Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: A pilot study

Luigi Rossi, Federica Tomao, Giuseppe Lo Russo, Anselmo Papa, Federica Zoratto, Raffaella Marzano, Enrico Basso, Erika Giordani, Monica Verrico, Fabio Ricci, Giulia Pasciuti, Edoardo Francini, Silverio Tomao

Research output: Contribution to journalArticle

Abstract

Background: Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy. Materials and methods: Twenty women were enrolled. All patients received epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS). Results: The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group. Conclusion: In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.

Original languageEnglish
Pages (from-to)457-462
Number of pages6
JournalTherapeutics and Clinical Risk Management
Volume9
Issue number1
DOIs
Publication statusPublished - 2013

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Chemotherapy
Adjuvant Chemotherapy
pain
Bone
cancer
Breast Neoplasms
Safety
Neutropenia
incidence
school grade
Group
prophylaxis
Bone and Bones
Pain
Toxicity
Blood
Drug Therapy
Incidence
lenograstim
pegfilgrastim

Keywords

  • Adjuvant anthracycline-based chemotherapy
  • Bone pain
  • Breast cancer
  • Lenograstim
  • Neutropenia
  • Pegfilgrastim

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Safety Research
  • Chemical Health and Safety

Cite this

Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100 : A pilot study. / Rossi, Luigi; Tomao, Federica; Russo, Giuseppe Lo; Papa, Anselmo; Zoratto, Federica; Marzano, Raffaella; Basso, Enrico; Giordani, Erika; Verrico, Monica; Ricci, Fabio; Pasciuti, Giulia; Francini, Edoardo; Tomao, Silverio.

In: Therapeutics and Clinical Risk Management, Vol. 9, No. 1, 2013, p. 457-462.

Research output: Contribution to journalArticle

Rossi, L, Tomao, F, Russo, GL, Papa, A, Zoratto, F, Marzano, R, Basso, E, Giordani, E, Verrico, M, Ricci, F, Pasciuti, G, Francini, E & Tomao, S 2013, 'Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: A pilot study', Therapeutics and Clinical Risk Management, vol. 9, no. 1, pp. 457-462. https://doi.org/10.2147/TCRM.S48387
Rossi, Luigi ; Tomao, Federica ; Russo, Giuseppe Lo ; Papa, Anselmo ; Zoratto, Federica ; Marzano, Raffaella ; Basso, Enrico ; Giordani, Erika ; Verrico, Monica ; Ricci, Fabio ; Pasciuti, Giulia ; Francini, Edoardo ; Tomao, Silverio. / Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100 : A pilot study. In: Therapeutics and Clinical Risk Management. 2013 ; Vol. 9, No. 1. pp. 457-462.
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title = "Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: A pilot study",
abstract = "Background: Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy. Materials and methods: Twenty women were enrolled. All patients received epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS). Results: The incidence of grade 3-4 neutropenia was 75{\%} in patients who received pegfilgrastim, and 25{\%} in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5{\%} of pegfilgrastim patients versus 58.3{\%} of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group. Conclusion: In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.",
keywords = "Adjuvant anthracycline-based chemotherapy, Bone pain, Breast cancer, Lenograstim, Neutropenia, Pegfilgrastim",
author = "Luigi Rossi and Federica Tomao and Russo, {Giuseppe Lo} and Anselmo Papa and Federica Zoratto and Raffaella Marzano and Enrico Basso and Erika Giordani and Monica Verrico and Fabio Ricci and Giulia Pasciuti and Edoardo Francini and Silverio Tomao",
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T1 - Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100

T2 - A pilot study

AU - Rossi, Luigi

AU - Tomao, Federica

AU - Russo, Giuseppe Lo

AU - Papa, Anselmo

AU - Zoratto, Federica

AU - Marzano, Raffaella

AU - Basso, Enrico

AU - Giordani, Erika

AU - Verrico, Monica

AU - Ricci, Fabio

AU - Pasciuti, Giulia

AU - Francini, Edoardo

AU - Tomao, Silverio

PY - 2013

Y1 - 2013

N2 - Background: Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy. Materials and methods: Twenty women were enrolled. All patients received epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS). Results: The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group. Conclusion: In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.

AB - Background: Neutropenia is a common toxicity in patients receiving myelosuppressive chemotherapy. In this prospective pilot study, we compared the efficacy and safety profiles of pegfilgrastim administered subcutaneously once per cycle and lenograstim administered subcutaneously daily six times per cycle, for primary neutropenia prophylaxis in women with breast cancer receiving adjuvant anthracycline-based chemotherapy. Materials and methods: Twenty women were enrolled. All patients received epirubicin 100 mg/m2 with 5-fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 and every 21 days thereafter, according to the FEC 100 chemotherapy regimen. Eight patients received a single dose of pegfilgrastim on day 2, while 12 patients were treated with daily administration of lenograstim from days five to ten. Absolute neutrophil count and duration of grade 3-4 neutropenia were monitored using seriated blood samples. The incidence of bone pain was evaluated using the visual analog scale (VAS). Results: The incidence of grade 3-4 neutropenia was 75% in patients who received pegfilgrastim, and 25% in patients who received lenograstim. One case of febrile neutropenia was shown in pegfilgrastim patients. The mean duration of grade 3-4 neutropenia was 2 days in pegfilgrastim group versus 1.4 days in the lenograstim group. Bone pain was present in 37.5% of pegfilgrastim patients versus 58.3% of lenograstim patients. The mean duration of bone pain in the pegfilgrastim group was 4 days versus 6 days in the lenograstim group. Conclusion: In our experience, a single injection of pegfilgrastim was less effective for controlling neutropenia than six daily injections of lenograstim. The safety profiles of pegfilgrastim and lenograstim were similar with a lower incidence of bone pain in patients treated with pegfilgrastim.

KW - Adjuvant anthracycline-based chemotherapy

KW - Bone pain

KW - Breast cancer

KW - Lenograstim

KW - Neutropenia

KW - Pegfilgrastim

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