytic infiltrate (LI) data collection.
resultsAcute toxicity was minimal. Patients completed neoadjuvant treatment without surgical delay. By independent radiographic review, 83% had stable disease during treatment. OS was 92%, 73%, and 69% at 12, 24, and 36 months, respectively. Histologic analysis suggested correlation between survival and tumor LI.
conclusionImmunotherapy regimen was tolerated. Survival results are encouraging.
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.