Introduction Febrile neutropenia, a common complication of systemic antineoplastic therapy, varies in risk depending on malignant disease, treatment, and patient factors. The risk increases with the depth and duration of neutropenia and can be reduced with prophylactic use of G-CSF. International guidelines are conflicting in several aspects and do not reflect all patient groups. We therefore updated the 2014 Infectious Diseases Working Party (AGIHO) guideline of the German Society of Hematology and Medical Oncology (DGHO) on evidence-based recommendations for the use of G-CSF in patients with cancer. Materials and Methods After a systematic literature search from January 2014 to December 2024 on PubMed and Medline several consensus meetings were held by an expert panel of the AGIHO to evaluate, discuss and consent on the level of evidence and strength of recommendation for the use of G-CSF in patients with cancer based on ESCMID criteria. Results Results from eligible (randomized) studies were grouped in evidence tables. Recommendations for different entities, risk groups, new G-CSF formulations and emerging strategies in immunotherapy were set up and put into comparison to 2014. Discussion Comprehensive literature search and expert panel consensus confirm most of the key recommendations of 2014. New recommendations on the use of G-CSF in immunotherapy settings provide insight and support for day-by-day clinical decision making in the care of patients with cancer.

Background: Primary tumor sidedness (PTS) with discrimination of left-sided (LC) and right-sided tumors (RC) guides patient selection for targeted first-line therapy in RAS wild-type (RAS-WT) metastatic colorectal cancer (mCRC). This study assessed the hypothesis whether considering PTS with additional clinical parameters better predicts the treatment benefit of targeted first-line treatment. Methods: In FIRE-3, first-line treatment with folinic acid, fluorouracil and irinotecan (FOLFIRI) plus cetuximab (FOLFIRI/Cet) was compared to FOLFIRI plus bevacizumab (FOLFIRI/Bev) in patients with RAS-WT mCRC and unresectable metastasis. We evaluated whether combining PTS with number of metastatic sites (NOM), liver-limited disease status (LLD), age, sex, or carcinoembryonic antigen level (CEA) better predicts treatment benefit regarding overall survival (OS). Here, Cox regression models with second-order interactions were applied. Further, the results were validated by policy learning and Lasso regression analysis. Findings: Among 400 RAS-WT mCRC patients, combining PTS with LLD status in a Cox regression model outperformed PTS alone for predicted treatment benefit (P = 0.005; c-index=0.603). Significant OS benefit from FOLFIRI/Cet over FOLFIRI/Bev was observed in LC/non-LLD patients (HR=0.62; 95 %-confidence interval [CI]= 0.46-0.82; P = 0.002), but mitigated in LC/LLD patients (HR=0.83; 95 %-CI=0.53-1.29; P = 0.400). In RC/nonLLD patients, FOLFIRI/Bev demonstrated a significant OS advantage over FOLFIRI/Cet (HR=2.09; 95 %-CI=1.20-3.63; P = 0.010). However, RC/LLD patients showed potential benefit from FOLFIRI/Cet, though not statistically significant (HR=0.59; 95 %-CI=0.25-1.39; P = 0.218). Interpretation: Incorporating PTS and LLD status might improve selection of targeted first-line treatment in RAS-WT mCRC patients. FOLFIRI/Cet appears to be particularly beneficial for LC/non-LLD patients with mitigated benefit in patients with LC/LLD. In contrast, FOLFIRI/Bev is significantly favoured over FOLFIRI/Cet in patients with RC/non-LLD. Notably, RC/LLD patients may still benefit from anti-EGFR therapy despite right-sided primary tumor. These results are hypothesis-generating and warrant further validation.

13 Background: Optimal patient selection for first-line treatment targeting epithelial growth factor receptor (EGFR) in RAS-WT mCRC is based on primary tumor sidedness (PTS) with anti-EGFR being the preferred option for patients with left-sided mCRC (LC). Right-sided mCRCs (RC) are preferentially treated in combination with bevacizumab targeting vascular endothelial growth factor (VEGF). Here, improvement in patient selection was evaluated by combining clinical biomarkers beyond PTS using the randomized phase III trial FIRE-3. Methods: FIRE-3 evaluated first-line FOLFIRI (folinic acid, fluorouracil and irinotecan) plus cetuximab (FOLFIRI/Cet) versus FOLFIRI plus bevacizumab (FOLFIRI/Bev) in patients with RAS-WT mCRC. Besides PTS, further clinical biomarkers were evaluated in pairwise combinations using Cox regression models and model-based recursive partitioning with Weibull models to predict treatment benefit of either treatment arm regarding overall survival (OS): age, sex, liver-limited disease status (LLD) and baseline carcinoembryonic antigen serum level (CEA). The resulting P-values of second-order interactions were adjusted using Holm-Bonferroni correction. The model with the best test statistics and P-value was chosen for further evaluations. Results: In 400 patients with RAS-WT mCRC, a model combining PTS and LLD status best predicted treatment outcome of either treatment arm (c-index = 0.603, p=0.005). Here, a significant survival benefit of FOLFIRI/Cet over FOLFIRI/Bev was evident in patients with LC/non-LLD (HR 0.62, p=0.02) compared to LC/LLD (HR 0.83, p=0.40). In patients with RC, FOLFIRI/Bev was significantly associated with increased OS compared to FOLFIRI/Cet when patients suffered from non-LLD (HR 2.09, p=0.010). However, patients with RC/LLD rather had a benefit from FOLFIRI/Cet compared to FOLFIRI/Bev (HR 0.59, p=0.218). Conclusions: Combining clinical biomarkers PTS and LLD status might improve optimal patient selection for targeted first-line treatment in RAS-WT mCRC. Validation in further data sets is warranted. Clinical trial information: NCT00433927 .

