Evidence map›Paper›PMID 39547453›Full record

ArticleInternational journal of radiation oncology, biology, physics2025

Phase 1 Study of Adjuvant Allogeneic Granulocyte-Macrophage Colony-Stimulating Factor-Transduced Pancreatic Tumor Cell Vaccine, Low-Dose Cyclophosphamide, and Stereotactic Body Radiation Therapy Followed by FOLFIRINOX in High-Risk Resected Pancreatic Ductal Adenocarcinoma.

Colin S Hill, Rose Parkinson, Elizabeth M Jaffee, Elizabeth Sugar, Lei Zheng, Beth Onners, Matthew J Weiss, Christopher L Wolfgang, John L Cameron, Timothy M Pawlik and 8 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–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

9 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Colin S HillLaura and Issac Perlmutter Cancer Center at New York University, Department of Radiation Oncology, New York University Grossman School of Medicine, New York, New York.
Rose ParkinsonThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Elizabeth M JaffeeThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Elizabeth SugarDivision of Biostatistics and Bioinformatics, The Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins School of Medicine, Baltimore, Maryland.
Lei ZhengThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Beth OnnersThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Matthew J WeissDepartment of Surgery, Zucker School of Medicine at Hofstra/Northwell, Lake Success, New York, New York.
Christopher L WolfgangDivision of Hepatobiliary and Pancreatic Surgery, Department of Surgery, New York, University Grossman School of Medicine, New York, New York.
John L CameronDepartment of Surgery, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Timothy M PawlikDepartment of Surgery, The Urban Meyer III and Shelley Meyer Chair for Cancer Research, The Ohio State University, Wexner Medical Center, Columbus, Ohio.
Lauren RosatiDepartment of Pediatrics, Heersink School of Medicine, University of Alabama, Birmingham, Alabama.
Dung T LeThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Amy Hacker-PrietzDepartment of Radiation Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Eric R LutzNacelle Bio, Inc., Baltimore, Maryland.
Richard SchulickDepartment of Surgery, University of Colorado School of Medicine, Aurora, Colorado; University of Colorado Cancer Center, Aurora, Colorado.
Amol K NarangDepartment of Radiation Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Daniel A LaheruThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Department of Oncology, Cancer Convergence Institute and Bloomberg-Kimmel Institute for Cancer Immunotherapy, Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: Laherda@jhmi.edu.
Joseph M HermanRadiation Medicine, Zucker School of Medicine at Hofstra/Northwell, Lake Success, New York, New York.. Electronic address: Jherman1@northwell.edu.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeLocal and distant progression remains common following resection of resectable pancreatic ductal adenocarcinoma (PDAC) despite adjuvant multiagent chemotherapy. We report a prospective institutional phase 1 trial incorporating adjuvant GVAX vaccine, low-dose cyclophosphamide (Cy), and stereotactic body radiation therapy (SBRT) followed by FOLFIRINOX (FFX) among patients who underwent resection of high-risk PDAC. PATIENTS AND

methodsThe study design was a modified 3+3. Cohort 1 received 5-fraction SBRT to 33 Gy to the tumor bed and 25 Gy to elective nodes followed by 6 cycles of full-dose FFX. After toxicity review, cohort 2 had SBRT and was switched to modified FFX (mFFX). Cohort 3 had 1 cycle of Cy/GVAX followed by SBRT, mFFX, and 4 cycles of maintenance Cy/GVAX with 6-month Cy/GVAX boosts until progression.

resultsNineteen patients were enrolled with a median follow-up of 36.2 months. To be eligible, patients were required to have close/positive margins (within ≤1 mm) (71%) and/or lymph node metastasis (79%). Overall, 63% of patients had both. In cohort 1, 67% of patients received 6 cycles of FFX; in cohort 2, 75% received 6 cycles of modified FFX. In cohort 3, 12 patients received the first dose of Cy/GVAX and SBRT with 10 individuals (83%) receiving 6 cycles of mFFX. Cohort 3 had acceptable levels of grade ≥3 thrombocytopenia, neutropenia, and diarrhea after 2 cycles of mFFX. Median overall survival (OS)/disease-free survival (DFS) for the overall cohort and cohort 3 was 36.2/18.2 months and 61.3/24.1 months, respectively. One- and 2-year OS for cohort 3 was 83%/75%, respectively. At the last follow-up (median = x), 5 patients were alive (42%) in cohort 3.

conclusionsThis is the first prospective trial to evaluate adjuvant GVAX, Cy, SBRT, and mFFX in resected PDAC patients with high-risk features. This combination regimen was well tolerated with limited toxicity and promising survival outcomes, warranting future studies to validate this regimen in the adjuvant setting.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Pancreatic DuctalCyclophosphamideGranulocyte-Macrophage Colony-Stimulating FactorPancreatic NeoplasmsRadiosurgeryAdultAgedAged, 80 and overCancer VaccinesChemotherapy, AdjuvantCombined Modality TherapyFemaleFluorouracilHumansIrinotecanCancer VaccinesCyclophosphamideFluorouracilfolfirinoxGranulocyte-Macrophage Colony-Stimulating FactorGVAX vaccineIrinotecanLeucovorinOxaliplatin

Identifiers

PMID39547453

What OpenQuestion holds

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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.