Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials.
Future Oncol
; 13(16): 1385-1393, 2017 Jul.
Article
en En
| MEDLINE
| ID: mdl-28453299
ABSTRACT
AIM:
This is a pooled subgroup analysis of Asian patients enrolled in two Phase III confirmatory studies comparing proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer. PATIENTS &METHODS:
Women were randomized to LA-EP2006 (n = 90) or reference (n = 84) pegfilgrastim (Neulasta®, Amgen, Inc., CA, USA) for ≤6 cycles of TAC chemotherapy. Primary end point was duration of severe neutropenia during Cycle 1 (number of consecutive days with absolute neutrophil count <0.5 × 109/l) with equivalence confirmed if 95% CIs were within a ±1-day margin.RESULTS:
Mean duration of severe neutropenia (days) in Cycle 1 was 1.36 ± 0.98 (LA-EP2006) versus 1.35 ± 1.06 (reference) (difference 0.01 days; 95% CI -0.30-0.32, indicating equivalence).CONCLUSION:
LA-EP2006 showed similar clinical efficacy and safety compared with reference pegfilgrastim.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Polietilenglicoles
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Neoplasias de la Mama
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Factor Estimulante de Colonias de Granulocitos
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Biosimilares Farmacéuticos
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Filgrastim
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Aged
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Female
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Humans
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Middle aged
Idioma:
En
Año:
2017
Tipo del documento:
Article