Evidence map›Paper›PMID 41324016›Full record

ArticleEClinicalMedicine2025

Pegylated granulocyte colony-stimulating factor primary prophylaxis versus no prophylaxis in patients with unresectable pancreatic cancer treated with modified-FOLFIRINOX: a randomized, open-label, multicenter, phase 2 trial.

Choong-Kun Lee, Ilhwan Kim, Dong Hyun Seo, Sejung Park, Minjae Kim, Sang Hun Lee, Yong June Lee, Jung Ho Kim, Chang Gon Kim, Hye Jin Choi

Abstract read
In one paragraph

Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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.

Choong-Kun LeeDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Ilhwan KimDivision of Oncology, Department of Internal Medicine, Inje University College of Medicine, Haeundae Paik Hospital, Busan, South Korea.
Dong Hyun SeoSondang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Sejung ParkSondang Institute for Cancer Research, Yonsei University College of Medicine, Seoul, South Korea.
Minjae KimYonsei University College of Medicine, Seoul, South Korea.
Sang Hun LeeDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Yong June LeeDivision of Oncology, Department of Internal Medicine, Inje University College of Medicine, Haeundae Paik Hospital, Busan, South Korea.
Jung Ho KimDivision of Infectious Diseases, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Chang Gon KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Hye Jin ChoiDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: FOLFIRINOX treatment for pancreatic cancer often causes severe neutropenia, leading to dose reductions and potentially fatal outcomes. Despite this, high-level evidence supporting pegylated granulocyte colony-stimulating factor (peg-GCSF) as the primary prophylaxis is lacking. This study aimed to determine whether primary prophylaxis of peg-GCSF can prevent severe neutropenia in patients with pancreatic cancer treated with modified-(m)FOLFIRINOX. Methods: This was an investigator-initiated, open-label, multi-institutional, randomized phase 2 trial in patients aged ≥19 years with treatment-naïve locally advanced or metastatic pancreatic cancer. Patients received oxaliplatin 85 mg/m Findings: Seventy-seven patients were enrolled from February 2022 to January 2024, with 38 in the peg-GCSF primary prophylaxis group and 39 in the control group. The primary endpoints were achieved, with significantly lower grade 3-4 neutropenia in the peg-GCSF group (2.6% vs. 38.5%, Interpretation: Peg-GCSF primary prophylaxis significantly reduced grade 3-4 neutropenia and febrile neutropenia in patients with locally advanced or metastatic pancreatic cancer treated with mFOLFIRINOX. Peg-GCSF primary prophylaxis also provided a numerical survival benefit with better patient-reported QOL. This study provides a rationale for peg-GCSF primary prophylaxis in patients with pancreatic cancer treated with mFOLFIRINOX. Funding: GC Biopharma Corp.; Severance Hospital Research Fund for Clinical Excellence; National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT).

Indexed as

FOLFIRINOXPancreatic cancerPeg-GCSFPegylated granulocyte colony-stimulating factorPrimary prophylaxis

Identifiers

PMID41324016
PMCPMC12663657

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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.