Abstract
PurposeThis study sought to compare the efficacy of prophylactic long-acting and standard granulocyte colony-stimulating factor (G-CSF) on febrile neutropenia, early infections, and treatment delay in patients with newly diagnosed multiple myeloma (MM) receiving the therapeutic regimen of bortezomib, lenalidomide, and dexamethasone (VRd).MethodsA prospective study with 68 consecutive patients with MM was conducted in three regional hospitals. Participants were randomly treated with the VRd regimen in combination with prophylactic long-acting G-CSF (treatment group) or prophylactic standard G-CSF (control group). The primary endpoints were the incidence rates of febrile neutropenia, early infection, and treatment delays. The secondary endpoint was clinical outcomes.ResultsThirty-three patients were assigned to the treatment group, and thirty-five patients were assigned to the control group. The incidence of febrile neutropenia was 6.1% and 17.1% in the treatment and control groups, respectively (p = 0.297). However, the rates of early infection and treatment delay were markedly lower in the treatment group than in the control group (6.1% vs. 25.7% and 9.1% vs. 31.4%; p < 0.05). Notably, all early infections occurred during the first four cycles of VRd therapy, and the most common type of infection was pneumonia. No significant difference in clinical efficacy was found between the two groups. All participants achieved at least partial remission.ConclusionsProphylactic administration of domestic long-acting G-CSF markedly reduced the rates of early infection and treatment delay as compared with standard G-CSF in patients newly diagnosed with MM. Notably, all early infections occurred during the first four cycles of VRd therapy. As such, it seems appropriate to administer long-acting G-CSF with the aim of primary prophylaxis of early infection in the setting of newly diagnosed MM.
Highlights
Patients with multiple myeloma (MM) experience an increased chance of infection than the general population, with the risk being 13 times more than that for pneumonia and 30 times more than that for sepsis [1, 2]
Efficacy was assessed every two cycles of treatment according to the new categories from the International Myeloma Working Group, which include stringent complete remission, complete remission (CR), very good partial remission (VGPR), partial remission (PR), minimal response (MR), stable disease, and progressive disease [18]
A total of 68 patients with MM were enrolled in this study, including 33 and 35 patients assigned to the treatment and control groups, respectively
Summary
Patients with multiple myeloma (MM) experience an increased chance of infection than the general population, with the risk being 13 times more than that for pneumonia and 30 times more than that for sepsis [1, 2]. Only a few studies (including just three clinical trials and three observational studies) have considered primary prophylaxis with pegfilgrastim for FN in refractory and relapsed patients with MM who received lenalidomide- or bendamustine-based regimens [10,11,12,13,14,15] These studies reported the supportive role of pegfilgrastim in ensuring scheduled chemotherapy and decreasing the rates of neutropenia and infection; all investigations were both single-armed or retrospective studies and only enrolled patients with recurrent or refractory MM. We included patients newly diagnosed with MM, aiming to compare the primary prophylactic efficacy of early infection using long-acting and standard G-CSF.
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