Pegfilgrastim for the prevention of chemotherapy-induced febrile neutropenia in patients with solid tumors

Bibliography

• Papers of special note have been highlighted as either of interest (·) or of considerable interest (··) to readers.
   Google Scholar

• Crawford J, Caserta C, Roila F, et al. Hematopoietic growth factors: ESMO clinical practice guidelines for the applications. Ann Oncol. 2010;21(Suppl 5):v248–51.
   PubMed Web of Science ®Google Scholar

··ESMO guidelines for the use of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Caggiano V, Weiss RV, Rickert TS, et al. Incidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy. Cancer. 2005;103(9):1916–1924.
   PubMed Web of Science ®Google Scholar
• Kuderer NM, Dale DC, Crawford J, et al. Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer. 2006;106(10):2258–2266.
   PubMed Web of Science ®Google Scholar
• Clark OAC, Lyman GH, Castro AA, et al. Colony-stimulating factors for chemotherapy-induced febrile neutropenia: a meta-analysis of randomized controlled trials. J Clin Oncol. 2005;23(18):4198–4214.
   PubMed Web of Science ®Google Scholar
• Sung L, Nathan PC, Alibhai SMH, et al. Meta-analysis: effect of prophylactic hematopoietic colony-stimulating factors on mortality and outcomes of infection. Ann Intern Med. 2007;147(6):400–411.
   PubMed Web of Science ®Google Scholar
• Kuderer NM, Dale DC, Crawford J, et al. 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. 2007;25(21):3158–3167.
   PubMed Web of Science ®Google Scholar
• Bohlius J, Herbst C, Reiser M, et al. Granulopoiesis-stimulating factors to prevent adverse effects in the treatment of malignant lymphoma. Cochrane Database Syst Rev.2008;4:CD003189.
   PubMed Web of Science ®Google Scholar
• Cooper KL, Madan J, Whyte S, et al. Granulocyte colony-stimulating factors for febrile neutropenia prophylaxis following chemotherapy: systematic review and meta-analysis. BMC Cancer. 2011;11:404.
   PubMed Web of Science ®Google Scholar

·Meta-analysis on the efficacy of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Flowers CR, Seidenfeld J, Bow EJ, et al. Antimicrobial prophylaxis and outpatient management of fever and neutropenia in adults treated for malignancy: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2013;31(6):794–810.
   PubMed Web of Science ®Google Scholar
• Smith TJ, Bohlke K, Lyman GH, et al. Recommendations for the use of WBC growth factors: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol. 2015;33(28):3199–3212.
   PubMed Web of Science ®Google Scholar

··ASCO guidelines for the use of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Aapro MS, Bohlius J, Cameron DA, et al. 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. 2011;47(1):8–32.
   PubMed Web of Science ®Google Scholar

··EORTC guidelines for the use of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• National Comprehensive Cancer Network clinical practice guidelines in oncology: myeloid growth factors; 2015 [cited 2015 Sep 5]. Available from: www.nccn.org/professionals/physician_gls/pdf/myeloid_growth.pdf.
   Google Scholar

··NCCN guidelines for the use of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Wright JD, Neugut AI, Ananth CV, et al. Deviations from guideline-based therapy for febrile neutropenia in cancer patients and their effect on outcomes. JAMA Intern Med. 2013;173(7):559–568.
   PubMed Web of Science ®Google Scholar
• Potosky AL, Malin JL, Kim B, et al. Use of colony-stimulating factors with chemotherapy: opportunities for cost savings and improved outcomes. J Natl Cancer Inst. 2011;103(12):979–982.
   PubMed Web of Science ®Google Scholar
• Bennett CL, Djulbegovic B, Norris LB, et al. Colony-stimulating factors for febrile neutropenia during cancer therapy. N Engl J Med. 2013;368(12):1131–1139.
   PubMed Web of Science ®Google Scholar
• Schnipper LE, Smith TJ, Raghavan D, et al. American Society of Clinical Oncology identifies five key opportunities to improve care and reduce costs: the top five list for oncology. J Clin Oncol. 2012;30(14):1715–1724.
