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ORIGINAL ARTICLEClinical Translational Therapeutics

A Phase II Trial of Vinflunine As Monotherapy or in Combination with Trastuzumab as First-Line Treatment of Metastatic Breast Cancer

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Pages 925-931 | Published online: 06 Aug 2010

REFERENCES

  • Fahy, J.; Duflos, A.; Ribet, J.P.; Jacquesy, J.C.; Berrier, C.; Jouannetaud, M.P.; Zunino, F. Vinca alkaloids in superacidic media: a method for creating a new family of antitumor derivatives. J Am Chem Soc 1997, 119, 8576–8577.
  • Braguer, D.; Barret, J.M.; McDaid, H.; Kruczynski, A. Antitumor activity of vinflunine: effector pathways and potential for synergies. Semin Oncol 2008, 35, S13–S21.
  • Etievant, C.; Barret, J.M.; Kruczynski, A.; Perrin, D.; Hill, B.T. Vinflunine (20’,20’-difluoro-3’,4’-dihydrovinorelbine), a novel vinca alkaloid, which participates in p-glycoprotein (pgp)-mediated multidrug resistance in vivo and in vitro. Invest New Drugs 1998, 16, 3–17.
  • Etievant, C.; Kruczynski, A.; Barret, J.M.; Tait, A.S.; Kavallaris, M.; Hill, B.T. Markedly diminished drug resistance-inducing properties of vinflunine (20’,20’-difluoro-3’,4’-dihydrovinorelbine) relative to vinorelbine, identified in murine and human tumour cells in vivo and in vitro. Cancer Chemother Pharmacol 2001, 48, 62–70.
  • Hill, BT. Vinflunine, a second generation novel vinca alkaloid with a distinctive pharmacological profile, now in clinical development and prospects for future mitotic blockers. Curr Pharm Des 2001, 7, 1199–1212.
  • Honore, S.; Pagano, A.; Gauthier, G.; Bourgarel-Rey, V.; Verdier-Pinard, P.; Civiletti, K.; Kruczynski, A.; Braguer, D. Antiangiogenic vinflunine affects EB1 localization and microtubule targeting to adhesion sites. Mol Cancer Ther 2008, 7, 2080–2089.
  • Kruczynski, A.; Hill, BT. Vinflunine, the latest vinca alkaloid in clinical development. A review of its preclinical anticancer properties. Crit Rev Oncol Hematol 2001, 40, 159–173.
  • Lobert, S.; Ingram, J.W.; Hill, B.T.; Correia, J.J. A comparison of thermodynamic parameters for vinorelbine- and vinflunine-induced tubulin self-association by sedimentation velocity. Mol Pharmacol 1998, 53, 908–915.
  • Pourroy, B.; Honore, S.; Pasquier, E.; Bourgarel-Rey, V.; Kruczynski, A.; Briand, C.; Braguer, D. Antiangiogenic concentrations of vinflunine increase the interphase microtubule dynamics and decrease the motility of endothelial cells. Cancer Res 2006, 66, 3256–3263.
  • Bachner, M.; De Santis, M. Vinflunine in the treatment of bladder cancer. Ther Clin Risk Manag 2008, 4, 1243–1253.
  • Bellmunt, J.; Delgado, F.M.; George, C. Clinical activity of vinflunine in transitional cell carcinoma of the urothelium and other solid tumors. Semin Oncol 2008, 35, S34–S43.
  • Bennouna, J.; Fumoleau, P.; Armand, J.P.; Raymond, E.; Campone, M.; Delgado, F.M.; Puozzo, C.; Marty, M. Phase I and pharmacokinetic study of the new vinca alkaloid vinflunine administered as a 10-min infusion every 3 weeks in patients with advanced solid tumours. Ann Oncol 2003, 14, 630–637.
