Evidence map›Paper›PMID 30486884›Full record

Trial reportJournal for immunotherapy of cancer2018

Re-induction using whole cell melanoma vaccine genetically modified to melanoma stem cells-like beyond recurrence extends long term survival of high risk resected patients - updated results.

Jacek Mackiewicz, Tomasz Burzykowski, Dariusz Iżycki, Andrzej Mackiewicz

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.8field-weighted citation impact, top 24% 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, 17 citations in OpenAlex.

  1. Article
  2. Article
  3. Cancer vaccines: current status and future directions.Journal of hematology & oncology · 2025
    Review
  4. Review
  5. Review
  6. The mOncogene · 2022
    Article
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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

4 authors at 2 institutions in 3 countries.

Jacek MackiewiczChair of Medical Biotechnology, University of Medical Sciences, 15 Garbary street, 61-866, Poznan, Poland. jmackiewicz@ump.edu.pl.ORCID 0000-0002-0177-2972
Tomasz BurzykowskiInteruniversity Institute for Biostatistics and statistical Bioinformatics, Hasselt University, 42 Martelarenlaan street, 3500, Diepenbeek, Belgium.
Dariusz IżyckiChair of Medical Biotechnology, University of Medical Sciences, 15 Garbary street, 61-866, Poznan, Poland.
Andrzej MackiewiczChair of Medical Biotechnology, University of Medical Sciences, 15 Garbary street, 61-866, Poznan, Poland.
Poznan University of Medical Sciences · PLHasselt University · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAGI-101H is an allogeneic gene modified whole cell therapeutic melanoma vaccine, evaluated in over 400 melanoma patients in the adjuvant and therapeutic settings. We present updated long-term survival results from two single-arm, phase II adjuvant trials (Trial 3 and Trial 5) with the focus on treatment beyond recurrence of the disease.

methodsPatients with resected high-risk melanoma (stage IIIB-IV) were enrolled to Trial 3 (n = 99) and Trial 5 (n = 97). The primary endpoint was disease-free survival (DFS), and the secondary was overall survival (OS). In the induction phase, the vaccine was administered every 2 weeks (eight times), followed by the maintenance phase every month until progression. At progression, maintenance was continued or re-induction was applied with or without surgery.

resultsIn Trial 3, the 10-year DFS was equal to 33.0% overall and to 52.4, 25.0, and 8.7% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 5, the overall 10-year DFS was equal to 24.2%, and to 37.5, 18.0, and 17.6% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 3, the 10-year OS was equal to 42.3% overall, and to 59.5, 37.5, and 17.4% for stage IIIB, IIIC, and stage IV patients, respectively. In Trial 5, the 10-year OS was equal to 34.3% overall and to 46.9, 28.0, and 29.4% for stage IIIB, IIIC, and stage IV patients, respectively. Among the 65 patients of Trial 3 who developed progression, 43 received re-induction with (n = 22) or without (n = 21) surgery. Two patients received surgery without re-induction. All the 22 progressing patients, who did not receive re-induction, died. Among the 75 patients of Trial 5 who experienced progression, 39 received re-induction with (n = 21) or without (n = 18) surgery. Among the 36 progressing patients who did not receive the re-induction, 35 died. Surgery and re-induction reduced (independently) the increase of mortality after progression in both trials, with the effect of re-induction reaching statistical significance in Trial 5.

conclusionsVaccination beyond recurrence of the disease with additional re-induction combined with surgery or alone increased long term survival of melanoma patients. However, further studies on larger patient cohorts are required.

trial registrationCentral Evidence of Clinical Trials (EudraCT Number 2008-003373-40 ).

Indexed as

AdultCancer VaccinesFemaleHumansMaleMelanomaMiddle AgedNeoplasm Recurrence, LocalNeoplastic Stem CellsSkin NeoplasmsSurvival AnalysisCancer VaccinesGenetic melanoma vaccineImmunotherapyLong-term survivalsMelanomaPhase II clinical trialsRe-induction

Identifiers

PMID30486884
PMCPMC6264600
OpenAlexW2902291621

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.