Evidence map›Paper›PMID 35289915›Full record

Trial reportThe oncologist2022

Impact of G-CSF Prophylaxis on Chemotherapy Dose-Intensity, Link Between Dose-Intensity and Survival in Patients with Metastatic Pancreatic Adenocarcinoma.

Clémence Canton, Olayidé Boussari, Mathieu Boulin, Karine Le Malicot, Julien Taieb, Laetitia Dahan, Anthony Lopez, Come Lepage, Jean-Baptiste Bachet

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT06135896 (An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT06135896 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers

TypeinterventionalSponsorNational Cancer Center, KoreaRan2024 to 2026Enrolled98ConditionsUnresectable Pancreatic Cancer, Unresectable Bile Duct Carcinoma, Unresectable Biliary Tract CarcinomaArmsTripegfilgrastim
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Clémence CantonDepartment of Hepato-Gastroenterology and Digestive Oncology, University Hospital of Dijon, Dijon, France.ORCID 0000-0002-4720-4110
Olayidé BoussariEPICAD INSERM LNC-UMR 1231 University of Burgundy and Franche-Comté, Dijon, France.
Mathieu BoulinEPICAD INSERM LNC-UMR 1231 University of Burgundy and Franche-Comté, Dijon, France.
Karine Le MalicotEPICAD INSERM LNC-UMR 1231 University of Burgundy and Franche-Comté, Dijon, France.ORCID 0000-0002-3226-8525
Julien TaiebDepartment of Hepato-Gastroenterology, Georges Pompidou European Hospital, Carpem, Sorbonne Paris City, Paris Descartes University, Paris, France.ORCID 0000-0002-9955-4753
Laetitia DahanDepartment of Hepato-Gastroenterology and Digestive Oncology, La Timone, AMU, Marseille, France.ORCID 0000-0001-5267-6190
Anthony LopezDepartment of Hepato-Gastroenterology, University Hospital Nancy-Brabois, Nancy, France.
Come LepageDepartment of Hepato-Gastroenterology and Digestive Oncology, University Hospital of Dijon, Dijon, France.
Jean-Baptiste BachetDepartment of Hepato-Gastroenterology, Pitié-Salpêtrière Hospital, Paris, France.ORCID 0000-0003-4337-286X
Inserm · FRCentre Hospitalier Régional et Universitaire de Nancy · FRHôpital de la Timone · FRSorbonne Université · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn metastatic pancreatic adenocarcinoma, few data are available on the use of granulocyte-colony stimulating factor (G-CSF) prophylaxis and its impact on dose-intensity (DI), or the link between DI and progression-free survival (PFS). This study assessed the impact of G-CSF prophylaxis on the DI received by patients and the relationship between full DI and PFS according to chemotherapy regimens. PATIENTS AND

methodsPatients from three first-line randomized phase II clinical trials were included in this retrospective cohort. G-CSF prophylaxis groups were identified and balanced according to baseline characteristics using a propensity score. Patients were classified into 2 treatment groups (FOLFIRINOX vs FOLFIRI/nab-paclitaxel (NAB)). DI was a binary variable (full/reduced). Adverse events were defined using NCI-CTCAE v4.0.

resultsOf the 498 patients, 154 (31%) were in "prophylaxis" group; 179 (36%) were treated by FOLFIRINOX and 319 (64%) by FOLFIRI/NAB. In FOLFIRINOX group, G-CSF prophylaxis was significantly associated with a higher rate of full DI (OR, 5.07; 95% CI, 1.52-16.90; P < .01) while in FOLFIRI/NAB group, it was significantly associated with a lower rate of full DI (OR, 0.23; 95% CI, 0.06-0.83; P = .03). Full DI was associated with a non-significant increase in PFS (FOLFIRINOX group: HR 0.83; 95% CI, 0.59-1.16; P = .27; FOLFIRI/NAB group: HR 0.84; 95% CI, 0.63-1.11; P = .22).

conclusionGranulocyte-colony stimulating factor prophylaxis was associated with a higher rate of full DI with FOLFIRINOX. Full DI was associated with a non-significant increase in PFS. These results need to be confirmed prospectively.

Indexed as

AdenocarcinomaPancreatic NeoplasmsAlbuminsAntineoplastic Combined Chemotherapy ProtocolsFluorouracilGranulocyte Colony-Stimulating FactorHumansPaclitaxelRetrospective StudiesAlbuminsFluorouracilGranulocyte Colony-Stimulating FactorPaclitaxeldose-intensitygranulocyte-colony stimulating factor prophylaxismetastatic pancreatic adenocarcinomaprogression-free survivalpropensity score

Identifiers

PMID35289915
PMCPMC9255980
OpenAlexW4214554632

What OpenQuestion holds

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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.