Phase II dose-finding study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

Gladkov, Oleg; Moiseyenko, Vladimir; Bondarenko, Igor; Shparyk, Yaroslav; Barash, Steven; Adar, Liat; Bias, Peter; Avisar, Noa

doi:10.1007/s12032-015-0623-x

Cited by 13 publications

(29 citation statements)

References 14 publications

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“…These molecular changes may have affected receptor‐binding ability and our ability to distinguish between the efficacy of the reference pegfilgrastim and the biosimilars. The second hypothesis is that the subjects of the present study are different from the subjects of previous studies 23‐25 . The median age of patients was 49.9‐53.4 years in previous studies; however, it was 63 years (range: 26‐92 years) in the present study.…”

Section: Discussioncontrasting

confidence: 66%

“…To date, published studies have shown no difference in efficacy and safety between reference pegfilgrastim and its biosimilars 15 . However, there is not enough evidence to draw a definitive conclusion because the number of studies is small; most of these studies were conducted in patients with breast cancer, and the interpretation of efficacy was mainly focused on the duration of neutropenia 23‐25 . In this study, the biosimilars were associated with a higher incidence of neutropenia and febrile neutropenia than the reference pegfilgrastim, especially in the first cycle of R‐CHOP chemotherapy.…”

Section: Discussionmentioning

confidence: 70%

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Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

et al. 2020

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Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte‐colony stimulating factor (G‐CSF) analog filgrastim with those of the reference pegfilgrastim. We retrospectively analyzed data from patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) who were treated with first‐line R‐CHOP chemotherapy and received pegylated G‐CSF for primary prophylaxis. The following pegylated G‐CSFs were analyzed in this study: reference pegfilgrastim (Neulasta®) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg®). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R‐CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P < .001). The number of patients with at least one episode of febrile neutropenia was also lowest in the reference cohort (pegfilgrastim: 67 of 193 patients, 34.7%; tripegfilgrastim: 38 of 69 patients, 55.1%; pegteograstim: 16 of 34 patients, 47.1%, P = .009). There were no differences in the duration of neutropenia and febrile neutropenia or treatment outcomes (rate of complete response or relapse and survival). There were no reports of grade 3 or higher adverse events requiring discontinuation of prophylactic pegylated G‐CSF in any group. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored.

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Section: Discussioncontrasting

confidence: 66%

Section: Discussionmentioning

confidence: 70%

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

et al. 2020

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“…The 40-and 50-mg-balugrastim doses were selected for evaluation based on a phase II, sequential dose-escalation pilot study of once-per-cycle 30, 40, and 50 mg of balugrastim versus 6 mg of pegfilgrastim in breast cancer patients receiving chemotherapy with doxorubicin and docetaxel [21].The phase II study suggested that, compared with pegfilgrastim, 40 and 50 mg of balugrastim provided similarly effective prophylactic neutrophil support in breast cancer patients receiving myelosuppressive chemotherapy. These findings were confirmed in the current phase III study.…”

Section: Discussionmentioning

confidence: 99%

“…This phase III noninferiority study aimed to evaluate the efficacy and safety of 40-and 50-mg doses of balugrastim versus a 6-mg dose of pegfilgrastim (Neulasta; Amgen Inc., Thousand Oaks, CA, http://www.amgen.com) for the prophylaxis of chemotherapy-induced neutropenia.The doses in the current study were chosen based on the results of a doseescalation phase II study that demonstrated similar safety and efficacy between the 40-and 50-mg doses of balugrastim and the active comparator, pegfilgrastim [21].…”

Section: Introductionmentioning

confidence: 99%

A Phase III Study of Balugrastim Versus Pegfilgrastim in Breast Cancer Patients Receiving Chemotherapy With Doxorubicin and Docetaxel