BACKGROUND:Oncological therapy is based on multidimensional therapy protocols. The requirements for standardized protocols and digitation are high. These protocols are created through several complex development stages to ensure standardized recording. The process involves analyzing original publications published in international journals and extracting key content. Standardized supportive therapy is then added, and compatibility with current guidelines and quality controls is checked. SUMMARY:The Onkopti® website is based on the WordPress content management system and provides protocols in a variety of formats, generated through the use of a relational SQL database (www.onkopti.de, www.onkopti.com, www.oncopti.com). It is continuously updated to include new therapeutic developments or changes to standard therapy. The protocols are stored in a relational database and can be exported to various application systems via a standardized XML format or other formats. The website and protocols are available in both German and English. As of January, 2025, there are over 2,700 protocols for parenteral and oral therapies for all oncological specialties. KEY MESSAGES:The digitalization of protocol selection, prescription, pharmacy preparation, hospital or practice information system documentation, billing, and prescription creation can accelerate, standardize, and streamline these processes. This optimization can significantly reduce personnel costs, resulting in cost savings, and improved quality.

Anemia in cancer should be diagnosed and treated according to guideline recommendations. The implementation of ESMO and German guidelines and their effect on anemia correction was analyzed. This retrospective epidemiological study, representative for Germany, analyzed data on anemia management of cancer patients with anemia ≥ grade 2. The Guideline Adherence Score (GLAD) for diagnosis (GLAD-D) and therapy (GLAD-T) was defined as follows: 2 points for complete, 1 point for partial, 0 point for no adherence. Data were analyzed for 1046 patients. Hb levels at diagnosis of anemia were 8–10 g/dL in 899 (85.9

Etwa 5-10% der Bevolkerung in Europa weisen eine Eisenmangelanamie auf, in bestimmten Patientengruppen mit chronischen Erkrankungen liegt der Anteil noch wesentlich hoher. Eine Anamie kann die Symptomatik und die Prognose verschiedener Erkrankungen verschlechtern, erhoht praoperativ das Risiko einer Bluttransfusion und korreliert mit der postoperativen Morbiditat und Mortalitat. Daher sollte jede Anamie fruhzeitig diagnostiziert und therapiert werden. Abstract The most common cause of anemia is iron deficiency, followed by anemia of chronic disease, which is due to an inflammatory reaction in chronic diseases such as heart failure, renal failure, rheumatoid diseases and cancer. Also from the therapeutic point of view, it is useful to divide iron deficiency anemia into two forms: absolute and functional iron deficiency. Absolute iron deficiency is characterized by low iron stores and low total iron. In functional iron deficiency, a sufficient amount of storage iron is present, but it cannot be mobilized. Therapy of iron deficient anemia should always eliminate the underlying cause. The goal of therapy is sustained normalization of hemoglobin concentration and total body iron. Therapy for absolute iron deficiency focuses on improving iron stores, eliminating chronic blood losses, and optimizing iron absorption via an iron-rich diet and iron supplementation. In the case of functional iron deficiency with inflammation present, IV iron supplementation is recommended in certain situations in addition to treatment of the underlying disease, especially in patients with cancer.

