Etirinotecan pegol for the treatment of breast cancer

References

• Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0, cancer incidence and mortality worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; [2013; cited 2015 Mar 17]. Available from: http://globocan.iarc.fr.
   Google Scholar
• Onitilo AA, Engel JM, Greenlee RT, et al. Breast cancer subtypes based on ER/PR and Her2 expression: comparison of clinicopathologic features and survival. Clin Med Res. 2009;7(1–2):4–13.
   PubMedGoogle Scholar
• Sørlie T. Molecular portraits of breast cancer: tumour subtypes as distinct disease entities. Eur J Cancer. 2004;40(18):2667–2775.
   PubMed Web of Science ®Google Scholar
• Cianfrocca M, Goldstein LJ. Prognostic and predictive factors in early-stage breast cancer. Oncologist. 2004;9(6):606–616.
   PubMed Web of Science ®Google Scholar
• Ayoub JP, Verma S, Verma S. Advances in the management of metastatic breast cancer: options beyond first-line chemotherapy. Curr Oncol. 2012;19(2):91–105.
   PubMed Web of Science ®Google Scholar
• Cortes J, Vidal M. Beyond taxanes: the next generation of microtubule-targeting agents. Breast Cancer Res Treat. 2012;133(3):821–830.
   PubMed Web of Science ®Google Scholar
• Perez EA. Modulating drug resistance in metastatic breast cancer. Commun Oncol. 2008;5(suppl 3):2–9.
   Google Scholar
• Perez EA. Impact, mechanisms, and novel chemotherapy strategies for overcoming resistance to anthracyclines and taxanes in metastatic breast cancer. Breast Cancer Res Treat. 2009;114(2):195–201.
   PubMed Web of Science ®Google Scholar
• Rivera E. Implications of anthracycline-resistant and taxane-resistant metastatic breast cancer and new therapeutic options. Breast J. 2010;16(3):252–263.
   PubMed Web of Science ®Google Scholar
• Roche H, Vahdat LT. Treatment of metastatic breast cancer: second line and beyond. Ann of Oncol. 2011;22(5):1000–1010.
   PubMed Web of Science ®Google Scholar
• Tevaarwerk AJ, Gray RJ, Schneider BP, et al. Survival in patients with metastatic recurrent breast cancer after adjuvant chemotherapy: little evidence of improvement over the past 30 years. Cancer. 2013;119(6):1140–1148.
   PubMed Web of Science ®Google Scholar
• Aslan B, Ozpolat B, Sood AK, et al. Nanotechnology in cancer therapy. J Drug Target. 2013;21(10):904–913.
   PubMed Web of Science ®Google Scholar
• Duncan R. Polymer therapeutics: top 10 selling pharmaceuticals - What next? J Control Release. 2014;190:371–380.
   PubMed Web of Science ®Google Scholar
• Estanqueiro M, Amaral MH, Conceição J, et al. Nanotechnological carriers for cancer chemotherapy: the state of the art. Colloids Surf B Biointerfaces. 2015;126C:631–648.
   Web of Science ®Google Scholar
• Peer D, Karp JM, Hong S, et al. Nanocarriers as an emerging platform for cancer therapy. Nat Nanotechnol. 2007;2(12):751–760.
   PubMed Web of Science ®Google Scholar
• Shroff K, Vidyasagar A. Polymer nanoparticles: newer strategies towards targeted cancer therapy. J Phys Chem Biophys. 2013;3:4.
   Google Scholar
• Tomuleasa C, Braicu C, Irimie A, et al. Nanopharmacology in translational hematology and oncology. Int J Nanomedicine. 2014;9:3465–3479.
   PubMed Web of Science ®Google Scholar
• Banerjee SS, Aher N, Patil R, et al. Poly(ethylene glycol)-prodrug conjugates: concept, design, and applications. J Drug Deliv. 2012;2012:103973.
   PubMedGoogle Scholar
• Wang X, Wang Y, Cheng Z, et al. Advances of cancer therapy by nanotechnology. Cancer Res Treat. 2009;41(1):1–11.
   PubMed Web of Science ®Google Scholar
• Milla P, Dosio F, Cattel L. PEGylation of proteins and liposomes: a powerful and flexible strategy to improve the drug delivery. Curr Drug Metab. 2012;13(1):105–119.
   PubMed Web of Science ®Google Scholar
• Rajora AK, Ravishankar D, Osborn H, et al. Impact of the enhanced permeability and retention (EPR) effect and cathepsins levels on the activity of polymer-drug conjugates. Polymers. 2014;6:2186–2220.