   PubMed Web of Science ®Google Scholar
• Barni S, Lorusso V, Giordano M, et al. A prospective observational study to evaluate G-CSF usage in patients with solid tumors receiving myelosuppressive chemotherapy in Italian clinical oncology practice. Med Oncol. 2014;31(1):797.
   PubMed Web of Science ®Google Scholar
• Waters GE, Corrigan P, Gatesman M, et al. Comparison of pegfilgrastim prescribing practice to national guidelines at a university hospital outpatient oncology clinic. J Oncol Pract. 2013;9(4):203–206.
   PubMedGoogle Scholar
• Crea F, Giovannetti E, Zinzani PL, et al. Pharmacologic rationale for early G-CSF prophylaxis in cancer patients and role of pharmacogenetics in treatment optimization. Crit Rev Oncol Hematol. 2009;72(1):21–44.
   PubMed Web of Science ®Google Scholar
• Hareng L, Hartung T. Induction and regulation of endogenous granulocyte colony-stimulating factor formation. Biol Chem. 2002;383(10):1501–1517.
   PubMed Web of Science ®Google Scholar
• Mauch P, Constine L, Greenberger J, et al. Hematopoietic stem cell compartment: acute and late effects of radiation therapy and chemotherapy. Int J Radiat Oncol Biol Phys. 1995;31(5):1319–1339.
   PubMed Web of Science ®Google Scholar
• Lalami Y, Paesmans M, Muanza F, et al. Can we predict the duration of chemotherapy-induced neutropenia in febrile neutropenic patients, focusing on regimen-specific risk factors? A retrospective analysis. Ann Oncol. 2006;17(3):507–514.
   PubMed Web of Science ®Google Scholar
• De Naurois J, Novitzky-Basso I, Gill MJ, et al. Management of febrile neutropenia: ESMO Clinical Practice Guidelines. Ann Oncol. 2010;21(Suppl 5):v252–6.
   PubMed Web of Science ®Google Scholar
• Rosa RG, Goldani LZ. Factors associated with hospital length of stay among cancer patients with febrile neutropenia. PloS One. 2014;9(10):e108969.
   PubMed Web of Science ®Google Scholar
• Klastersky J, Paesmans M, Rubenstein EB, et al. The Multinational Association for Supportive Care in Cancer risk index: a multinational scoring system for identifying low-risk febrile neutropenic cancer patients. J Clin Oncol. 2000;18(16):3038–3051.
   PubMed Web of Science ®Google Scholar
• De Souza Viana L, Serufo JC, da Costa Rocha MO, et al. Performance of a modified MASCC index score for identifying low-risk febrile neutropenic cancer patients. Support Care Cancer. 2008;16(7):841–846.
   PubMed Web of Science ®Google Scholar
• Bosly A, Bron D, Van Hoof A, et al. Achievement of optimal average relative dose intensity and correlation with survival in diffuse large B-cell lymphoma patients treated with CHOP. Ann Hematol. 2008;87(4):277–283.
   PubMed Web of Science ®Google Scholar
• Chirivella I, Bermejo B, Insa A, et al. Optimal delivery of anthracycline-based chemotherapy in the adjuvant setting improves outcome of breast cancer patients. Breast Cancer Res Treat. 2009;114(3):479–484.
   PubMed Web of Science ®Google Scholar
• Bonadonna G, Valagussa P, Moliterni A, et al. Adjuvant cyclophosphamide, methotrexate, and fluorouracil in node-positive breast cancer: the results of 20 years of follow-up. N Engl J Med. 1995;332(14):901–906.
   PubMed Web of Science ®Google Scholar
• Budman DR, Berry DA, Cirrincione CT, et al. Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. The Cancer and Leukemia Group B. J Natl Cancer Inst. 1998;90(16):1205–1211.
