Pegfilgrastim prophylaxis in patients at different levels of risk for chemotherapy-associated febrile neutropenia: an observational study

Abstract

Background:

Guidelines for using granulocyte colony-stimulating factor (G-CSF) in patients receiving chemotherapies with 10–20% (intermediate) risk for febrile neutropenia (FN) recommend additional assessment of patient-related FN risk factors.

Objective:

The current study evaluated adherence to guideline recommendations and analysed modalities of pegfilgrastim use.

Methods:

Adult cancer patients scheduled to receive a chemotherapy regimen assessed by the investigators as intermediate FN risk and who received pegfilgrastim were prospectively enrolled in this observational study from 2007–2010. Risk factors at study entry, treatment modalities and FN assessment were documented by investigators, whereas guideline adherence was centrally checked in a post-hoc analysis, according to guideline categorizations.

Results:

Thirty-seven centres enrolled 335 evaluable patients with solid and hematologic neoplasias. Although physicians initially rated the FN risk of all chemotherapies as intermediate, after central re-assessment this applied only to 63.9% of regimens; 21.2% were reassessed as low risk and 14.9% as high risk. Pegfilgrastim was used as primary prophylaxis in 80.3% of all patients. The most frequent FN risk factors considered by physicians when deciding to use pegfilgrastim were female gender, advanced disease, age ≥65 years, and anaemia. FN incidence was higher in patients with ≥4 FN risk factors than those with <4 risk factors (10% vs. 4.3%; p = 0.055) and in patients with severe comorbidity than those without (13.6% vs. 4.5%; p = 0.014). Overall FN rate was 5.7%.

Limitations:

Due to the observational design of the study, findings are descriptive in nature. Post-hoc assessment of chemotherapy FN risk was determined by author’s opinion in some cases.

Conclusions:

Overall, there was good adherence of Austrian physicians to guideline recommendations; however, there are chemotherapy regimens and clinical settings in which FN risk assignment is unclear in the literature. FN incidence with pegfilgrastim prophylaxis was similar to that reported in other observational and randomized studies.

Keywords::

• Chemotherapy
• Febrile neutropenia
• Malignancy
• Pegfilgrastim
• Risk category

Transparency

Declaration of funding

This study was sponsored by Amgen GmbH. Amgen and M.F. designed the study. M.F. performed the research, analysed and interpreted the data, and wrote the manuscript; study data to be used in the manuscript were provided by M.F. to Amgen’s Global Biomedical Data Sciences group for the purpose of verification and quality control. G.G.S., M.S., W.E., and W.W. performed the research and edited the manuscript. CJ. analysed and interpreted the data and edited the manuscript. The authors made the final decision to submit the manuscript for publication.

Declaration of financial/other relationships

M.F. received honoraria for data management and analysis (Amgen GmbH). The contributors received a case fee (Amgen GmbH). C.J. is an employee of Amgen GmbH. G.G.S., M.S., W.E., and W.W. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers may have received honoraria for their review work. The peer reviewers on this manuscript have disclosed that they have no relevant financial relationships.

Acknowledgements

Contributing physicians (Austrian centres) were: P. Durkovic (Mistelbach); D. Nitsche (Linz); R. Kolb (Wels); P. Kier (Wien); W. Scheithauer (Wien); S. Six-Wittner (Wien); A. Schulenburg (Wien); P. Sevelda (Wien); G. Zickero (Baden); H. Musil (Mistelbach); F. Keil (Leoben); T. Schneider (Klagenfurt); F. Renner (Ried); H. Oexle (Hall); A. Lanz-Veit (Graz); S. Sormann (Graz); H. Koch (Salzburg); J. Mühlmann (Salzburg); G. Winder (Dornbirn); A. Lang (Feldkirch); D. Gunegger (Rottenmann); M. Schiffer (Bad Ischl); K. Wilthoner (Vöcklabruck); F. Haslbauer (Vöcklabruck); B. Celedin (Villach); A. Keckeis (Hohenems); M. Gerold (Knittelfeld); J. Andel (Steyr); A. Guttmann (Fürstenfeld); M. Schnallinger (St. Johann/Tirol); R. Leikermoser (Linz); A. Pacher (Warmbad Villach). The authors wish to express their thanks to Dr. Eva Müller, Vienna, for assistance with preparation of the first draft of the manuscript, funded by Amgen. Subsequent editorial assistance was provided by James O’Kelly, an employee of Amgen Ltd.