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Proposed biosimilar pegfilgrastim (LA-EP2006) compared with reference pegfilgrastim in Asian patients with breast cancer: an exploratory comparison from two Phase III trials.

Publication ,  Journal Article
Harbeck, N; Gascon, P; Jones, CM; Nixon, A; Krendyukov, A; Nakov, R; Li, Y; Blackwell, K
Published in: Future Oncol
July 2017

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.

Duke Scholars

Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

July 2017

Volume

13

Issue

16

Start / End Page

1385 / 1393

Location

England

Related Subject Headings

  • Treatment Outcome
  • Polyethylene Glycols
  • Oncology & Carcinogenesis
  • Neutropenia
  • Middle Aged
  • Humans
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • Female
  • Drug-Related Side Effects and Adverse Reactions
 

Citation

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MLA
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Harbeck, N., Gascon, P., Jones, C. M., Nixon, A., Krendyukov, A., Nakov, R., … Blackwell, K. (2017). 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. https://doi.org/10.2217/fon-2017-0041
Harbeck, Nadia, Pere Gascon, Clyde M. Jones, Allen Nixon, Andriy Krendyukov, Roumen Nakov, Yuhan Li, and Kimberly Blackwell. “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, no. 16 (July 2017): 1385–93. https://doi.org/10.2217/fon-2017-0041.
Harbeck, Nadia, et al. “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, vol. 13, no. 16, July 2017, pp. 1385–93. Pubmed, doi:10.2217/fon-2017-0041.
Harbeck N, Gascon P, Jones CM, Nixon A, Krendyukov A, Nakov R, Li Y, Blackwell K. 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. 2017 Jul;13(16):1385–1393.
Journal cover image

Published In

Future Oncol

DOI

EISSN

1744-8301

Publication Date

July 2017

Volume

13

Issue

16

Start / End Page

1385 / 1393

Location

England

Related Subject Headings

  • Treatment Outcome
  • Polyethylene Glycols
  • Oncology & Carcinogenesis
  • Neutropenia
  • Middle Aged
  • Humans
  • Granulocyte Colony-Stimulating Factor
  • Filgrastim
  • Female
  • Drug-Related Side Effects and Adverse Reactions