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A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice


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 × 109/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.

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  1. Granulokine® is the Italian brand name for Neupogen®.

  2. Granulokine® is the Italian brand name for Neupogen®.

  3. Granulokine® is the Italian brand name for Neupogen®.


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This study was supported by Amgen-Dompé, Milan, Italy. Wanda J. Krall, PhD, a medical writer funded by Amgen (Europe) GmbH, assisted with the drafting of this manuscript. Thanks to Valter Torri for providing some additional statistical analysis.

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The authors declare no conflict of interest.

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Correspondence to S. Barni.

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This study was carried out on behalf of OBSERVE investigators.

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Barni, S., Lorusso, V., Giordano, M. et al. A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice. Med Oncol 31, 797 (2014).

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  • G-CSF
  • Solid tumors
  • Observational study
  • Oncology practice
  • Italy
  • Guidelines