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.
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.



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.



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.



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.
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy. claudiocerc@hotmail.com.
Claudio
0000-0002-9104-5436
C
Cerchione
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Amalia
A
De Renzo
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Maria
M
Di Perna
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Roberta
R
Della Pepa
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Novella
N
Pugliese
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Lucio
L
Catalano
Hematology, Department of Clinical Medicine and Surgery, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Fabrizio
F
Pane
Department of Advanced Biomedical Science, Azienda Ospedaliera Universitaria Federico II, Via Pansini 5, 80131, Naples, Italy.
Marco
M
Picardi
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects; D064147:Febrile Neutropenia / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D005260:Female; D000069585:Filgrastim / Q000627:therapeutic use; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011446:Prospective Studies; D011788:Quality of Life; D011994:Recombinant Proteins / Q000627:therapeutic use; D000069283:Rituximab / Q000008:administration & dosage / Q000009:adverse effects
D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride; D000069585:Filgrastim