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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)
- Source :
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 19(11)
- Publication Year :
- 2010
-
Abstract
- Preliminary data suggest that pegfilgrastim given on day 4 (P4) might be superior to pegfilgrastim on day 2 (P2) in reducing grade 4 leucopenia. Patients with node-positive primary breast cancer receiving epirubicin–paclitaxel–cyclophosphamide chemotherapy were randomized to receive P2 versus P4. Primary endpoint was leucopenia grade 4, assuming a risk reduction of 50% with P4 from 50% in P2 to 25% with P4. Three-hundred fifty-one patients were randomized to P2 (n = 174) versus P4 (n = 177). The rate of leucopenia (grade 4) was 47.1% with P2 and 42.0% with P4 (p = 0.387), neutropenia (grade 3 + 4) was 47.9% versus 40.8% (p = 0.337), FN was 4.7% versus 8.0% (p = 0.271), and infections was 29.9% versus 25.4% (p = 0.404), respectively. 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.
- Subjects :
- Oncology
Adult
medicine.medical_specialty
Neutropenia
Time Factors
Dose-dense chemotherapy
Fever
Filgrastim
Paclitaxel
medicine.medical_treatment
Breast Neoplasms
Drug Administration Schedule
Polyethylene Glycols
Young Adult
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
Clinical endpoint
Medicine
Humans
Prospective Studies
Prospective cohort study
Cyclophosphamide
Aged
Epirubicin
Chemotherapy
business.industry
Leukopenia
Middle Aged
medicine.disease
Recombinant Proteins
Female
business
Febrile neutropenia
Pegfilgrastim
medicine.drug
Subjects
Details
- ISSN :
- 14337339
- Volume :
- 19
- Issue :
- 11
- Database :
- OpenAIRE
- Journal :
- Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
- Accession number :
- edsair.doi.dedup.....34b3c806858f0453f082a2e52b459f71