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Harbeck, Nadia; Lipatov, Oleg; Frolova, Mona; Udovitsa, Dmitry; Topuzov, Eldar; Ganea-Motan, Doina Elena; Nakov, Roumen; Singh, Pritibha; Rudy, Anita; Blackwell, Kimberly (2016): Randomized, double-blind study comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in breast cancer. In: Future Oncology, Vol. 12, No. 11: pp. 1359-1367
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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 (R), 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 x 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.