Prophylactic long-acting granulocyte-colony stimulating factors (G-CSF) in gynecologic malignancies: an oncologic expert statement

Petru, Edgar; Singer, Christian F.; Polterauer, Stephan; Galid, A.; Schauer, Christian; Klocker, Johann G.; Seifert, Michael; Reinthaller, Alexander; Benedicic, Christoph; Hubalek, Michael; Hefler, Lukas; Marth, Christian; Scholl-Firon, Tonja; Bogner, Gerhard; Zeimet, A.

doi:10.1007/s10354-015-0392-3

Cited by 5 publications

(3 citation statements)

References 53 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In chemotherapy for lung cancer, FN develops in 3.7-28% of patients (Smith et al, 2006), and therefore, FN is not a rare complication. With the advent of granulocyte-colony stimulating factor (G-CSF) preparations, progress has been made in the treatment and prevention of FN, but it is still a complication requiring clinical attention (Petru et al, 2015). Pretreatment weight loss (underweight) and hypoalbuminemia have been reported to be two of the important risk factors of the development of FN in several hematological and nonhematological malignant diseases (Aoyagi, Morii, Tajima, Yoshiyama, & Ichimura, 2015;Kobayashi et al, 2019;Lapointe et al, 2005;Pettengell et al, 2009;Schwenkglenks, Bendall, Pfeil, Szabo, & Pettengell, 2013).…”

Section: Introductionmentioning

confidence: 99%

Change in Body Weight and Serum Albumin Levels in Febrile Neutropenic Lung Cancer Patients

Kayauchi

Nakagawa

Oteki

et al. 2020

Asian Pac Isl Nurs Js

View full text Add to dashboard Cite

Although advances have been made in the treatment and prevention of febrile neutropenia (FN) in cancer patients treated with chemotherapy, it is still a complication that requires clinical attention. Impaired nutritional status in patients who develop FN can affect the continuation of cancer treatment, but it has not been investigated. We conducted a retrospective longitudinal study in order to clarify (1) if body weight and serum albumin levels change in lung cancer patients who do and do not develop FN, and (2) if these indicators are more likely to worsen in patients with FN than in patients without FN. Patients undergoing cytotoxic chemotherapy between January 2011 and June 2020 were consecutively included in the study. Changes in body weight and serum albumin levels were investigated in a case–control study of patients with FN, and control patients without FN who were matched by age, gender, histopathology, and stage of lung cancer, at a ratio of 1:2. During the study period, 226 patients received cytotoxic chemotherapy. Among those, 33 (14.6%) patients developed FN during the first course of cytotoxic chemotherapy. We found a more pronounced decrease in both body weight and serum albumin level at four weeks after the initiation of chemotherapy in FN patients. In order to safely administer effective chemotherapy, medical staff need to pay close attention to the nutritional status of patients receiving chemotherapy.

show abstract

Section: Introductionmentioning

confidence: 99%

Change in Body Weight and Serum Albumin Levels in Febrile Neutropenic Lung Cancer Patients

Kayauchi

Nakagawa

Oteki

et al. 2020

Asian Pac Isl Nurs Js

View full text Add to dashboard Cite

show abstract

“…This may impact the success of treatment, particularly when treatment intent is either curative or to prolong survival (1). In patients undergoing cytotoxic chemotherapy, both primary and secondary prophylaxis with granulocyte colony-stimulating factors (GCSFs) have been demonstrated to reduce the incidence of severe and FN, length of neutropenia, neutropenia-associated complications, antibiotic use and the duration of hospitalization (2). Pegfilgrastim (PG) is a sustained-duration pegylated form of filgrastim, a recombinant methionyl form of human GCSF that is widely used in CIN management (3,4).…”

Section: Introductionmentioning

confidence: 99%

Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies

Brekkan

López-Lázaro

Plan³

et al. 2019

AAPS J

View full text Add to dashboard Cite

In this work, a previously developed pegfilgrastim (PG) population pharmacokinetic-pharmacodynamic (PKPD) model was used to evaluate potential factors of importance in the assessment of PG PK and PD similarity. Absolute neutrophil count (ANC) was the modelled PD variable. A two-way cross-over study was simulated where a reference PG and a potentially biosimilar test product were administered to healthy volunteers. Differences in delivered dose amounts or potency between the products were simulated. A different baseline absolute neutrophil count (ANC) was also considered. Additionally, the power to conclude PK or PD similarity based on areas under the PG concentration-time curve (AUC) and ANC-time curve (AUEC) were calculated. Delivered dose differences between the products led to a greater than dose proportional differences in AUC but not in AUEC, respectively. A 10% dose difference from a 6 mg dose resulted in 51% and 7% differences in AUC and AUEC, respectively. These differences were more pronounced with low baseline ANC. Potency differences up to 50% were not associated with large differences in either AUCs or AUECs. The power to conclude PK similarity was affected by the simulated dose difference; with a 4% dose difference from 6 mg the power was approximately 29% with 250 subjects. The power to conclude PD similarity was high for all delivered dose differences and sample sizes.

show abstract

“…Several studies of solid tumours have also included patients with ovarian cancer 18–20. Despite a statement from multiple experts on gynaecological cancers regarding the application of prophylactic long-acting G-CSF,21 there is still very little evidence in terms of its efficiency and safety in gynaecological cancer. Additionally, in a study of Asian patients with lymphoma, pegfilgrastim prophylaxis did not show a therapeutic advantage in terms of preventing neutropenic outcomes compared with filgrastim prophylaxis 22…”

Section: Introductionmentioning

confidence: 99%

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

Prophylactic long-acting granulocyte-colony stimulating factors (G-CSF) in gynecologic malignancies: an oncologic expert statement

Cited by 5 publications

References 53 publications

Change in Body Weight and Serum Albumin Levels in Febrile Neutropenic Lung Cancer Patients

Change in Body Weight and Serum Albumin Levels in Febrile Neutropenic Lung Cancer Patients

Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies

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

Contact Info

Product

Resources

About