Primary Prophylaxis Lapelga® in Early Breast Cancer: A Real-World Experience

Curr Oncol. 2023 Mar 9;30(3):3217-3222. doi: 10.3390/curroncol30030244.

Abstract

Background: Lapelga® was approved by Health Canada as a pegfilgrastim biosimilar in 2019 and remains the most commonly used biosimilar in Ontario and is fully reimbursed under the Ontario Drug Benefit program in this category. We explored the efficacy and tolerability of Lapelga® in a retrospective analysis of patients with early breast cancer who underwent adjuvant chemotherapy supported with Lapelga® as a primary prophylaxis.

Methods: Adult patients with early breast cancer treated with adjuvant chemotherapy at the London Regional Cancer Program in London, ON, Canada between May 2019 and June 2022 were included. All of these patients were supported with Lapelga® as the primary prophylaxis. Patients' age, tumour, and nodal status, their type of chemotherapy, co-morbid conditions, and incidence of febrile neutropenia (FN) and its related details as well as any reported side effects to Lapelga® were collected.

Results: A total of 201 patients were included in this review with majority (78%) of patients under 65 years of age. One third of patients were treated with the adriamycin and cyclophosphamide (AC)-Paclitaxel dose dense chemotherapy and a quarter of patients with either a docetaxel and cyclophosphamide (TC) combination or an AC-dose dense with Paclitaxel weekly, and 10% or less patients had FEC-D (5-fluorouracil, epirubicin, and cyclophosphamide) and AC chemotherapy. FN incidence was only 3.48% in this review (7/201 patients). Patients with FN were admitted to hospital and recovered completely with no mortality reported. No cases of a switch to a different granulocyte colony growth factor were seen. The most frequent side effects from Lapelga® included musculoskeletal pain, fever, and headache. However, the majority of patients (88.6%; 178/201) did not have any reported side effects specifically assigned to Lapelga®.

Conclusions: In this single centre retrospective study, early breast cancer patients (n = 201) treated with adjuvant chemotherapy supported with primary prophylaxis with Lapelga® had a low incidence of FN (3.48%). This supports Lapelga® being an effective strategy as the primary prophylaxis when used with common chemotherapy regimens in the real-world setting.

Keywords: Lapelga®; breast cancer; febrile neutropenia; pegfilgrastim.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Biosimilar Pharmaceuticals* / therapeutic use
  • Breast Neoplasms* / pathology
  • Cyclophosphamide / therapeutic use
  • Doxorubicin / therapeutic use
  • Female
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Humans
  • Ontario
  • Paclitaxel / therapeutic use
  • Retrospective Studies

Substances

  • Biosimilar Pharmaceuticals
  • Granulocyte Colony-Stimulating Factor
  • Cyclophosphamide
  • Doxorubicin
  • Paclitaxel

Grants and funding

Unrestricted research grant funding from Apobiologix was obtained for creation of the Canadian Breast Cancer Registry Database that was used to extract the data for this retrospective study. Funders had no role in the study design, data collection and analysis, interpretation and writing, or in the decision of manuscript submission. All co-authors operate independently of the funding agencies.