Metronomic treatment of vinorelbine with oral capecitabine is tolerable in the randomized Phase 2 study XeNa including patients with HER2 non-amplified metastatic breast cancer

References

• Harbek N, Penault-Llorca F, Cortes J, et al. Breast cancer. Nat Rev Dis Primers. 2019;5:66.
   PubMed Web of Science ®Google Scholar
• Tubiana-Mathieu N, Bougnoux P, Becquart D, et al. All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an international phase II trial. Br J Cancer. 2009;101(2):232–237.
   PubMed Web of Science ®Google Scholar
• Liedtke C, Kolberg HC. Systemic therapy of advanced/metastatic breast cancer - current evidence and future concepts. Breast Care (Basel). 2016;11(4):275–281.
   PubMed Web of Science ®Google Scholar
• Cardoso F, Costa A, Senkus E, et al. 3rd ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 3). Breast. 2017;31:244–259.
   PubMed Web of Science ®Google Scholar
• Kerbel RS, Kamen BA. The anti-angiogenic basis of metronomic chemotherapy. Nat Rev Cancer. 2004;4(6):423–436.
   PubMed Web of Science ®Google Scholar
• Scharovsky OG, Mainetti LE, Rozados VR. Metronomic chemotherapy: changing the paradigm that more is better. Curr Oncol. 2009;16(2):7–15.
   PubMed Web of Science ®Google Scholar
• Briasoulis E, Pappas P, Puozzo C, et al. Dose-ranging study of metronomic oral vinorelbine in patients with advanced refractory cancer. Clin Cancer Res. 2009;15(20):6454–6461.
   PubMed Web of Science ®Google Scholar
• Hanahan D, Bergers G, Bergsland E. Less is more, regularly: metronomic dosing of cytotoxic drugs can target tumor angiogenesis in mice. J Clin Invest. 2000;105(8):1045–1047.
   PubMed Web of Science ®Google Scholar
• Hobson B, Denekamp J. Endothelial proliferation in tumours and normal tissues: continuous labelling studies. Br J Cancer. 1984;49(4):405–413.
   PubMed Web of Science ®Google Scholar
• Cazzaniga ME, Camerini A, Addeo R, et al. Metronomic oral vinorelbine in advanced breast cancer and non-small-cell lung cancer: current status and future development. Future Oncol. 2016;12(3):373–387.
   PubMed Web of Science ®Google Scholar
• Munzone E, Colleoni M. Clinical overview of metronomic chemotherapy in breast cancer. Nat Rev Clin Oncol. 2015;12(11):631–644.
   PubMed Web of Science ®Google Scholar
• Montagna E, Cancello G, Dellapasqua S, et al. Metronomic therapy and breast cancer: a systematic review. Cancer Treat Rev. 2014;40(8):942–950.
   PubMed Web of Science ®Google Scholar
• Blum JL, Dieras V, Lo Russo PM, et al. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer. 2001;92(7):1759–1768.
   PubMed Web of Science ®Google Scholar
• Mackean M, Planting A, Twelves C, et al. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients with advanced and/or metastatic cancer. J Clin Oncol. 1998;16(9):2977–2985.
   PubMed Web of Science ®Google Scholar
• Reigner B, Blesch K, Weidekamm E. Clinical pharmacokinetics of capecitabine. Clin Pharmacokinet. 2001;40(2):85–104.
   PubMed Web of Science ®Google Scholar
• Bruno S, Puerto VL, Mickiewicz E, et al. Phase II trial of weekly i.v. vinorelbine as a single agent in first-line advanced breast cancer chemotherapy. The Latin-American experience. Am J Clin Oncol. 1995;18(5):392–396.
   PubMed Web of Science ®Google Scholar
• García-Conde J, Lluch A, Martin M, et al. Phase II trial of weekly IV vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol Off J Eur Soc Med Oncol. 1994;5(9):854–857.
   PubMed Web of Science ®Google Scholar
• Fumoleau P, Delgado FM, Delozier T, et al. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol. 1993;11(7):1245–1252.
   PubMed Web of Science ®Google Scholar
• Terenziani M, Demicheli R, Brambilla C, et al. Vinorelbine: an active, non cross-resistant drug in advanced breast cancer. Results from a phase II study. Breast Cancer Res Treat. 1996;39(3):285–291.
   PubMed Web of Science ®Google Scholar
• Langkjer ST, Ejlertsen B, Mouridsen H, et al. Vinorelbine as first-line or second-line therapy for advanced breast cancer: a Phase I-II trial by the Danish Breast Cancer Co-operative Group. Acta Oncol. 2008;47(4):735–739.