   Web of Science ®Google Scholar
• Gogineni K, DeMichele A. Current approaches to the management of Her2-negative metastatic breast cancer. Breast Cancer Res. 2012;14(2):205.
   PubMed Web of Science ®Google Scholar
• Beslija S, Bonneterre J, Hj B, et al Third consensus on medical treatment of metastatic breast cancer. Ann Oncol. 2009;20:1771–1785.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Harbeck N, Fallowfield L, et al, on behalf of the ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2012;23(suppl7):vi11–vi19.
   Google Scholar
• Cardosa F, Costa A, Norton L, et al. ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014;25:1871–1888.
   PubMed Web of Science ®Google Scholar
• Harbeck N, Marschner N, Untch M, et al. Second international consensus conference on advanced breast cancer (ABC2), Lisbon, 11/09/2013: the German perspective. Breast Care (Basel). 2014;9(1):52–59.
   PubMed Web of Science ®Google Scholar
• NCCN.org. NCCN clinical practice guidelines in oncology: breast cancer, version 3. [2014; cited 2015 Mar 17]. Available from: http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
   Google Scholar
• Partridge AH, Rumble RB, Carey LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American society of clinical oncology clinical practice guideline. J Clin Oncol. 2014;32(29):3307–3329.
   PubMed Web of Science ®Google Scholar
• Banerji U, Kuciejewska A, Ashley S, et al. Factors determining outcome after third line chemotherapy for metastatic breast cancer. The Breast. 2007;16:359–366.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Di Leo A, Lohrisch C, et al. Second and subsequent lines of chemotherapy for metastatic breast cancer: what did we learn in the last two decades? Ann Oncol. 2002;13(2):197–207.
   PubMed Web of Science ®Google Scholar
• Palumbo R, Sottotetti F, Riccardi A, et al. Which patients with metastatic breast cancer benefit from subsequent lines of treatment? An update for clinicians. Ther Adv Med Oncol. 2013;5(6):334–350.
   PubMed Web of Science ®Google Scholar
• Seah DS, Luis IV, Macrae E, et al. Use and duration of chemotherapy in patients with metastatic breast cancer according to tumor subtype and line of therapy. J Natl Compr Canc Netw. 2014;12(1):71–80.
   PubMed Web of Science ®Google Scholar
• Arslan C, Altundag K, Dizdar O. Emerging drugs in metastatic breast cancer: an update. Expert Opin Emerg Drugs. 2011;16(4):647–667.
   PubMed Web of Science ®Google Scholar
• Cortes J, O’Shaughnessy J, Loesch D, et al. Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914–923.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Halaven™ (eribulin mesylate) injection. [2010; cited 2015 Mar 17]. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/201532lbl.pdf.
   Google Scholar
• Rugo H, Barry WT, Mareno-Aspitia A, et al. CALGB 40502/NCCTG N063H: randomized phase III trial of weekly paclitaxel compared to weekly nanoparticle albumin bound nab-paclitaxel or ixabepilone with or without bevacizumab as first-line therapy for locally recurrent or metastatic breast cancer. Presented at the 2012 ASCO Annual Meeting; 2012 Jun 1-5; Chicago, IL. Abstract CRA1002.
   Google Scholar
• Coley H. Mechanisms and strategies to overcome chemotherapy resistance in metastatic breast cancer. Cancer Treat Rev. 2008;34(4):378–390.
   PubMed Web of Science ®Google Scholar
• Florea A-M, Büsselberg D. Breast cancer and possible mechanisms of therapy resistance. J Local Global Health Sci. 2013;2. doi:10.5339/jlghs.2013.2
   Google Scholar
• Wong ST, Goodin S. Overcoming drug resistance in patients with metastatic breast cancer. Pharmacotherapy. 2009;29(8):954–965.
   PubMed Web of Science ®Google Scholar
• Andreopoulou E, Sparano J. Chemotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer: an overview. Curr Breast Cancer Rep. 2013;5(1):42–50.
   PubMedGoogle Scholar
• Moreno-Aspitia A, Perez EA. Treatment options for breast cancer resistant to anthracycline and taxane. Mayo Clin Pro. 2009;84(6):533–545.
   PubMed Web of Science ®Google Scholar
• Oostendorp LJ, Stalmeier PF, Donders AR, et al. Efficacy and safety of palliative chemotherapy for patients with advanced breast cancer pretreated with anthracyclines and taxanes: a systematic review. Lancet Oncol. 2011;12:1053–1061.
