Evidence map›Paper›PMID 33400000›Full record

Trial reportAnnals of surgical oncology2021

Phase II Trial of Adjuvant Dendritic Cell Vaccine in Combination with Celecoxib, Interferon-α, and Rintatolimod in Patients Undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Metastases.

Rajesh Ramanathan, Haroon Choudry, Heather Jones, Mark Girgis, William Gooding, Pawel Kalinski, David L Bartlett

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of surgical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.6field-weighted citation impact, top 5% 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

18 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
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  9. Article
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  13. Rintatolimod (AmpligenCancers · 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

7 authors at 3 institutions in 1 country.

Rajesh RamanathanDivision of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Haroon ChoudryDivision of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Heather JonesDivision of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Mark GirgisDivision of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
William GoodingDepartment of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.
Pawel KalinskiMedical Oncology, Roswell Park Cancer Institute, Buffalo, NY, USA.
David L BartlettDivision of Surgical Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. David.Bartlett@AHN.org.
University of Pittsburgh Medical Center · USRoswell Park Comprehensive Cancer Center · USUniversity of Pittsburgh · US

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI JOHN C. BYRD · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA047904
6 · The paper itself

Abstract

backgroundPeritoneal metastases portend poor prognosis in the setting of standard chemotherapy. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) improves outcomes, but relapse is common. We report a phase II trial evaluating the safety and efficacy of adjuvant αDC1 vaccination with chemokine modulation (CKM) after CRS/HIPEC.

methodsPatients undergoing CRS/HIPEC for appendiceal cancer, colorectal cancer, or peritoneal mesothelioma were enrolled. In addition to standard adjuvant chemotherapy, patients received intranodal and intradermal injections of autologous tumor-loaded αDC1 vaccine. After each vaccine booster, patients received CKM over 4 days, consisting of celecoxib, interferon (IFN)-α, and rintatolimod.

resultsForty-six patients underwent CRS/HIPEC followed by αDC1 treatment, including 24 appendiceal primaries, 20 colorectal, and 2 mesotheliomas. DC maturation was successful, with 97% expressing HLA-DR and CD86. Tumor cell recovery from peritoneal tumors was challenging, resulting in only 17% of patients receiving the target dose of αDC1. The αDC1 and CKM regimen was well tolerated. CKM successfully modulated serum inflammatory cytokine and chemokine levels. Median progression-free survival (PFS) for appendiceal primaries was 50.4, 34.2, and 8.9 months for grade 1, 2, and 3 tumors, respectively, while median PFS for colorectal cancer was 20.5 and 8.9 months for moderately and poorly differentiated tumors, respectively.

conclusionsAdjuvant autologous tumor antigen-loaded αDC1 vaccine and CKM is well tolerated. The mucinous nature of peritoneal metastases limits the feasibility of obtaining adequate autologous tumor cells. The improvement in median PFS did not meet our predefined thresholds, leading us to conclude that αDC1 vaccination is not appropriate for patients undergoing CRS/HIPEC for peritoneal metastases.

Indexed as

Colorectal NeoplasmsHyperthermia, InducedPeritoneal NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCelecoxibCytoreduction Surgical ProceduresDendritic CellsHumansHyperthermic Intraperitoneal ChemotherapyInterferon-alphaNeoplasm Recurrence, LocalPoly I-CPoly UCelecoxibInterferon-alphaPoly I-Cpoly(I).poly(c12,U)Poly U

Identifiers

PMID33400000
PMCPMC7784622
OpenAlexW3119474879

What OpenQuestion holds

Textmetadata
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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.