Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study)

Aapro, Matti; Ludwig, Heinz; Bokemeyer, Carsten; Gascón, Pere; Boccadoro, Mario; Denhaerynck, Kris; Krendyukov, Andriy; Gorray, Michael; MacDonald, Karen; Abraham, Ivo

doi:10.1093/annonc/mdw309

Cited by 29 publications

(32 citation statements)

References 22 publications

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“…These indications are approved in Europe and Japan, but some indications are not approved for the recently approved biosimilars, Accofil® and Grastofil®. The efficacy and safety of the biosimilar of filgrastim were confirmed by the clinical trials or surveillances . The safety profile of biosimilars are consistent with what is known about the clinical safety of filgrastim.…”

Section: Introductionsupporting

confidence: 70%

Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Kobayashi

Kamada

Komura

et al. 2017

Pharmacoepidemiology and Drug

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Section: Introductionsupporting

confidence: 70%

Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Kobayashi

Kamada

Komura

et al. 2017

Pharmacoepidemiology and Drug

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“…The analyses reported here warrant some caution in addition to limitations identified in our prior reports on the MONITOR-GCSF study [5, 6]. We classified patients into three levels of prophylaxis intensity, and further gradations might be possible.…”

Section: Discussionmentioning

confidence: 95%

“…In keeping with our prior reports [5, 6], we distinguish between results using patients and results using cycles as the unit of analysis. The patient-level evaluations focus on outcomes “ever” experienced anytime during the whole period of chemotherapy and inform about patient outcomes across this line of chemotherapy.…”

Section: Introductionmentioning

confidence: 99%

Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study

Bokemeyer

Gascón

Aapro

et al. 2017

Support Care Cancer

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PurposeIn the MONITOR-GCSF study of chemotherapy-induced (febrile) neutropenia with biosimilar filgrastim, 56.6% of patients were prophylacted according to amended EORTC guidelines, but 17.4% were prophylacted below and 26.0% above guideline recommendations.MethodsMONITOR-GCSF is a prospective, observational study of 1447 evaluable patients from 140 cancers centers in 12 European countries treated with myelosuppressive chemotherapy for up to 6 cycles receiving biosimilar GCSF prophylaxis. Patients were classified as under-, correctly-, or over-prophylacted with GCSF relative to guideline recommendations based on their chemotherapy risk, individual risk factors, and type of GCSF prophylaxis (primary versus secondary).ResultsDifferences between under- (17.4%), correctly- (56.6%), or over-prophylacted (26.0%) groups were found in terms of patient risk factors (age, performance status, history of FN, comorbid conditions) as well as prophylaxis patterns (type of prophylaxis, day of GCSF initiation, and GCSF duration). Rates of chemotherapy-induced neutropenia (CIN) (all grades), FN, and CIN-related hospitalizations were consistently lower in over-prophylacted patients relative to under- and correctly-prophylacted patients. No differences were observed between under- and correctly-prophylacted patients except for CIN/FN-related chemotherapy disturbances. No GCSF safety differences were found between groups (except for headaches).ConclusionsThe real-world evidence provided by the MONITOR-GCSF study indicates that providing GCSF support may yield better CIN, FN, and CIN/FN-related hospitalization outcomes if patients are prophylacted at levels above guideline recommendations. Patients who are under-prophylacted are at higher risk for disturbances to their chemotherapy regimens. Our findings support the guideline recommendation that CIN/FN risk be assessed at the beginning of each chemotherapy cycle.

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“…For supportive care with filgrastim-sndz, we considered six cycles of prophylaxis with five biosimilar filgrastim injections each (30 total), the latter being the median number of injections recorded in the European MONITOR-GCSF study, the first large postapproval study of the Sandoz biosimilar filgrastim (marketed commercially in Europe as Zarzio) [17][18][19][20]. For obinutuzumab in patients with relapsing/refractory follicular lymphoma, we used the longest possible treatment regimen specified in the US label [21]: three administrations in cycle 1, one administration in cycles 2-6, followed by one administration every 2 months for 2 years.…”

Section: • Expanded Access Treatmentsmentioning

confidence: 99%

Expanded access to cancer treatments from conversion to neutropenia prophylaxis with biosimilar filgrastim-sndz

McBride

Balu²,

Campbell³

et al. 2017

Future Oncol.

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Aim: Biosimilar medicines offer significant cost-savings potential over their reference products, which can be re-allocated to provide access to other cancer treatments on a budget-neutral basis. Methods: Simulation study using cost data for the USA under consideration of several prophylaxis patterns. Results: Potential savings from conversion from reference filgrastim to biosimilar filgrastim-sndz are significant. These savings expand budget-neutral access to novel immunotherapies (obinutuzumab; pembrolizumab) or supportive care (filgrastimsndz). Conclusion: The combination of biosimilar savings and expanded access increases the value of cancer care as the same supportive care is provided at lower cost, additional cancer care is enabled at no additional cost, and more patients will have access to cancer care.

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Predictive modeling of the outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (MONITOR-GCSF study)

Cited by 29 publications

References 22 publications

Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Comparative study of the number of report and time‐to‐onset of the reported adverse event between the biosimilars and the originator of filgrastim

Over- and under-prophylaxis for chemotherapy-induced (febrile) neutropenia relative to evidence-based guidelines is associated with differences in outcomes: findings from the MONITOR-GCSF study

Expanded access to cancer treatments from conversion to neutropenia prophylaxis with biosimilar filgrastim-sndz

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