  • Campone, M.; Cortes-Funes, H.; Vorobiof, D.; Martin, M.; Slabber, C.F.; Ciruelos, E.; Bourbouloux, E.; Mendiola, C.; Delgado, F.M.; Colin, C.; Aslanis, V.; Fumoleau, P. Vinflunine: a new active drug for second-line treatment of advanced breast cancer. Results of a phase II and pharmacokinetic study in patients progressing after first-line anthracycline/taxane-based chemotherapy. Br J Cancer 2006, 95, 1161–1166.
  • Culine, S.; Theodore, C.; De Santis, M.; Bui, B.; Demkow, T.; Lorenz, J.; Rolland, F.; Delgado, F.M.; Longerey, B.; James, N. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer 2006, 94, 1395–1401.
  • Goldstein, D.; Ackland, S.P.; Bell, D.R.; Olver, I.N.; Davis, I.D.; Rosenthal, M.A.; Toner, G.C.; Pinel, M.C.; Byrne, M. Phase II study of vinflunine in patients with metastatic renal cell carcinoma. Invest New Drugs 2006, 24, 429–434.
  • Talbot, D.C.; Margery, J.; Dabouis, G.; Dark, G.; Taylor, H.; Boussemart, H.; Cadic, V.; Pinel, M.C.; Riviere, A.; Ollivier, L.; Ruffie, P. Phase II study of vinflunine in malignant pleural mesothelioma. J Clin Oncol 2007, 25, 4751–4756.
  • Fumoleau, P.; Cortes-Funes, H.; Taleb, A.B.; Chan, S.; Campone, M.; Pouget, J.C.; Tubiana-Hulin, M.; Slabber, C.F.; Caroff-Paraiso, I.; Alberts, A.S.; Ayed, F.B. Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy. Am J Clin Oncol 2009, 32, 375–380.
  • Barni, S.; Ardizzoia, A.; Bernardo, G.; et al. Vinorelbine as single agent in pretreated patients with advanced breast cancer. Tumori 1994, 80, 280–282.
  • Canobbio, L.; Boccardo, F.; Pastorino, G.; Brema, F.; Martini, C.; Resasco, M.; Santi, L. Phase-II study of navelbine in advanced breast cancer. Semin Oncol 1989, 16, 33–36.
  • Degardin, M.; Bonneterre, J.; Hecquet, B.; Pion, J.M.; Adenis, A.; Horner, D.; Demaille, A. Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer. Ann Oncol 1994, 5, 423–426.
  • Domenech, G.H.; Vogel, CL. A review of vinorelbine in the treatment of breast cancer. Clin Breast Cancer 2001, 2, 113–128.
  • Fumoleau, P.; Delgado, F.M.; Delozier, T.; Monnier, A.; Gil Delgado, M.A.; Kerbrat, P.; Garcia-Giralt, E.; Keiling, R.; Namer, M.; Closon, M.T. Phase II trial of weekly intravenous vinorelbine in first-line advanced breast cancer chemotherapy. J Clin Oncol 1993, 11, 1245–1252.
  • Garcia-Conde, J.; Lluch, A.; Martin, M.; Casado, A.; Gervasio, H.; De Oliveira, C.; De Pablo, J.L.; Gorostiaga, J.; Giron, G.C.; Cervantes, A. Phase II trial of weekly IV vinorelbine in first-line advanced breast cancer chemotherapy. Ann Oncol 1994, 5, 854–857.
  • Gasparini, G.; Caffo, O.; Barni, S.; Frontini, L.; Testolin, A.; Guglielmi, R.B.; Ambrosini, G. Vinorelbine is an active antiproliferative agent in pretreated advanced breast cancer patients: A phase II study. J Clin Oncol 1994, 12, 2094–2101.
  • Ibrahim, N.K.; Rahman, Z.; Valero, V.; Willey, J.; Theriault, R.L.; Buzdar, A.U.; Murray, J.L., 3rd; Bast, R.; Hortobagyi, G.N. Phase II study of vinorelbine administered by 96-hr infusion in patients with advanced breast carcinoma. Cancer 1999, 86, 1251–1257.
  • Livingston, R.B.; Ellis, G.K.; Gralow, J.R.; Williams, M.A.; White, R.; McGuirt, C.; Adamkiewicz, B.B.; Long, C.A. Dose-intensive vinorelbine with concurrent granulocyte colony-stimulating factor support in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1997, 15, 1395–1400.
