Evidence map›Paper›PMID 39049803›Full record

Observational studyThe oncologist2024

Treatment of locally advanced pancreatic cancer using localized trans-arterial micro perfusion of gemcitabine: combined analysis of RR1 and RR2.

Hassan Hatoum, Alexander Rosemurgy, J Augusto Bastidas, Emmanuel Zervos, Peter Muscarella, Barish H Edil, Jacob Cynamon, D Thor Johnson, Christopher Thomas, Bradley M Swinson and 6 more

2 registry-linked trialsAbstract readObservational Study
In one paragraph

Observational study in The oncologist, 2024. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02237157 phase1completednot on this map

A Dose Escalation Safety Study of Locally-Delivered (Intra-Arterial) Gemcitabine in Unresectable Adenocarcinoma of the Pancreas

TypeinterventionalSponsorRenovoRxRan2015 to 2016Enrolled20ConditionsPancreatic CancerArmsGemcitabine, local delivery
NCT02591082 completednot on this map

A Multi-Center, Post-Marketing, Prospective, Observational Study Following Treatment With Intra-Arterial Delivery of Chemotherapeutic Agents Using the RenovoCath™ RC120 Catheter

TypeobservationalSponsorRenovoRxRan2015 to 2021Enrolled25ConditionsPancreatic NeoplasmsArmsRenovoCath™ R120 Catheter
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
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

16 authors.

Hassan HatoumDepartment of Internal Medicine Hematology-Oncology Section, University of Oklahoma College of Medicine, Oklahoma City, OK, United States.ORCID 0000-0001-7553-1963
Alexander RosemurgyFlorida Hospital, Tampa, Tampa, FL, United States.
J Augusto BastidasNational Surgical Associates, Los Gatos, CA, United States.
Emmanuel ZervosDivision of Surgical Oncology, Brody School of Medicine, East Carolina University, Greenville, NC, United States.
Peter MuscarellaMontefiore Medical Center, Bronx, NY, United States.
Barish H EdilDepartment of Surgery, University of Oklahoma College of Medicine, Oklahoma City, OK, United States.
Jacob CynamonMontefiore Medical Center, Bronx, NY, United States.
D Thor JohnsonUniversity of Colorado Hospital, Aurora, CO, United States.
Christopher ThomasEast Carolina University Health, Greenville, NC, United States.
Bradley M SwinsonEast Carolina University Health, Greenville, NC, United States.
Aaron NordgrenFawcett Memorial Hospital, Port Charlotte, FL, United States.
Paul VitulliFlorida Hospital, Tampa, Tampa, FL, United States.
Charles NuttingEndovascular Consultants of Colorado, Lone Tree, CO, United States.
Matthew GipsonRIA Endovascular, Greenwood Village, CO, United States.
Alex TsobanoudisRenovoRx, Inc., Los Altos, CA, United States.
Ramtin AgahRenovoRx, Inc., Los Altos, CA, United States.

Funding

RenovoRx, Inc.
6 · The paper itself

Abstract

backgroundLocally advanced pancreatic cancer (LAPC) comprises 40% of pancreatic cancer diagnoses and has a relatively poor prognosis. Trans-arterial micro perfusion (TAMP)-mediated chemotherapy delivery to the primary tumor is a novel approach worthy of investigation. The RR1 (dose escalation) and RR2 (observational) studies examined the safety and preliminary efficacy of TAMP-delivered gemcitabine for LAPC. PATIENTS AND

methodsRR1 and RR2 data were pooled. Both studies enrolled patients with LAPC with histologically confirmed adenocarcinoma. Participant data, including age, sex, race, stage, previous treatments, toxicity, disease progression, and death, were collected. Median number of cycles and average treatment dosage were calculated. Overall survival (OS) was determined for the whole group and separately for patients who received and did not receive previous treatments. Aims of the analysis were to assess procedure safety, OS, and evaluate factors associated with OS.

resultsThe median age of the 43 patients enrolled in RR1 and RR2 was 72 years (range, 51-88 years). Median OS for the 35 eligible patients with stage III disease was 12.6 months (95% CI, 2.1-54.2 months). Previous chemoradiation was associated with significantly longer OS [27.1 months (95% CI, 8.4-40.6 months)] compared to previous systemic chemotherapy [14.6 months (95% CI, 6.4-54.2 months)] or no prior treatment [7.0 months (95% CI, 2.1-35.4 months)] (P < .001). The most common adverse events were GI related (abdominal pain, emesis, and vomiting); the most common grade 3 toxicity was sepsis.

conclusionStudy results indicate that TAMP-mediated gemcitabine delivery in patients with LAPC is potentially safe, feasible, and provides potential clinical benefits. CLINICAL

trial registrationNCT02237157 (RR1) and NCT02591082 (RR2).

Indexed as

DeoxycytidineGemcitabinePancreatic NeoplasmsAdenocarcinomaAgedAged, 80 and overAntimetabolites, AntineoplasticFemaleHumansMaleMiddle AgedAntimetabolites, AntineoplasticDeoxycytidineGemcitabinelocally advanced pancreatic cancerRR1 clinical study (NCT02237157)RR2 clinical study (NCT02591082)trans-arterial chemotherapy

Identifiers

PMID39049803
PMCPMC11299923

What OpenQuestion holds

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LicenceCC BY-NC
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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.