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)

被引：24

作者：

Loibl, Sibylle ^{[1
]}

Mueller, Volkmar ^{[2
]}

von Minckwitz, Gunter ^{[1
]}

Conrad, Bettina ^{[3
]}

Koehne, Claus-Henning ^{[4
]}

Kremers, Stephan ^{[5
]}

Forstbauer, Helmut ^{[6
]}

Linder, Mattea ^{[1
]}

Nekljudova, Valentina ^{[1
]}

Moebus, Volker ^{[7
]}

机构：

[1] German Breast Grp, D-63263 Neu Isenburg, Germany

[2] Univ Klinikum Hamburg Eppendorf, Hamburg, Germany

[3] Elisabeth Hosp, Kassel, Germany

[4] Klinikum Oldenburg, Oldenburg, Germany

[5] Caritas Krankenhaus Lebach, Lebach, Germany

[6] GOSPL Gesell Onkol Studien Hamatol & Onkol, Troisdorf, Germany

[7] Stadt Kliniken Frankfurt Hochst, Frankfurt, Germany

来源：

SUPPORTIVE CARE IN CANCER | 2011年 / 19卷 / 11期

关键词：

Pegfilgrastim; Neutropenia; Primary breast cancer; Dose-dense chemotherapy; Leucopenia; Febrile; SINGLE-ADMINISTRATION PEGFILGRASTIM; FEBRILE NEUTROPENIA; DAILY FILGRASTIM; RANDOMIZED-TRIAL;

D O I：

10.1007/s00520-010-1020-9

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1789 / 1795

页数：7

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