Trial reportFuture oncology (London, England)2016
Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.
Trial report in Future oncology (London, England), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01735175 (A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy), which is not on this map. Cited by 22 papers, 3 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.
A Randomized, Double-blind, Parallel-group, Multi-center Phase 3 Comparative Study Investigating Efficacy and Safety of LA-EP2006 and Neulasta® in Breast Cancer Patients Treated With Myelosuppressive Chemotherapy
Who cites it
22 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.
- Comparative Safety Profiles of Oncology Biosimilars: A Systematic Review and Network Meta-analysis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2023Pooled it
- Meta-analysis of Pharmacokinetic/Pharmacodynamic Results of 3 Phase 1 Studies with Biosimilar Pegfilgrastim.Clinical pharmacology in drug development · 2021Pooled 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
- A large multicentre, randomized, double-blind, cross-over study in healthy volunteers to compare pharmacokinetics, pharmacodynamics and safety of a pegfilgrastim biosimilar with its US- and EU-reference biologics.British journal of clinical pharmacology · 2020Trial
- Randomized phase 3 efficacy and safety trial of proposed pegfilgrastim biosimilar MYL-1401H in the prophylactic treatment of chemotherapy-induced neutropenia.Annals of hematology · 2019Trial
- Trial
- Proposed biosimilar pegfilgrastim shows similarity in pharmacokinetics and pharmacodynamics to reference pegfilgrastim in healthy subjects.British journal of clinical pharmacology · 2018Trial
- A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.Journal of cancer research and clinical oncology · 2018Trial
- Pooled analysis of two randomized, double-blind trials comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Trial
- Comparative efficacy and safety of four long-acting granulocyte colony-stimulating factors for primary prophylaxis in patients with breast cancer: a prospective observational cohort study in China.EClinicalMedicine · 2026Article
- Efficacy, safety, and cost-effectiveness of pegylated PEG-rhg-CSF in pediatric patients receiving high-intensity chemotherapy: results from a phase II study.Frontiers in pharmacology · 2024Article
- Review
- Cost-effectiveness analysis of pegfilgrastim in patients with non-small cell lung cancer receiving ramucirumab plus docetaxel in Japan.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022Article
- Economic Analysis on Adoption of Biosimilar Granulocyte Colony-Stimulating Factors in Patients With Nonmyeloid Cancer at Risk of Febrile Neutropenia Within the Oncology Care Model Framework.JCO oncology practice · 2021Article
- Pegfilgrastim Biosimilars: Where Are We Now?Journal of the advanced practitioner in oncology · 2021Article
- Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim.Cancer medicine · 2020Article
- PF-06881894, a Proposed Biosimilar to Pegfilgrastim, Versus US-Licensed and EU-Approved Pegfilgrastim Reference Products (NeulastaAdvances in therapy · 2020Article
- Biosimilar Pegfilgrastim: Improving Access and Optimising Practice to Supportive Care that Enables Cure.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020Review
- Article
- Trial Design and Statistical Considerations on the Assessment of Pharmacodynamic Similarity.The AAPS journal · 2019Article
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 5 institutions in 3 countries.
Funding
Abstract
aimThis randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1). PATIENTS &
methodsWomen (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.
resultsFor DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26).
conclusionLA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.
Indexed as
Identifiers
What OpenQuestion holds
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.