   PubMed Web of Science ®Google Scholar
• Ribeiro JT, Macedo LT, Curigliano G, et al. Cytotoxic drugs for patients with breast cancer in the era of targeted treatment: back to the future? Ann Oncol. 2012;23(3):547–555.
   PubMed Web of Science ®Google Scholar
• Hoch U, Staschen C-M, Johnson R, et al. Nonclinical pharmacokinetics and activity of etirinotecan pegol (NKTR-102), a long-acting topoisomerase 1 inhibitor, in multiple cancer models. Cancer Chemother Pharmacol. 2014;74(6):1125–1137.
   PubMed Web of Science ®Google Scholar
• Hertzberg RP, Caranfa MJ, Hecht SM. On the mechanism of topoisomerase I inhibition by camptothecin: evidence for binding to an enzyme-DNA complex. Biochemistry. 1989;28(11):4629–4638.
   PubMed Web of Science ®Google Scholar
• Moukharskaya J, Verschraegen C. Topoisomerase 1 inhibitors and cancer therapy. Hematol Oncol Clin North Am. 2012;26(3):507–525.
   PubMed Web of Science ®Google Scholar
• Kawato Y, Aonuma M, Hirota Y, et al. Intracellular roles of SN-38, a metabolite of the camptothecin derivative CPT-11, in the antitumor effect of CPT-11. Cancer Res. 1991;51:4187–4191.
   PubMed Web of Science ®Google Scholar
• Liu LF, Desai SD, Li TK, et al. Mechanism of action of camptothecin. Ann N Y Acad Sci. 2000;922:1–10.
   PubMed Web of Science ®Google Scholar
• Bjornsti MA, Benedetti P, Vigliantti GA, et al. Expression of human DNA topoisomerase I in yeast cells lacking yeast DNA topoisomerase I: restoration of sensitivity of the cells to the anti-tumor drug camptothecin. Cancer Res. 1989;49:6318–6323.
   PubMed Web of Science ®Google Scholar
• Pommier Y. DNA topoisomerase I inhibitors: chemistry, biology, and interfacial inhibition. Chem Rev. 2009;109(7):2894–2902.
   PubMed Web of Science ®Google Scholar
• Stenvang J, Kümler I, Nygård SB, et al. Biomarker-guided repurposing of chemotherapeutic drugs for cancer therapy: a novel strategy in drug development. Front Oncol. 2013;3:313.
   PubMedGoogle Scholar
• Pommier Y. Topoisomerase I inhibitors: camptothecins and beyond. Nat Rev Cancer. 2006;6(10):789–802.
   PubMed Web of Science ®Google Scholar
• Chabot GG. Clinical pharmacokinetics of irinotecan. Clin Pharmacokinet. 1997;33(4):245–259.
   PubMed Web of Science ®Google Scholar
• Kehrer DF, Yamamoto W, Verweij J, et al. Factors involved in prolongation of the terminal disposition phase of SN-38: clinical and experimental studies. Clin Cancer Res. 2000;6(9):3451–3458.
   PubMed Web of Science ®Google Scholar
• Pitot HC, Goldberg RM, Reid JM, et al. Phase I dose-finding and pharmacokinetic trial of irinotecan hydrochloride (CPT-11) using a once-every-three-week dosing schedule for patients with advanced solid tumor malignancy. Clin Cancer Res. 2000;6(6):2236–2244.
   PubMed Web of Science ®Google Scholar
• Rothenberg ML, Kuhn JG, Schaaf LJ, et al. Phase I dose-finding and pharmacokinetic trial of irinotecan (CPT-11) administered every two weeks. Ann Oncol. 2001;12(11):1631–1641.
   PubMed Web of Science ®Google Scholar
• Sparreboom A, Mja DJ, De Bruijn P, et al. Irinotecan (CPT-11) metabolism and disposition in cancer patients. Clin Cancer Res. 1998;4:2747–275.
   PubMed Web of Science ®Google Scholar
• Perez EA, Hillman DW, Mailliard JA, et al. Randomized phase II study of two irinotecan schedules for patients with metastatic breast cancer refractory to an anthracycline, a taxane, or both. J Clin Oncol. 2004;22(14):2849–2855.
   PubMed Web of Science ®Google Scholar
• Tan WW, Hillman DW, Salim M, et al. N0332 phase 2 trial of weekly irinotecan hydrochloride and docetaxel in refractory metastatic breast cancer: a North Central Cancer Treatment Group (NCCTG) trial. Ann Oncol. 2010;21(3):493–497.
