Vinflunine as second-line treatment in platin-resistant metastatic urothelial carcinoma: A review

Anti-Cancer Drugs

Volumn 22, Issue 1, 2011, Pages 9-17

  Gerullis, Holger ^a,b,c   Ecke, Thorsten ^d   Eimer, Christoph ^a,c   Wishahi, Mohamed ^e   Otto, Thomas ^a,b,c  

^a Lukaskrankenhaus GmbH   (Germany)

^b UNIVERSITY HOSPITAL ESSEN   (Germany)

^c Evaluation of Innovative Techniques in Medicine (DZITM)   (Germany)

^d HELIOS Klinikum Bad Saarow   (Germany)

^e Egypt   (Egypt)

Author keywords

Second line therapy; Urothelial cancer; Vinflunine

Indexed keywords

2 (2 DIMETHYLAMINOETHYL) 9 METHOXY 5 NITROPYRAZOLO[3,4,5 KL]ACRIDINE; ALPHA INTERFERON; BORTEZOMIB; CAPECITABINE; CARBOPLATIN; CETUXIMAB; CISPLATIN; DOCETAXEL; ERLOTINIB; FLUOROURACIL; GEMCITABINE; IFOSFAMIDE; METHOTREXATE; OXALIPLATIN; PACLITAXEL; PEMETREXED; PIRITREXIM; SORAFENIB; SUNITINIB; TRASTUZUMAB; VINFLUNINE; VORINOSTAT;

ABDOMINAL PAIN; ADVANCED CANCER; ALOPECIA; ANEMIA; ASTHENIA; CANCER COMBINATION CHEMOTHERAPY; CANCER RESISTANCE; CONSTIPATION; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG MECHANISM; DRUG TOLERANCE; FATIGUE; FEBRILE NEUTROPENIA; HUMAN; ILEUS; INJECTION SITE REACTION; METASTASIS; MYALGIA; NAUSEA AND VOMITING; NEUROTOXICITY; NEUTROPENIA; PRIORITY JOURNAL; REVIEW; SENSORY NEUROPATHY; SIDE EFFECT; SOLID TUMOR; STOMATITIS; THROMBOCYTOPENIA; TRANSITIONAL CELL CARCINOMA; TREATMENT PLANNING;

ANIMALS; ANTINEOPLASTIC AGENTS; CARCINOMA, TRANSITIONAL CELL; DRUG RESISTANCE, NEOPLASM; HUMANS; NEOPLASM METASTASIS; ORGANOPLATINUM COMPOUNDS; UROLOGIC NEOPLASMS; VINBLASTINE;

EID: 78650511003     PISSN: 09594973     EISSN: None     Source Type: Journal    
DOI: 10.1097/CAD.0b013e3283404db0     Document Type: Review

References (72)

