Biosimilar medicines in oncology: single-center experience with biosimilar G-CSF.

Abstract

AIMS:

A biosimilar medicine is one with proven similarity to a reference biological product for which the patent has expired and whose active ingredient is produced or derived from a living organism. Recombinant granulocyte colony-stimulating growth factors (G-CSF) are used for the prophylaxis of febrile neutropenia.

MATERIALS & METHODS:

In this observational, single-center study, a total of 48 patients with solid tumors were treated with a new biosimilar G-CSF (Zarzio(®)) for 4-14 days from the day following the end of chemotherapy.

RESULTS:

Between October 2010 and July 2011, biosimilar G-CSF was administered as primary prophylaxis in 37 patients and as secondary prophylaxis in 11 patients in our clinic. The median length of G-CSF administration was 7 days (range: 1-12 days). Three cases of febrile neutropenia were reported: two in patients with prostate adenocarcinoma and one in a patient with pulmonary squamous cell carcinoma and multiple secondary skeletal lesions. These patients were treated with antibiotics and improved within 24 h without the need for hospitalization. Nonfebrile grade 4 neutropenia was observed in a further six patients.

CONCLUSION:

Our experience indicates that the use of biosimilar G-CSF is safe and effective at reducing neutropenic complications in patients with solid tumors and may be associated with cost savings.

• Authors: Nello Salesi, Barbara Di Cocco, Maria Colonna, Enzo Veltri
• Journal: Future oncology (London, England) (Future Oncol) Vol. 8 Issue 5 Pg. 625-30 (May 2012) ISSN: 1744-8301 [Electronic] England
• PMID: 22401144 (Publication Type: Journal Article)

Chemical References

• Biosimilar Pharmaceuticals
• Granulocyte Colony-Stimulating Factor

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Biosimilar Pharmaceuticals (administration & dosage, adverse effects, therapeutic use)
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage, adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Neoplasms (complications, drug therapy)
• Neutropenia (chemically induced, prevention & control)
• Treatment Outcome