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

Journal Article (Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Harbeck, N; Lipatov, O; Frolova, M; Udovitsa, D; Topuzov, E; Ganea-Motan, DE; Nakov, R; Singh, P; Rudy, A; Blackwell, K

Published Date

  • June 2016

Published In

Volume / Issue

  • 12 / 11

Start / End Page

  • 1359 - 1367

PubMed ID

  • 27020170

Pubmed Central ID

  • PMC5705792

Electronic International Standard Serial Number (EISSN)

  • 1744-8301

Digital Object Identifier (DOI)

  • 10.2217/fon-2016-0016


  • eng

Conference Location

  • England