Evidence map›Paper›PMID 23650429›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized selection design trial evaluating CD8+-enriched versus unselected tumor-infiltrating lymphocytes for adoptive cell therapy for patients with melanoma.

Mark E Dudley, Colin A Gross, Robert P T Somerville, Young Hong, Nicholas P Schaub, Shannon F Rosati, Donald E White, Debbie Nathan, Nicholas P Restifo, Seth M Steinberg and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 136 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 1 pooled it
13.5field-weighted citation impact, top 1% 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

136 citing papers in PubMed, 1 synthesis or guideline pooled it, 228 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. PD-1Clinical cancer research : an official journal of the American Association for Cancer Research · 2017
    Trial
  5. Trial
  6. Trial
  7. Review
  8. Structural basis for T-cell receptor recognition of p53Acta crystallographica. Section D, Structural biology · 2026
    Article
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
  14. Review
  15. Article
  16. Review
  17. Review
  18. Facts and Hopes for Neoantigen-Enriched TIL.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Review
  19. Review
  20. Engineering adoptive cell therapy for solid tumors.Medical oncology (Northwood, London, England) · 2025
    Review

76 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 1 institution in 1 country.

Mark E DudleySurgery Branch, National Cancer Institute, National Institutes of Health, CRC 3W-5752, 10 Center Dr, Bethesda, MD 20892, USA. mark_dudley@nih.gov
Colin A Gross
Robert P T Somerville
Young Hong
Nicholas P Schaub
Shannon F Rosati
Donald E White
Debbie Nathan
Nicholas P Restifo
Seth M Steinberg
John R Wunderlich
Udai S Kammula
Richard M Sherry
James C Yang
Giao Q Phan
Marybeth S Hughes
Carolyn M Laurencot
Steven A Rosenberg
National Institutes of Health · US

Funding

Adoptive Cell Transfer Immunotherapy of CancerZIABC010984 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2025
$56.8M
Building on the success of the adoptive immunotherapy of cancerZIABC010763 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSENBERG, STEVEN · 2009 to 2020
$25.0M
Surgery Branch Cell Prep CoreZICBC010905 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HALAS, HYUNMI · 2009 to 2025
$23.9M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Cell Production Facility CoreZICBC011020 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI DUDLEY, MARK · 2009 to 2013
$6.5M
6 · The paper itself

Abstract

purposeAdoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TILs) and high-dose interleukin-2 (IL-2) administered to lymphodepleted patients with melanoma can cause durable tumor regressions. The optimal TIL product for ACT is unknown. PATIENTS AND

methodsPatients with metastatic melanoma were prospectively assigned to receive unselected young TILs versus CD8(+)-enriched TILs. All patients received lymphodepleting chemotherapy and high-dose IL-2 therapy and were assessed for response, toxicity, survival, and immunologic end points.

resultsThirty-four patients received unselected young TILs with a median of 8.0% CD4(+) lymphocytes, and 35 patients received CD8(+)-enriched TILs with a median of 0.3% CD4(+) lymphocytes. One month after TIL infusion, patients who received CD8(+)-enriched TILs had significantly fewer CD4(+) peripheral blood lymphocytes (P = .01). Twelve patients responded to therapy with unselected young TILs (according to Response Evaluation Criteria in Solid Tumors [RECIST]), and seven patients responded to CD8(+)-enriched TILs (35% v 20%; not significant). Retrospective studies showed a significant association between response to treatment and interferon gamma secretion by the infused TILs in response to autologous tumor (P = .04), and in the subgroup of patients who received TILs from subcutaneous tumors, eight of 15 patients receiving unselected young TILs responded but none of eight patients receiving CD8(+)-enriched TILs responded.

conclusionA randomized selection design trial was feasible for improving individualized TIL therapy. Since the evidence indicates that CD8(+)-enriched TILs are not more potent therapeutically and they are more laborious to prepare, future studies should focus on unselected young TILs.

Indexed as

AdolescentAdultAgedCD8-Positive T-LymphocytesChildFemaleHumansImmunotherapy, AdoptiveInterferon-gammaInterleukin-2Lymphocytes, Tumor-InfiltratingMaleMelanomaMiddle AgedProspective StudiesTumor Cells, CulturedInterferon-gammaInterleukin-2

Identifiers

PMID23650429
PMCPMC3731980
OpenAlexW1965029629

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.