Journal Article
. 2005 Feb; 23(6):1178-84.
doi: 10.1200/JCO.2005.09.102.

First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study

Charles L Vogel 1 Marek Z Wojtukiewicz  Robert R Carroll  Sergei A Tjulandin  Luis Javier Barajas-Figueroa  Brian L Wiens  Theresa A Neumann  Lee S Schwartzberg  
Affiliations
  • PMID: 15718314
  •     117 citations

Abstract

Purpose: We evaluated the efficacy of pegfilgrastim to reduce the incidence of febrile neutropenia associated with docetaxel in breast cancer patients.

Patients And Methods: Patients were randomly assigned to either placebo or pegfilgrastim 6 mg subcutaneously on day 2 of each 21-day chemotherapy cycle of 100 mg/m(2) docetaxel. The primary end point was the percentage of patients developing febrile neutropenia (defined as body temperature >/= 38.2 degrees C and neutrophil count < 0.5 x 10(9)/L on the same day of the fever or the day after). Secondary end points were incidence of hospitalizations associated with a diagnosis of febrile neutropenia, intravenous (IV) anti-infectives required for febrile neutropenia, and the ability to maintain planned chemotherapy dose on time. Patients with febrile neutropenia were converted to open-label pegfilgrastim in subsequent cycles.

Results: Nine hundred twenty-eight patients received placebo (n = 465) or pegfilgrastim (n = 463). Patients receiving pegfilgrastim, compared with patients receiving placebo, had a lower incidence of febrile neutropenia (1% v 17%, respectively; P < .001), febrile neutropenia-related hospitalization (1% v 14%, respectively; P < .001), and use of IV anti-infectives (2% v 10%, respectively; P < .001). The percentage of patients receiving the planned dose on time was similar between patients receiving pegfilgrastim and patients who initially received placebo (80% and 78%, respectively), as would be expected of the study design. Pegfilgrastim was generally well tolerated and safe, and the adverse events reported were typical of this patient population.

Conclusion: First and subsequent cycle use of pegfilgrastim with a moderately myelosuppressive chemotherapy regimen markedly reduced febrile neutropenia, febrile neutropenia-related hospitalizations, and IV anti-infective use.

