title: Four doses of unpegylated versus one dose of pegylated filgrastim as supportive therapy in R-CHOP-14 for elderly patients with diffuse large B-cell lymphoma.
abstract: The primary objective of this prospective, randomized study was to compare the efficacy of a reduced regimen of only four doses of unpegylated filgrastim from day +8 to +11 per cycle with a standard once per cycle administration of pegylated filgrastim to maintain dose-intensity of R-CHOP-14 (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone given every 14 d) in previously untreated elderly patients with diffuse large B-cell lymphoma (DLBCL). We included 51 patients (median age 66 years, range 60-76). Median dose intensity did not differ between the group of 24 patients receiving four doses of unpegylated filgrastim of each cycle (87·5%) and the group of 27 patients receiving pegylated filgrastim once per cycle on day 2 (89·4%) (P = 0·9). There was also no difference in the frequency of adverse events, such as episodes of neutropenic fever and unplanned hospitalizations. Patient characteristics that negatively influenced dose intensity were reduced performance status, advanced stage disease and poor-risk International Prognostic Index, with Eastern Cooperative Oncology Group performance status ≥2 being the most significant factor. In conclusion, a limited support with 4 d of filgrastim appears to be equivalent to pegylated filgrastim administered once per cycle, and appears to be sufficient to maintain dose-intensity of the R-CHOP-14 regimen in elderly patients with DLBCL without risk factors.
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Valentina
authors.initials: V
authors.lastname: Bozzoli
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Tisi
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Elena
authors.initials: E
authors.lastname: Maiolo
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Eleonora
authors.initials: E
authors.lastname: Alma
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Bellesi
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: D'Alo'
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Maria T
authors.initials: MT
authors.lastname: Voso
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Leone
authors.affiliation: Institute of Haematology, Catholic University S. Cuore, Rome, Italy.
authors.forename: Stefan
authors.initials: S
authors.lastname: Hohaus
mesh_terms: D000367:Age Factors; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015897:Comorbidity; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011241:Prednisone / Q000009:adverse effects / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000008:administration & dosage; D012307:Risk Factors; D000069283:Rituximab; D016896:Treatment Outcome; D014750:Vincristine / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; C571759:R-CHOP protocol; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069283:Rituximab; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim; D011241:Prednisone
keywords: G-CSF; R-CHOP-14; diffuse large B-cell lymphoma; pegylated G-CSF