title: A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice.
abstract: Febrile neutropenia (FN) is a severe dose-limiting side effect of myelosuppressive chemotherapy in patients with solid tumors. Clinical practice guidelines recommend primary prophylaxis with G-CSF in patients with an overall ≥ 20 % risk of FN. AIOM Italian guidelines recommend starting G-CSF within 24-72 h after chemotherapy; for daily G-CSF, administration should continue until the absolute neutrophil count (ANC) is 1 × 10(9)/L post-nadir and should not be terminated after ANC increase in the early days of administration. The aim of this study was to assess guideline adherence in oncology practice in Italy. In this multicenter, prospective, observational study, patients were enrolled at the first G-CSF use in any cycle and were followed for two subsequent cycles (or until the end of chemotherapy if less than two additional cycles). Primary objective was to explore G-CSF use in Italian clinical practice; therefore, data were collected on the G-CSF type, timing of administration, and number of doses. 512 eligible patients were enrolled (median age, 62). The most common tumor types were breast (36 %), lung (18 %), and colorectal (13 %). A total of 1,164 G-CSF cycles (daily G-CSF, 718; pegfilgrastim, 446) were observed. Daily G-CSF was administered later than 72 h after chemotherapy in 42 % of cycles, and the median [range] number of doses was four [1, 10]. Pegfilgrastim was administered later than 72 h in 8 % of cycles. G-CSF prophylaxis in Italy is frequently administered in a manner which is not supported by evidence-based guidelines. As this practice may lead to poor outcomes, educational initiatives are recommended.
authors.affiliation: Oncology Department, Azienda Ospedaliera Treviglio, Treviglio, BG, Italy, sandro.barni@ospedale.treviglio.bg.it.
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.forename: M
authors.initials: M
authors.lastname: Giordano
authors.forename: G
authors.initials: G
authors.lastname: Sogno
authors.forename: T
authors.initials: T
authors.lastname: Gamucci
authors.forename: A
authors.initials: A
authors.lastname: Santoro
authors.forename: R
authors.initials: R
authors.lastname: Passalacqua
authors.forename: V
authors.initials: V
authors.lastname: Iaffaioli
authors.forename: N
authors.initials: N
authors.lastname: Zilembo
authors.forename: M
authors.initials: M
authors.lastname: Mencoboni
authors.forename: M
authors.initials: M
authors.lastname: Roselli
authors.forename: G
authors.initials: G
authors.lastname: Pappagallo
authors.forename: P
authors.initials: P
authors.lastname: Pronzato
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000378:metabolism* / Q000627:therapeutic use*; D019983:Guideline Adherence; D006801:Humans; D007558:Italy; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000097:blood / Q000188:drug therapy*; D009504:Neutrophils / Q000166:cytology; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D016179:Granulocyte Colony-Stimulating Factor