Evidence map›Paper›PMID 23229886›Full record

Trial reportJournal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract2013

Addition of algenpantucel-L immunotherapy to standard adjuvant therapy for pancreatic cancer: a phase 2 study.

Jeffrey M Hardacre, Mary Mulcahy, William Small, Mark Talamonti, Jennifer Obel, Smitha Krishnamurthi, Caio S Rocha-Lima, Howard Safran, Heinz-Joseph Lenz, E Gabriela Chiorean

2 registry-linked trialsAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 107 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing 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.

NCT00569387 phase2completednot on this map

A Phase II Study of Algenpantucel-L (HyperAcute Pancreas) Cancer Vaccine in Subjects With Surgically Resected Pancreatic Cancer

TypeinterventionalSponsorNewLink Genetics CorporationRan2007 to 2014Enrolled73ConditionsPancreatic CancerArmsHyperAcute(R)-Pancreatic Cancer Vaccine
NCT01072981 phase3completednot on this map

A Phase III Study of Chemotherapy and Chemoradiotherapy With or Without Algenpantucel-L (HyperAcute®-Pancreas) Immunotherapy in Subjects With Surgically Resected Pancreatic Cancer

TypeinterventionalSponsorNewLink Genetics CorporationRan2010 to 2016Enrolled722ConditionsPancreatic CancerArmsHyperAcute-Pancreas Immunotherapy, Gemcitabine, 5FU Chemoradiation
3 · Its place in the literature

Who cites it

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

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  18. Clinical immunotherapy in pancreatic cancer.Cancer immunology, immunotherapy : CII · 2024
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47 more citing papers are in PubMed but not listed here.

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

10 authors.

Jeffrey M HardacreDepartment of Surgery, University Hospitals Seidman Cancer Center and Case Western Reserve University, 11100 Euclid Avenue, Cleveland, OH 44106, USA. jeffrey.hardacre@UHhospitals.org
Mary Mulcahy
William Small
Mark Talamonti
Jennifer Obel
Smitha Krishnamurthi
Caio S Rocha-Lima
Howard Safran
Heinz-Joseph Lenz
E Gabriela Chiorean

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDespite continued investigation, limited progress has been made in the adjuvant treatment of resected pancreatic cancer. Novel or targeted therapies are needed.

methodsMulti-institutional, open-label, dose-finding, phase 2 trial evaluating the use of algenpantucel-L (NewLink Genetics Corporation, Ames, IA) immunotherapy in addition to chemotherapy and chemoradiotherapy in the adjuvant setting for resected pancreatic cancer (ClinicalTrials.gov identifier, NCT00569387). The primary outcome was 12-month disease-free survival. Secondary outcomes included overall survival and toxicity.

resultsSeventy patients were treated with gemcitabine and 5-fluorouracil-based chemoradiotherapy as well as algenpantucel-L (mean 12 doses, range 1-14). After a median follow-up of 21 months, the 12-month disease-free survival was 62 %, and the 12-month overall survival was 86 %. The most common adverse events were injection site pain and induration.

conclusionsThe addition of algenpantucel-L to standard adjuvant therapy for resected pancreatic cancer may improve survival. A multi-institutional, phase 3 study is ongoing (ClinicalTrials.gov identifier, NCT01072981).

Indexed as

Immunotherapy, ActivePancreatectomyPancreaticoduodenectomyAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCancer VaccinesChemoradiotherapy, AdjuvantChemotherapy, AdjuvantDeoxycytidineDrug Administration ScheduleFemaleFluorouracilFollow-Up StudiesAlgenpantucel-Lalpha-galactosyl epitopeCancer VaccinesDeoxycytidineFluorouracilGemcitabineTrisaccharides

Identifiers

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.