   PubMed Web of Science ®Google Scholar
• Bonneterre J, Roché H, Kerbrat P, et al. Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial. J Clin Oncol. 2005;23(12):2686–2693.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Dale DC, Crawford J. Incidence and predictors of low dose-intensity in adjuvant breast cancer chemotherapy: a nationwide study of community practices. J Clin Oncol. 2003;21(24):4524–4531.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Dale DC, Tomita D, et al. A retrospective evaluation of chemotherapy dose intensity and supportive care for early-stage breast cancer in a curative setting. Breast Cancer Res Treat. 2013;139(3):863–872.
   PubMed Web of Science ®Google Scholar
• Crawford J, Ozer H, Stoller R, et al. Reduction by granulocyte colony-stimulating factor of fever and neutropenia induced by chemotherapy in patients with small-cell lung cancer. N Engl J Med. 1991;325(3):164–170.
   PubMed Web of Science ®Google Scholar
• Green MD, Koelbl H, Baselga J, et al. A randomized double-blind multicenter phase III study of fixed-dose single-administration pegfilgrastim versus daily filgrastim in patients receiving myelosuppressive chemotherapy. Ann Oncol. 2003;14(1):29–35.
   PubMed Web of Science ®Google Scholar
• Holmes FA, O’Shaughnessy JA, Vukelja S, et al. 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. 2002;20(3):727–731.
   PubMed Web of Science ®Google Scholar
• Bondarenko I, Gladkov OA, Elsaesser R, et al. 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. 2013;13:386.
   PubMed Web of Science ®Google Scholar
• Volovat C, Gladkov OA, Bondarenko IM, et al. Efficacy and safety of balugrastim compared with pegfilgrastim in patients with breast cancer receiving chemotherapy. Clin Breast Cancer. 2014;14(2):101–108.
   PubMed Web of Science ®Google Scholar
• Buchner A, Elsässer R, Bias P. A randomized, double-blind, active control, multicenter, dose-finding study of lipegfilgrastim (XM22) in breast cancer patients receiving myelosuppressive therapy. Breast Cancer Res Treat. 2014;148(1):107–116.
   PubMed Web of Science ®Google Scholar
• Buchner A, Lammerich A, Abdolzade-Bavil A, et al. Lipegfilgrastim: pharmacodynamics and pharmacokinetics for body-weight-adjusted and 6 mg fixed doses in two randomized studies in healthy volunteers. Curr Med Res Opin. 2014;30(12):2523–2533.
   PubMed Web of Science ®Google Scholar
• Pfeil AM, Allcott K, Pettengell R, et al. Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: a systematic review. Support Care Cancer. 2015;23(2):525–545.
   PubMed Web of Science ®Google Scholar
• Yang B-B, Kido A. Pharmacokinetics and pharmacodynamics of pegfilgrastim. Clin Pharmacokinet. 2011;50(5):295–306.
   PubMed Web of Science ®Google Scholar
• Panopoulos AD, Watowich SS. Granulocyte colony-stimulating factor: molecular mechanisms of action during steady state and “emergency” hematopoiesis. Cytokine. 2008;42(3):277–288.
   PubMed Web of Science ®Google Scholar
• Yang B-B, Lum PK, Hayashi MM, et al. Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats. J Pharm Sci. 2004;93(5):1367–1373.
   PubMed Web of Science ®Google Scholar
• Holmes FA, Jones SE, O’Shaughnessy J, et al. 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. 2002;13(6):903–909.
   PubMed Web of Science ®Google Scholar
• Vogel CL, Wojtukiewicz MZ, Carroll RR, et al. 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. 2005;23(6):1178–1184.
   PubMed Web of Science ®Google Scholar
• Romieu G, Clemens M, Mahlberg R, et al. Pegfilgrastim supports delivery of FEC-100 chemotherapy in elderly patients with high risk breast cancer: a randomized phase 2 trial. Crit Rev Oncol Hematol. 2007;64(1):64–72.
