nach oben

Erschienen in:

01.03.2016 | Original Article

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

verfasst von: Matteo Lambertini, Paolo Bruzzi, Francesca Poggio, Simona Pastorino, Giovanni Gardin, Matteo Clavarezza, Claudia Bighin, Paolo Pronzato, Lucia Del Mastro

Erschienen in: Supportive Care in Cancer | Ausgabe 3/2016

Einloggen, um Zugang zu erhalten

Abstract

Purpose

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 × 10³/μl and 67.8 × 10³/μl). Patients in cohort C experienced the highest median value of WBC count at day 13 in both anthracycline and taxane cycles (19.4 × 10³/μl and 24.2 × 10³/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.

Trial registration

This study is registered with https://clinicaltrials.gov/ct2/show/NCT00433420.

Bonilla L, Ben-Aharon I, Vidal L, et al (2010) Dose-dense chemotherapy in nonmetastatic breast cancer: a systematic review and meta-analysis of randomized controlled trials. J Natl Cancer Inst 102:1845–1854PubMedCentralCrossRefPubMed

Aapro MS, Bohlius J, Cameron DA, et al (2011) 2010 update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer 47:8–32CrossRefPubMed

Crawford J, Caserta C, Roila F, Guidelines Working Group ESMO (2010) Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol 21(Suppl 5):v248–v251CrossRefPubMed

Smith TJ, Khatcheressian J, Lyman GH, et al (2006) 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 24:3187–3205CrossRefPubMed

Yang B-B, Kido A (2011) Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 50:295–306CrossRefPubMed

Holmes FA, O’Shaughnessy JA, Vukelja S, et al (2002) Blinded, randomized, multicenter study to evaluate single administration pegfilgrastim once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients with high-risk stage II or stage III/IV breast cancer. J Clin Oncol 20:727–731CrossRefPubMed

Green MD, Koelbl H, Baselga J, et al (2003) A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol 14:29–35CrossRefPubMed

Siena S, Piccart MJ, Holmes FA, et al (2003) A combined analysis of two pivotal randomized trials of a single dose of pegfilgrastim per chemotherapy cycle and daily filgrastim in patients with stage II-IV breast cancer. Oncol Rep 10:715–724PubMed

Burstein HJ, Parker LM, Keshaviah A, et al (2005) Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J Clin Oncol 23:8340–8347CrossRefPubMed

10.

Arshad M, Seiter K, Bilaniuk J, et al (2005) Side effects related to cancer treatment: CASE 2. Splenic rupture following pegfilgrastim. J Clin Oncol 23:8533–8534CrossRefPubMed

11.

Watring NJ, Wagner TW, Stark JJ (2007) Spontaneous splenic rupture secondary to pegfilgrastim to prevent neutropenia in a patient with non-small-cell lung carcinoma. Am J Emerg Med 25:247–248CrossRefPubMed

12.

Hershman D, Neugut AI, Jacobson JS, et al (2007) Acute myeloid leukemia or myelodysplastic syndrome following use of granulocyte colony-stimulating factors during breast cancer adjuvant chemotherapy. J Natl Cancer Inst 99:196–205CrossRefPubMed

13.

Del Mastro L, De Placido S, Bruzzi P, et al (2015) Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2 × 2 factorial, randomised phase 3 trial. Lancet 385:1863–1872CrossRefPubMed

14.

Giles FJ, Shen Y, Kantarjian HM, et al (2001) Leukapheresis reduces early mortality in patients with acute myeloid leukemia with high white cell counts but does not improve long- term survival. Leuk Lymphoma 42:67–73CrossRefPubMed

15.

Ganzel C, Becker J, Mintz PD, et al (2012) Hyperleukocytosis, leukostasis and leukapheresis: practice management. Blood Rev 26:117–122CrossRefPubMed

16.

Senkus E, Kyriakides S, Penault-Llorca F et al (2013) Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 24 Suppl 6:vi7–23.

17.

NCCN Clinical Practice Guidelines in Oncology. http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#breast. Accessed 20 July 2015.

18.

Rossi L, Tomao F, Lo Russo G, et al (2013) Efficacy and safety analysis of once per cycle pegfilgrastim and daily lenograstim in patients with breast cancer receiving adjuvant myelosuppressive chemotherapy FEC 100: a pilot study. Ther Clin Risk Manag 9:457–462PubMedCentralCrossRefPubMed

19.

Lambertini M, Del Mastro L, Bellodi A, Pronzato P (2014) The five “Ws” for bone pain due to the administration of granulocyte-colony stimulating factors (G-CSFs). Crit Rev Oncol Hematol 89:112–128CrossRefPubMed

20.

Engert A, Bredenfeld H, Döhner H, et al (2006) Pegfilgrastim support for full delivery of BEACOPP-14 chemotherapy for patients with high-risk Hodgkin’s lymphoma: results of a phase II study. Haematologica 91:546–549PubMed

21.

Zwick C, Hartmann F, Zeynalova S, et al (2011) Randomized comparison of pegfilgrastim day 4 versus day 2 for the prevention of chemotherapy-induced leukocytopenia. Ann Oncol 22:1872–1877CrossRefPubMed

22.

Whitworth JM, Matthews KS, Shipman KA, et al (2009) The safety and efficacy of day 1 versus day 2 administration of pegfilgrastim in patients receiving myelosuppressive chemotherapy for gynecologic malignancies. Gynecol Oncol 112:601–604CrossRefPubMed

23.

Burris HA, Belani CP, Kaufman PA, et al (2010) Pegfilgrastim on the same day versus next day of chemotherapy in patients with breast cancer, non-small-cell lung cancer, ovarian cancer, and non-Hodgkin’s lymphoma: results of four multicenter, double-blind, randomized phase II studies. J Oncol Pract 6:133–140PubMedCentralCrossRefPubMed

24.

Loibl S, Mueller V, von Minckwitz G, et al (2011) 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). Support Care Cancer 19:1789–1795CrossRefPubMed

25.

Skarlos DV, Timotheadou E, Galani E, et al (2009) Pegfilgrastim administered on the same day with dose-dense adjuvant chemotherapy for breast cancer is associated with a higher incidence of febrile neutropenia as compared to conventional growth factor support: matched case-control study of the Hellenic Cooperative Oncology Group. Oncology 77:107–112CrossRefPubMed

Titel: 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
verfasst von: Matteo Lambertini
Paolo Bruzzi
Francesca Poggio
Simona Pastorino
Giovanni Gardin
Matteo Clavarezza
Claudia Bighin
Paolo Pronzato
Lucia Del Mastro
Publikationsdatum: 01.03.2016
Verlag: Springer Berlin Heidelberg
Erschienen in: Supportive Care in Cancer / Ausgabe 3/2016
Print ISSN: 0941-4355
Elektronische ISSN: 1433-7339
DOI: https://doi.org/10.1007/s00520-015-2907-2

Springer Medizin

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