Effectiveness and Safety of Filgrastim (Neupogen™) versus Filgrastim-aafi (Nivestim™) in Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia: An Observational Cohort Study.

BACKGROUND: Despite the demonstrated efficacy and safety of biosimilar filgrastim-aafi (Nivestim™), few studies have compared its use in real-life clinical practice to the originator filgrastim (Neupogen™). OBJECTIVES: This study aimed to compare the effectiveness and safety of filgrastim and filgrastim-aafi for the primary prophylaxis of chemotherapy induced-febrile neutropenia in the real-life setting. PATIENTS AND METHODS: A retrospective cohort study included all adult cancer patients at the King Hussein Cancer Centre requiring primary prophylaxis for chemotherapy-induced febrile neutropenia between 2014 and 2016. Two cohorts were selected: patients who received filgrastim and those who received filgrastim-aafi. The primary endpoint was the incidence of febrile neutropenia; the secondary endpoints were the incidence of adverse drug reactions (ADRs), hospital admissions due to febrile neutropenia, and the mean length of hospitalization. Chi-squared tests were performed to evaluate differences between groups. Logistic regression was conducted to adjust for confounding factors. RESULTS: A total of 268 patients were identified, with 88 in the filgrastim cohort and 180 in the filgrastim-aafi cohort; 64%were females. The mean age was 47 (±15) years. The incidence of febrile neutropenia was 21.6% in the filgrastim cohort and 15% in the filgrastim-aafi cohort (P = 0.179). No statistically significant differences were detected in the incidence of hospital admission (P = 0.551) or ADRs (P = 0.623) between the two cohorts. Upon adjusting for the confounding factors, results remained statistically insignificant. CONCLUSION: Filgrastim and filgrastim-aafi had comparable effectiveness and safety as primary prophylaxis for chemotherapy-induced febrile neutropenia. More extensive prospective studies with additional insight on the cost implications are required.

Impact of severe oral mucositis in pediatric cancer patients on resource utilization and cancer treatment plans.

BACKGROUND: Oral mucositis is a common chemotherapy-related adverse event that may result in serious complications. Few studies have evaluated mucositis in pediatric patients. OBJECTIVE: To evaluate the impact of severe mucositis on resource utilization and on treatment plans of pediatric cancer patients. SETTING: Comprehensive cancer center in Amman, Jordan. METHOD: Retrospective study on pediatric patients undergoing active cancer treatment with a hospital admission diagnosis of severe oral mucositis (January 2015-December 2019). Patients undergoing bone marrow transplant were excluded. Severe oral mucositis was defined as interfering with oral intake and requiring intravenous opioids. MAIN OUTCOME MEASURE: We reviewed the electronic billing system and patient medical charts to determine the resources utilized during hospitalization, cost, and the impact on subsequent treatment protocols. RESULTS: During the study period, 200 patients were eligible; the average age was 8.6±5.6 years (SD) and 45% had acute lymphoblastic leukemia. The median hospital stay was 6 days (range 2-21) with a total median cost of US$ 2,176 (range 635-13,976) per admission. The median medication cost was US$ 1,075 (range 135-9010), and 85% of the patients received antibiotics during hospitalization, at a median cost of US$ 487 (range 23-2,193). Modification of the chemotherapy treatment protocol was required in 110 patients, which included dose reduction (60%), delay (38%), and discontinuation (2%). CONCLUSION: Severe oral mucositis is associated with significant resource utilization and modification of the treatment protocols. Further studies are needed to identify strategies to reduce the impact of mucositis in this patient population.

Early versus delayed administration of granulocyte-colony stimulating factor following chemotherapy in pediatric patients with Ewing sarcoma.

BACKGROUND: The optimal timing of initiating granulocyte-colony stimulating factor following chemotherapy in pediatric patients has not been clearly defined. This study aimed to compare the administration of granulocyte-colony stimulating factor on day 1 versus day 3 postchemotherapy in pediatric patients with Ewing sarcoma. METHOD: A retrospective study of pediatric patients with Ewing sarcoma who received granulocyte-colony stimulating factor following chemotherapy between January 2016 and September 2018 at a comprehensive cancer center. The institution's chemotherapy protocol for Ewing sarcoma was modified in April 2017 to include granulocyte-colony stimulating factor initiation on day 3 instead of day 1 post-chemotherapy. Febrile neutropenia requiring hospitalization, duration of hospital stay, and chemotherapy delay were compared for patients before and after the protocol change. RESULTS: Over the study period, 250 cycles were evaluated with day 1 granulocyte-colony stimulating factor and 221 cycles with day 3 granulocyte-colony stimulating factor. There were no differences between the day 1 and day 3 groups in the number of cycles associated with Febrile neutropenia requiring hospitalization (34 vs. 19, p = 0.086), and the length of Febrile neutropenia-related hospitalization (mean 4 ± 2.1 vs. 4.6 ± 1.8, p = 0.123). However, delay in chemotherapy due to neutropenia was reported in significantly more cycles in the day 1 group, compared to the day 3 group (37 vs. 16, p = 0.01). CONCLUSIONS: Febrile neutropenia resulting in hospital admission and the length of hospital stay was not different between pediatric patients with Ewing sarcoma who received granulocyte-colony stimulating factor on day 1 or day 3 post-chemotherapy. Chemotherapy delay due to neutropenia was higher in patients who received granulocyte-colony stimulating factor on day 1. Larger studies are required to fully determine the impact of delayed initiation of granulocyte-colony stimulating factor.