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IMPACT OF PROPHYLACTIC USE OF COLONY STIMULATING FACTORS ON THE PATTERN OF NEUTROPENIA AND INFECTIONS IN MODERATELY INTENSIVE CHEMOTHERAPY.

ABSTRACT: In this study, colony stimulating factors (CSF) were used to prevent neutropenia during moderately intensive chemotherapy in 26 episodes of chemotherapy (12 of acute lymphoblastic leukaemia (ALL) and 14 patients with other malignancies). CSF was administered in doses of 5 µg/kg of body weight within 24 hours of completion of chemotherapy for 7 days in 6 patients and for 10 days in others. Twenty six age and sex matched patients of ALL were included as controls. In the CSF group, incidence of severe neutropenia (grades 3 and 4) reduced significantly by 42.3 per cent though overall incidence of neutropenia did not differ much. Mean duration of neutropenia reduced by 4 days. Nadir total leucocyte count and absolute neutrophil count were significantly higher. There was no difference in the incidence of anaemia, thrombocytopenia and requirement of blood transfusions. Overall infections were less and incidence of severe infections reduced by 42.3 per cent. The duration of infection and of fever was shortened. Requirement of antibiotics was also reduced. All patients in CSF group recovered from infection, while 1 patient died in the control group. Mean duration of delay in chemotherapy was reduced from 10 days in control group to 3 days in CSF group. CSF administration resulted in an escalation of the cost by 112.24 per cent. However shortened duration of antibiotics, hospitalisation, reduced laboratory expenses compensated it by 66.94 per cent Our study indicates that the prophylactic use of CSF is beneficial and cost effective in moderately intensive chemotherapy with a high incidence of febrile neutropenia. Administration for 10 days appears to be more beneficial than 7 days.

SUBMITTER: Rao RR

PROVIDER: S-EPMC5530983 | biostudies-other | 1997 Jul

REPOSITORIES: biostudies-other

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Project description:ObjectiveInappropriate granulocyte colony-stimulating factor use with myelosuppressive chemotherapy has been reported. Using the Oncology Services Comprehensive Electronic Records electronic medical record database, prophylactic granulocyte colony-stimulating factor (pegfilgrastim/filgrastim) use in cancer patients was assessed by febrile neutropenia risk level.MethodsPatients with nonmetastatic or metastatic breast, head/neck, colorectal, ovarian/gynecologic, lung cancer, or non-Hodgkin's lymphoma who received myelosuppressive chemotherapy from June 2013 to May 2014 were included. Prophylactic granulocyte colony-stimulating factor use with high-risk, intermediate-risk, and low-risk chemotherapy and distribution of National Comprehensive Cancer Network risk factors with intermediate-risk regimens were assessed.ResultsOverall, 86,189 patients received ?4.2 million chemotherapy cycles (high risk, 9%; intermediate risk, 48%; low risk, 43%). Prophylactic granulocyte colony-stimulating factor was given in 24% of cycles (high risk, 59%; intermediate risk, 29%; low risk, 11%). For nonmetastatic solid tumors, granulocyte colony-stimulating factor was given in 78% (high risk), 31% (intermediate risk), and 6% (low risk) of cycles. For metastatic solid tumors or non-Hodgkin's lymphoma, granulocyte colony-stimulating factor was given in 50% (high risk), 27% (intermediate risk), and 11% (low risk) of cycles. Among patients receiving intermediate-risk regimens with granulocyte colony-stimulating factor, febrile neutropenia risk factors were identified in 56% (95% confidence interval, 51.1-60.9%) of patients with nonmetastatic solid tumors (n?=?400) and in 70% (64.5-73.5%) of patients with metastatic solid tumors or non-Hodgkin's lymphoma (n?=?400).ConclusionProphylactic granulocyte colony-stimulating factor use was appropriately highest for high-risk regimens and lowest for low-risk regimens yet still potentially underused in high risk regimens, overused in low-risk regimens, and not appropriately targeted in intermediate-risk regimens, indicating a need for further education on febrile neutropenia risk evaluation and appropriate granulocyte colony-stimulating factor use.

Project description:BACKGROUND:Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. MATERIALS AND METHODS:Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. RESULTS:Eligible patients were randomized 1:1 to study arms (eflapegrastim, n =?196; pegfilgrastim, n =?210). The incidence of cycle 1 severe neutropenia was 16% (n =?31) for eflapegrastim versus 24% (n =?51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. CONCLUSION:These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. IMPLICATIONS FOR PRACTICE:Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.

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IMPACT OF PROPHYLACTIC USE OF COLONY STIMULATING FACTORS ON THE PATTERN OF NEUTROPENIA AND INFECTIONS IN MODERATELY INTENSIVE CHEMOTHERAPY.

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