RESUMO
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.
RESUMO
CONTEXT: The International Narcotics Control Board's (INCB) opioids consumption data are often cited in the literature and by policy makers to benchmark the adequacy of pain management among different countries. This practice may be inaccurate as INCB data does not account for variations in disease burden and use of other pain medications and only controls for population sizes differences among countries. OBJECTIVE: To demonstrate that INCB consumption data may not be an accurate/sensitive indicator for pain management adequacy due to significant inter-country variations in disease burden and in the use of pain medications that are not reported by INCB. METHODS: We compared opioid consumption data between 2012 and 2016 for Jordan and King Hussein Cancer Center vs five high-income countries (United States of America, United Kingdom, France, Sweden, and Japan) taking into consideration the cancer burden in those countries. In addition, we examined the significance of tramadol utilization in the setting of cancer pain management. RESULTS: Jordan's INCB-reported opioid consumption is ostensibly low at a median of 291 sDDD/million inhabitants/day. Compared to Jordan, the median consumption in the five HICs is 34 (range 4-172) times that of Jordan. However, when consumption is adjusted to cancer burden data, the gap is significantly reduced to a median of 2 (range 0.2-24) times that of Jordan and in the case of one institution's experience, the gap is eliminated. Furthermore, Jordan's tramadol's median consumption between 2012-2016 of 176 kg is equivalent to 127% of morphine consumption on an equianalgesic basis. CONCLUSION: INCB data should not be utilized to benchmark the adequacy of pain management among different countries without taking into consideration variations in disease burden and the use of tramadol and other pain drugs.