   PubMed Web of Science ®Google Scholar
• Mathé G, Reizenstein P. Phase I pharmacologic study of a new Vinca alkaloid: navelbine. Cancer Lett. 1985;27(3):285–293.
   PubMed Web of Science ®Google Scholar
• Dieras V, Extra JM, Bellissant E, et al. Efficacy and tolerance of vinorelbine and fluorouracil combination as first-line chemotherapy of advanced breast cancer: results of a phase II study using a sequential group method. J Clin Oncol. 1996;14(12):3097–3104.
   PubMed Web of Science ®Google Scholar
• Saridaki Z, Malamos N, Kourakos P, et al. A phase I trial of oral metronomic vinorelbine plus capecitabine in patients with metastatic breast cancer. Cancer Chemother Pharmacol. 2012;69(1):35–42.
   PubMed Web of Science ®Google Scholar
• Marty M, Fumoleau P, Adenis A, et al. Oral vinorelbine pharmacokinetics and absolute bioavailability study in patients with solid tumors. Ann Oncol. 2001;12(11):1643–1649.
   PubMed Web of Science ®Google Scholar
• Variol P, Nguyen L, Tranchand B, et al. A simultaneous oral/intravenous population pharmacokinetic model for vinorelbine. Eur J Clin Pharmacol. 2002;58(7):467–476.
   PubMed Web of Science ®Google Scholar
• Nolè F, Catania C, Sanna G, et al. Dose-finding and pharmacokinetic study of an all-oral combination regimen of oral vinorelbine and capecitabine for patients with metastatic breast cancer. Ann Oncol. 2006;17(2):322–329.
   PubMed Web of Science ®Google Scholar
• Briasoulis E, Aravantinos G, Kouvatseas G, et al. Dose selection trial of metronomic oral vinorelbine monotherapy in patients with metastatic cancer: a Hellenic cooperative oncology group clinical translational study. BMC Cancer. 2013;13(1):263.
   PubMed Web of Science ®Google Scholar
• Welt A, von Minckwitz G, Oberhoff C, et al. Phase I/II study of capecitabine and vinorelbine in pretreated patients with metastatic breast cancer. Ann Oncol. 2005;16(1):64–69.
   PubMed Web of Science ®Google Scholar
• Cazzaniga ME, Torri V, Villa F, et al. Efficacy and safety of the all-oral schedule of metronomic vinorelbine and capecitabine in locally advanced or metastatic breast cancer patients: the phase I-II VICTOR-1 study. Int J Breast Cancer. 2014;2014:769790.
   PubMedGoogle Scholar
• Cazzaniga ME, Torri V, Riva F, et al. Efficacy and safety of vinorelbine-capecitabine oral metronomic combination in elderly metastatic breast cancer patients: VICTOR-1 study. Tumori. 2017;103(1):e4–e8.
   PubMed Web of Science ®Google Scholar
• Cazzaniga ME, Cortesi L, Ferzi A, et al. Metronomic chemotherapy with oral vinorelbine (mVNR) and capecitabine (mCAPE) in advanced HER2-negative breast cancer patients: is it a way to optimize disease control? Final results of the VICTOR-2 study. Breast Cancer Res Treat. 2016;160(3):501–509.
   PubMed Web of Science ®Google Scholar
• Liu Y, Gu F, Liang J, et al. The efficacy and toxicity profile of metronomic chemotherapy for metastatic breast cancer: a meta-analysis. PLoS One. 2017;12(3):e0173693.
   PubMed Web of Science ®Google Scholar
• Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228–247.
   PubMed Web of Science ®Google Scholar
• Finek J, Holubec L, Svoboda T, et al. A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer. Anticancer Res. 2009;29(2):667–670.
   PubMed Web of Science ®Google Scholar
• Jones A, O'Brien M, Sommer H, et al. Phase II study of oral vinorelbine in combination with capecitabine as second line chemotherapy in metastatic breast cancer patients previously treated with anthracyclines and taxanes. Cancer Chemother Pharmacol. 2010;65(4):755–763.
   PubMed Web of Science ®Google Scholar
• Canobbio L, Boccardo F, Pastorino G, et al. Phase-II study of Navelbine in advanced breast cancer. Semin Oncol. 1989;16(4):33–36.
   PubMed Web of Science ®Google Scholar
• Freyer G, Delozier T, Lichinister M, et al. Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol. 2003;21(1):35–40.
   PubMed Web of Science ®Google Scholar