title: Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline- and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial.
abstract: OBJECTIVE
  To evaluate the safest timing of pegfilgrastim administration in dose-dense anthracycline- and taxane-based chemotherapy, three different cohorts of patients enrolled in the Gruppo Italiano Mammella (GIM) 2 study and treated at the coordinating center received pegfilgrastim 24 h (cohort A) or 72 h (cohort B) or 96 h (cohort C) after chemotherapy.
  
  
  METHODS
  A total of 41 patients were included. The safety of pegfilgrastim administration in terms of occurrence of early and late leukocytosis and the behavior of white blood cells (WBC) counts in the three cohorts across all chemotherapy cycles were evaluated. Anthracycline and taxane cycles were analyzed separately.
  
  
  RESULTS
  The occurrence of early leukocytosis was a more common event in patients in cohort A in both anthracycline and taxane cycles (75 and 66.7%) as compared to cohort B (50 and 60%) and cohort C (66.7 and 33.3%). More patients in cohort C developed late leukocytosis in both anthracycline and taxane cycles (50 and 100%) as compared to cohort A (0 and 66.7%) and cohort B (35.7 and 86.7%). Patients in cohort A experienced the highest median value of WBC count 24 h after pegfilgrastim administration in both anthracycline and taxane cycles (61.2 × 10(3)/μl and 67.8 × 10(3)/μl). Patients in cohort C experienced the highest median value of WBC count at day 13 in both anthracycline and taxane cycles (19.4 × 10(3)/μl and 24.2 × 10(3)/μl).
  
  
  CONCLUSIONS
  For the prevention of leukocytosis, the safest timing of pegfilgrastim administration based on WBC count in dose-dense anthracycline- and taxane-based regimens seems to be 72 h after chemotherapy.
  
  
  BACKGROUND
  This study is registered with https://clinicaltrials.gov/ct2/show/NCT00433420.
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. matteo.lambertini85@gmail.com.
authors: Matteo
authors: M
authors: Lambertini
authors: Department of Epidemiology, IRCCS AOU San Martino-IST, Genova, Italy. paolo.bruzzi@hsanmartino.it.
authors: Paolo
authors: P
authors: Bruzzi
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. francesca.poggio.1987@gmail.com.
authors: Francesca
authors: F
authors: Poggio
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. simona.pastorino@hsanmartino.it.
authors: Simona
authors: S
authors: Pastorino
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. giogardin2@gmail.com.
authors: Giovanni
authors: G
authors: Gardin
authors: Department of Medical Oncology, U.O. Oncologia Medica, Ospedali Galliera, Genova, Italy. matclava78@libero.it.
authors: Matteo
authors: M
authors: Clavarezza
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. claudia.bighin@hsanmartino.it.
authors: Claudia
authors: C
authors: Bighin
authors: Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino-IST, Largo Rosanna Benzi, 10, 16132, Genova, Italy. paolo.pronzato@hsanmartino.it.
authors: Paolo
authors: P
authors: Pronzato
authors: Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino-IST, Genova, Italy. lucia.delmastro@hsanmartino.it.
authors: Lucia
authors: L
authors: Del Mastro
mesh_terms: D000328:Adult; D018943:Anthracyclines / Q000627:therapeutic use*; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001952:Bridged-Ring Compounds / Q000627:therapeutic use*; D015331:Cohort Studies; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D006801:Humans; D007558:Italy; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012307:Risk Factors; D043823:Taxoids / Q000627:therapeutic use*; D013997:Time Factors
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D001952:Bridged-Ring Compounds; D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; C080625:taxane; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim
keywords: Breast cancer; Dose-dense chemotherapy; Pegfilgrastim; Safety; Timing