1. Jemal A, Siegel R,Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007; 57:43-66.
2. Aben KK, Witjes JA, Schoenberg MP, Hulsbergen-van de Kaa C, Verbeek AL, Kiemeney LA. Familial aggregation of urothelial cell carcinoma. Int J Cancer 2002; 98:274-278.
3. De Braud F, Maffezzini M, Vitale V, Bruzzi P, Gatta G, Hendry WF, et al. Bladder cancer. Crit Rev Oncol Hematol 2002; 41:89-106.
4. Sternberg CN, Yagoda A, Scher HI, Watson RC, Geller N, Herr HW, et al. Methotrexate, vinblastine, doxorubicin, and cisplatin for advanced transitional cell carcinoma of the urothelium: Efficacy and patterns of response and relapse. Cancer 1989; 64:2448-2458.
5. Von der Maase H, Hansen SW, Roberts JT, Doglioti L, Oliver T, Moore MJ, et al. Gemcitabine and cisplatin versus methotrexate, vinblastine, doxorubicin, and cisplatin in advanced or metastatic bladder cancer: Results of a large, randomized, multinational, multicenter, Phase III study. J Clin Oncol 2000; 18:3068-3077.
6. Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: A systematic review and metaanalysis. Lancet 2003; 361:1927-1934.
7. Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: Update of a systematic review and meta-analysis of individual patient data: Advanced bladder cancer (ABC) meta-analysis collaboration. Eur Urol 2005; 48:202-205.
8. Stenzl A, Cowan NC, De Santis M, Jakse G, Kuczyk MA, Merseburger AS, et al. The updated EAU guidelines on muscle-invasive and metastatic bladder cancer. Eur Urol 2009; 55:815-825.
9. Gomez-Albumin G, Winquist E, Stadler WM, Pond G, Degendorfer P, Wright J, et al. A phase II study of PS-341 (Bortezomib) in advanced or metastatic urothelial cancer. A trial of the Princess Margaret Hospital and University of Chicago phase II consortia. Invest New Drugs 2007; 25:181-185.
10. Wülfing C, Machiels JP, Richel DJ, Grimm MO, Treiber U, De Groot MR, et al. A single-arm, multicenter, open-label phase 2 study of lapatinib as the second-line treatment of patients with locally advanced or metastatic transitional cell carcinoma. Cancer 2009; 115:2881-2890.
11. Cheung EM, Quinn DI, Tsao-Wie DD, Groshen SG, Aparicio AM, Twardowski P, et al.; California Cancer Consortium. Phase II study of vorinostat (suberoylanilide hydroxamic acid, SAHA) in patients with advanced transitional cell urothelial cancer (TCC) after platinumbased therapy: California Cancer Consortium/University of Pittsburgh NCI/CTEP-sponsored trial [Abstr 16058]. J Clin Oncol 2008; 26 (Suppl).
12. Dreicer R, Li S, Manola J, Haas NB, Roth BJ, Wilding G; Eastern Cooperative Oncology Group. Phase 2 trial of epothilone B analog BMS-247550 (ixabepilone) in advanced carcinoma of the urothelium (E3800): A trial of the Eastern Cooperative Oncology Group. Cancer 2007; 110:759-763.
13. Gallagher DJ, Milowsky MI, Gerst SR, Ishill N, Riches J, Regazzi A, et al. Phase II study of sunitinib in patients with metastatic urothelial cancer. J Clin Oncol 2010; 28:1373-1379.
14. Rosenberg JE, Halabi S, Sanford BL, Himelstein AL, Atkins JN, Hohl RJ; Cancer and Leukemia Group B. Phase II study of bortezomib in patients with previously treated advanced urothelial tract transitional cell carcinoma: CALGB 90207. Ann Oncol 2008; 19:946-950.
15. McCaffrey JA, Hilton S, Mazumdar M, Sadan S, Kelly WK, Scher HI, et al. Phase II trial of docetaxel in patients with advanced or metastatic transitional-cell carcinoma. J Clin Oncol 1997; 15:1853-1857. (Pubitemid 27209514)
16. Lorusso V, Pollera CF, Antimi M, Luporini G, Gridelli C, Frassineti GL, et al.; Italian Co-operative Group on Bladder Cancer. A phase II study of gemcitabine in patients with transitional cell carcinoma of the urinary tract previously treated with platinum. Eur J Cancer 1998; 34:1208-1212.
17. Witte RS, Manola J, Burch PA, Kuzel T, Weinshel EL, Loehrer PJ Sr. Topotecan in previously treated advanced urothelial carcinoma: An ECOG phase II trial. Invest New Drugs 1998; 16:191-195.