   PubMed Web of Science ®Google Scholar
• Fox E, Widemann BC, Hawkins DS, et al. Randomized trial and pharmacokinetic study of pegfilgrastim versus filgrastim after dose-intensive chemotherapy in young adults and children with sarcomas. Clin Cancer Res. 2009;15(23):7361–7367.
   PubMed Web of Science ®Google Scholar
• Hecht JR, Pillai M, Gollard R, et al. A randomized, placebo-controlled phase ii study evaluating the reduction of neutropenia and febrile neutropenia in patients with colorectal cancer receiving pegfilgrastim with every-2-week chemotherapy. Clin Colorectal Cancer. 2010;9(2):95–101.
   PubMed Web of Science ®Google Scholar
• Siena S, Piccart MJ, Holmes FA, et al. 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. 2003;10(3):715–724.
   PubMed Web of Science ®Google Scholar

·Meta-analysis on the efficacy of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Pinto L, Liu Z, Doan Q, et al. 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. 2007;23(9):2283–2295.
   PubMed Web of Science ®Google Scholar

·Meta-analysis on the efficacy of G-CSF to reduce the incidence of chemotherapy-induced febrile neutropenia

• Bonilla L, Ben-Aharon I, Vidal L, et al. Dose-dense chemotherapy in nonmetastatic breast cancer: a systematic review and meta-analysis of randomized controlled trials. J Natl Cancer Inst. 2010;102(24):1845–1854.
   PubMed Web of Science ®Google Scholar
• Senkus E, Kyriakides S, Ohno S, et al. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2015;26(Suppl 5):v8–v30.
   PubMed Web of Science ®Google Scholar
• Cunningham D, Hawkes EA, Jack A, et al. Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisolone in patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: a phase 3 comparison of dose intensification with 14-day versus 21-day cycles. Lancet. 2013;381(9880):1817–1826.
   PubMed Web of Science ®Google Scholar
• Tilly H, Vitolo U, Walewski J, et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2012;23(Suppl 7):vii78–82.
   PubMed Web of Science ®Google Scholar
• Danova M, Bencardino K, Manzoni M, et al. In vivo biological effects of pegfilgrastim after myelosuppressive chemotherapy in breast cancer. Anticancer Res. 2007;27(5A):3399–3402.
   PubMed Web of Science ®Google Scholar
• Invernizzi R, Grasso D, Travaglino E, et al. Biological effects of pegfilgrastim on circulating neutrophils in breast cancer patients undergoing dose-dense chemotherapy. Oncology. 2008;75(3–4):237–244.
   PubMed Web of Science ®Google Scholar
• Yang B-B, Kido A, Shibata A. Serum pegfilgrastim concentrations during recovery of absolute neutrophil count in patients with cancer receiving pegfilgrastim after chemotherapy. Pharmacotherapy. 2007;27(10):1387–1393.
   PubMed Web of Science ®Google Scholar
• Pirker R, Ulsperger E, Messner J, et al. Achieving full-dose, on-schedule administration of ACE chemotherapy every 14 days for the treatment of patients with extensive small-cell lung cancer. Lung. 2006;184(5):279–285.
   PubMed Web of Science ®Google Scholar
• Burstein HJ, Parker LM, Keshaviah A, et al. Efficacy of pegfilgrastim and darbepoetin alfa as hematopoietic support for dose-dense every-2-week adjuvant breast cancer chemotherapy. J Clin Oncol. 2005;23(33):8340–8347.
   PubMed Web of Science ®Google Scholar
• Natoli C, Cianchetti E, Tinari N, et al. A phase II study of dose-dense epirubicin plus cyclophosphamide followed by docetaxel plus capecitabine and pegfilgrastim support as preoperative therapy for patients with stage II, IIIA breast cancer. Ann Oncol. 2007;18(6):1015–1020.
   PubMed Web of Science ®Google Scholar
• Kahán Z, Spanik S, Wagnerova M, et al. Feasibility of two dose-dense FEC regimens with growth factor support for adjuvant therapy in patients with early breast cancer: results from a randomised study of the Central European Cooperative Oncology Group (CECOG). Breast Cancer Res Treat. 2008;112(3):557–563.
