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G-CSF use in patients receiving first-line chemotherapy for non-Hodgkin’s lymphoma (NHL) and granulocyte-colony stimulating factors (G-CSF) as observed in clinical practice in Italy

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Abstract

Treatment of non-Hodgkin lymphoma (NHL) requires chemotherapy regimens with significant risk of febrile neutropenia (FN). For patients at ≥20% FN risk, guidelines recommend primary prophylaxis (PP) with granulocyte-colony stimulating factor (G-CSF). This study assessed whether G-CSF use in NHL was in line with recommendations in routine practice. This was a retrospective, observational study of adult NHL patients receiving first-line (R)CHOP-like chemotherapy and G-CSF support between June 2010 and 2012, in Italy. The primary outcome was whether G-CSF was provided as PP, which was defined as G-CSF initiation on days 1–3 after chemotherapy, ≥3 days’ use for daily G-CSFs and continued prophylaxis from cycle 1 across all cycles. Secondary prophylaxis was defined as continued prophylaxis from cycle 2 or later, and all other use was defined as Suboptimal. The analysis included 199 patients, 61% of whom had diffuse large B cell lymphoma and 21% follicular lymphoma. (R)CHOP-21 was given to 52% of patients and (R)CHOP-14 to 32%. Overall, 29% of patients received PP, while two-thirds received Suboptimal G-CSF. Of patients receiving daily G-CSF, 3% received PP and 94% received Suboptimal use; with pegfilgrastim, 65% received PP and 26% Suboptimal use. FN occurred in 13 patients (7%) and grade 3/4 neutropenia in 43%. Chemotherapy dose delays occurred in 22% and dose reductions in 18% of patients. Delivery of G-CSF, particularly daily G-CSFs, was not in accordance with guideline or product label recommendations in a large proportion of NHL patients receiving chemotherapy in Italy.

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Acknowledgements

This study was sponsored by Amgen.

Author’s contributions

Authors UV, FA and MF conducted the clinical research, and all authors were responsible for the study conduct, as well as interpretation and reporting of the data. With financial support from Amgen, Claudio Iannacone, Sparc Consulting, Milan, Italy, provided statistical support, Giovanna DiTuri, McCann Complete Medical, Milan, Italy, provided project management support and helped to develop the eCRF and Linda Woodford, Claris2 GmbH, Zug, Switzerland, provided medical writing support. James O’Kelly, Amgen Ltd, provided critical review of the manuscript.

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Authors and Affiliations

  1. A.O.U Città della Salute e della Scienza di Torino, Turin, Italy

    Umberto Vitolo

  2. Ospedale Spirito Santo, Pescara, Italy

    Francesco Angrili

  3. Amgen Ltd, London, UK

    Lucy DeCosta & Sally Wetten

  4. Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica, Università di Modena e Reggio Emilia, Modena, Italy

    Massimo Federico

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  1. Umberto Vitolo
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Correspondence to Sally Wetten.

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Conflict of interest

Authors LD and SW are employees of Amgen and own shares in Amgen. Authors UV, FA and MF have received consultation fees from Amgen. Author UV has received honoraria for speaking at symposia from Roche, Celgene, Janssen, Takeda and Gilead and has participated in advisory boards for Roche and Janssen.

Ethical approval

Approval was obtained from the Ethics Committees of the University Hospital San Giovanni Battista, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Province of Modena, University Hospital Careggi, University Hospital San Andrea, University of Pescara, University Hospital “Policlinico—Vittorio Emanuele”, IRCCS Ospedale Oncologico di Bari and the Università Cattolica del Sacro Cuore—University Hospital Agostino Gemelli in Italy. All procedures performed in this study were in accordance with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Vitolo, U., Angrili, F., DeCosta, L. et al. G-CSF use in patients receiving first-line chemotherapy for non-Hodgkin’s lymphoma (NHL) and granulocyte-colony stimulating factors (G-CSF) as observed in clinical practice in Italy. Med Oncol 33, 139 (2016). https://doi.org/10.1007/s12032-016-0850-9

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