18. Moore M,Winquist E, Vokes E, Hirte H, Hoving K, Stadler M. Phase II study of oxaliplatin in patients with inoperable, locally advanced or metastatic transitional cell carcinoma of the urothelial tract (TCC) who have received prior chemotherapy [Abstr 1638]. Proc Am Soc Clin Oncol 2003; 22:408.
19. Vaughn DJ, Broome CM, Hussain M, Gutheil JC, Markowitz AB. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol 2002; 20:937-940.
20. Sweeney CJ, Roth BJ, Kabbinavar FF, Vaughn DJ, Arning M, Curiel RE, et al. Phase II study of pemetrexed for second-line treatment of transitional cell cancer of the urothelium. J Clin Oncol 2006; 24:3451-3457.
21. Roth BJ, Manola J, Dreicer R, Graham D, Wilding G; Eastern Cooperative Oncology Group. Piritrexim in advanced, refractory carcinoma of the urothelium (E3896): A phase II trial of the Eastern Cooperative Oncology Group. Invest New Drugs 2002; 20:425-429. (Pubitemid 35252786)
22. Dodd PM, McCaffrey JA, Mazumdar M, Icasiano E, Higgins G, Herr H, et al. Phase II trial of pyrazoloacridine as second-line therapy for patients with unresectable or metastatic transitional cell carcinoma. Invest New Drugs 2000; 18:247-251.
23. Sella A, Logothetis CJ, Fitz K, Dexeus FH, Amato R, Kilbourn R, et al. Phase II study of interferon-alpha and chemotherapy (5-fluorouracil and mitomycin C) in metastatic renal cell cancer. J Urol 1992; 147:573-577.
24. Tu SM, Hossan E, Amato R, Kilbourn R, Logothetis CJ. Paclitaxel, cisplatin and methotrexate combination chemotherapy is active in the treatment of refractory urothelial malignancies. J Urol 1995; 154:1719-1722.
25. De Mulder PH, Theodore C, Sella A, Koriakine O, Sternberg CN, Collette L, et al. Phase II EORTC trial with 5-fluorouracil, cisplatin and interferon-alpha as second-line treatment of advanced transitional cell cancer of the urothelial tract. Ann Oncol 2000; 11:1391-1394.
26. Krege S, Rembrink V, Börgermann C, Otto T, Rübben H. Docetaxel and ifosfamide as second line treatment for patients with advanced or metastatic urothelial cancer after failure of platinum chemotherapy: A phase 2 study. J Urol 2001; 165:67-71.
27. Bellmunt J, Cos J, Clèries R, Pérez M, Ribas A, Eres N, et al. Feasibility trial of methotrexate-paclitaxel as a second line therapy in advanced urothelial cancer. Cancer Invest 2002; 20:673-685.
28. Pagliaro LC, Millikan RE, Tu SM,Williams D, Daliani D, Papandreou CN, et al. Cisplatin, gemcitabine, and ifosfamide as weekly therapy: A feasibility and phase II study of salvage treatment for advanced transitional-cell carcinoma. J Clin Oncol 2002; 20:2965-2970.
29. Chen AC, Hovey E, Shelton G, Fitzsimmons J, Randall A, Taub R, et al. Phase I/II study of docetaxel (D), gemcitabine (G), carboplatin (C) in poor prognosis and previously treated patients (pts) with urothelial carcinoma (UTC). J Clin Oncol 2004; 22 (Suppl):4580.
30. Lin CC, Hsu CH, Huang CY, Keng HY, Tsai YC, Huang KH, et al. Gemcitabine and ifosfamide as a second-line treatment for cisplatinrefractory metastatic urothelial carcinoma: A phase II study. Anticancer Drugs 2007; 18:487-491.
31. Sternberg CN, Calabrò F, Pizzocaro G, Marini L, Schnetzer S, Sella A. Chemotherapy with an every-2-week regimen of gemcitabine and paclitaxel in patients with transitional cell carcinoma who have received prior cisplatinbased therapy. Cancer 2001; 92:2993-2998.
32. Takahashi T, Higashi S, Nishiyama H, Segawa T, Nakamura E, Kinoshita H, et al. Biweekly paclitaxel and gemcitabine for patients with advanced urothelial cancer ineligible for cisplatin-based regimen. Jpn J Clin Oncol 2006; 36:104-108.
33. Suyama T, Ueda T, Fukasawa S, Imamura Y, Nakamura K, Miyasaka K, et al. Combination of gemcitabine and paclitaxel as second-line chemotherapy for advanced urothelial carcinoma. Jpn J Clin Oncol 2009; 39:244-250.
