Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2015
Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy.
Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 48 papers, 5 of them syntheses that pooled 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.
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.
An Open-label, Randomized, Multicenter, Phase II Tripegfilgrastim Trial to Reduce the Risk of Severe Neutropenia in Patients With Unresectable Pancreaticobiliary Cancers
Who cites it
48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 101 citations in OpenAlex.
- Effectiveness and safety of primary prophylaxis with G-CSF during chemotherapy for invasive breast cancer: a systematic review and meta-analysis from Clinical Practice Guidelines for the Use of G-CSF 2022.International journal of clinical oncology · 2024Pooled it
- Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Pooled it
- Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis.Scientific reports · 2019Pooled 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
- Prophylactic antibiotics or G(M)-CSF for the prevention of infections and improvement of survival in cancer patients receiving myelotoxic chemotherapy.The Cochrane database of systematic reviews · 2015Pooled it
- Efbemalenograstim Alfa, an Fc Fusion Protein, Long‑Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open‑Label Trial.Clinical drug investigation · 2025Trial
- Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Trial
- Efficacy and safety of pegfilgrastim biosimilar MD-110 in patients with breast cancer receiving chemotherapy: Single-arm phase III.Cancer medicine · 2023Trial
- Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2020Trial
- Trial
- Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.The oncologist · 2020Trial
- A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Trial
- Effectiveness and safety of pegylated filgrastim (Pelgraz®) for the prevention of febrile neutropenia during cancer chemotherapy in all-day practice in Germany.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Observational
- The safety and effectiveness of pegfilgrastim to reduce cancer chemotherapy-induced febrile neutropenia in real-world practice in Japan: a post-marketing surveillance study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Observational
- Article
- Is it appropriate to select patients for primary prophylactic use of pegfilgrastim based on the risk of febrile neutropenia?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025Article
- Optimal Primary Prophylaxis for Febrile Neutropenia During Neoadjuvant Cisplatin and 5-Fluorouracil Plus Docetaxel for Esophageal Cancer: A Retrospective Cohort Study.Cancer medicine · 2025Article
- Caught in the Crossfire: A Case of Splenic Infarction Amid G-CSF therapy in Chronic Myelomonocytic Leukaemia.European journal of case reports in internal medicine · 2025Article
- The use of granulocyte colony-stimulating factors in the management of breast cancer patients.Frontiers in oncology · 2025Review
- Severe Pseudomonas aeruginosa Pneumonia in a Breast Cancer Patient Despite Pegfilgrastim Administration.Cureus · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 9 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePegfilgrastim is a pegylated form of filgrastim, a recombinant protein of granulocyte colony-stimulating factor, that is used to reduce the risk of febrile neutropenia (FN). Here, we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide (TC) chemotherapy.
methodsWe conducted a double-blind, placebo-controlled, randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients. A total of 351 women (177 in the pegfilgrastim group and 174 in the placebo group) between 20 and 69 years of age with stage I-III invasive breast carcinoma who were to receive TC chemotherapy (docetaxel 75 mg/m(2) and cyclophosphamide 600 mg/m(2) every 3 weeks) as either neoadjuvant or adjuvant therapy were enrolled; 346 of these patients were treated with either pegfilgrastim (n = 173) or placebo (n = 173).
resultsThe incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group (1.2 vs. 68.8 %, respectively; P < 0.001). In addition, patients in the pegfilgrastim group required less hospitalization and antibiotics for FN. Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy.
conclusionsPegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients.
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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.