Trial reportJCI insight2019
Skin cancer precursor immunotherapy for squamous cell carcinoma prevention.
Trial report in JCI insight, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 44 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.
Phase I, Dual Arm, Open-Label, Trial of Intralesional 5-Fluorouracil (5FU) and Intralesional 5FU Combined With Topical Calcipotriene in Patients With Squamous Cell Carcinoma (SCC) of the Lower Extremities
Calcipotriol Plus 5-Flourouracil Immunotherapy Before Transplantation for Skin Cancer Prevention in Organ Transplant Recipients
Calcipotriol Plus 5-Fluorouracil Immunotherapy for Skin Cancer Prevention in Organ Transplant Recipients
Who cites it
44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 102 citations in OpenAlex.
- Genome-wide association study of actinic keratosis identifies new susceptibility loci implicated in pigmentation and immune regulation pathways.Communications biology · 2022Pooled it
- Tissue-Resident Memory T Cells in Skin Diseases: A Systematic Review.International journal of molecular sciences · 2021Pooled it
- Topical treatment of actinic keratoses in organ transplant recipients: a feasibility study for SPOT (Squamous cell carcinoma Prevention in Organ transplant recipients using Topical treatments).The British journal of dermatology · 2022Trial
- Randomized controlled trial of fractionated laser resurfacing on aged skin as prophylaxis against actinic neoplasia.The Journal of clinical investigation · 2021Trial
- Single-Cell Transcriptomic Mapping of PD-L1/TLR4 Remodeling Informs Topical Immunoprevention Timing in Skin Carcinogenesis.bioRxiv : the preprint server for biology · 2026Article
- Review
- Article
- Local Chemotherapy of Skin Pre-Neoplastic Lesions and Malignancies from the Perspective of Current Pharmaceutics.Pharmaceutics · 2025Review
- Chemoprevention of Keratinocyte Cancers: Could Aspirin Be the Solution?Journal of cancer prevention · 2025Review
- Epigenomic regulation of stemness contributes to the low immunogenicity of the most mutated human cancer.Cell reports · 2025Article
- Calcipotriol as a daylight photodynamic therapy enhancer: a case-control study.Dermatology reports · 2025Article
- T helper 2 cell-directed immunotherapy eliminates precancerous skin lesions.The Journal of clinical investigation · 2025Article
- Type 2 immunity to the rescue: enhancing antitumor immunity for skin cancer prevention.The Journal of clinical investigation · 2025Article
- Identification and Validation of Hub Genes in Hidradenitis Suppurativa.Clinical, cosmetic and investigational dermatology · 2025Article
- Calcipotriol and 5-Fluorouracil Combination Therapy for the Treatment of Actinic Keratosis in the Clinic: A Review Article.Clinical drug investigation · 2024Review
- Skin Cancer Care in US Veterans-Serving Those Who Served.JAMA dermatology · 2024Article
- Nonhealing vulvar ulcer associated with hyperkeratotic depigmented plaques.International journal of women's dermatology · 2024Article
- Epidemiology and Risk Factors of Actinic Keratosis. What is New for The Management for Sun-Damaged Skin.Dermatology practical & conceptual · 2024Review
- Therapeutic Approaches for Non-Melanoma Skin Cancer: Standard of Care and Emerging Modalities.International journal of molecular sciences · 2024Review
- Tumor initiation and early tumorigenesis: molecular mechanisms and interventional targets.Signal transduction and targeted therapy · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 3 institutions in 1 country.
Funding
Abstract
backgroundTopical calcipotriol plus 5-fluorouracil (5-FU) combination is an effective immunotherapy against actinic keratosis (AK), which is a precursor to squamous cell carcinoma (SCC). However, the long-term effectiveness of calcipotriol plus 5-FU treatment for SCC prevention is unknown.
methodsWe performed a blinded prospective cohort study on participants of a randomized double-blind clinical trial in which a 4-day course of topical calcipotriol plus 5-FU combination was compared to Vaseline plus 5-FU (control) for AK treatment. SCC and basal cell carcinoma (BCC) incidences were assessed at 1, 2, and 3 years after trial. Tissues were analyzed for calcipotriol plus 5-FU-induced T cell immunity in the skin.
resultsCalcipotriol plus 5-FU-induced tissue-resident memory T (Trm) cell formation in face and scalp skin associated with significantly higher erythema scores compared with control (P < 0.01). Importantly, more participants in the test cohort remained SCC-free over the more than 1,500-day follow-up period (P = 0.0765), and significantly fewer developed SCC on the treated face and scalp within 3 years (2 of 30 [7%] versus 11 of 40 [28%] in control group, hazard ratio 0.215 [95% CI: 0.048-0.972], P = 0.032). Accordingly, significantly more epidermal Trm cells persisted in the calcipotriol plus 5-FU-treated face and scalp skin compared with control (P = 0.0028). There was no significant difference in BCC incidence between the treatment groups.
conclusionA short course of calcipotriol plus 5-FU treatment on the face and scalp is associated with induction of robust T cell immunity and Trm formation against AKs and significantly lowers the risk of SCC development within 3 years of treatment.
fundingThis research was supported by internal academic funds and by grants from the Burroughs Wellcome Fund, Sidney Kimmel Foundation, Cancer Research Institute, and NIH.
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.