title: An open-label, randomized, multicenter dose-finding study of once-per-cycle pegfilgrastim versus daily filgrastim in Chinese breast cancer patients receiving TAC chemotherapy.
abstract: A chemotherapy regimen of docetaxel, doxorubicin and cyclophosphamide (TAC) has been accepted as a standard care because of their superior clinical benefit in early-stage breast cancer patients, but with a higher risk of neutropenia. Pegfilgrastim is a once-per-cycle therapy for prophylactic neutrophil support and neutropenia prevention. There was still a lack of direct evidences for finding an optimal fixed dose of pegfilgrastim in Chinese breast cancer patients receiving TAC regimen. An open-label, randomized, phase II study was designed to compare the effects of pegfilgrastim with filgrastim. Eighteen centers in China enrolled 171 eligible female breast cancer patients with cycles of TAC chemotherapy treatment, randomized into four arms, received a single subcutaneous injection of pegfilgrastim (60, 100 or 120 µg/kg) per chemotherapy cycle or daily subcutaneous injections of filgrastim 5 µg/kg 24 h after chemotherapy. Efficacy and safety were analyzed. In ITT population, the mean duration of grade 3+ neutropenia (neutrophil count <1.0 × 10(9)/l) was 2.09, 1.53 and 1.73 days in patients who received pegfilgrastim 60, 100 and 120 µg/kg/cycle, respectively, and 1.69 days in patients who received 5 µg/kg/day filgrastim (P = 0.043). The incidence of grade 3+ neutropenia was 76, 83 and 74 % for doses of pegfilgrastim and 90 % for filgrastim (P = 0.409). The results for febrile neutropenia, time to neutrophil recovery and neutrophil profile were also not significantly different between arms. The safety profiles of pegfilgrastim and filgrastim were similar. A single dose of 100 µg/kg once-per-cycle administration of pegfilgrastim provided neutrophil support and a safety profile comparable to daily subcutaneous injections of filgrastim in Chinese breast cancer patients receiving TAC chemotherapy.
authors.affiliation: Department of Health Statistics, School of Preventive Medicine, Fourth Military Medical University, No. 169 Changle West Road, Xi'an, 710032, Shaanxi, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Zhang
authors.forename: Zhiwei
authors.initials: Z
authors.lastname: Jiang
authors.forename: Ling
authors.initials: L
authors.lastname: Wang
authors.forename: Chanjuan
authors.initials: C
authors.lastname: Li
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D044466:Asian People; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage*; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D000069585:Filgrastim / Q000008:administration & dosage*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage*
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim
references.citation: Ann Oncol. 2002 Jun;13(6):903-9
references.pmid: 12123336
references.citation: BMC Cancer. 2011 Sep 23;11:404
references.pmid: 21943360
references.citation: Ann Oncol. 2006 Aug;17(8):1205-12
references.pmid: 16766587
references.citation: J Clin Oncol. 2006 Jul 1;24(19):3187-205
references.pmid: 16682719
references.citation: Lancet. 2012 Feb 4;379(9814):432-44
references.pmid: 22152853
references.citation: J Clin Oncol. 2002 Feb 1;20(3):727-31
references.pmid: 11821454
references.citation: Ann Oncol. 2008 Feb;19(2):292-8
references.pmid: 17846019
references.citation: Ann Oncol. 2005 Jan;16(1):56-63
references.pmid: 15598939
references.citation: N Engl J Med. 2010 Dec 2;363(23):2200-10
references.pmid: 21121833
references.citation: N Engl J Med. 2005 Jun 2;352(22):2302-13
references.pmid: 15930421
references.citation: J Clin Oncol. 2012 Mar 10;30(8):806-12
references.pmid: 22312106
references.citation: Anticancer Drugs. 2013 Jul;24(6):641-7
references.pmid: 23571496
references.citation: J Clin Oncol. 1989 Oct;7(10):1554-62
references.pmid: 2789274
references.citation: J Clin Oncol. 2008 Jan 1;26(1):44-53
references.pmid: 18165639
references.citation: Ann Oncol. 2003 Jan;14(1):29-35
references.pmid: 12488289
references.citation: J Clin Oncol. 2009 Mar 10;27(8):1168-76
references.pmid: 19204205
references.citation: Pharmacotherapy. 2003 Aug;23(8 Pt 2):9S-14S
references.pmid: 12921217
references.citation: N Engl J Med. 1991 Jul 18;325(3):164-70
references.pmid: 1711156
references.citation: J Clin Oncol. 2003 Apr 15;21(8):1431-9
references.pmid: 12668651
references.citation: Eur J Cancer. 2011 Jan;47(1):8-32
references.pmid: 21095116
references.citation: Invest New Drugs. 2013 Oct;31(5):1300-6
references.pmid: 23677653
references.citation: Lancet Oncol. 2013 Jan;14(1):72-80
references.pmid: 23246022
references.citation: N Engl J Med. 1988 Jun 2;318(22):1414-22
references.pmid: 2452983
references.citation: Lancet. 2005 May 14-20;365(9472):1687-717
references.pmid: 15894097
references.citation: J Clin Oncol. 2011 Oct 10;29(29):3877-84
references.pmid: 21911726
references.citation: Lancet. 1988 Mar 26;1(8587):667-72
references.pmid: 2895212
references.citation: Lancet Oncol. 2005 Nov;6(11):886-98
references.pmid: 16257797