Comparison of pegfilgrastim on day 2 vs. day 4 as primary prophylaxis of intense dose-dense chemotherapy in patients with node-positive primary breast cancer within the prospective, multi-center GAIN study: (GBG 33)

Loibl, Sibylle; Mueller, Volkmar; Minckwitz, Gϋnter von; Conrad, Bettina; Koehne, Claus-Henning; Kremers, Stephan; Forstbauer, Helmut; Linder, Mattea; Nekljudova, Valentina; Moebus, Volker; Ago,; groups, Noggo study

doi:10.1007/s00520-010-1020-9

Cited by 25 publications

(10 citation statements)

References 21 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Here, the nadir occurs in a narrow time interval which might be difficult to capture in a clinical trial. This could explain the results of Loibl et al ( 2011 ) who observed a (non-significant) trend towards better performance of the d4 schedule compared to d2.…”

Section: Discussionmentioning

confidence: 82%

“…In clinical trials, it is practically impossible to control for each of these factors. Therefore, only limited attempts were made to compare the efficacy of different G-CSF schedules in the context of clinical trials (Danova et al 2009 ; Holmes et al 2002 ; Loibl et al 2011 ; Lyman et al 2009 ; Vose et al 2003 ; Zwick et al 2011 ; Faber et al 2006 ; Crawford et al 1997 ; Leonard et al 2015 ). However, available clinical trials showed that considerable improvements can be expected by optimized G-CSF schedules.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Model-based optimization of G-CSF treatment during cytotoxic chemotherapy

Schirm

Engel

Loibl

et al. 2017

J Cancer Res Clin Oncol

Self Cite

View full text Add to dashboard Cite

PurposeAlthough G-CSF is widely used to prevent or ameliorate leukopenia during cytotoxic chemotherapies, its optimal use is still under debate and depends on many therapy parameters such as dosing and timing of cytotoxic drugs and G-CSF, G-CSF pharmaceuticals used and individual risk factors of patients.MethodsWe integrate available biological knowledge and clinical data regarding cell kinetics of bone marrow granulopoiesis, the cytotoxic effects of chemotherapy and pharmacokinetics and pharmacodynamics of G-CSF applications (filgrastim or pegfilgrastim) into a comprehensive model. The model explains leukocyte time courses of more than 70 therapy scenarios comprising 10 different cytotoxic drugs. It is applied to develop optimized G-CSF schedules for a variety of clinical scenarios.ResultsClinical trial results showed validity of model predictions regarding alternative G-CSF schedules. We propose modifications of G-CSF treatment for the chemotherapies ‘BEACOPP escalated’ (Hodgkin’s disease), ‘ETC’ (breast cancer), and risk-adapted schedules for ‘CHOP-14’ (aggressive non-Hodgkin’s lymphoma in elderly patients).ConclusionsWe conclude that we established a model of human granulopoiesis under chemotherapy which allows predictions of yet untested G-CSF schedules, comparisons between them, and optimization of filgrastim and pegfilgrastim treatment. As a general rule of thumb, G-CSF treatment should not be started too early and patients could profit from filgrastim treatment continued until the end of the chemotherapy cycle.Electronic supplementary materialThe online version of this article (10.1007/s00432-017-2540-1) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionmentioning

confidence: 82%

Section: Introductionmentioning

confidence: 99%

Model-based optimization of G-CSF treatment during cytotoxic chemotherapy

Schirm

Engel

Loibl

et al. 2017

J Cancer Res Clin Oncol

Self Cite

View full text Add to dashboard Cite

show abstract

“…Patients who received pegfilgrastim on the day after chemotherapy had less severe and shorter suppression of the ANC than patients who received pegfilgrastim on the same day as chemotherapy 29. A prospective, multicenter GAIN study did not demonstrate that pegfilgrastim was more efficacious on day 4 than on day 2 with respect to grade 4 leucopenia, FN or infections 30. Pegfilgrastim injected as a single dose of either 100 µg/kg or as a total dose of 6 mg (general approach) is considered an equally effective in terms of grade 3 neutropenia and above in patients with less intense chemotherapy 31.…”

