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 |
Journal | Future Oncol |
Volume | 12 |
Issue | 11 |
Pagination | 1359-67 |
Date Published | 2016 Jun |
ISSN | 1744-8301 |
Keywords | Antineoplastic Agents, Biosimilar Pharmaceuticals, Breast Neoplasms, Double-Blind Method, Female, Filgrastim, Granulocyte Colony-Stimulating Factor, Humans, Middle Aged, Neutropenia, Polyethylene Glycols, Recombinant Proteins |
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. |
DOI | 10.2217/fon-2016-0016 |
Alternate Journal | Future Oncol |
Original Publication | Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. |
PubMed ID | 27020170 |
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.
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