Chemotherapy-associated treatment burden in breast cancer patients receiving lipegfilgrastim or pegfilgrastim: secondary efficacy data from a phase III study

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• 作者：Oleg A. Gladkov ; Anton Buchner ; Peter Bias ; Udo M眉ller…
• 关键词：Granulocyte colony ; stimulating factor ; Antibiotics ; Febrile neutropenia ; Breast neoplasms ; Hospitalization
• 刊名：Supportive Care in Cancer
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：24
• 期：1
• 页码：395-400
• 全文大小：277 KB
• 参考文献：1.Crawford J, Dale DC, Lyman GH (2004) Chemotherapy-induced neutropenia: risks, consequences, and new directions for its management. Cancer 100:228鈥?37. doi:10.鈥?002/鈥媍ncr.鈥?1882 CrossRef PubMed
  2.Kuderer NM, Dale DC, Crawford J, Cosler LE, Lyman GH (2006) Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer 106:2258鈥?266. doi:10.鈥?002/鈥媍ncr.鈥?1847 CrossRef PubMed
  3.Cooper KL, Madan J, Whyte S, Stevenson MD, Akehurst RL (2011) Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer 11:404. doi:10.鈥?186/鈥?471-2407-11-404 PubMedCentral CrossRef PubMed
  4.Crawford J, Caserta C, Roila F (2010) Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol 21(suppl 5):v248鈥搗251. doi:10.鈥?093/鈥媋nnonc/鈥媘dq195 CrossRef PubMed
  5.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鈥?2. doi:10.鈥?016/鈥媕.鈥媏jca.鈥?010.鈥?0.鈥?13 CrossRef PubMed
  6.NCCN Clinical Practice Guidelines in Oncology (2014) Myeloid Growth Factors v.2.2014. National Comprehensive Cancer Network. www.鈥媙ccn.鈥媜rg/鈥媝rofessionals/鈥媝hysician_鈥媑ls/鈥媐_鈥媑uidelines.鈥媋sp . Accessed 1 May 2015
  7.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鈥?205. doi:10.鈥?200/鈥婮CO.鈥?006.鈥?6.鈥?451 CrossRef PubMed
  8.Neupogen [package insert] (2013) Amgen Inc., Thousand Oaks, CA
  9.Yang BB, Kido A (2011) Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet 50:295鈥?06. doi:10.鈥?165/鈥?1586040-000000000-00000 CrossRef PubMed
  10.Neulasta [package insert] (2014) Amgen Inc., Thousand Oaks, CA
  11.Lonquex: Summary of Product Characteristics. (2013) European Medicines Agency, London, UK
  12.Bondarenko I, Gladkov OA, Elsaesser R, Buchner A, Bias P (2013) Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy. BMC Cancer 13:386鈥?98. doi:10.鈥?186/鈥?471-2407-13-386 PubMedCentral CrossRef PubMed
  13.Buchner A, Elsasser R, Bias P (2014) A randomized, double-blind, active control, multicenter, dose-finding study of lipegfilgrastim (XM22) in breast cancer patients receiving myelosuppressive therapy. Breast Cancer Res Treat 148:107鈥?16. doi:10.鈥?007/鈥媠10549-014-3120-6 PubMedCentral CrossRef PubMed
  14.Montella L, Addeo R, Guarrasi R et al (2010) Once-per-cycle pegfilgrastim in breast cancer patients treated with docetaxel/epidoxorubicin/cyclophosphamide. Eur J Cancer Care (Engl) 19:200鈥?04. doi:10.鈥?111/鈥媕.鈥?365-2354.鈥?008.鈥?1004.鈥媥
  15.Ngamphaiboon N, O'Connor TL, Advani PP, Levine EG, Kossoff EB (2012) Febrile neutropenia in adjuvant docetaxel and cyclophosphamide (TC) with prophylactic pegfilgrastim in breast cancer patients: a retrospective analysis. Med Oncol 29:1495鈥?501. doi:10.鈥?007/鈥媠12032-011-0035-5 CrossRef PubMed
  16.Ozer H, Mirtsching B, Rader M et al (2007) Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist 12:484鈥?94. doi:10.鈥?634/鈥媡heoncologist.鈥?2-4-484 CrossRef PubMed
  17.Siena S, Piccart MJ, Holmes FA, Glaspy J, Hackett J, Renwick JJ (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鈥揑V breast cancer. Oncol Rep 10:715鈥?24PubMed
  18.von Minckwitz G, Kummel S, du Bois A et al (2008) Pegfilgrastim +/鈭?ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol 19:292鈥?98. doi:10.鈥?093/鈥媋nnonc/鈥媘dm438
