Kahan, Zsuzsanna and Grecea, Daniela and Smakal, Martin and Tjulandin, Sergei and Bondarenko, Igor and Perjesi, Luca and Illes, Andras and Horvat-Karajz, Karoly and Aradi, Ildiko (2019) Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy. BMC Cancer, Vol.19. p. 122. ISSN 1471-2407
|
Text
s12885-019-5329-6.pdf Download (831kB) | Preview |
Abstract
Background: Treatment with recombinant human granulocyte-colony stimulating factor (G-CSF) is accepted standard for prevention of chemotherapy-induced neutropenia. RGB-02 (Gedeon Richter) is a proposed biosimilar to pegylated G-CSF (Neulasta®, Amgen) with sustained release properties. This is a randomized, comparative, doubleblind, multicenter study to evaluate efficacy and safety of RGB-02 in breast cancer patients receiving cytotoxic regimen. Methods: Two hundred thirty-nine women presenting with breast cancer were randomized to RGB-02 (n = 121) and the reference product (n = 118). All patients received up to 6 cycles of docetaxel/doxorubicin chemotherapy combination and a once-per-cycle injection of a fixed 6 mg dose of pegfilgrastim. Primary endpoint was the duration of severe neutropenia (ANC < 0.5 × 109 /L) in Cycle 1 (2-sided CI 95%). Secondary endpoints included incidence and duration of severe neutropenia (in cycles 2–4), incidence of febrile neutropenia, time to ANC recovery, depth of ANC nadir, and safety outcomes. Results: The mean duration of severe neutropenia in Cycle 1 was 1.7 (RGB-02) and 1.6 days (reference), with a difference (LS Mean) of 0.1 days (95% CI -0.2, 0.4). Equivalence could be established as the CI for the difference in LS Mean lay entirely within the pre-defined range of ±1 day. This positive result was supported by the analysis of secondary endpoints, which also revealed no clinical meaningful differences. Safety profiles were comparable between groups. No neutralizing antibodies against pegfilgrastim were identified. Conclusions: Treatment equivalence in reducing the duration of chemotherapy induced neutropenia between RGB-02 and Neulasta® could be demonstrated. Similar efficacy and safety profiles of the once-per-cycle administration of RGB-02 and the pegfilgrastim reference were demonstrated. Trial registration: The trial was registered prospectively, prior to study initiation. EudraCT number (2013–003166- 14). The date of registration was 12 July, 2013.
| Item Type: | Article |
|---|---|
| Additional Information: | https://doi.org/10.1186/s12885-019-5329-6 |
| Uncontrolled Keywords: | Pegfilgrastim; Biosimilar; Chemotherapy-induced neutropenia; RGB-02; Clinical study; Breast Cancer; Therapeutic equivalence; KeyWords Plus:COLONY-STIMULATING FACTORS; SINGLE-ADMINISTRATION PEGFILGRASTIM; INDUCED FEBRILE NEUTROPENIA; PER-CYCLE PEGFILGRASTIM; DAILY FILGRASTIM; EORTC GUIDELINES; ADULT PATIENTS; MULTICENTER; PROPHYLAXIS; PHARMACOKINETICS |
| Subjects: | Oncology |
| Divisions: | Departments > Department of Oncology and Medical Radiology |
| Depositing User: | Елена Шрамко |
| Date Deposited: | 28 Feb 2019 08:52 |
| Last Modified: | 28 Feb 2019 08:52 |
| URI: | http://repo.dma.dp.ua/id/eprint/3856 |
Actions (login required)
 |
View Item |
