Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2009 Dec;11(12):842-8.
doi: 10.1007/s12094-009-0453-4.

Use of pegfilgrastim support on day 9 to maintain relative dose intensity of chemotherapy in breast cancer patients receiving a day 1 and 8 CMF regimen

Rodolfo Mattioli  1 , Cesare Gridelli, Javier Castellanos, Antonio Duque, Alfredo Falcone, Mauro Mansutti, Pam Bacon, Sue Lawrinson, Tomas Skacel, Ana Casas
Affiliations
Clinical Trial

Use of pegfilgrastim support on day 9 to maintain relative dose intensity of chemotherapy in breast cancer patients receiving a day 1 and 8 CMF regimen

Rodolfo Mattioli et al. Clin Transl Oncol. 2009 Dec.

Abstract

Aim: In several commonly used regimens, chemotherapy doses are split across different days of the cycle. We aimed to determine the feasibility of growth factor support with once-per-cycle pegfilgrastim in this setting.

Methods: This phase II study in breast cancer patients assessed the utility of a single 6 mg subcutaneous dose of pegfilgrastim administered on day 9 of an intravenous (IV) "split" CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2) and 5-fluorouracil 600 mg/m(2)) chemotherapy regimen administered on days 1 and 8 and repeated every 28 days for 6 cycles.

Results: Fifty-eight patients were enrolled, with 49 completing the study. For the primary endpoint, 48 patients (83%) received >or=85% of the relative dose intensity (RDI) of chemotherapy over all 6 cycles (95% confidence interval [CI], 71-91%). Across all chemotherapy cycles, 41 patients (71%) received all scheduled cycles on time and most patients (n=49, 84%) received >or=85% of the planned dose of all chemotherapy agents in all cycles. In total, 295/319 cycles (92%) were delivered on schedule and >or=85% of the planned dose of all chemotherapy agents were administered in 309/319 cycles (97%). Febrile neutropenia was reported in only 2 patients (3%). There were no grade 4 adverse events related to pegfilgrastim.

Discussion: Day 9 pegfilgrastim administration was well tolerated and provided effective protection against neutropenia in patients receiving IV CMF on days 1 and 8, allowing chemotherapy to be delivered on time and at the scheduled dose in most patients.

Trial registration: ClinicalTrials.gov NCT00124111.

PubMed Disclaimer

References

    1. Pharmacotherapy. 2003 Aug;23(8 Pt 2):9S-14S - PubMed
    1. Curr Hematol Rep. 2004 Nov;3(6):419-23 - PubMed
    1. Blood. 1992 Sep 15;80(6):1430-6 - PubMed
    1. Br J Cancer. 2003 Dec 1;89(11):2062-8 - PubMed
    1. J Thorac Oncol. 2007 Jun;2(6):520-5 - PubMed

Publication types

MeSH terms

Supplementary concepts

Associated data