|Title||Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.|
|Publication Type||Journal Article|
|Year of Publication||2016|
|Authors||Harbeck, Nadia, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, and Kimberly Blackwell|
|Date Published||2016 Jun|
|Keywords||Antineoplastic Agents, Biosimilar Pharmaceuticals, Breast Neoplasms, Double-Blind Method, Female, Filgrastim, Granulocyte Colony-Stimulating Factor, Humans, Middle Aged, Neutropenia, Polyethylene Glycols, Recombinant Proteins|
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.
|Alternate Journal||Future Oncol|
|Original Publication||Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.|
|PubMed Central ID||PMC5705792|
|Grant List||P01 CA142538 / CA / NCI NIH HHS / United States|
Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer.