Febrile neutropenia and related complications in breast cancer patients receiving pegfilgrastim primary prophylaxis versus current practice neutropaenia management: Results from an integrated analysis

European Journal of Cancer

Volumn 45, Issue 4, 2009, Pages 608-617

  von Minckwitz, G ^a   Schwenkglenks, M ^b   Skacel, T ^c   Lyman, G H ^d   Pousa, A Lopez ^e   Bacon, P ^c   Easton, V ^f   Aapro, M S ^g  

^a GOETHE UNIVERSITY   (Germany)

^b UNIVERSITY OF BASEL   (Switzerland)

^c AMGEN INC   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e HOSPITAL SANT PAU   (Spain)

^f AMGEN LTD   (United Kingdom)

^g Institut Multidisciplinaire d'Oncologie   (Switzerland)

Author keywords

Breast neoplasms; Drug therapy; Granulocyte colony stimulating factor; Human; Neutropaenia chemically induced; Pegfilgrastim; Primary prevention; Taxane

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; GEMCITABINE; GRANULOCYTE COLONY STIMULATING FACTOR; NAVELBINE; PACLITAXEL; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR;

ADULT; ARTICLE; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER INCIDENCE; CANCER PATIENT; CANCER RISK; CANCER STAGING; CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFICACY; FEBRILE NEUTROPENIA; FEMALE; HOSPITALIZATION; HUMAN; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MEDICAL PRACTICE; NEUTROPENIA; OBSERVATIONAL STUDY; PRIORITY JOURNAL; PROPHYLAXIS; TREATMENT OUTCOME;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; FEMALE; FEVER; FILGRASTIM; HUMANS; LEUKOPENIA; MALE; MIDDLE AGED; NEUTROPENIA; OPPORTUNISTIC INFECTIONS; TREATMENT OUTCOME;

EID: 60149086849     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2008.11.021     Document Type: Article

References (34)

1. Kuderer N.M., Dale D.C., Crawford J., Cosler L.E., and Lyman G.H. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 106 (2006) 2258-2266
2. Bonadonna G., Valagussa P., Moliterni A., Zambetti M., and Brambilla C. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. New Engl J Med 332 (1995) 901-906
3. Chirivella I., Bermejo B., Insa A., et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant setting improves outcome of breast cancer patients. Breast Cancer Res Treat (2008) epub.
4. Aapro M.S., Cameron D.A., Pettengell R., et al. EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphomas and solid tumours. Eur J Cancer 42 (2006) 2433-2453
5. Hryniuk W., Frei E., and Wright F.A. A single scale for comparing dose-intensity of all chemotherapy regimens in breast cancer: summation of dose intensity. J Clin Oncol 16 (1998) 3137-3147
6. Crawford J., Ozer H., Stoller R., et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. New Engl J Med 325 (1991) 164-170
7. Trillet-Lenoir V., Green J., Manegold C., et al. Recombinant granulocyte colony stimulating factor reduces the infectious complications of cytotoxic chemotherapy. Eur J Cancer 29A (1993) 319-324
8. Holmes F.A., O'Shaughnessy J.A., Vukelja S., et al. Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20 (2002) 727-731
9. Green M.D., Koelbl H., Baselga J., et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 14 (2003) 29-35
10. Johnston E., Crawford J., Blackwell S., et al. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol 18 (2000) 2522-2528
11. Vogel C.L., Wojtukiewicz M.Z., Carroll R.R., et al. First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 23 (2005) 1178-1184
12. Scott S.D., Chrischilles E.A., Link B.K., Delgado D.J., Fridman M., and Stolshek B.S. Days of prophylactic filgrastim use to reduce febrile neutropenia in patients with non-Hodgkin's lymphoma treated with chemotherapy. J Manage Care Pharm 9 2 Suppl. (2003) 15-21
13. Koumakis G., Vassilomanolakis M., Barbounis V., et al. Optimal timing (preemptive versus supportive) of granulocyte colony-stimulating factor administration following high-dose cyclophosphamide. Oncology 56 (1999) 28-35
14. Schwenkglenks M., Jackisch C., Constenla M., et al. Neutropenic event risk and impaired chemotherapy delivery in six European audits of breast cancer treatment. Support Care Cancer 14 (2006) 901-909
15. Von Minckwitz G., Kümmel S., du Bois A., et al. Pegfilgrastim ± ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO Study. Ann Oncol 19 (2008) 292-298
16. Lopez Pousa A., Rifa J., Casas Fernandez de Tejerina A., et al. Risk assessment model for first-cycle chemotherapy-induced neutropenia (CIN) among breast cancer (BrCa) patients. On behalf of the DELFOS Study Group. Ann Oncol 17 Suppl. 9 (2006) ix296 Abstract no. 1028P
17. Balducci L., Al-Halawani H., Charu V., et al. Elderly cancer patients receiving chemotherapy benefit from first cycle pegfilgrastim. Oncologist 12 (2007) 1416-1424
18. Morrison V.A., Wong M., Hershman D., Campos L.T., Ding B., and Malin J. Observational study of the prevalence of febrile neutropenia in patients who received filgrastim or pegfilgrastim associated with 3-4 week chemotherapy regimens in community oncology practices. J Manage Care Pharm 13 (2007) 337-348
19. Pettengell P., Schwenkglenks M., Leonard R., et al., for the Impact of Neutropenia in Chemotherapy - European Study Group (INC-EU). Support Care Cancer 22 (2008) 33 E-publication ahead of print
20. Holmes F.A., Jones S.E., O'Shaughnessy J., et al. Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13 (2002) 903-909
21. Kaufman P.A., Paroly W., Rinaldi D., et al. Randomized double-blind phase 2 study evaluating same-day versus next-day administration of pegfilgrastim with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with early stage and advanced breast cancer. Breast Cancer Res Treat 88 1 Suppl. (2004) 22-23 Abstract no. 1054
22. Ozer H., Mirtsching B., Rader M., et al. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist 12 (2007) 484-494
23. Bendel R.B., and Afifi A.A. Comparison of stopping rules in forward stepwise regression. J Am Stat Assoc 72 (1977) 46-53
24. Bontenbal M., Creemers G.J., Braun H.J., et al. Phase II to III study comparing doxorubicin and docetaxel with fluorouracil, doxorubicin, and cyclophosphamide as first-line chemotherapy in patients with metastatic breast cancer: results of a Dutch Community Setting Trial for the Clinical Trial Group of the Comprehensive Cancer Centre. J Clin Oncol 23 (2005) 7081-7088
25. Harvey V., Mouridsen H., Semiglazov V., et al. Phase III trial comparing three doses of docetaxel for second-line treatment of advanced breast cancer. J Clin Oncol 24 (2006) 4963-4970
26. Martin M., Lluch A., Segui M.A., et al. Toxicity and health-related quality of life in breast cancer patients receiving adjuvant docetaxel, doxorubicin, cyclophosphamide (TAC) or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC): impact of adding primary prophylactic granulocyte-colony stimulating factor to the TAC regimen. Ann Oncol 17 (2006) 1205-1212
27. Polyzos A., Tsavaris N., Kosmas C., et al. Docetaxel and epirubicin supported by granulocyte colony-stimulating factor first-line in advanced breast cancer. Anticancer Res 23 (2003) 2917-2923
28. Schippinger W., Holub R., Dandachi N., Bauernhofer T., and Samonigg H. Frequency of febrile neutropenia in breast cancer patients receiving epirubicin and docetaxel/paclitaxel with colony-stimulating growth factors: a comparison of filgrastim or lenograstim with pegfilgrastim. Oncology 70 (2006) 290-293
29. Siena S., Piccart M.J., Holmes F.A., Glaspy J., Hackett J., and Renwick J.J. A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily Filgrastim in patients with stage II-IV breast cancer. Oncol Rep 10 (2003) 715-724
30. Weycker D., Hackett J., Edelsberg J.S., Oster G., and Glass A.G. Are shorter courses of filgrastim prophylaxis associated with increased risk of hospitalization?. Ann Pharmacother 40 (2006) 402-407
31. Smith T.J., Khatcheressian J., Lyman G.H., et al. 2006 Update of Recommendations for the Use of White Blood Cell Growth Factors: an evidence-based clinical practice guideline. J Clin Oncol 24 (2006) 3187-3205
32. Lyman G.H., Dale D.C., and Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol 21 (2003) 4524-4531
33. Kuderer N.M., Dale D.C., Crawford J., and Lyman G.H. Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol 25 (2007) 3158-3167
34. Lyman G.H., and Kuderer N.M. The strengths and limitations of meta-analyses based on aggregate data. BMC Med Res Methodol 5 (2005) 14