title: A randomized double blind control trial comparing filgrastim and pegfilgrastim in cyclophosphamide peripheral blood hematopoietic stem cell mobilization.
abstract: There are few randomized trials comparing filgrastim and pegfilgrastim in peripheral blood stem cell mobilization (PBSCM). None of the trials studied the effects of the timing of pegfilgrastim administration on the outcomes of mobilization. We conducted a randomized triple blind control trial comparing the outcomes of filgrastim 5 µg/kg daily from day 3 onwards, 'early' pegfilgrastim 6 mg on day 3 and 'delayed' pegfilgrastim 6 mg on day 7 in cyclophosphamide PBSCM in patients with no previous history of mobilization. Peripheral blood (PB) CD34+ cell count was checked on day 8 and day 11 onward. Apheresis was started when PB CD34+ ≥ 10/µl from day 11 onward. The primary outcome was the successful mobilization rate, defined as cumulative collection of ≥ 2 × 10(6)/kg CD34+ cells in three or less apheresis. The secondary outcomes were the day of neutrophil and platelet engraftment post transplantation. There were 156 patients randomized and 134 patients' data analyzed. Pegfilgrastim 6 mg day 7 produced highest percentage of successful mobilization, 34 out of 48 (70.8%) analyzed patients, followed by daily filgrastim, 28 out of 44 (63.6%) and day 3 pegfilgrastim, 20 out of 42 (47.6%) (p = 0.075). Pegfilgrastim day 7 and daily filgrastim reported 1.48 (p = 0.014) and 1.49 (p = 0.013) times higher successful mobilization rate respectively as compared to pegfilgrastim day 3 after adjusting for disease, gender and exposure to myelotoxic agent. Multiple myeloma patients were three times more likely to achieve successful mobilization as compared to acute leukemia or lymphoma patients. Pegfilgrastim avoided the overshoot of white cells compared to filgrastim. There was no difference in the duration of both white cells and platelet recovery post transplantation between the three interventional arms.
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia. Electronic address: kuanjewwin@gmail.com.
authors.forename: Jew-Win
authors.initials: JW
authors.lastname: Kuan
authors.affiliation: Department of Community Medicine and Public Health, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia.
authors.forename: Anselm-Ting
authors.initials: AT
authors.lastname: Su
authors.affiliation: Department of Pharmacy, Ampang Hospital, Selangor, Malaysia.
authors.forename: Shu-Ping
authors.initials: SP
authors.lastname: Wong
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Xavier Yoon-Han
authors.initials: XY
authors.lastname: Sim
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: See-Guan
authors.initials: SG
authors.lastname: Toh
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Tee-Chuan
authors.initials: TC
authors.lastname: Ong
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Jay-Suria
authors.initials: JS
authors.lastname: Rajasuriarr
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Su-Hong
authors.initials: SH
authors.lastname: Lim
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Yong-Khee
authors.initials: YK
authors.lastname: Guan
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Hong-Keng
authors.initials: HK
authors.lastname: Liew
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Pek-Kuen
authors.initials: PK
authors.lastname: Liew
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Jerome Tsen-Chuen
authors.initials: JT
authors.lastname: Tan
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Ahlam-Naila
authors.initials: AN
authors.lastname: Kori
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Yuin-Yin
authors.initials: YY
authors.lastname: Cheng
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Sen-Mui
authors.initials: SM
authors.lastname: Tan
authors.affiliation: Department of Medicine, Faculty of Medicine and Health Sciences, Universiti Malaysia Sarawak, Sarawak, Malaysia; Department of Hematology, Ampang Hospital, Selangor, Malaysia.
authors.forename: Kian-Meng
authors.initials: KM
authors.lastname: Chang
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D064592:Autografts; D002648:Child; D003520:Cyclophosphamide / Q000008:administration & dosage*; D004311:Double-Blind Method; D000069585:Filgrastim / Q000008:administration & dosage*; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D019650:Hematopoietic Stem Cell Mobilization / Q000379:methods*; D006801:Humans; D007938:Leukemia / Q000097:blood* / Q000628:therapy; D008223:Lymphoma / Q000097:blood* / Q000628:therapy; D008875:Middle Aged; D009101:Multiple Myeloma / Q000097:blood* / Q000628:therapy; D036102:Peripheral Blood Stem Cell Transplantation; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D003520:Cyclophosphamide; D000069585:Filgrastim
keywords: Filgrastim; Granulocyte colony-stimulating factor; Hematopoietic stem cell mobilization; Pegfilgrastim