Eine Anämie bei onkologischen Patienten sollte immer abgeklärt werden. Häufig bestehen ein funktioneller oder absoluter Eisenmangel, verursacht durch tumorbedingte vermehrte Produktion inflammatorischer Zytokine und insbesondere von Hepcidin, das zu einer verminderten intestinalen Eisenresorption und Verschiebung von zirkulierendem Eisen in zelluläre Eisenspeicher führt. Weiters findet sich häufig ein relativer oder, seltener, ein absoluter Mangel an Erythropoetin. Beide Faktoren stellen die häufigsten Ursachen für eine Tumoranämie dar, die durch Tumortherapie weiter verstärkt werden kann. Zur Absicherung der Diagnose Tumoranämie sollten andere Faktoren wie Hämolyse, Blutverlust, Hämodilution, Hypersplenismus, Vitamin-B12- und Folsäuremangel sowie seltene Formen von erworbenen (myelodysplastische Neoplasien, aplastische Anämie) und genetisch bedingten Anämien (Fanconi-Anämie, Thalassämie, Sichelzellanämie etc.) ausgeschlossen werden. Eine kausale Therapie sollte, wenn immer möglich, prioritär angestrebt werden. Bei chemotherapieinduzierter, symptomatischer Anämie ist eine Stimulation der Erythropoese mit Epoetinen indiziert, bei Vorliegen eines absoluten oder funktionellen Eisenmangels empfiehlt sich zusätzlich eine Substitution mit intravenös verabreichtem Eisen, da eine orale Behandlung aufgrund der bei Entzündungen und bei aktiven Tumoren stark reduzierten enteralen Eisenresorption keine ausreichende Versorgung der Erythropoese mit Eisen gewährleistet kann. Für die Kombinationstherapie aus Erythropoese-stimulierenden Agenzien (ESA) und intravenös verabreichtem Eisen wurden außerdem ein geringerer Transfusionsbedarf und ESA-Verbrauch und eine Verbesserung der Lebensqualität der Patienten nachgewiesen. Die Verabreichung von Erythrozytenkonzentraten (EK) ist in der Regel erst beim Unterschreiten eines Hb-Werts von 7–8 g/dl (4,35–4,97 mmol/l) unter Berücksichtigung der Gesamtsituation des Patienten indiziert. Wenn möglich sollte nur ein EK transfundiert werden. Die Transfusionsrate sollte weitgehend minimiert werden, eventuell im Rahmen einer interdisziplinären Kooperation und Verfolgung von etablierten Blutmanagement-Algorithmen.

The most common cause of anemia is iron deficiency, followed by anemia of chronic disease, which is due to an inflammatory reaction in chronic diseases such as heart failure, renal failure, rheumatoid diseases and cancer. Also from the therapeutic point of view, it is useful to divide iron deficiency anemia into two forms: absolute and functional iron deficiency. Absolute iron deficiency is characterized by low iron stores and low total iron. In functional iron deficiency, a sufficient amount of storage iron is present, but it cannot be mobilized. Therapy of iron deficient anemia should always eliminate the underlying cause. The goal of therapy is sustained normalization of hemoglobin concentration and total body iron. Therapy for absolute iron deficiency focuses on improving iron stores, eliminating chronic blood losses, and optimizing iron absorption via an iron-rich diet and iron supplementation. In the case of functional iron deficiency with inflammation present, IV iron supplementation is recommended in certain situations in addition to treatment of the underlying disease, especially in patients with cancer.

Purpose Clinical practice guidelines recommend the use of all approved granulocyte colony-stimulating factors (G-CSFs), including filgrastim and pegfilgrastim, as primary febrile neutropenia (FN) prophylaxis in patients receiving high- or intermediate-risk regimens (in those with additional patient risk factors). Previous studies have examined G-CSF cost-effectiveness by cancer type in patients with a high baseline risk of FN. This study evaluated patients with breast cancer (BC), non-small cell lung cancer (NSCLC), or non-Hodgkin’s lymphoma (NHL) receiving therapy who were at intermediate risk for FN and compared primary prophylaxis (PP) and secondary prophylaxis (SP) using biosimilar filgrastim or biosimilar pegfilgrastim in Austria, France, and Germany. Methods A Markov cycle tree-based model was constructed to evaluate PP versus SP in patients with BC, NSCLC, or NHL receiving therapy over a lifetime horizon. Cost-effectiveness was evaluated over a range of willingness-to-pay (WTP) thresholds for incremental cost per quality-adjusted life year (QALY) gained. Sensitivity analyses evaluated uncertainty. Results Results demonstrated that using biosimilar filgrastim as PP compared to SP resulted in incremental cost-effectiveness ratios (ICERs) well below the most commonly accepted WTP threshold of €30,000. Across all three countries, PP in NSCLC had the lowest cost per QALY, and in France, PP was both cheaper and more effective than SP. Similar results were found using biosimilar pegfilgrastim, with ICERs generally higher than those for filgrastim. Conclusions Biosimilar filgrastim and pegfilgrastim as primary prophylaxis are cost-effective approaches to avoid FN events in patients with BC, NSCLC, or NHL at intermediate risk for FN in Austria, France, and Germany.

The most common cause of anemia is iron deficiency, followed by anemia of chronic disease, which is due to an inflammatory reaction in chronic diseases such as heart failure, renal failure, rheumatoid diseases and cancer. Also from the therapeutic point of view, it is useful to divide iron deficiency anemia into two forms: absolute and functional iron deficiency. Absolute iron deficiency is characterized by low iron stores and low total iron. In functional iron deficiency, a sufficient amount of storage iron is present, but it cannot be mobilized. Therapy of iron deficient anemia should always eliminate the underlying cause. The goal of therapy is sustained normalization of hemoglobin concentration and total body iron. Therapy for absolute iron deficiency focuses on improving iron stores, eliminating chronic blood losses, and optimizing iron absorption via an iron-rich diet and iron supplementation. In the case of functional iron deficiency with inflammation present, IV iron supplementation is recommended in certain situations in addition to treatment of the underlying disease, especially in patients with cancer.