XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Giglio, Auro del; Eniu, Alexandru; Ganea-Motan, D.E.; Топузов, Э Э; Lubenau, Heinz

doi:10.1186/1471-2407-8-332

Cited by 100 publications

(92 citation statements)

References 11 publications

(15 reference statements)

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“…Previous studies have demonstrated a DSN of approximately 3.8 days in cycle 1 for breast cancer patients not treated with G-CSF during chemotherapy with doxorubicin and docetaxel [24]. Treatment with 6 mg of pegfilgrastim has demonstrated a decrease in DSN in cycle 1, with values ranging from 1.3 to 1.8 days, which is consistent with the values observed for pegfilgrastim during cycle 1 of the present study (1.2 days) [10,11,23].…”

Section: Discussionsupporting

confidence: 90%

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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Section: Discussionsupporting

confidence: 90%

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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“…Comparable safety and efficacy profiles for XM02 administered for up to a maximum of six chemotherapy cycles versus Neupogen was demonstrated. 21 The incidence of observed or protocol defined febrile neutropenia (FN) in cycle 1 was 15.0% and 8.8% in the XM02 and Neupogen groups, respectively. The most often reported drug-related adverse effects in this study were myalgia, back pain, anemia, and headache, all known adverse drug reactions to G-CSFs.…”

Section: Appropriateness Of the Use Of Filgrastim Biosimilar In Practicementioning

confidence: 99%

Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation

Barosi¹,

Bosi²,

Abbracchio³

et al. 2011

Haematologica

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The term “biosimilars” (“follow-on biologics” in the USA) has been used by the European Medicines Agency (EMA) to describe officially-approved subsequent versions of innovator biotechnological products made by a different competitor after the patent and exclusivity rights have expired.1 Biosimilars pose a problem to the clinician who is bound to require guidance on how best to capitalize on these new pharmacological opportunities. In its mandate to promote the best hematologic care, the Italian Society of Hematology (SIE) and the affiliate societies SIES (Società Italiana di Ematologia Sperimentale) and GITMO (Gruppo Italiano Trapianto di Midollo Osseo) convened an expert panel to produce a position paper on the two marketed biosimilars in hematology, i.e. epoetin and filgrastim. The panel of 8 experts was selected according to the conceptual framework elements of the NIH Consensus Development Program.2 Panel bias was minimized by eliminating from consideration strong advocates for or against the use of biosimilars. Each panel member was asked to disclose any tie he or she may have had with pharmaceutical companies manufacturing the drugs considered in the paper in the last five years. The project was conducted independently from any pharmaceutical company which sold either conventional drugs or biosimilars

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“…23 The use of biosimilars 24,25 or of a pegylated and long-lasting form of rhG-CSF 26,27 is unlikely to significantly improve the 'mobilization index'. Parathyroid hormone was even tested in a phase I trial for mobilization, and was well tolerated, with successful collection in 9 out of 20 poorly mobilizing patients.…”

Section: Discussionmentioning

confidence: 99%

Ancestim (r-metHuSCF) plus filgrastim and/or chemotherapy for mobilization of blood progenitors in 513 poorly mobilizing cancer patients: the French compassionate experience

Lapierre

Heshmati

et al. 2010

Bone Marrow Transplant

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Ancestim (r-MetHuSCF) is available in France for compassionate use in patients who are candidates for high-dose chemotherapy and autologous transplantation, and who failed in previous attempts at mobilization and collection. We report here data from 513 adult patients who benefited from this program, between January 1998 and July 2007. Given with systematic premedication, ancestim was generally well tolerated, although severe but not life-threatening adverse events were reported in 12 individuals. Overall, a graft was obtained or completed for 235 patients (46%). The median number of collected CD34 þ cells was 3.00 Â 10 6 /kg (range: 0.03-39.50). The target threshold of 2 Â 10 6 CD34 þ cells/kg was reached in 161 patients (31%). Factors associated with collection were diagnosis of myeloma, no previous autologous transplant, no more than one previous failed attempt and a mobilization regimen including cytotoxic agents. A total of 207 patients (40%) proceeded to high-dose chemotherapy and autologous transplantation. The median time to reach 0.5 Â 10 9 /L neutrophils and 20 Â 10 9 /L platelets was 12 (6-40) and 13 (0-31) days, respectively. We conclude that a combination of ancestim with filgrastim successfully mobilized CD34 þ cells in peripheral blood, and allowed adequate collection in preparation for autologous transplantation in approximately one-third of poorly mobilizing patients.

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XM02 is superior to placebo and equivalent to Neupogen™ in reducing the duration of severe neutropenia and the incidence of febrile neutropenia in cycle 1 in breast cancer patients receiving docetaxel/doxorubicin chemotherapy

Abstract: Background: Recombinant granulocyte colony-stimulating factors (G-CSFs) such as Filgrastim are used to treat chemotherapy-induced neutropenia. We investigated a new G-CSF, XM02, and compared it to Neupogen™ after myelotoxic chemotherapy in breast cancer (BC) patients.

Cited by 100 publications

References 11 publications

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

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

Key concepts and critical issues on epoetin and filgrastim biosimilars. A position paper from the Italian Society of Hematology, Italian Society of Experimental Hematology, and Italian Group for Bone Marrow Transplantation

Ancestim (r-metHuSCF) plus filgrastim and/or chemotherapy for mobilization of blood progenitors in 513 poorly mobilizing cancer patients: the French compassionate experience

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