Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: A randomized phase 2 trial

• Published in: Critical reviews in oncology/hematology Vol. 64; no. 1; pp. 64 - 72
• Main Authors: Romieu, G, Clemens, M, Mahlberg, R, Fargeot, P, Constenla, M, Schütte, M, Easton, V, Skacel, T, Bacon, P, Brugger, W
• Format: Journal Article
• Language: English
• Published: Shannon Elsevier Ireland Ltd 01.10.2007; Elsevier Science
• Subjects: Aged; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - toxicity; Biological and medical sciences; Breast Neoplasms - complications; Breast Neoplasms - drug therapy; Chemotherapy; Cyclophosphamide - administration & dosage; Cyclophosphamide - toxicity; Elderly; Epirubicin - administration & dosage; Epirubicin - toxicity; Female; Filgrastim; Fluorouracil - administration & dosage; Fluorouracil - toxicity; Granulocyte colony-stimulating factor; Granulocyte Colony-Stimulating Factor - administration & dosage; Granulocyte Colony-Stimulating Factor - toxicity; Gynecology. Andrology. Obstetrics; Hematology, Oncology and Palliative Medicine; Humans; Immunosuppressive agents; Mammary gland diseases; Medical sciences; Neutropenia; Neutropenia - chemically induced; Neutropenia - prevention & control; Opportunistic Infections - chemically induced; Pharmacology. Drug treatments; Polyethylene Glycols; Premedication; Recombinant Proteins; Treatment Outcome; Tumors; Granulocyte colony-stimulating factor; Antineoplastic agents; Elderly; Immunosuppressive agents; Neutropenia; Antineoplastic agent; High risk; Hemopathy; Granulocyte colony stimulating factor; Randomization; Cancerology; Phase II trial; Epirubicin; Pegylated form; Fluorouracil; Human; Drug combination; Leukopenia; Enzyme; Fluoropyrimidine derivatives; Transferases; Cytokine; Enzyme inhibitor; Breast cancer; Malignant tumor; Thymidylate synthase; Mammary gland diseases; Alkylating agent; Oxazaphosphinane derivatives; Chemotherapy; Cyclophosphamide; Pegfilgrastim; Treatment; Antimetabolic; Methyltransferases; Nitrogen mustard; Pyrimidine derivatives; Anthracyclins; Immunosuppressive agent; Therapeutic protocol
• ISSN: 1040-8428; 1879-0461
• DOI: 10.1016/j.critrevonc.2006.12.007

Abstract This randomized phase 2 study explored the feasibility of delivering four to six cycles of the dose-intensified regimen FEC-100 (5-fluorouracil, epirubicin, and cyclophosphamide) to elderly patients with stage II–III breast cancer, using pegfilgrastim for neutrophil support. Sixty patients aged 65–77 years received single 6 mg doses of pegfilgrastim on day 2 of FEC-100, either as primary prophylaxis (all cycles: PP), or as secondary prophylaxis (all cycles following a neutropenic event: SP). Neutropenic events (a composite endpoint that included grade 3 neutropenia + fever, grade 4 neutropenia, infectious complication requiring systemic anti-infectives and chemotherapy dose delay/reduction) occurred in 24/30 (80%) of the PP and 21/29 (72%) of the SP group in the first cycle. Most patients received all chemotherapy cycles at full dose on schedule (26/30 [87%] PP; 20/29 [69%] SP). These data indicate that delivery of FEC-100 is feasible with pegfilgrastim support in elderly breast cancer patients.