34. Bellmunt J, Théodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009; 27:4454-4461.
35. Kavallaris M. Microtubules and resistance to tubulin-binding agents. Nat Rev Cancer 2010; 10:194-204.
36. Fahy J, Hellier P, Breillout F, Bailly C. Vinflunine: Discovery and synthesis of a novel microtubule inhibitor. Semin Oncol 2008; 35 (3 Suppl):S3-S5.
37. Lobert S, Ingram JW, Hill BT, Correia JJ. A comparison of thermodynamic parameters for vinorelbine- and vinflunine-induced tubulin self-association by sedimentation velocity. Mol Pharmacol 1998; 53:908-915.
38. Fabre C, Czaplicki J, Wright M, Hill B, Barret JM, Fahy J, et al. Differential binding to the alpha/beta-tubulin dimer of vinorelbine and vinflunine revealed by nuclear magnetic resonance analyses. Biochem Pharmacol 2002; 64:733-740.
39. Kruczynski A, Barret JM, Etiévant C, Colpaert F, Fahy J, Hill BT. Antimitotic and tubulin-interacting properties of vinflunine, a novel fluorinated vinca alkaloid. Biochem Pharmacol 1998; 55:635-648. (Pubitemid 28077822)
40. Singer W, DandHimes RH. Cellular uptake and tubulin binding properties of four vinca alkaloids. Biochem Pharmacol 1992; 43:545-551.
41. Jordan MA, Himes RH, Wilson L. Comparison of the effects of vinblastine, vincristine, vindesine, and vinepidine on microtubule dynamics and cell proliferation in vitro. Cancer Res 1985; 45:2741-2747.
42. 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.
43. Ngan VK, Bellman K, Panda D, Hill BT, Jordan MA,Wilson L. Novel actions of the antitumor drugs vinflunine and vinorelbine on microtubules. Cancer Res 2000; 60:5045-5051.
44. Jordan MA, Horwitz SB, Lobert S, Correia JJ. Exploring the mechanisms of action of the novel microtubule inhibitor vinflunine. Semin Oncol 2008; 35 (Suppl 3):S6-S12.
45. Kruczynski A, Etiévant C, Perrin D, Chansard N, Duflos A, Hill BT. Characterization of cell death induced by vinflunine, the most recent vinca alkaloid in clinical development. Br J Cancer 2002; 86:143-150.
46. Pourroy B, CarréM, HonoréS, Bourgarel-Rey V, Kruczynski A, Briand C, et al. Low concentrations of vinflunine induce apoptosis in human SK-N-SH neuroblastoma cells through a postmitotic G1 arrest and a mitochondrial pathway. Mol Pharmacol 2004; 66:580-591.
47. Braguer D, Barret JM, McDaid H, Kruczynski A. Antitumor activity of vinflunine: Effector pathways and potential for synergies. Semin Oncol 2008; 35 (Suppl 3):S13-S21.
48. Kruczynski A, Colpaert F, Tarayre JP, Mouillard P, Fahy J, Hill BT. Preclinical in vivo antitumor activity of vinflunine, a novel fluorinated vinca alkaloid. Cancer Chemother Pharmacol 1998; 41:437-447.
49. Hill BT, Fiebig HH, Waud WR, Poupon MF, Colpaert F, Kruczynski A. Superior in vivo experimental antitumour activity of vinflunine, relative to vinorelbine, in a panel of human tumour xenografts. Eur J Cancer 1999; 35:512-520.
50. Barret JM, Etiévant C, Hill BT. In vitro synergistic effects of vinflunine, a novel fluorinated vinca alkaloid, in combination with other anticancer drugs. Cancer Chemother Pharmacol 2000; 45:471-476.
51. Holwell SE, Hill BT, Bibby MC. Anti-vascular effects of vinflunine in the MAC 15A transplantable adenocarcinoma model. Br J Cancer 2001; 84:290-295.
52. HonoréS, Pagano A, Gauthier G, Bourgarel-Rey V, Verdier-Pinard P, Civiletti K, et al. Antiangiogenic vinflunine affects EB1 localization and microtubule targeting to adhesion sites. Mol Cancer Ther 2008; 7:2080-2089.
53. Etiévant C, Kruczynski A, Barret JM, Tait AS, Kavallaris M, Hill BT. Markedly diminished drug resistance-inducing properties of vinflunine (200,200- difluoro-30,40-dihydrovinorelbine) relative to vinorelbine, identified in murine and human tumour cells in vivo and in vitro. Cancer Chemother Pharmacol 2001; 48:62-70.
54. Kavallaris M, Annereau J-P, Barret J-M. Potential mechanisms of resistance to microtubule inhibitors. Semin Oncol 2008; 35:S22-S27.
