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This month, in Supportive Cancer Care, Claudio Cerchione from the Azienda Ospedaliera Universitaria Federico II, Naples, Italy, and colleagues published results of their prospective study, which compared secondary prophylaxis with filgrastim (control) versus primary prophylaxis with pegfilgrastim (peg group) in patients with iNHL after induction with bendamustine-rituximab.
In total, 122 patients with untreated iNHL were eligible for analysis with a median age of 45.3 years (range, 31–77). The histological subtypes were FL (n=83), MZL (n=32), SLL (n=4), and LPL (n=3).
The authors concluded by stating that in newly diagnosed iNHL after treatment with BR, primary prophylaxis with pegfilgrastim appears to reduce chemotherapy disruptions due to febrile neutropenia and the days of hospitalization. Additionally, they added that pegfilgrastim was advantageous due to its mono-administration, and was well tolerated providing the opportunity of maintaining the planned treatment schedule. Lastly, they stressed that their preliminary results should be validated in controlled clinical trials.
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 Lymphoma (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 Secondary 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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