   PubMed Web of Science ®Google Scholar
• Kümler I, Brünner N, Stenvang J, et al. A systematic review on topoisomerase 1 inhibition in the treatment of metastatic breast cancer. Breast Cancer Res Treat. 2013;138(2):347–358.
   PubMed Web of Science ®Google Scholar
• Bala V, Rao S, Boyd BJ, et al. Prodrug and nanomedicine approaches for the delivery of the camptothecin analogue SN38. J Control Release. 2013;172(1):48–61.
   PubMed Web of Science ®Google Scholar
• Alemany C. Etirinotecan pegol: development of a novel conjugated topoisomerase I inhibitor. Curr Oncol Rep. 2014;16:367–372.
   PubMed Web of Science ®Google Scholar
• Awada A, Garcia AA, Chan S, et al. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013;14(12):1216–1225.
   PubMed Web of Science ®Google Scholar
• Edith A, Perez EA, Awada A, et al. Etirinotecan pegol (NKTR-102) versus treatment of physician’s choice in women with anthracycline-, taxane-, and capecitabine-treated advanced breast cancer: a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2015;16(15):1556–1568. doi:10.1016/S1470-2045(15)00332-0
   Web of Science ®Google Scholar
• Hoch U. Method for predicting and evaluating responsiveness to cancer treatment with DNA-damaging chemotherapeutic agents. US20140357659. 2014.
   Google Scholar
• Danhier F, Feron O, Préat V. To exploit the tumor microenvironment: passive and active tumor targeting of nanocarriers for anti-cancer drug delivery. J Control Release. 2010;148(2):135–146.
   PubMed Web of Science ®Google Scholar
• Eldon MA, Antonian L, Burton K, et al. NKTR-102, a novel PEGylated irinotecan-conjugate, demonstrates improved pharmacokinetics with sustained exposure of irinotecan and its active metabolite. Presented at the 14th European Cancer Conference (ECCO 14); 2007 Sep 23–27; Barcelona, Spain. P-0727.
   Google Scholar
• Eldon MA, Antonian L, Staschen C-M, et al. Anti-tumor activity and pharmacokinetics of NKTR-102, a novel PEGylated-irinotecan conjugate, in irinotecan-resistant colorectal tumors implanted in mice. Presented at the 14th European Cancer Conference (ECCO 14); 2007 Sep 23–27; Barcelona, Spain. P–0722.
   Google Scholar
• Persson H, Antonian L, Staschen C-M, et al. NKTR-102, a novel polyethylene glycol conjugate of irinotecan, has improved anti-tumor activity in three mouse xenograft models. Poster presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2007 Oct 22–26; San Francisco, CA, USA. Poster C10.
   Google Scholar
• Eldon MA, Staschen C-M, Viegas T, et al. NKTR-102, a novel PEGylated-irinotecan conjugate, results in sustained tumor growth inhibition in mouse models of human colorectal and lung tumors that is associated with increased and sustained tumor SN38 exposure. Poster presented at the 2007 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics; 2007 Oct 22–26; San Francisco, CA, USA. Poster C157.
   Google Scholar
• Von Hoff DD, Jameson GS, Borad MJ, et al. First phase 1 trial of NKTR-102 (peg-irinotecan) reveals early evidence of broad antitumor activity in three different schedules. Presented at the 20th EORTC-NCI-AACR symposium on Molecular Targets and Cancer Therapeutics meeting; 2008 Oct 21–24; Geneva, Switzerland. Poster 595.
   Google Scholar
• Jameson GS, Hamm JT, Weiss GJ, et al. Multicenter, phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of etirinotecan pegol in patients with refractory solid tumors. Clin Cancer Res. 2013;19(1):268–278.
   PubMed Web of Science ®Google Scholar
• Nounou MI, Hoch U, Adkins C, et al. Etirinotecan pegol accumulates in breast cancer brain metastases and prolongs survival in an experimental model of brain metastases of human triple negative breast cancer. Poster Presented at The American Association of Cancer Research (AACR) annual meeting; 2014 Apr 5–9; San Diego, CA, USA. Poster no. 22.
   Google Scholar
• Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205–216.
   PubMed Web of Science ®Google Scholar
• Hecht JR. Gastrointestinal toxicity of irinotecan. Oncology. 1998;12:72–78.
   PubMed Web of Science ®Google Scholar
• Cortés J, Calvo E, Vivancos A, et al. New approach to cancer therapy based on a molecularly defined cancer classification. CA Cancer J Clin. 2014;64(1):70–74.
   PubMed Web of Science ®Google Scholar