Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.

Abstract

AIM:

This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1).

PATIENTS & METHODS:

Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 10(9)/l) with equivalence confirmed if 90% and 95% CIs were within a ±1 day margin.

RESULTS:

For DSN, LA-EP2006 was equivalent to reference (difference: 0.07 days; 90% CI: -0.09-0.23; 95% CI: -0.12-0.26).

CONCLUSION:

LA-EP2006 and reference pegfilgrastim showed no clinically meaningful differences regarding efficacy and safety in breast cancer patients receiving chemotherapy.

• Authors: Nadia Harbeck, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, Kimberly Blackwell
• Journal: Future oncology (London, England) (Future Oncol) Vol. 12 Issue 11 Pg. 1359-67 (Jun 2016) ISSN: 1744-8301 [Electronic] England
• PMID: 27020170 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antineoplastic Agents
• Biosimilar Pharmaceuticals
• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Filgrastim

Topics

• Antineoplastic Agents (adverse effects)
• Biosimilar Pharmaceuticals (therapeutic use)
• Breast Neoplasms (drug therapy)
• Double-Blind Method
• Female
• Filgrastim
• Granulocyte Colony-Stimulating Factor (pharmacology, therapeutic use)
• Humans
• Middle Aged
• Neutropenia (chemically induced, prevention & control)
• Polyethylene Glycols
• Recombinant Proteins (pharmacology, therapeutic use)