et al. 2015

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Objectives. This study aimed to evaluate the efficacy and safety of once-per-cycle balugrastim versus pegfilgrastim for neutrophil support in breast cancer patients receiving myelosuppressive chemotherapy. Methods. Breast cancer patients (n 5 256) were randomized to 40 or 50 mg of subcutaneous balugrastim or 6 mg of pegfilgrastim 24 hours after chemotherapy (60 mg/m 2 doxorubicin and 75 mg/m 2 docetaxel, every 21 days for up to 4 cycles). The primary efficacy parameter was the duration of severe neutropenia (DSN) in cycle 1. Secondary parameters included DSN (cycles 2-4), absolute neutrophil count (ANC) nadir, febrile neutropenia rates, and time to ANC recovery (cycles 1-4). Safety, pharmacokinetics, and immunogenicity were assessed.Results. Mean cycle 1 DSN was 1.0 day with 40 mg of balugrastim, 1.3with50mgofbalugrastim,and1.2withpegfilgrastim(upperlimit of 95% confidence intervals for between-group DSN differences was ,1.0 day for both balugrastim doses versus pegfilgrastim). Between-group efficacy parameters were comparable except for time to ANC recovery in cycle 1 (40 mg of balugrastim, 2.0 days; 50 mg of balugrastim, 2.1; pegfilgrastim, 2.6). Median terminal elimination half-life was 37 hours for 40 mg of balugrastim, 36 for 50 mg of balugrastim, and 45 for pegfilgrastim. Antibody response to balugrastim was low and transient, with no neutralizing effect. Conclusion. Once-per-cycle balugrastim is not inferior to pegfilgrastim in reducing cycle 1 DSN in breast cancer patients receiving chemotherapy; both drugs have comparable safety profiles. The Oncologist 2016;21:7-15 Implications for Practice: This paper provides efficacy and safety data for a new, once-per-cycle granulocyte colony-stimulating factor, balugrastim, for the prevention of chemotherapy-induced neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. In this phase III trial, balugrastim was shown to be not inferior to pegfilgrastim in the duration of severe neutropenia in cycle 1 of doxorubicin/docetaxel chemotherapy, and the safety profiles of the two agents were similar. Once-per-cycle balugrastim is a safe and effective alternative to pegfilgrastim for hematopoietic support in patients with breast cancer receiving myelosuppressive chemotherapy associated with a greater than 20% risk of developing febrile neutropenia.

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“…Neutropenia and febrile neutropenia (FN) represent two frequent complications of chemotherapy treatments. 1 Neutropenia can be defined as a reduction in the normal count of neutrophils, while FN represents a medical emergency in which the absolute neutrophils count (ANC) falls below the value of 0.5×10 9 /L and the body temperature is equal or superior to 38°C for >1 hour. 2 Neutrophils act as early responders against pathogens.…”

Section: Introduction To Balugrastim and Management Issues In Chemothmentioning

confidence: 99%

New developments in the treatment of chemotherapy-induced neutropenia: focus on balugrastim

Ghidini¹,

Hahne²,

Trevisani³

et al. 2016

TCRM

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Neutropenia and febrile neutropenia are two major complications of chemotherapy. Dose reductions, delays in treatment administration, and the use of granulocyte colony-stimulating factors are equally recommended options to preserve absolute neutrophil count in case of chemotherapy regimens bringing a risk of febrile neutropenia of 20% or higher. Recombinant granulocyte colony-stimulating factors, such as filgrastim and lenograstim, have a short elimination half-life (t1/2) and need to be used daily, while others, like pegfilgrastim and lipegfilgrastim, are characterized by a long t1/2 requiring only a single administration per cycle. Balugrastim is a novel long-acting recombinant granulocyte colony-stimulating factor obtained by means of a genetic fusion between recombinant human serum albumin and granulocyte colony-stimulating factor. Albumin binding increases the molecular weight and determines a high plasmatic stability leading to a t1/2 of ~19 days. Balugrastim’s efficacy, safety, and tolerability have been assessed in four different clinical trials involving breast cancer patients treated with doxorubicin and docetaxel. Pegfilgrastim was chosen as a comparator. Balugrastim was noninferior to pegfilgrastim with regard to the reduction of mean duration of severe neutropenia during cycle 1. Moreover, both treatments were comparable in terms of efficacy and safety profile. Balugrastim was well tolerated, with the only related adverse event being mild to moderate bone pain. The aim of this review is to summarize the currently available literature data on balugrastim.

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Phase II dose-finding study of balugrastim in breast cancer patients receiving myelosuppressive chemotherapy

Cited by 13 publications

References 14 publications

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

A Phase III Study of Balugrastim Versus Pegfilgrastim in Breast Cancer Patients Receiving Chemotherapy With Doxorubicin and Docetaxel

New developments in the treatment of chemotherapy-induced neutropenia: focus on balugrastim

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