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

Wuerstlein, Rachel; Harbeck, Nadia; Grischke, Eva‐Maria; Forstmeyer, Dirk; Schumann, Raquel von; Krabisch, Petra; Lüdtke-Heckenkamp, Kerstin; Stefek, Andrea; Stoetzer, Oliver J.; Grafe, Andrea; Kaltenecker, Gabriele; Forstbauer, Helmut; Augustin, Doris; Schrader, Iris; Tio, Joke; Nitz, Ulrike; Gluz, Oleg; Kates, Ronald; Graeser, Monika

doi:10.1159/000506622

Cited by 3 publications

(2 citation statements)

References 15 publications

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“…The incidence of chemotherapy delays in a cycle was higher than in the phase III study (the highest 22.6% vs. 16.2%) (data not shown), and longer was the average delay across all cycles (median 7.0 [range, 1.0 to 77.0] vs. 0.0 [0.0 to 14.0] days) [10]. In the Protroca study, assessing the effectiveness and safety of lipegfilgrastim in non-selected breast cancer patients the incidence of delay of chemotherapy was similar to our study [11]. Timmer-Bonte et al reported higher rates of delay, but their study included also the patients with haematological malignancies and solid tumours other than breast cancer [12].…”

Section: Discussionsupporting

confidence: 83%

Efficacy and Safety of Lipegfilgrastim for the Prophylaxis of Chemotherapy-induced Neutropenia in Breast Cancer Patients in Poland

Streb

Kucharz

Lipa³

et al. 2021

Arch Med Sci

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IntroductionLipegfilgrastim is a long-acting glycopegylated granulocyte-colony stimulating factor (G-CSF) used to prevent chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). The aim of the current study was to obtain data on the drug efficacy and safety in real-world clinical practice.Material and methodsThis is an exploratory analysis of Polish breast cancer patients participating in a pan-European study of lipegfilgrastim in primary and secondary prophylaxis for patients receiving cytotoxic chemotherapy (Lonquex ObsErvational Cohort Study, LEOS). Patients were followed since the start of neutropenia prophylaxis until 6 to 8 weeks after the last dose of the lipegfilgrastim . The efficacy measures were chemotherapy dose reductions, omissions, delays and the proportion of the planned cumulative dose actually delivered.ResultsA total of 45 mostly high risk of FN patients were included in the analysis. Overall, 31 of 212 chemotherapy cycles (14.6%) were delayed in 19 patients (42.2%). Cumulative dose of chemotherapy was reduced in 1.4% of the cycles in 4.4% of the patients. The mean percentage of cumulative dose planned actually administrated was 99.95% across all cycles. Only one patient had FN. There were 15 episodes of neutropenia in 3 patients (6.7%), A total of 69 adverse events were reported, which 65% were drug-related. The most common were musculoskeletal pain (17.8%) and myalgia (11.1%) Four adverse events were serious and two of them were related to lipegfilgrastim.ConclusionsLipegfilgrastim proved to be effective and well-tolerated for CIN prophylaxis in patients with breast cancer receiving myelosuppressive chemotherapy in a real-life setting.

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Section: Discussionsupporting

confidence: 83%

Efficacy and Safety of Lipegfilgrastim for the Prophylaxis of Chemotherapy-induced Neutropenia in Breast Cancer Patients in Poland

Streb

Kucharz

Lipa³

et al. 2021

Arch Med Sci

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“…The higher FN rate within NADENS may be due to the more intense CTx regimen applied, the unselected patient population, and/or the prophylactic use of systemically active antibiotics in one RCT for patients at high risk for infection [20]. A recently published real-world study in BC patients (Protroca) showed for the subgroup of patients with primary prophylaxis comparable results: the observed rate of FN across up to 4 cycles of CTx is 2.25% versus 2.1% in NADENS [21]. SN was experienced in 33.3% of patients during the first dd cycle and in 46.5% of patients during the entire 4 documented dd cycles in NADENS.…”

Section: Discussionmentioning

confidence: 99%

Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS)

et al. 2022

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Introduction: Non-interventional study (NIS) on application and effectiveness of primary G-CSF prophylaxis with lipegfilgrastim in primary breast cancer patients undergoing dose dense (dd) or intense dose dense (idd) chemotherapy regimen (CTx) in daily clinical practice. Methods: Prospective, multi-center, single-arm, NIS in 41 private practices and 27 hospitals in Germany. Results: Data analysis of 282 patients with a mean age of 49 years (93.6% of patients < 65 years). Hormone receptor status was triple-negative in 29.8% of patients, 81.9% of patients were HER2 negative. 73.8% of patients received 'EC dd -> taxane CTx'. Patients received lipegfilgrastim prophylaxis in 97.5% of 1121 documented dd/idd cycles. Overall, the study registered 275 events of SN (CTCAE grade 3 or 4) and 9 events of FN. During first dd cycle, SN occurred in 33.3% and FN in 1.1% of patients. Chemotherapy delay or dose reduction due to neutropenia was required in 2.5% of patients during the 4 dd cycles with lipegfilgrastim support. Overall, 314 adverse events (AE) were reported from 107 patients, and 27 serious AEs from 21 patients. None of the SAEs was 'fatal', CTCAE grade was mostly (89.6%) assessed as '1' or '2'. According to the treating physicians, 99.3% of all patients benefitted from lipegfilgrastim prophylaxis and tolerability was mostly rated 'very good' or 'good'. Discussion/Conclusion: These results suggest that primary lipegfilgrastim prophylaxis is effective and safe in clinical routine and is beneficial in primary breast cancer patients undergoing dd/idd-ETC chemotherapy.

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Lipegfilgrastim

2021

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Fever and thrombocytopenia: 2 case reportsIn a non-interventional study of 222 female patients, enrolled between 13 October 2015 and 25 September 2017, two female patients [ages not stated] were described, who developed fever and thrombocytopenia, respectively during prophylactic therapy with lipegfilgrastim for chemotherapy-induced neutropenia.The females, who were diagnosed with breast cancer, started receiving prophylactic treatment with lipegfilgrastim [Lonquex; routes and dosages not stated] for chemotherapy-induced neutropenia along with unspecified chemotherapy. During the treatment, one woman developed garde 3 fever (without neutropenia) and another woman developed grade 4 thrombocytopenia, secondary to lipegfilgrastim [durations of treatments to reactions onsets not stated]. Eventually, the woman who had developed fever, recovered from it, while thrombocytopenia improved in another woman.

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

Cited by 3 publications

References 15 publications

Efficacy and Safety of Lipegfilgrastim for the Prophylaxis of Chemotherapy-induced Neutropenia in Breast Cancer Patients in Poland

Efficacy and Safety of Lipegfilgrastim for the Prophylaxis of Chemotherapy-induced Neutropenia in Breast Cancer Patients in Poland

Prophylaxis of Neutropenia with Lipegfilgrastim in Breast Cancer Patients with Dose-Dense Chemotherapy: Results of a Noninterventional Study on Therapeutic Routine in Germany (NADENS)

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