Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016
Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
10 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Time toxicity in cancer care: a systematic review of definitions and measurement methods.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Pooled it
- Pooled Analysis on the Effectiveness and Safety of Lipegfilgrastim in Patients With Urological Malignancies in the Real-World Setting.Frontiers in oncology · 2021Pooled it
- Meta-analysis and indirect treatment comparison of lipegfilgrastim with pegfilgrastim and filgrastim for the reduction of chemotherapy-induced neutropenia-related events.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2018Pooled it
- A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant.Annals of hematology · 2020Trial
- Risks of haematological malignancies in patients treated for solid tumours associated with the use of pegylated granulocyte colony-stimulating factors: A single centre study since 2005.Oncology letters · 2025Article
- A comparative assessment of neutropenia events, healthcare resource use, and costs among cancer patients treated with lipegfilgrastim compared with pegfilgrastim in Germany.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Cost-Utility Analysis of Lipegfilgrastim Compared to Pegfilgrastim for the Prophylaxis of Chemotherapy-Induced Neutropenia in Patients with Stage II-IV Breast Cancer.Frontiers in pharmacology · 2017Article
- Lipegfilgrastim in the management of chemotherapy-induced neutropenia of cancer patients.Biologics : targets & therapy · 2016Review
- The Effectiveness of Febrile Neutropenia Prophylaxis with Lipegfilgrastim in Routine Clinical Practice.In vivo (Athens, Greece)Review
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeLipegfilgrastim is a once-per-cycle glycoPEGylated granulocyte colony-stimulating factor (G-CSF). Noninferiority of lipegfilgrastim versus pegfilgrastim was demonstrated in a phase III trial in chemotherapy (CTx)-naïve breast cancer patients. Secondary outcomes relating to treatment burden are reported here.
methodsPatients with high-risk stage II, III, or IV breast cancer were randomized to receive lipegfilgrastim 6 mg (n = 101) or pegfilgrastim 6 mg (n = 101) subcutaneously on day 2 of each CTx cycle. Doxorubicin 60 mg/m(2) plus docetaxel 75 mg/m(2) commenced on day 1, for up to four cycles. Secondary end points included days in the hospital or intensive care unit (ICU), use of intravenous antibiotics for febrile neutropenia (FN) or related infections, and measures of CTx delivery (dose delays, reductions, and omissions).
resultsOne lipegfilgrastim recipient and two pegfilgrastim recipients were hospitalized in cycle 1 because of FN or associated infection. The lipegfilgrastim-treated patient spent 1 day in the ICU for FN, and the two pegfilgrastim-treated patients were hospitalized for FN for 5 and 6 days, respectively. All hospitalized patients received antibiotics. An additional pegfilgrastim-treated patient received antibiotics but was not hospitalized. Most patients received CTx as scheduled; over 98% received their planned doxorubicin and docetaxel doses in all cycles. In the lipegfilgrastim group, no patients had a CTx dose reduced or omitted; eight patients in the pegfilgrastim group had a CTx dose reduced or omitted during cycles 2-4.
conclusionsThe burden of treatment associated with myelosuppressive CTx was similar in breast cancer patients treated with lipegfilgrastim or pegfilgrastim.
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Registered trials
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