  19.Aapro M, Schwenkglenks M, Lyman GH et al (2010) Pegfilgrastim primary prophylaxis vs. current practice neutropenia management in elderly breast cancer patients receiving chemotherapy. Crit Rev Oncol Hematol 74:203鈥?10. doi:10.鈥?016/鈥媕.鈥媍ritrevonc.鈥?009.鈥?6.鈥?04 CrossRef PubMed
  20.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鈥?31CrossRef PubMed
  21.von Minckwitz G, Schwenkglenks M, Skacel T et al (2009) Febrile neutropenia and related complications in breast cancer patients receiving pegfilgrastim primary prophylaxis versus current practice neutropaenia management: results from an integrated analysis. Eur J Cancer 45:608鈥?17. doi:10.鈥?016/鈥媕.鈥媏jca.鈥?008.鈥?1.鈥?21 CrossRef
  22.Naeim A, Henk HJ, Becker L et al (2013) Pegfilgrastim prophylaxis is associated with a lower risk of hospitalization of cancer patients than filgrastim prophylaxis: a retrospective United States claims analysis of granulocyte colony-stimulating factors (G-CSF). BMC Cancer 13:11. doi:10.鈥?186/鈥?471-2407-13-11 PubMedCentral CrossRef PubMed
  23.Weycker D, Malin J, Kim J et al (2009) Risk of hospitalization for neutropenic complications of chemotherapy in patients with primary solid tumors receiving pegfilgrastim or filgrastim prophylaxis: a retrospective cohort study. Clin Ther 31:1069鈥?081. doi:10.鈥?016/鈥媕.鈥媍linthera.鈥?009.鈥?5.鈥?19 CrossRef PubMed
  24.Klastersky J, Awada A (2011) Prevention of febrile neutropenia in chemotherapy-treated cancer patients: Pegylated versus standard myeloid colony stimulating factors. Do we have a choice? Crit Rev Oncol Hematol 78:17鈥?3. doi:10.鈥?016/鈥媕.鈥媍ritrevonc.鈥?010.鈥?2.鈥?05 CrossRef PubMed
  25.Vogel CL, Wojtukiewicz MZ, Carroll RR et al (2005) First and subsequent cycle use of pegfilgrastim prevents febrile neutropenia in patients with breast cancer: a multicenter, double-blind, placebo-controlled phase III study. J Clin Oncol 23:1178鈥?184. doi:10.鈥?200/鈥婮CO.鈥?005.鈥?9.鈥?02 CrossRef PubMed
  26.Caggiano V, Weiss RV, Rickert TS, Linde-Zwirble WT (2005) Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer 103:1916鈥?924. doi:10.鈥?002/鈥媍ncr.鈥?0983 CrossRef PubMed
  27.Johnson P, Bancroft T, Barron R et al (2014) Discrete choice experiment to estimate breast cancer patients' preferences and willingness to pay for prophylactic granulocyte colony-stimulating factors. Value Health 17:380鈥?89. doi:10.鈥?016/鈥媕.鈥媕val.鈥?014.鈥?1.鈥?02 CrossRef PubMed
  28.Fortner BV, Tauer K, Zhu L et al (2004) Medical visits for chemotherapy and chemotherapy-induced neutropenia: a survey of the impact on patient time and activities. BMC Cancer 4:22. doi:10.鈥?186/鈥?471-2407-4-22 PubMedCentral CrossRef PubMed
  29.Jenkins P, Scaife J, Freeman S (2012) Validation of a predictive model that identifies patients at high risk of developing febrile neutropaenia following chemotherapy for breast cancer. Ann Oncol 23:1766鈥?771. doi:10.鈥?093/鈥媋nnonc/鈥媘dr493 CrossRef PubMed
  
• 作者单位：Oleg A. Gladkov (1)
  Anton Buchner (2)
  Peter Bias (3)
  Udo M眉ller (3)
  Reiner Els盲sser (3)
  
  1. Chelyabinsk Regional Clinical Oncology Dispensary, 42 Blukhera str, Chelyabinsk, 454087, Russian Federation
  2. Merckle GmbH, Graf-Arco-Strasse 3, 89079, Ulm, Germany
  3. Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany
  
• 刊物类别：Medicine
• 刊物主题：Medicine & Public Health
  Oncology
  Nursing
  Nursing Management and Research
  Pain Medicine
  Rehabilitation Medicine
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1433-7339

文摘

Purpose Lipegfilgrastim is a once-per-cycle glycoPEGylated granulocyte colony-stimulating factor (G-CSF). Noninferiority of lipegfilgrastim versus pegfilgrastim was demonstrated in a phase III trial in chemotherapy (CTx)-na茂ve breast cancer patients. Secondary outcomes relating to treatment burden are reported here.