Evidence map›Paper›PMID 32306076›Full record

Trial reportCancer immunology, immunotherapy : CII2020

Tumor infiltrating lymphocytes as adjuvant treatment in stage III melanoma patients with only one invaded lymph node after complete resection: results from a multicentre, randomized clinical phase III trial.

Amir Khammari, Jean-Michel Nguyen, Marie-Thérèse Leccia, Bernard Guillot, Soraya Saiagh, Marie-Christine Pandolfino, Anne-Chantal Knol, Gaëlle Quéreux, Anne Chiffolettau, Nathalie Labarrière and 1 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer immunology, immunotherapy : CII, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Engaging T cells for cleanup.Frontiers in immunology · 2025
    Review
  5. Article
  6. Article
  7. Review
  8. Review
  9. Biomimetic nanoparticles for tumor immunotherapy.Frontiers in bioengineering and biotechnology · 2022
    Review
  10. Review
  11. Past, Present, and Future of Anticancer Nanomedicine.International journal of nanomedicine · 2020
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 1 country.

Amir KhammariDermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France.
Jean-Michel NguyenSEME, PHU11, Saint-Jacques Hospital, CRCINA, INSERM, University of Nantes, Nantes, France.
Marie-Thérèse LecciaDepartment of Dermatology, Allergology and Photobiology, CHU A Michallon, Grenoble, France.
Bernard GuillotDépartement of Dermatology, University of Montpellier, CHU de Montpellier, Montpellier, France.
Soraya SaiaghUTCG, CHU Nantes, Nantes, France.
Marie-Christine PandolfinoUTCG, CHU Nantes, Nantes, France.
Anne-Chantal KnolCRCINA, INSERM, University of Angers, University of Nantes, Nantes, France.
Gaëlle QuéreuxDermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France.
Anne ChiffolettauPharmacovigilance Department, CHU Nantes, Nantes, France.
Nathalie LabarrièreCRCINA, INSERM, University of Angers, University of Nantes, Nantes, France.
Brigitte DrénoDermato-cancérology Department, CHU Nantes, CIC 1413, CRCINA, INSERM, University of Nantes, CHU Nantes-Hôtel-Dieu, 1 Place Alexis Ricordeau, 44093, Nantes Cedex 01, France. brigitte.dreno@atlanmed.fr.
Centre Hospitalier Universitaire de Nantes · FRNantes Université · FRInserm · FRCentre Hospitalier Universitaire de Grenoble · FRUniversité de Montpellier · FR

Funding

LABoratoires d'EXcellence IGO (FR) ANR-11-LABX-0016-01
6 · The paper itself

Abstract

backgroundAdoptive tumor-infiltrating lymphocytes (TIL) therapy and interleukin-2 (IL-2) have been investigated in melanoma.

aimTo confirm previously observed preventive effects of TIL + IL2 in a subgroup of patients with relapsing metastatic stage III melanoma. METHODOLOGY: Open-label, randomized two-group, multicenter five-year trial in adult stage III melanoma patients with only one invaded lymph node after complete resection. Patients received TIL + IL2 or abstention. TIL + IL2 was administered within 8 weeks after lymph node resection and 4 weeks after. Disease-free survival was assessed every 2 months up to month 18, every 3 months up to month 36 and every 4 months up to 5 years. A once-a-year follow-up was scheduled beyond the five-year follow-up. Safety was assessed throughout the trial.

resultsOverall, 49 patients accounted for the modified intent-to-treat and 47 for the PP. Slightly more male than female patients participated; mean age was 57.7 ± 11.4 years in the TIL + IL2 group and 53.5 ± 13.0 years in the abstention group. After 5 years of follow-up, 11/26 patients in the TIL + IL2 group and 13/23 in the abstention group had relapsed. There was no statistical difference between the groups (HR: 0.63 CI 95% [0.28-1.41], p = 0.258), nine patients in the TIL + IL2 and 11 in the abstention group died with no significant difference between the two groups (HR: 0.65 CI95% [0.27 - 1.59], p = 0.34). Safety was good.

conclusionWe did not confirm results of a previous trial. However, ulceration of the primary melanoma may be considered predictive of the efficacy of TIL in melanoma in adjuvant setting, in a manner similar to interferon α.

Indexed as

Adjuvants, ImmunologicAdolescentAdultAgedFemaleFollow-Up StudiesHumansImmunotherapy, AdoptiveInterleukin-2Lymphatic MetastasisLymph NodesLymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedNeoplasm Recurrence, LocalAdjuvants, ImmunologicIL2 protein, humanInterleukin-2Adjuvant therapyDisease-free survivalInterleukin-2MelanomaOverall survivalTumor infiltrating lymphocytes

Identifiers

PMID32306076
PMCPMC11027668
OpenAlexW3017306586

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.