Evidence map›Paper›PMID 26892612›Full record

Trial reportInternational journal of oncology2016

Triple peptide vaccination as consolidation treatment in women affected by ovarian and breast cancer: Clinical and immunological data of a phase I/II clinical trial.

Morena Antonilli, Hassan Rahimi, Valeria Visconti, Chiara Napoletano, Ilary Ruscito, Ilaria Grazia Zizzari, Salvatore Caponnetto, Giacomo Barchiesi, Roberta Iadarola, Luca Pierelli and 4 more

Abstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in International journal of oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Antigen-specific active immunotherapy for ovarian cancer.The Cochrane database of systematic reviews · 2018
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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

14 authors.

Morena AntonilliDepartment of Gynecology, Obstetrics and Urology, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Hassan RahimiDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Valeria ViscontiDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Chiara NapoletanoDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Ilary RuscitoDepartment of Gynecology, Obstetrics and Urology, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Ilaria Grazia ZizzariDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Salvatore CaponnettoDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Giacomo BarchiesiDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Roberta IadarolaDepartment of Gynecology, Obstetrics and Urology, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Luca PierelliDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Aurelia RughettiDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Filippo BellatiDepartment of Gynecology, Obstetrics and Urology, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Pierluigi Benedetti PaniciDepartment of Gynecology, Obstetrics and Urology, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.
Marianna NutiDepartment of Experimental Medicine, 'Sapienza' University of Rome, Policlinico Umberto I, 00161 Rome, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Vaccination with priming and expansion of tumour reacting T cells is an important therapeutic option to be used in combination with novel checkpoint inhibitors to increase the specificity of the T cell infiltrate and the efficacy of the treatment. In this phase I/II study, 14 high-risk disease-free ovarian (OC) and breast cancer (BC) patients after completion of standard therapies were vaccinated with MUC1, ErbB2 and carcinoembryonic antigen (CEA) HLA-A2+-restricted peptides and Montanide. Patients were subjected to 6 doses of vaccine every two weeks and a recall dose after 3 months. ECOG grade 2 toxicity was observed at the injection site. Eight out of 14 patients showed specific CD8+ T cells to at least one antigen. None of 4 patients vaccinated for compassionate use showed a CD8 activation. An OC patient who suffered from a lymph nodal recurrence, showed specific anti-ErbB2 CD8+ T cells in the bulky aortic lymph nodes suggesting homing of the activated T cells. Results confirm that peptide vaccination strategy is feasible, safe and well tolerated. In particular OC patients appear to show a higher response rate compared to BC patients. Vaccination generates a long-lasting immune response, which is strongly enhanced by recall administrations. The clinical outcome of patients enrolled in the trial appears favourable, having registered no deceased patients with a minimum follow-up of 8 years. These promising data, in line with the results of similar studies, the high compliance of patients observed and the favourable toxicity profile, support future trials of peptide vaccination in clinically disease-free patients who have completed standard treatments.

Indexed as

AdultAgedBreast NeoplasmsCancer VaccinesCarcinoembryonic AntigenDisease-Free SurvivalErb-b2 Receptor Tyrosine KinasesFemaleFlow CytometryHLA-A2 AntigenHumansImmunotherapyLymph NodesMiddle AgedMucin-1Ovarian NeoplasmsCancer VaccinesCarcinoembryonic AntigenERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesHLA-A2 AntigenMUC1 protein, humanMucin-1Peptide Fragments

Identifiers

PMID26892612
PMCPMC4777599

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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.