Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
A multinational, drug utilization study of lipegfilgrastim use in real-world setting in Europe.
СтатьяНазвание и аннотация: Перевод в очереди
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Kaplan Sigal, Bogojevic Dana Ilic, Rainville Carolyn, Gross Nicholas
Аннотация
PURPOSE: Lipegfilgrastim (Lonquex, Teva Pharma B.V.) is approved for reduction in neutropenia duration and febrile neutropenia incidence. In the framework of lipegfilgrastim regulatory approval in the EU, the Health Authorities requested a drug utilization study. This study was conducted to characterize prescribing patterns of lipegfilgrastim and quantify the extent of on- and off-label use of lipegfilgrastim in real-world setting in Europe.
METHODS: Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle.
RESULTS: Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%). For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%).
CONCLUSION: Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.
METHODS: Information on lipegfilgrastim use between January 2014 and March 2020 was abstracted from medical records in hospital and outpatient clinical settings. Indication for lipegfilgrastim was classified either as on-label or off-label use according to pre-determined criteria. The primary endpoint was the extent of lipegfilgrastim off-label use based on the most recent lipegfilgrastim cycle.
RESULTS: Records of 481 patients were obtained from five European countries. Lipegfilgrastim was most commonly prescribed for prevention of neutropenia by oncologists and hematologists. Patients who were administered lipegfilgrastim were primarily ≥ 55 years old (65.1%) and female (65.7%). The most frequent underlying diagnosis was breast cancer (38.3%). For the most recent lipegfilgrastim cycle, on-label use was recorded in 452/459 patients with no missing data (98.5%), while off-label use was recorded in 7/459 patients (1.5%). The majority of off-label use was attributed to use with non-cytotoxic chemotherapy (57.1%). Off-label use of lipegfilgrastim across all treatment cycles with no missing data was 11/1547 cycles (0.7%).
CONCLUSION: Using real-world data, these findings confirm the low rate of lipegfilgrastim off-label use as reported in a preceding feasibility study, indicating very high adherence to the approved indication.