   PubMed Web of Science ®Google Scholar
• Dang C, D’Andrea G, Lake D, et al. Prolonged dose-dense epirubicin and cyclophosphamide followed by paclitaxel in breast cancer is feasible. Clin Breast Cancer. 2008;8(5):418–424.
   PubMed Web of Science ®Google Scholar
• Miller AA, Wang XF, Gu L, et al. Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol. 2008;3(10):1159–1165.
   PubMed Web of Science ®Google Scholar
• Jones RL, Walsh G, Ashley S, et al. A randomised pilot phase II study of doxorubicin and cyclophosphamide (AC) or epirubicin and cyclophosphamide (EC) given 2 weekly with pegfilgrastim (accelerated) vs 3 weekly (standard) for women with early breast cancer. Br J Cancer. 2009;100(2):305–310.
   PubMed Web of Science ®Google Scholar
• Skarlos DV, Timotheadou E, Galani E, et al. 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. 2009;77(2):107–112.
   PubMed Web of Science ®Google Scholar
• Yardley DA, Zubkus J, Daniel B, et al. A phase II trial of dose-dense neoadjuvant gemcitabine, epirubicin, and albumin-bound paclitaxel with pegfilgrastim in the treatment of patients with locally advanced breast cancer. Clin Breast Cancer. 2010;10(5):367–372.
   PubMed Web of Science ®Google Scholar
• Hendler D, Rizel S, Yerushalmi R, et al. Different schedules of granulocyte growth factor support for patients with breast cancer receiving adjuvant dose-dense chemotherapy: a prospective nonrandomized study. Am J Clin Oncol. 2011;34(6):619–624.
   PubMed Web of Science ®Google Scholar
• Loibl S, Mueller V, von Minckwitz G, et al. 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. 2011;19(11):1789–1795.
   PubMed Web of Science ®Google Scholar
• Pippen J, Paul D, Vukelja S, et al. Dose-dense doxorubicin and cyclophosphamide followed by dose-dense albumin-bound paclitaxel plus bevacizumab is safe as adjuvant therapy in patients with early stage breast cancer. Breast Cancer Res Treat. 2011. Epub 2011 Oct 6.
   PubMed Web of Science ®Google Scholar
• Dalla Chiesa M, Tomasello G, Buti S, et al. Sequential chemotherapy with dose-dense docetaxel, cisplatin, folinic acid and 5-fluorouracil (TCF-dd) followed by combination of oxaliplatin, folinic acid, 5-fluorouracil and irinotecan (COFFI) in metastatic gastric cancer: results of a phase II trial. Cancer Chemother Pharmacol. 2011;67(1):41–48.
   PubMed Web of Science ®Google Scholar
• Rimmer Y, Chester J, Joffe J, et al. Accelerated BEP: a phase I trial of dose-dense BEP for intermediate and poor prognosis metastatic germ cell tumour. Br J Cancer. 2011;105(6):766–772.
   PubMed Web of Science ®Google Scholar
• Petty WJ, Laudadio J, Brautnick L, et al. Phase II trial of dose-dense chemotherapy followed by dose-intense erlotinib for patients with newly diagnosed metastatic non-small cell lung cancer. Int J Oncol. 2013;43(6):2057–2063.
   PubMed Web of Science ®Google Scholar
• Burkard ME, Wisinski KB, Njiaju UO, et al. Feasibility of 4 cycles of docetaxel and cyclophosphamide every 14 days as an adjuvant regimen for breast cancer: a Wisconsin Oncology Network study. Clin Breast Cancer. 2014;14(3):205–211.
   PubMed Web of Science ®Google Scholar
• Choueiri TK, Jacobus S, Bellmunt J, et al. Neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with pegfilgrastim support in muscle-invasive urothelial cancer: pathologic, radiologic, and biomarker correlates. J Clin Oncol. 2014;32(18):1889–1894.
