Incidence of bone pain in patients with breast cancer treated with lipegfilgrastim or pegfilgrastim: an integrated analysis from phase II and III studies

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• 作者：I. M. Bondarenko ; P. Bias ; A. Buchner
• 关键词：Lipegfilgrastim ; Pegfilgrastim ; Bone pain ; Drug ; related side effect ; Docetaxel ; Doxorubicin
• 刊名：Supportive Care in Cancer
• 出版年：2016
• 出版时间：January 2016
• 年：2016
• 卷：24
• 期：1
• 页码：267-273
• 全文大小：221 KB
• 参考文献：1.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
  2.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
  3.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
  4.(2014) NCCN Clinical Practice Guidelines in Oncology. 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 23 January 2015
  5.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
  6.Lonquex: summary of product characteristics (2013) European Medicines Agency, London, UK
  7.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
  8.Tigue CC, McKoy JM, Evens AM, Trifilio SM, Tallman MS, Bennett CL (2007) Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer: an overview of safety considerations from the Research on Adverse Drug Events and Reports project. Bone Marrow Transplant 40:185鈥?92. doi:10.鈥?038/鈥媠j.鈥媌mt.鈥?705722 CrossRef PubMed
  9.Lambertini M, Del Mastro L, Bellodi A, Pronzato P (2013) The five 鈥淲s鈥?for bone pain due to the administration of granulocyte-colony stimulating factors (G-CSFs). Crit Rev Oncol Hematol 89:112鈥?28. doi:10.鈥?016/鈥媕.鈥媍ritrevonc.鈥?013.鈥?8.鈥?06 CrossRef PubMed
  10.Holmes FA, Jones SE, O鈥橲haughnessy J et al (2002) Comparable efficacy and safety profiles of once-per-cycle pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia: a multicenter dose-finding study in women with breast cancer. Ann Oncol 13:903鈥?09CrossRef PubMed
  11.Holmes FA, O鈥橲haughnessy 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
  12.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鈥?5CrossRef PubMed
  13.Kirshner JJ, Heckler CE, Janelsins MC et al (2012) Prevention of pegfilgrastim-induced bone pain: a phase III double-blind placebo-controlled randomized clinical trial of the University of Rochester Cancer Center Clinical Community Oncology Program Research Base. J Clin Oncol 30:1974鈥?979. doi:10.鈥?200/鈥婮CO.鈥?011.鈥?7.鈥?364 PubMedCentral CrossRef PubMed
  14.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
  15.Kubista E, Glaspy J, Holmes FA, Green MD, Hackett J, Neumann T (2003) Bone pain associated with once-per-cycle pegfilgrastim is similar to daily filgrastim in patients with breast cancer. Clin Breast Cancer 3:391鈥?98CrossRef PubMed
  16.Kirshner JJ, Hickok J, Hofman M (2007) Pegfilgrastim-induced bond pain: incidence, risk factors, and management in a community practice. Community Oncol 4:455鈥?59CrossRef
  17.Buchner A, Bias P, Kaufmann M, Mueller U (2012) A randomized, double-blind, active control, multicenter, dose finding study of lipegfilgrastim in breast cancer patients receiving myelosuppressive therapy [abstract 1004]. Support Care Cancer 20:S240
  18.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
  19.Alba E, Martin M, Ramos M et al (2004) Multicenter randomized trial comparing sequential with concomitant administration of doxorubicin and docetaxel as first-line treatment of metastatic breast cancer: a Spanish Breast Cancer Research Group (GEICAM-9903) phase III study. J Clin Oncol 22:2587鈥?593. doi:10.鈥?200/鈥婮CO.鈥?004.鈥?8.鈥?25 CrossRef PubMed
  20.Nabholtz JM, Falkson C, Campos D et al (2003) Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol 21:968鈥?75CrossRef PubMed
  21.Waller CF, Semiglazov VF, Tjulandin S, Bentsion D, Chan S, Challand R (2010) A phase III randomized equivalence study of biosimilar filgrastim versus Amgen filgrastim in patients receiving myelosuppressive chemotherapy for breast cancer. Onkologie 33:504鈥?11. doi:10.鈥?159/鈥?00319693 CrossRef PubMed
  22.Pinto L, Liu Z, Doan Q, Bernal M, Dubois R, Lyman G (2007) Comparison of pegfilgrastim with filgrastim on febrile neutropenia, grade IV neutropenia and bone pain: a meta-analysis of randomized controlled trials. Curr Med Res Opin 23:2283鈥?295. doi:10.鈥?185/鈥?30079907X219599鈥?/span> CrossRef PubMed
  23.Andre N, El Kababri M, Bertrand P et al (2007) Safety and efficacy of pegfilgrastim in children with cancer receiving myelosuppressive chemotherapy. Anticancer Drugs 18:277鈥?81. doi:10.鈥?097/鈥婥AD.鈥?b013e328011a532鈥?/span> CrossRef PubMed
  24.Almenar D, Mayans J, Juan O et al (2009) Pegfilgrastim and daily granulocyte colony-stimulating factor: patterns of use and neutropenia-related outcomes in cancer patients in Spain鈥攔esults of the LEARN Study. Eur J Cancer Care 18:280鈥?86. doi:10.鈥?111/鈥媕.鈥?365-2354.鈥?008.鈥?0959.鈥媥 CrossRef
  25.Kuderer NM, Dale DC, Crawford J, Lyman GH (2007) Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol 25:3158鈥?167. doi:10.鈥?200/鈥婮CO.鈥?006.鈥?8.鈥?823 CrossRef PubMed
  26.Volovat C, Bondarenko IM, Gladkov OA, et al (2015) Phase III, randomized, double-blind, placebo-controlled, multicenter study of lipegfilgrastim in patients with non鈥搒mall cell lung cancer receiving myelosuppressive therapy. SpringerPlus: in press
  
• 作者单位：I. M. Bondarenko (1)
  P. Bias (2)
  A. Buchner (3)
  
  1. Dnipropetrovsk State Medical Academy, City Clinical Hospital N 4, 31, Blizhnaya Str, Dnipropetrovsk, 49102, Ukraine
  2. Teva Ratiopharm, Graf-Arco-Strasse 3, 89079, Ulm, Germany
  3. Merckle GmbH, 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, fixed-dose, glycoPEGylated recombinant granulocyte colony-stimulating factor (G-CSF) recently approved in Europe to reduce the duration of chemotherapy-induced neutropenia and incidence of febrile neutropenia in patients with cancer receiving chemotherapy. Bone pain-related (BPR) adverse events are commonly associated with G-CSF therapy. This post hoc analysis examined BPR treatment-emergent adverse events (TEAEs) in two comparative studies of lipegfilgrastim or pegfilgrastim in patients receiving chemotherapy.