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).

Abstract

BACKGROUND:

Preliminary data suggest that pegfilgrastim given on day 4 (P4) might be superior to pegfilgrastim on day 2 (P2) in reducing grade 4 leucopenia.

METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

• Authors: Sibylle Loibl, Volkmar Mueller, Gunter von Minckwitz, Bettina Conrad, Claus-Henning Koehne, Stephan Kremers, Helmut Forstbauer, Mattea Linder, Valentina Nekljudova, Volker Moebus, GBG/AGO/NOGGO study groups
• Journal: Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer (Support Care Cancer) Vol. 19 Issue 11 Pg. 1789-95 (Nov 2011) ISSN: 1433-7339 [Electronic] Germany
• PMID: 20953803 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• Granulocyte Colony-Stimulating Factor
• pegfilgrastim
• Polyethylene Glycols
• Epirubicin
• Cyclophosphamide
• Paclitaxel
• Filgrastim

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Breast Neoplasms (drug therapy)
• Cyclophosphamide (administration & dosage)
• Drug Administration Schedule
• Epirubicin (administration & dosage)
• Female
• Fever (prevention & control)
• Filgrastim
• Granulocyte Colony-Stimulating Factor (administration & dosage, therapeutic use)
• Humans
• Leukopenia (chemically induced, prevention & control)
• Middle Aged
• Neutropenia (chemically induced, prevention & control)
• Paclitaxel (administration & dosage)
• Polyethylene Glycols
• Prospective Studies
• Recombinant Proteins (administration & dosage, therapeutic use)
• Time Factors
• Young Adult