   PubMed Web of Science ®Google Scholar
• Grimison PS, Stockler MR, Chatfield M, et al. Accelerated BEP for metastatic germ cell tumours: a multicenter phase II trial by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). Ann Oncol. 2014;25(1):143–148.
   PubMed Web of Science ®Google Scholar
• Plimack ER, Hoffman-Censits JH, Viterbo R, et al. Accelerated methotrexate, vinblastine, doxorubicin, and cisplatin is safe, effective, and efficient neoadjuvant treatment for muscle-invasive bladder cancer: results of a multicenter phase II study with molecular correlates of response and toxicity. J Clin Oncol. 2014;32(18):1895–1901.
   PubMed Web of Science ®Google Scholar
• Tomasello G, Liguigli W, Poli R, et al. Efficacy and tolerability of chemotherapy with modified dose-dense TCF regimen (TCF-dd) in locally advanced or metastatic gastric cancer: final results of a phase II trial. Gastric Cancer. 2014;17(4):711–717.
   PubMed Web of Science ®Google Scholar
• Del Mastro L, De Placido S, Bruzzi P, et al. 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. 2015;385(9980):1863–1872.
   PubMed Web of Science ®Google Scholar
• Lambertini M, Bruzzi P, Poggio F, et al. 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. Support Care Cancer. 2015. Epub 2015 Aug 27. doi:10.1007/s00520-015-2907-2
   PubMedGoogle Scholar
• Wenzel C, Bartsch R, Locker GJ, et al. Preoperative chemotherapy with epidoxorubicin, docetaxel and capecitabine plus pegfilgrastim in patients with primary breast cancer. Anticancer Drugs. 2005;16(4):441–445.
   PubMed Web of Science ®Google Scholar
• Balducci L, Al-Halawani H, Charu V, et al. Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist. 2007;12(12):1416–1424.
   PubMed Web of Science ®Google Scholar
• Ozer H, Mirtsching B, Rader M, et al. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist. 2007;12(4):484–494.
   PubMed Web of Science ®Google Scholar
• Riedel RF, Andrews C, Garst J, et al. A phase II trial of carboplatin/vinorelbine with pegfilgrastim support for the treatment of patients with advanced non-small cell lung cancer. J Thorac Oncol. 2007;2(6):520–525.
   PubMed Web of Science ®Google Scholar
• Von Minckwitz G, Kümmel S, du Bois A, et al. Pegfilgrastim ± ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Ann Oncol. 2008;19(2):292–298.
   PubMed Web of Science ®Google Scholar
• Rossi L, Tomao F, Lo Russo G, et al. 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. 2013;9:457–462.
   PubMed Web of Science ®Google Scholar
• Rader M, Breyer W, Luedke S, et al. Low rate of neutropenia and related events in patients with breast cancer receiving pegfilgrastim from the first cycle of chemotherapy in community practices. Commun Oncol. 2010;7(6):273–280.
   Google Scholar
• Schippinger W, Holub R, Dandachi N, et al. Frequency of febrile neutropenia in breast cancer patients receiving epirubicin and docetaxel/paclitaxel with colony-stimulating growth factors: a comparison of filgrastim or lenograstim with pegfilgrastim. Oncology. 2006;70(4):290–293.
   PubMed Web of Science ®Google Scholar
• Morrison VA, Wong M, Hershman D, et al. Observational study of the prevalence of febrile neutropenia in patients who received filgrastim or pegfilgrastim associated with 3-4 week chemotherapy regimens in community oncology practices. J Manag Care Pharm. 2007;13(4):337–348.
   PubMed Web of Science ®Google Scholar
• Almenar D, Mayans J, Juan O, et al. Pegfilgrastim and daily granulocyte colony-stimulating factor: patterns of use and neutropenia-related outcomes in cancer patients in Spain—results of the LEARN study. Eur J Cancer Care. 2009;18(3):280–286.