Section: Discussionmentioning

confidence: 95%

The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study

et al. 2019

BMJ Support Palliat Care

View full text Add to dashboard Cite

ObjectiveThis study explored the prophylactic effects of long-acting granulocyte colony-stimulating factor (G-CSF) for febrile neutropenia (FN) in newly diagnosed patients with epithelial ovarian cancer (EOC).MethodsPatients were randomised into a study group (long-acting G-CSF for all chemotherapy cycles) and a control group (short-acting G-CSF for first cycle and treatment per physician discretion for subsequent cycles) at a ratio of 1:2. The incidences of FN and myelosuppression and the number of clinical visits, medication doses, complete blood count (CBC) tests and adverse events were compared between the two groups. A regression model was used to determine the risk factors for FN.ResultsFrom 30 November 2018 to 1 April 2019, 84 cases were included in the final analysis; there were 24 (28.6%) and 60 (71.4%) patients in the study and control groups, respectively, and 605 chemotherapy cycles. The study group or chemotherapy cycles utilising long-acting G-CSF had significantly fewer utilisations and doses of short-acting G-CSF; clinical visits; CBC tests; and incidences of FN and myelosuppression; and less G-CSF-associated pain. The utilisation of G-CSF was the only independent factor for FN in a binary regression model.ConclusionLong-acting G-CSF could effectively reduce the incidences of FN and myelosuppression and had mild adverse effects in newly diagnosed patients with EOC receiving chemotherapy.Trial registration number NCT03740464.

show abstract

“…Eligible patients were identified from the study databases of the adjuvant or neoadjuvant trials of the German Breast Group and the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Breast Study Group [6][7][8][9][10][11][12][13][14][15]. All of them had been treated with either docetaxel or paclitaxel as part of their primary treatment (adjuvant or neoadjuvant chemotherapy) and had had a local or distant relapse reported.…”

Section: Patient Characteristicsmentioning

confidence: 99%

Rechallenging taxanes in recurrent breast cancer in patients treated with (neo-) adjuvant taxane-based therapy.

Guo¹,

Loibl²,

Untch³

et al. 2011

JCO

View full text Add to dashboard Cite

Keywords Docetaxel · Paclitaxel · Adjuvant · Recurrent breast cancer SummaryBackground: Docetaxel and paclitaxel are among the most active substances for the treatment of breast cancer. As both drugs are used today in adjuvant regimens, efficacy data from pivotal trials in the metastatic setting in taxanenaive populations cannot reliably be used as references. Patients and Methods:The Taxane Re-Challenge Cohort Study identified participants from 6 prospective (neo-)adjuvant taxane-based studies with recurrent disease and collected data on their subsequent treatment. Out of 381 recurrent patients, 106 (27.8%) were re-challenged with a taxane-based treatment as first-or later-line therapy for recurrent disease. Results: Taxanes were used as first-line therapy in 74 patients and showed a response rate of 48.6% (including complete responses in 27.0%). The response rate was dependent on the disease-free interval (< 1 year: 34.8%; 1-2 years: 42.9%; > 2 years: 63.3%; p = 0.04) and visceral metastasis (present: 62.5%; not present 32.4%; p = 0.01). Patients without visceral metastasis and with a disease-free interval of > 2 years achieved the longest overall survival. Hormone and HER2 receptor status were not predictive; however, triple-negative tumors responded in 50.0%. The overall response rate of later-line taxane-based treatment was 28.2%. Conclusion: Re-challenging taxanes appears to be effective and therefore represents a reasonable option in this population.

show abstract

Comparison of pegfilgrastim on day 2 vs. day 4 as primary prophylaxis of intense dose-dense chemotherapy in patients with node-positive primary breast cancer within the prospective, multi-center GAIN study: (GBG 33)

Abstract: This study failed to demonstrate that pegfilgrastim on day 4 was more efficacious than on day 2 with respect to grade 4 leucopenia (the primary endpoint), febrile neutropenia, or infections.

Cited by 25 publications

References 21 publications

Model-based optimization of G-CSF treatment during cytotoxic chemotherapy

Model-based optimization of G-CSF treatment during cytotoxic chemotherapy

The prophylactic effects of long-acting granulocyte colony-stimulating factor for febrile neutropenia in newly diagnosed patients with epithelial ovarian cancer: a randomised controlled study

Rechallenging taxanes in recurrent breast cancer in patients treated with (neo-) adjuvant taxane-based therapy.

Contact Info

Product

Resources

About