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. 2017 Mar;25(3):839-845.
doi: 10.1007/s00520-016-3468-8. Epub 2016 Nov 3.

Pegfilgrastim in primary prophylaxis of febrile neutropenia following frontline bendamustine plus rituximab treatment in patients with indolent non-Hodgkin lymphoma: a single center, real-life experience

Claudio Cerchione  1 , Amalia De Renzo  2 , Maria Di Perna  2 , Roberta Della Pepa  2 , Novella Pugliese  2 , Lucio Catalano  2 , Fabrizio Pane  2 , Marco Picardi  3
Affiliations

Pegfilgrastim in primary prophylaxis of febrile neutropenia following frontline bendamustine plus rituximab treatment in patients with indolent non-Hodgkin lymphoma: a single center, real-life experience

Claudio Cerchione et al. Support Care Cancer. 2017 Mar.

Abstract

Background: In this prospective study, the impact of granulocyte colony-stimulating factors (G-2 CSF) administered during induction treatment with bendamustine plus rituximab for indolent non- Hodgkin Llymphoma (NHL) was evaluated by comparing patients who received secondary prophylaxis with filgrastim (control group) versus. patients who received pegfilgrastim as primary prophylaxis (peg-group). The primary endpoint was the incidence rate of febrile neutropenia (FN)- related chemotherapy disruptions (regarding dose-dense and/or dose-intensity of schedule). The Ssecondary endpoint included days of hospitalization due to FN, and G-CSF-related side effects (grade ≥3 WHO toxicity criteria) in each group.

Methods: One hundred twenty-two: 122 consecutive patients, with untreated indolent NHL, were referred to our outpatient unit for remission induction immuno-chemotherapy with bendamustine-rituximab. During the first period, 61 patients received secondary prophylaxis with filgrastim, given "on demand" if ANC was <1000/mm3. During the second period, 61 patients received primary prophylaxis with pegfilgrastim in a single administration.

Results: Pegfilgrastim was significantly associated with fewer incidence rate of FN-related chemotherapy disruptions (11.4% in the control group vs. 1.6% in the peg-group, p = 0.04) and fewer days of hospitalization due to FN (median number 18 days in the control group vs. 6 in the peg-group, p = 0.04). In terms of G-CSF-related extra-hematological grade III side effects, no significant difference has been found in the two groups (9.8% in the control group vs. 11.5% in the peg-group, p = 0.77). Only one patient stopped the treatment in the peg-group due to intolerance.

Conclusions: In patients with indolent NHL, in front-line treatment with bendamustine plus rituximab, primary prophylaxis with pegfilgrastim seems to reduce the incidence of chemotherapy disruptions due to FN, and the days of hospitalization. Moreover, it is well- tolerated and may increase the opportunity to maintain the planned schedule of treatment. These results make pegfilgrastim an advantageous option in most cases both in terms of cost-effectiveness and quality of life. These preliminary observations need to be validated by controlled clinical trials.

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Conflict of interest statement

Compliance with ethical standards The protocol was approved by the local ethics committee; the study complied with the Declaration of Helsinki and its amendments. It was done in accordance with the Good Clinical Practice guidelines. All patients gave written informed consent. Conflict of interest The authors declare that they have no conflicts of interest.

Figures

Fig. 1
Fig. 1
Flow chart shows patient selection during the study. *Other immuno-chemotherapy regimens included R-CHOP, R-CVP, and R-FC [15]. **Immuno-chemotherapy with rituximab plus bendamustine was conducted according to Rummel et al. study [1]
See this image and copyright information in PMC

References

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