55. Bonfil RD, Russo DM, Binda MM, Delgado FM, Vincenti M. Higher antitumor activity of vinflunine than vinorelbine against an orthotopic murine model of transitional cell carcinoma of the bladder. Urol Oncol 2002; 7:159-166.
56. Le Chevalier T, Brisgand D, Douillard JY, Pujol JL, Alberola V, Monnier A, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: Results of a European multicenter trial including 612 patients. J Clin Oncol 1994; 12:360-367.
57. Souquet PJ, Krzakowski M, Ramlau R, Sun XS, Lopez-Vivanco G, Puozzo C, et al. Phase I/II and pharmacokinetic study of intravenous vinflunine in combination with cisplatin for the treatment of chemonaive patients with advanced non-small-cell lung cancer. Clin Lung Cancer 2010; 11:105-113.
58. Bennouna J, Fumoleau P, Armand JP, Raymond E, Campone M, Delgado FM, et al. 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.
59. Bennouna J, Campone M, Delord JP, Pinel MC. Vinflunine: A novel antitubulin agent in solid malignancies. Expert Opin Invest Drugs 2005; 14: 1259-1267.
60. Johnson P, Geldart T, Fumoleau P, Pinel MC, Nguyen L, Judson I. Phase I study of vinflunine administered as a 10-min infusion on days 1 and 8 every 3 weeks. Invest New Drugs 2006; 24:223-231.
61. CHMP Assessment Report for JAVLOR International Nonproprietary Name Javlor European Public Assessment Report doc EMEA/CHMP/370293/ 2009.
62. Simoens C, Vermorken JB, Korst AE, Pauwels B, De Pooter CM, Pattyn GG, et al. Cell cycle effects of vinflunine, the most recent promising vinca alkaloid, and its interaction with radiation, in vitro. Cancer Chemother Pharmacol 2006; 58:210-218.
63. Kruczynski A, Poli M, Dossi R, Chazottes E, Berrichon G, Ricome C, et al. Anti-angiogenic, vascular-disrupting and anti-metastatic activities of vinflunine, the latest vinca alkaloid in clinical development. Eur J Cancer 2006; 42:2821-2832.
64. Vermorken JB, Stupp R, NguyenN L, Pinel MC, Delord JP. Phase I study of IV vinflunine given on a weekly schedule in previously untreated patients (pts) with advanced solid tumors [Abstr 887]. Proc Am Soc Clin Oncol 2003; 22:221.
65. Sanoff HK, Davies J,Walko C, Buie L, Chiu WK, Ivanova A, et al. Phase I trial of vinflunine and pemetrexed in refractory solid tumors. Invest New Drugs 2009. [Epub ahead of print]
66. Paridaens R,Wildiers H, Dalenc F, Rixe O, Cadic V, Pinel M, et al. Vinflunine in combination with trastuzumab for treatment of HER2-positive metastatic breast cancer. J Clin Oncol 2007; 25 (18 Suppl):1058.
67. Bennouna J, Breton JL, Tourani JM, Ottensmeier C, O'Brien M, Kosmidis P, et al. Vinflunine - an active chemotherapy for treatment of advanced nonsmall- cell lung cancer previously treated with a platinum-based regimen: Results of a phase II study. Br J Cancer 2006; 94:1383-1388.
68. Lemarie E, Bennouna J, Grossi F, Pinel MC, Sennellart H, Longerey B, et al. Vinflunine (VFL) in combination with gemcitabine (GEM) for treatment of advanced non-small cell lung cancer (NSCLC) in chemonaive patients (pts): Preliminary results of the phase I and pharmacokinetic study. J Clin Oncol 2005; (Suppl):7266.
69. www.clinicaltrials.gov.
70. Culine S, Theodore C, De Santis M, Bui B, Demkow T, Lorenz J, et al. A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen. Br J Cancer 2006; 94:1395-1401.
71. Vaughn DJ, Srinivas S, Stadler WM, Pili R, Petrylak D, Sternberg CN, et al. Vinflunine in platinum-pretreated patients with locally advanced or metastatic urothelial carcinoma: Results of a large phase 2 study. Cancer 2009; 115:4110-4117.
72. Bellmunt J, Choueiri TK, Fougeray R, Schutz FA, Salhi Y, Winquist E, et al. Prognostic factors in patients with advanced transitional cell carcinoma of the urothelial tract experiencing treatment failure with platinum-containing regimens. J Clin Oncol 2010; 28:1850-1855.