The efficacy and safety of FSK0808, filgrastim biosimilar: a multicenter, non-randomized study in Japanese patients with breast cancer.

Abstract

OBJECTIVE:

FSK0808 is a filgrastim biosimilar. This study assessed the efficacy and safety of FSK0808 in patients with breast cancer.

METHODS:

One hundred and four breast cancer patients undergoing chemotherapy were enrolled in the study. FSK0808 was used to treat the neutropenia experienced by the patients in the course of their chemotherapy. Efficacy was evaluated by the recovery of absolute neutrophil count following FSK0808 administration based on the duration of neutropenia in patients who received pre- or postoperative chemotherapy containing fluorouracil, epirubicin and cyclophosphamide. Adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events version 3.0. The incidence of febrile neutropenia and generation of an anti-granulocyte colony-stimulating factor antibody were also evaluated.

RESULTS:

The average duration of neutropenia in Cycle 2 was 2.2 days with a standard deviation of 1.5 days. The upper limit of the 97.5% one-sided confidence interval was 2.5 days and was confirmed not to exceed 3.0 days, which was defined as the threshold value of absolute neutrophil count recovery. The incidence of febrile neutropenia across all treatment cycles was 34.6%. Observed adverse drug reactions with an incidence of > 5% were back pain (60.6%), bone pain (9.6%), alanine aminotransferase increase (8.7%), aspartate aminotransferase increase (5.8%) and arthralgia (5.8%). Production of the anti-granulocyte colony-stimulating factor antibody was not observed in any patient during the study.

CONCLUSIONS:

FSK0808 was safe and well tolerated in breast cancer patients undergoing chemotherapy and effectively stimulated neutrophil recovery.

• Authors: Yoshiaki Sagara, Kazuhiko Sato, Eisuke Fukuma, Kenji Higaki, Mitsuhiro Mizutani, Akihiko Osaki, Toshimi Takano, Yutaka Tokuda, Shinji Ohno, Norikazu Masuda, Masato Suzuki, Toshiaki Saeki
• Journal: Japanese journal of clinical oncology (Jpn J Clin Oncol) Vol. 43 Issue 9 Pg. 865-73 (Sep 2013) ISSN: 1465-3621 [Electronic] England
• PMID: 23858037 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Biosimilar Pharmaceuticals
• FSK0808
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• Epirubicin
• Cyclophosphamide
• Filgrastim
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Biosimilar Pharmaceuticals (therapeutic use)
• Breast Neoplasms (chemically induced, drug therapy, etiology)
• Cyclophosphamide (adverse effects)
• Drug-Related Side Effects and Adverse Reactions (drug therapy, prevention & control)
• Epirubicin (adverse effects)
• Female
• Filgrastim
• Fluorouracil (adverse effects)
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects, therapeutic use)
• Humans
• Incidence
• Japan (epidemiology)
• Leukocyte Count
• Middle Aged
• Neutropenia (chemically induced, drug therapy, epidemiology, prevention & control)
• Neutrophils (drug effects)
• Recombinant Proteins