{
  "abstract": "Chemotherapy-induced neutropenia (CIN) constitutes a substantial disease burden globally. Although pegfilgrastim (a long-acting granulocyte-colony stimulating factor) has demonstrated efficacy in preventing CIN, it is not yet available in China. This is the first clinical study to evaluate a pegfilgrastim biosimilar in China. This multicenter, randomized, double-blind, parallel-controlled, phase 3 equivalence study aims to evaluate the efficacy and safety of GB-K02 (a pegfilgrastim biosimilar) in preventing CIN among 250 patients with breast cancer. The primary efficacy endpoint was the duration of grade 4 neutropenia (DG4N) in cycle 1 of chemotherapy. The DG4N (LSMean ± SE) in cycle 1 was 0.58 ± 0.13 days versus 0.80 ± 0.13 days (p = 0.2139) for the GB-K02 group and the pegfilgrastim group, respectively. Other efficacy endpoints and safety were also similar between the two groups in 4 cycles of chemotherapy. Overall, GB-K02 demonstrated proper equivalence to pegfilgrastim and might offer an option in preventing CIN in China.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": "Article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "name": "Jinhai Lin"
    },
    {
      "name": "Hengxin Peng"
    },
    {
      "name": "Yijia Zhang"
    },
    {
      "name": "Yufang Yi"
    },
    {
      "name": "Kangsheng Yang"
    },
    {
      "name": "Yanqing Lin"
    },
    {
      "name": "Huiping Li"
    },
    {
      "name": "Suofu Qin",
      "orcid": "0000-0002-3323-8846"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/86e6a5zwc1ba6.bib",
  "cited_by": 0,
  "doi": "10.1016/j.isci.2026.117766",
  "fulltext_url": "https://europepmc.org/articles/PMC13677192",
  "id": "86e6a5zwc1ba6",
  "issns": [
    "2589-0042"
  ],
  "landing_url": "https://www.cell.com/iscience/fulltext/S2589-0042(26)03147-0",
  "language": "eng",
  "licence": "CC-BY-NC-ND-4.0",
  "licence_label": "CC BY-NC-ND 4.0",
  "licence_source": "article",
  "licence_url": "http://creativecommons.org/licenses/by-nc-nd/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Interventions"
    ],
    [
      "heading",
      "Oncology"
    ],
    [
      "openalex",
      "2730|Neutropenia and Cancer Infections"
    ]
  ],
  "openalex": "W7221197890",
  "pdf_url": "https://europepmc.org/articles/PMC13677192?pdf=render",
  "pmcid": "PMC13677192",
  "pmid": "42894857",
  "published": "2026-10-09",
  "publisher": "Elsevier BV",
  "ris": "https://research.draconitic.com/paper/86e6a5zwc1ba6.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:17:16Z",
      "native_id": "10.1016/j.isci.2026.117766",
      "source": "feed-cell",
      "url": "https://www.cell.com/iscience/fulltext/S2589-0042(26)03147-0"
    },
    {
      "first_seen": "2026-10-30T12:17:49Z",
      "native_id": "10.1016/j.isci.2026.117766",
      "source": "crossref",
      "url": "https://linkinghub.elsevier.com/retrieve/pii/S2589004226031470"
    },
    {
      "first_seen": "2026-10-30T12:19:33Z",
      "native_id": "MED:42894857",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42894857"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "heading:Oncology",
      "subfield": "oncology"
    }
  ],
  "title": "A phase 3 trial of GB-K02 pegfilgrastim biosimilar for preventing chemotherapy-induced neutropenia in breast cancer",
  "title_text": "A phase 3 trial of GB-K02 pegfilgrastim biosimilar for preventing chemotherapy-induced neutropenia in breast cancer",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:33Z",
  "url": "https://research.draconitic.com/paper/86e6a5zwc1ba6",
  "venue": "iScience",
  "versions": []
}