Evidence map›Paper›PMID 41273402›Full record

Observational studySupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2025

The safety and effectiveness of pegfilgrastim to reduce cancer chemotherapy-induced febrile neutropenia in real-world practice in Japan: a post-marketing surveillance study.

Nobuhiro Shibata, Hiroshi Kuwazawa, Tomoharu Yasukawa, Manabu Iwabuchi, Shigehira Saji

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Potentially preventable unplanned hospitalizations due to adverse events in patients receiving systemic anticancer therapy: a retrospective single-center study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Article
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

5 authors.

Nobuhiro ShibataDepartment of Clinical Oncology, Kansai Medical University Hospital, Hirakata, Japan. shibanob.kmu@gmail.com.ORCID http://orcid.org/0000-0001-8647-5098
Hiroshi KuwazawaKyowa Kirin Co., Ltd, Tokyo, Japan.
Tomoharu YasukawaKyowa Kirin Co., Ltd, Tokyo, Japan.
Manabu IwabuchiKyowa Kirin Co., Ltd, Tokyo, Japan.
Shigehira SajiDepartment of Medical Oncology, Fukushima Medical University, Fukushima, Japan.ORCID http://orcid.org/0000-0002-6732-8030

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe performed post-marketing surveillance of the safety and effectiveness of 3.6 mg pegfilgrastim to prevent chemotherapy-induced febrile neutropenia (FN) in real-world conditions in Japan.

methodsPatients were registered between June 2015 and May 2017 and followed prospectively. Pegfilgrastim was administered once every chemotherapy cycle (maximum 6 cycles). Use of pegfilgrastim, safety, and effectiveness in reducing FN were evaluated.

resultsFrom 300 institutions, 1,597 patients were registered and 1,479 patients were analyzed. Pegfilgrastim was given as primary prophylaxis (750 patients), as secondary prophylaxis (727 patients), or for therapeutic purposes (2 patients). The most common primary diseases were breast cancer (51.4%) and non-Hodgkin lymphoma (25.6%). Adverse events (AEs) occurred in 36.4% of patients and adverse drug reactions (ADR) in 18.5%. Common ADRs included back pain (3.6%), pyrexia (3.1%), arthralgia (2.1%), hepatic function abnormal (1.5%), myalgia (1.4%), and bone pain (1.0%). All back and/or bone pain-related ADRs were non-serious and well-controlled with non-steroidal anti-inflammatory drugs. Docetaxel-cyclophosphamide therapy among breast cancer patients was a factor influencing bone and/or back pain-related AEs by multivariate logistic regression analysis (odds ratios vs. fluorouracil-epirubicin-cyclophosphamide therapy: 2.32, P = 0.031). FN was observed in 5.3% (primary prophylaxis) and 2.5% (secondary prophylaxis) of the effectiveness analysis set in cycle 1 and decreased with increasing cycles.

conclusionThis survey confirmed that both primary and secondary prophylaxis using pegfilgrastim reduced FN in the real-world setting. No new safety concerns were identified. This survey was retrospectively registered on 26 April 2024 in the University Hospital Medical Information Network Clinical Trial Registry (UMIN000054267).

Indexed as

Antineoplastic AgentsChemotherapy-Induced Febrile NeutropeniaFilgrastimNeoplasmsAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedPolyethylene GlycolsProduct Surveillance, PostmarketingProspective StudiesYoung AdultAntineoplastic AgentsFilgrastimpegfilgrastimPolyethylene GlycolsChemotherapyFebrile neutropeniaG-CSFPegfilgrastimPost-marketing surveillanceReal-world data

Identifiers

PMID41273402
PMCPMC12640309

What OpenQuestion holds

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Registered trials

None linked

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.