   PubMed Web of Science ®Google Scholar
• Heaney ML, Toy EL, Vekeman F, et al. Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-induced neutropenia. Cancer. 2009;115(20):4839–4848.
   PubMed Web of Science ®Google Scholar
• Hershman D, Hurley D, Wong M, et al. Impact of primary prophylaxis on febrile neutropenia within community practices in the US. J Med Econ. 2009;12(3):203–210.
   PubMedGoogle Scholar
• Von Minckwitz G, Schwenkglenks M, Skacel T, et al. 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. 2009;45(4):608–617.
   PubMed Web of Science ®Google Scholar
• Weycker D, Malin J, Kim J, et al. 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. 2009;31(5):1069–1081.
   PubMed Web of Science ®Google Scholar
• Tan H, Tomic K, Hurley D, et al. Comparative effectiveness of colony-stimulating factors for febrile neutropenia: a retrospective study. Curr Med Res Opin. 2011;27(1):79–86.
   PubMed Web of Science ®Google Scholar
• Jenkins P, Scaife J, Freeman S. Validation of a predictive model that identifies patients at high risk of developing febrile neutropaenia following chemotherapy for breast cancer. Ann Oncol. 2012;23(7):1766–1771.
   PubMed Web of Science ®Google Scholar
• Ngamphaiboon N, O’Connor TL, Advani PP, et al. Febrile neutropenia in adjuvant docetaxel and cyclophosphamide (TC) with prophylactic pegfilgrastim in breast cancer patients: a retrospective analysis. Med Oncol. 2012;29(3):1495–1501.
   PubMed Web of Science ®Google Scholar
• Di Lorenzo G, DʼAniello C, Buonerba C, et al. Peg-filgrastim and cabazitaxel in prostate cancer patients. Anticancer Drugs. 2013;24(1):84–89.
   PubMed Web of Science ®Google Scholar
• Almenar Cubells D, Bosch Roig C, Jiménez Orozco E, et al. Effectiveness of daily versus non-daily granulocyte colony-stimulating factors in patients with solid tumours undergoing chemotherapy: a multivariate analysis of data from current practice. Eur J Cancer Care. 2013;22(3):400–412.
   PubMed Web of Science ®Google Scholar
• Naeim A, Henk HJ, Becker L, et al. 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. 2013;13:11.
   PubMed Web of Science ®Google Scholar
• Fagnani D, Isa L, Verga MF, et al. Granulocyte colony-stimulating factors used in clinical practice: PoloNord Registry-Based Cohort Italian Study. Tumori. 2014;100(5):491–498.
   PubMed Web of Science ®Google Scholar
• Kourlaba G, Dimopoulos MA, Pectasides D, et al. Comparison of filgrastim and pegfilgrastim to prevent neutropenia and maintain dose intensity of adjuvant chemotherapy in patients with breast cancer. Support Care Cancer. 2015;23(7):2045–2051.
   PubMed Web of Science ®Google Scholar
• Leung M, Florendo J, Kano J, et al. A modified filgrastim regimen does not reduce pain burden compared to pegfilgrastim in women receiving chemotherapy for non-metastatic breast cancer. Support Care Cancer. 2015;23(6):1669–1677.
   PubMed Web of Science ®Google Scholar
• Aapro M, Schwenkglenks M, Lyman GH, et al. Pegfilgrastim primary prophylaxis vs. current practice neutropenia management in elderly breast cancer patients receiving chemotherapy. Crit Rev Oncol Hematol. 2010;74(3):203–210.
   PubMed Web of Science ®Google Scholar
• Lambertini M, Del Mastro L, Bellodi A, et al. The five “Ws” for bone pain due to the administration of granulocyte-colony stimulating factors (G-CSFs). Crit Rev Oncol Hematol. 2014;89(1):112–128.
   PubMed Web of Science ®Google Scholar
• Gregory SA, Schwartzberg LS, Mo M, et al. Evaluation of reported bone pain in cancer patients receiving chemotherapy in pegfilgrastim clinical trials: a retrospective analysis. Commun Oncol. 2010;7:297–308.