  • Romero, A.; Rabinovich, M.G.; Vallejo, C.T.; Perez, J.E.; Rodriguez, R.; Cuevas, M.A.; Machiavelli, M.; Lacava, J.A.; Langhi, M.; Romero Acuna, L. Vinorelbine as first-line chemotherapy for metastatic breast carcinoma. J Clin Oncol 1994, 12, 336–341.
  • Twelves, C.J.; Dobbs, N.A.; Curnow, A.; Coleman, R.E.; Stewart, A.L.; Tyrrell, C.J.; Canney, P.; Rubens, R.D. A phase II, multicentre, UK study of vinorelbine in advanced breast cancer. Br J Cancer 1994, 70, 990–993.
  • Vogel, C.; O’Rourke, M.; Winer, E.; Hochster, H.; Chang, A.; Adamkiewicz, B.; White, R.; McGuirt, C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Ann Oncol 1999, 10, 397–402.
  • Weber, B.L.; Vogel, C.; Jones, S.; Harvey, H.; Hutchins, L.; Bigley, J.; Hohneker, J. Intravenous vinorelbine as first-line and second-line therapy in advanced breast cancer. J Clin Oncol 1995, 13, 2722–2730.
  • Burstein, H.J.; Harris, L.N.; Marcom, P.K.; Lambert-Falls, R.; Havlin, K.; Overmoyer, B.; Friedlander, R.J., Jr.; Gargiulo, J.; Strenger, R.; Vogel, C.L.; Ryan, P.D.; Ellis, M.J.; Nunes, R.A.; Bunnell, C.A.; Campos, S.M.; Hallor, M.; Gelman, R.; Winer, E.P. Trastuzumab and vinorelbine as first-line therapy for HER2-overexpressing metastatic breast cancer: multicenter phase II trial with clinical outcomes, analysis of serum tumor markers as predictive factors, and cardiac surveillance algorithm. J Clin Oncol 2003, 21, 2889–2895.
  • Burstein, HJ, Keshaviah, A., Baron, A.D., Hart, R.D., Lambert-Falls, R., Marcom, P.K., Gelman, R., Winer, E.P. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer 2007, 110, 965–972.
  • Burstein, H.J.; Kuter, I.; Campos, S.M.; Gelman, R.S.; Tribou, L.; Parker, L.M.; Manola, J.; Younger, J.; Matulonis, U.; Bunnell, C.A.; Partridge, A.H.; Richardson, P.G.; Clarke, K.; Shulman, L.N.; Winer, E.P. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol 2001, 19, 2722–2730.
  • Chan, A. A review of the use of trastuzumab (herceptin) plus vinorelbine in metastatic breast cancer. Ann Oncol 2007, 18, 1152–1158.
  • Jahanzeb, M.; Mortimer, J.E.; Yunus, F.; Irwin, D.H.; Speyer, J.; Koletsky, A.J.; Klein, P.; Sabir, T.; Kronish, L. Phase II trial of weekly vinorelbine and trastuzumab as first-line therapy in patients with HER2(+) metastatic breast cancer. Oncologist 2002, 7, 410–417.
  • Tubiana-Mathieu, N.; Bougnoux, P.; Becquart, D.; Chan, A.; Majois, F.; Espie, M.; Aubert, D.; Bourlard, T.; Villanova, G.; Conte, P.F. Phase II study of an all-oral combination of oral vinorelbine (NVBO) and capecitabine (x) in HER2-negative metastatic breast cancer (MBC): First results of an international phase ii trial. Breast Cancer Res Treat 2006, 100, s280.
  • Paridaens, R.; Wildiers, H.; Dalenc, F.; Rixe, O.; Cadic, V.; Pinel, M.; Roche, H. Vinflunine in combination with trastuzumab for treatment of HER2-positive metastatic breast cancer (ASCO Meeting Abstracts). J Clin Oncol 2007, 25, 1058.
  • Therasse, P.; Arbuck, S.G.; Eisenhauer, E.A.; Wanders, J.; Kaplan, R.S.; Rubinstein, L.; Verweij, J.; Van Glabbeke, M.; van Oosterom, A.T.; Christian, M.C.; Gwyther, S.G. New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92, 205–216.
  • Kaplan, E.; Meier, P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53, 457–481.

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