NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim - First Interim Analysis

Kurbacher, Christian M.; Fietz, Thomas; Diel, Ingo J.; Egert, Matthias; Hurtz, Hans-Jürgen; Lück, Andreas; Weide, Rudolf; Salat, Christoph; Wolff, Thomas; Zaiss, Matthias; Klare, Peter; Losem, Christoph; Illmer, Thomas; Weißenborn, Georg; Steffens, Claus-Christoph; Schulze, Matthias; Tesch, Hans; Oskay-Oezcelik, G.; Teichmann, Beate; Harde, Johanna; Scheuerlein, Robert Willy

doi:10.1159/000381631

Cited by 12 publications

(7 citation statements)

References 19 publications

(26 reference statements)

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“…A real-world study in Belgium and Luxembourg found that patients receiving lipegfilgrastim had a lower incidence of grade 3 and grade 4 neutropenia than did those receiving it secondarily (13). Another prospective, non-interventional, multicenter study conducted in Germany also reported that primarily administration of lipegfilgrastim demonstrated a lower incidence of severe neutropenia compared with secondary administration (14). These findings are in line with our results.…”

Section: Discussionsupporting

confidence: 91%

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study

Ma¹,

Huang²,

Fu³

et al. 2021

Ann Transl Med

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Background: Chemotherapy-induced neutropenia is commonly encountered in clinical practice. The management of neutropenia has been evolving from short-acting granulocyte colony-stimulating factors (G-CSFs) to long-acting G-CSFs. However, an evaluation of the safety and effectiveness of long-acting G-CSFs in clinical practice is still lacking.Methods: This multicenter, non-interventional study was aimed at exploring the safety and effectiveness of mecapegfilgrastim in different cancer patients in China. All patients provided written informed consent prior to the study and were treated according to routine clinical practice. Different prophylactic strategies (primary or secondary prophylaxis) were also compared.Results: This study included 638 patients from May 2019 to November 2020. More than half of the participants were breast cancer patients. The mean age of all the patients was 56 years. White blood cell increase (6.2%) was the most frequently reported adverse event (AE) possibly related to the study drug. No unexpected AEs were reported. Grade ≥3 neutropenia in chemotherapy treatment cycle 1 was reported in 36 (5.6%) patients. Incidence of grade ≥3 neutropenia in cycle 1 in the primary and secondary prophylaxis subgroups were of 4.3% and 9.2%, respectively. A decreasing trend of severe neutropenia incidence was observed from cycle 1 to cycle 4.Conclusions: Mecapegfilgrastim was generally well tolerated, and no unexpected AEs were observed in this study. Primary administration of mecapegfilgrastim led to a lower incidence of neutropenia than did secondary administration. Continuous administration of mecapegfilgrastim could keep the incidence of neutropenia to a relatively low level.

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Section: Discussionsupporting

confidence: 91%

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study

Ma¹,

Huang²,

Fu³

et al. 2021

Ann Transl Med

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“…Furthermore, within Protroca, the FN rate was calculated over all CT cycles and not only for the first cycle. In the NIS NADIR that investigated the use of lipegfilgrastim as prophylaxis for cancer patients, FN was only observed in patients receiving secondary prophylaxis and was 2.9 and 7.1% for all cancer and BC patients, respectively [16]. Patients with primary prophylaxis did not exhibit any FN in the first CT cycle of the NADIR study (rate = 0%) in contrast to Protroca, where, in addition, all CT cycles were taken into account.…”

Section: Discussionmentioning

confidence: 99%

Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients

Wuerstlein¹,

Harbeck²,

Grischke

et al. 2020

Breast Care

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Background: Protroca evaluated the efficacy and safety of primary and secondary prophylaxis of neutropenia with lipegfilgrastim (Lonquex®) in breast cancer patients receiving neoadjuvant or adjuvant chemotherapy (CT). Patients and Methods: Of the 255 patients enrolled, 248 patients were evaluable for the intent-to-treat (ITT) and 194 patients for the per-protocol set. Primary and secondary end points after lipegfilgrastim treatment were assessed. Results: Nine patients of the ITT set receiving lipegfilgrastim as primary prophylaxis (n = 222) had febrile neutropenia of grade 3–4 (5 patients) or infection of grade 3–4 (4 patients); 1/26 of those receiving secondary prophylaxis had an event. Dose reductions were performed in 9.5% of the patients. Postponement of cancer CT cycles for >3 days occurred in <15% of patients; 10.8% (92/851 AEs) and 8% (2/25 SAEs) of documented adverse events and serious adverse events, respectively, were related to lipegfilgrastim. Conclusions: Application of lipegfilgrastim was effective as primary and secondary prophylaxis in the prevention of CT-induced neutropenia in breast cancer.

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“…The interim results were reported previously. 18,19 The primary objective of this NIS was the incidence of chemotherapy-induced severe neutropenia, FN, and neutropeniaassociated complications. Here, we present the final data on patients with NHL including a subgroup of patients treated with the dosedense regimens CHOP-14, R-CHOP-14, or R-CHOEP-14, which are all associated with a high risk of FN.…”

Section: The Non-interventional Study Nadirmentioning

confidence: 99%

“…In 2013, the non‐interventional study (NIS) NADIR was initiated in Germany to evaluate the effectiveness and safety of lipegfilgrastim in patients with different tumor entities under chemotherapy in routine clinical practice. The interim results were reported previously . The primary objective of this NIS was the incidence of chemotherapy‐induced severe neutropenia, FN, and neutropenia‐associated complications.…”

Section: Introductionmentioning

confidence: 99%

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

Wolff¹,

Schulz²,

Losem

et al. 2018

European J of Haematology

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Objective The prospective non‐interventional study (NIS) NADIR was designed to evaluate both effectiveness and safety of prophylactic use of lipegfilgrastim (Lonquex®), a glycopegylated granulocyte colony‐stimulating factor, in cancer patients with different tumor entities undergoing chemotherapy in routine clinical practice. The primary objective was incidence of severe neutropenia, febrile neutropenia (FN), and neutropenia‐associated complications. Method NADIR was a national, multicenter, prospective NIS. Results Here, we present the data on patients with non‐Hodgkin lymphoma (NHL). Final analysis comprised 337 NHL patients having received ≥1 administration of lipegfilgrastim. Primary prophylaxis with lipegfilgrastim was documented in 78.7% of patients with high risk to develop FN. In total, ≥1 severe neutropenia (grade 3/4) was reported in 115 (34.1%) patients and ≥1 event of FN documented in 15 (4.5%) patients. Grade 3/4 infections were reported in 22 (6.5%) patients overall. Most frequently reported adverse events (AEs) related to lipegfilgrastim in total were bone pain (5.4%), leukocytosis (2.1%), back pain (1.8%), platelet count decreased (1.2%), and myalgia (1.2%). Fatal serious AEs were documented in 9 (2.7%) patients; none were attributable to lipegfilgrastim. Conclusion Prophylaxis or therapeutic intention with lipegfilgrastim in NHL patients in routine clinical practice showed similar effectiveness and safety as demonstrated in the pivotal trials.

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NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim - First Interim Analysis

Cited by 12 publications

References 19 publications

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study

Prophylaxis of neutropenia with mecapegfilgrastim in patients with non-myeloid malignancies: a real-world study

Protroca: A Noninterventional Study on Prophylactic Lipegfilgrastim against Chemotherapy-Induced Neutropenia in Nonselected Breast Cancer Patients

Prophylaxis of chemotherapy‐induced neutropenia and febrile neutropenia with lipegfilgrastim in patients with non‐Hodgkin lymphoma (NADIR study)

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