   Google Scholar
• Arshad M, Seiter K, Bilaniuk J, et al. Side effects related to cancer treatment: CASE 2. Splenic rupture following pegfilgrastim. J Clin Oncol. 2005;23(33):8533–8534.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Dale DC, Wolff DA, et al. Acute myeloid leukemia or myelodysplastic syndrome in randomized controlled clinical trials of cancer chemotherapy with granulocyte colony-stimulating factor: a systematic review. J Clin Oncol. 2010;28(17):2914–2924.
   PubMed Web of Science ®Google Scholar
• Wolff AC, Blackford AL, Visvanathan K, et al. Risk of marrow neoplasms after adjuvant breast cancer therapy: the national comprehensive cancer network experience. J Clin Oncol. 2015;33(4):340–348.
   PubMed Web of Science ®Google Scholar
• Arslan C, Uslu R. Secondary haematological malignancies in the BCIRG 001 study. Lancet Oncol. 2013;14(3):e87–8.
   Google Scholar
• Lyman GH, Michels SL, Reynolds MW, et al. Risk of mortality in patients with cancer who experience febrile neutropenia. Cancer. 2010;116(23):5555–5563.
   PubMed Web of Science ®Google Scholar
• Repetto L. CIPOMO investigators. Incidence and clinical impact of chemotherapy induced myelotoxicity in cancer patients: an observational retrospective survey. Crit Rev Oncol Hematol. 2009;72(2):170–179.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Dale DC, Culakova E, et al. The impact of the granulocyte colony-stimulating factor on chemotherapy dose intensity and cancer survival: a systematic review and meta-analysis of randomized controlled trials. Ann Oncol. 2013;24(10):2475–2484.
   PubMed Web of Science ®Google Scholar
• Barnes G, Pathak A, Schwartzberg L. Pharmacoeconomics of granulocyte colony-stimulating factor: a critical review. Adv Ther. 2014;31(7):683–695.
   PubMed Web of Science ®Google Scholar
• Aarts MJ, Grutters JP, Peters FP, et al. Cost effectiveness of primary pegfilgrastim prophylaxis in patients with breast cancer at risk of febrile neutropenia. J Clin Oncol. 2013;31(34):4283–4289.
   PubMed Web of Science ®Google Scholar
• Danova M, Chiroli S, Rosti G, et al. Cost-effectiveness of pegfilgrastim versus six days of filgrastim for preventing febrile neutropenia in breast cancer patients. Tumori. 2009;95(2):219–226.
   PubMed Web of Science ®Google Scholar
• Lyman GH, Lalla A, Barron RL, et al. Cost-effectiveness of pegfilgrastim versus filgrastim primary prophylaxis in women with early-stage breast cancer receiving chemotherapy in the United States. Clin Ther. 2009;31(5):1092–1104.
   PubMed Web of Science ®Google Scholar
• Aarts MJ, Peters FP, Mandigers CM, et al. Primary granulocyte colony-stimulating factor prophylaxis during the first two cycles only or throughout all chemotherapy cycles in patients with breast cancer at risk for febrile neutropenia. J Clin Oncol. 2013;31(34):4290–4296.
   PubMed Web of Science ®Google Scholar
• Bennett CL, Chen B, Hermanson T, et al. Regulatory and clinical considerations for biosimilar oncology drugs. Lancet Oncol. 2014;15(13):e594–605.
   PubMed Web of Science ®Google Scholar
• Welte K. G-CSF: filgrastim, lenograstim and biosimilars. Expert Opin Biol Ther. 2014;14(7):983–993.
   PubMed Web of Science ®Google Scholar
• Rofail P, Tadros M, Ywakim R, et al. Pegfilgrastim: a review of the pharmacoeconomics for chemotherapy-induced neutropenia. Expert Rev Pharmacoecon Outcomes Res. 2012;12(6):699–709.
   PubMed Web of Science ®Google Scholar