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Yusuke Kitagawa, Hiroki Osumi, +10 authors, Kensei Yamaguchi.
BMC Cancer, 2020 Apr 30; 20(1). PMID: 32345249    Free PMC article.
Clinical Safety and Efficacy of Secondary Prophylactic Pegylated G-CSF in Advanced Pancreatic Cancer Patients Treated with mFOLFIRINOX: A Single-center Retrospective Study.
Kentaro Yamao, Mamoru Takenaka, +13 authors, Masatoshi Kudo.
Intern Med, 2019 Apr 19; 58(14). PMID: 30996164    Free PMC article.
Is PEGylated G-CSF superior to G-CSF in patients with breast cancer receiving chemotherapy? A systematic review and meta-analysis.
Xiang Li, Huan Zheng, +4 authors, Juan Xu.
Support Care Cancer, 2020 Jul 06; 28(11). PMID: 32621264    Free PMC article.
Systematic Review.
Prophylactic antibiotics or G(M)-CSF for the prevention of infections and improvement of survival in cancer patients receiving myelotoxic chemotherapy.
Nicole Skoetz, Julia Bohlius, +3 authors, Jörg-Janne Vehreschild.
Cochrane Database Syst Rev, 2015 Dec 22; (12). PMID: 26687844    Free PMC article.
Systematic Review.
Rethinking clinical oncology drug research in an era of value-based cancer care: A role for chemotherapy pathways.
J Russell Hoverman.
Cancer Med, 2020 Jun 12; 9(15). PMID: 32524722    Free PMC article.
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A randomized multicenter phase II trial of mecapegfilgrastim single administration versus granulocyte colony-stimulating growth factor on treating chemotherapy-induced neutropenia in breast cancer patients.
Tao Wang, Biao Wu, +9 authors, Zefei Jiang.
Ann Transl Med, 2019 Jun 18; 7(9). PMID: 31205914    Free PMC article.
The prophylactic and therapeutic effects of moxibustion combined with traditional Chinese medicine decoction for treating chemotherapy-induced myelosuppression in early-stage breast cancer: study protocol for a randomized controlled trial.
Yajie Ji, Siyu Li, +19 authors, Xiaohong Xue.
Trials, 2020 Oct 14; 21(1). PMID: 33046128    Free PMC article.
The incidence and clinical features of PEGylated filgrastim-induced acute aortitis in patients with breast cancer.
Sang Yoon Lee, Eun Kyoung Kim, +6 authors, Duk-Kyung Kim.
Sci Rep, 2020 Oct 31; 10(1). PMID: 33122662    Free PMC article.
Predicting neutropenia risk in patients with cancer using electronic data.
Pamala A Pawloski, Avis J Thomas, +3 authors, Gary H Lyman.
J Am Med Inform Assoc, 2016 Sep 18; 24(e1). PMID: 27638907    Free PMC article.
A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI.
John Eckstrom, Trace Bartels, +6 authors, Ali McBride.
Support Care Cancer, 2018 Aug 10; 27(3). PMID: 30090991
Real-world use of granulocyte colony-stimulating factor in ambulatory breast cancer patients: a cross-sectional study.
Florence Van Ryckeghem, Chloë Haverbeke, +5 authors, Simon Van Belle.
Support Care Cancer, 2018 Aug 14; 27(3). PMID: 30099601
The timing of docetaxel initiation in metastatic castrate-sensitive prostate cancer and the rate of chemotherapy-induced toxicity.
Igal Kushnir, Kim Koczka, +4 authors, M Neil Reaume.
Med Oncol, 2019 Jan 23; 36(2). PMID: 30666463
Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy.
Zsuzsanna Kahan, Daniela Grecea, +6 authors, Ildiko Aradi.
BMC Cancer, 2019 Feb 08; 19(1). PMID: 30727980    Free PMC article.
Febrile neutropenia (FN) and pegfilgrastim prophylaxis in breast cancer and non-Hodgkin's lymphoma patients receiving high (> 20%) FN-risk chemotherapy: results from a prospective observational study.
Jean Paul Salmon, Martin Smakal, +5 authors, James O'Kelly.
Support Care Cancer, 2018 Sep 28; 27(4). PMID: 30259136
Pegfilgrastim Maintains Relative Dose Intensity and Decreases Hospitalisations in Patients With Endometrial Cancer.
Kenro Chikazawa, Ken Imai, +5 authors, Ryo Konno.
In Vivo, 2020 Nov 05; 34(6). PMID: 33144483    Free PMC article.
Randomized and dose-escalation trials of recombinant human serum albumin /granulocyte colony-stimulating factor in patients with breast cancer receiving anthracycline-containing chemotherapy.
Shanshan Chen, Yiqun Han, +15 authors, Binghe Xu.
BMC Cancer, 2021 Apr 02; 21(1). PMID: 33789616    Free PMC article.
Administration of docetaxel plus ramucirumab with primary prophylactic pegylated-granulocyte colony-stimulating factor for pretreated non-small cell lung cancer: a phase II study.
Norimitsu Kasahara, Noriaki Sunaga, +16 authors, Takeshi Hisada.
Support Care Cancer, 2020 Jan 27; 28(10). PMID: 31982960
A Multicenter Study of Docetaxel at a Dose of 100 mg/m2 in Japanese Patients with Advanced or Recurrent Breast Cancer.
Taizo Hirata, Shinji Ozaki, +9 authors, Hiroyoshi Doihara.
Intern Med, 2020 Nov 17; 60(8). PMID: 33191320    Free PMC article.
Effectiveness of Herbal Medicine for Leukopenia/Neutropenia Induced by Chemotherapy in Adults with Colorectal Cancer: A Systematic Review and Meta-analysis.
Shao-Hua Yan, Shuo Feng, +11 authors, Yu-Fei Yang.
Integr Cancer Ther, 2021 Jun 13; 20. PMID: 34116595    Free PMC article.
Risk factor analysis for taxane-associated acute pain syndrome under the dexamethasone prophylaxis.
Yoshitaka Saito, Yoh Takekuma, +3 authors, Mitsuru Sugawara.
Support Care Cancer, 2021 Jul 07;. PMID: 34228171