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)

German Breast Group, Neu-Isenburg, Germany.
Supportive Care in Cancer (Impact Factor: 2.36). 10/2010; 19(11):1789-95. DOI: 10.1007/s00520-010-1020-9
Source: PubMed


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.

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    • "Moreover, the on-schedule definition is supported by clinical evidence: The phase 3 registrational studies used the ~24 h after chemotherapy schedule [12, 13] and a comparison of same-day versus next-day pegfilgrastim dosing in breast cancer and NHL patients suggested administration 24 h after chemotherapy provided better efficacy, although differences were not statistically significant [29]. Clinical data also supports G-CSF as prophylaxis given no later than 3 days after chemotherapy, with conflicting results as to whether 1 or 3 days after chemotherapy is superior [30, 31]. Although the FN risk is greatest in the first cycle, the risk continues in subsequent cycles [32], and patients should be supported equally in all cycles during which they are at high risk. "
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