European Journal of Cancer
Volume 45, Issue 1 , Pages 48-55 , January 2009

An EORTC phase I study of Bortezomib in combination with oxaliplatin, leucovorin and 5-fluorouracil in patients with advanced colorectal cancer

  • F. Caponigro

      Affiliations

    • Medical Oncology B, National Tumour Institute of Naples ‘Fondazione G. Pascale’ Via M. Semmola, 80131 Naples, Italy
    • Corresponding Author InformationCorresponding author: Tel.: +39 081 5903362; fax: +39 081 5903822.
  • ,
  • D. Lacombe

      Affiliations

    • European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
  • ,
  • C. Twelves

      Affiliations

    • St. James’s Institute of Oncology, Leeds, United Kingdom
  • ,
  • J. Bauer

      Affiliations

    • Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland
  • ,
  • A.-S. Govaerts

      Affiliations

    • European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
  • ,
  • S. Marréaud

      Affiliations

    • European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium
  • ,
  • A. Milano

      Affiliations

    • Medical Oncology B, National Tumour Institute of Naples ‘Fondazione G. Pascale’ Via M. Semmola, 80131 Naples, Italy
  • ,
  • A. Anthoney

      Affiliations

    • St. James’s Institute of Oncology, Leeds, United Kingdom

Received 14 July 2008 ,Revised 4 August 2008 ,Accepted 6 August 2008.

References 

  1. De Gramont A, Figer A, Seymour M, et al. Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer. J Clin Oncol. 2000;18:2938–2947
  2. Hurwitz H, Fehrenbacher L, Novotny W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. New Engl J Med. 2004;350:2335–2342
  3. Giantonio DJ. Bevacizumab in the treatment of metastatic colorectal cancer (mCRC) in second- and third-line settings. Semin Oncol. 2006;33:15–18
  4. Cunningham D, Humblet Y, Siena S, et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. New Engl J Med. 2004;351:337–345
  5. Glickman MH, Ciechanover A. The ubiquitin-proteasome proteolytic pathway: destruction for the sake of construction. Physiol Rev. 2002;82:373–428
  6. Adams J. The proteasome structure, function, and role in the cell. Cancer Treat Rev. 2003;29:3–9
  7. Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. New Engl J Med. 2005;352:2487–2498
  8. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of Bortezomib in relapsed, refractory myeloma. New Engl J Med. 2003;348:2609–2617
  9. Jagannath S, Barlogie B, Berenson J, et al. A phase 2 study of two doses of Bortezomib in relapsed or refractory myeloma. Br J Haematol. 2004;127:165–172
  10. Milano A, Iaffaioli RV, Caponigro F. The proteasome: a worthwhile target for the treatment of solid tumours?. Eur J Cancer. 2007;43:1125–1133
  11. Iqbal S, Cole S, Yang D, et al. Phase I study of PS-341 (Bortezomib) with 5-fluorouracil/leucovorin (5-FU/LV) in advanced solid tumors: a California Cancer Consortium study. Proc Am Soc Clin Oncol. 2004;22:[Abstract 2057]
  12. Stoehlmacher J, Park DJ, Zhang W, et al. A multivariate analysis of genomic polymorphisms: prediction of clinical outcome to 5-FU/oxaliplatin combination chemotherapy in refractory colorectal cancer. Br J Cancer. 2004;91:344–354
  13. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–481
  14. Mann HB, Whitney DR. On a test of whether one of two random variables is statistically larger than the other. Ann Math Stat. 1947;18:50–60
  15. Fisher RA. Statistical methods for research workers. Edinburgh: Oliver and Boyd; 1925;
  16. Papandreou CN, Daliani DD, Nix D, et al. Phase I trial of the proteasome inhibitor Bortezomib in patients with advanced solid tumors with observations in androgen-independent prostate cancer. J Clin Oncol. 2004;11:2108–2121
  17. Dy GK, Thomas JP, Wilding G, et al. A phase I and pharmacologic trial of two schedules of the proteasome inhibitor, PS-341 (Bortezomib, Velcade), in patients with advanced cancer. Clin Cancer Res. 2005;11:3410–3416
  18. Hegewisch S, Sterneck M, Schubert U, et al. Phase I/II trial of Bortezomib in patients with unresectable hepatocellular carcinoma (HCC). Proc Am Soc Clin Oncol. 2004;22:[Abstract 4089]
  19. Messersmith WA, Baker SD, Lassiter L, et al. Phase I trial of Bortezomib in combination with docetaxel in patients with advanced solid tumors. Clin Cancer Res. 2006;12:1270–1275
  20. Shapiro CL, Ramaswamy B, Young D, et al. Phase I trial of Bortezomib (Velcade) in combination with paclitaxel in advanced solid tumor patients (pts). Proc Am Soc Clin Oncol. 2005;23:[Abstract 3104]
  21. Ryan DP, O’Neil BH, Supko JG, et al. A phase I study of Bortezomib plus irinotecan in patients with advanced solid tumors. Cancer. 2006;107:2688–2697
  22. Ryan DP, Appleman LJ, Lynch T, et al. Phase I clinical trial of Bortezomib in combination with gemcitabine in patients with advanced solid tumors. Cancer. 2006;107:2482–2489
  23. Davies M, Lara PN, Lau DH, et al. The proteasome inhibitor bortezomib in combination with gemcitabine and carboplatin in advanced non-small cell lung cancer: a California Cancer Consortium Phase I study. J Thorac Oncol. 2008;3(1):68–74
  24. Agajanian C, Dizon DS, Sabbatini P, Raizer JJ, Dupont J, Spriggs DR. Phase I trial of Bortezomib and carboplatin in recurrent ovarian or primary peritoneal cancer. J Clin Oncol. 2004;23:5943–5949
  25. Markovic S, Geyer SM, Dawkins F, et al. A phase II study of Bortezomib in the treatment of metastatic malignant melanoma. Cancer. 2005;103:2584–2589
  26. Maki RG, Kraft AS, Scheu K, et al. A Multicenter phase II study of Bortezomib in recurrent or metastatic sarcomas. Cancer. 2005;103:1431–1438
  27. Shah MH, Young D, Kindler HL, et al. Phase II Study of the proteasome inhibitor Bortezomib (PS-341) in patients with metastatic neuroendocrine tumors. Clin Cancer Res. 2004;10:6111–6118
  28. Mackay H, Hedley D, Major P, et al. A phase II trial with pharmacodynamic endpoints of the proteasome inhibitor bortezomib in patients with metastatic colorectal cancer. Clin Cancer Res. 2005;11:5526–5533
  29. Kondagunta GV, Druker B, Schwartz L, et al. Phase II trial of Bortezomib for patients with advanced renal cell carcinoma. J Clin Oncol. 2004;22:3720–3725
  30. Davis NB, Taber DA, Ansari RH, et al. Phase II trial of PS-341 in patients with renal cell cancer: A University of Chicago phase II Consortium Study. J Clin Oncol. 2004;22:111–119
  31. Brown J, Von Roenn J, O’Regan R, et al. A phase II study of the proteasome inhibitor PS-341 in patients (pts) with metastatic breast cancer (MBC). Proc Am Soc Clin Oncol. 2004;22:[Abstract 546]
  32. Yang CH, Gonzalez-Angulo AM, Reuben JM, et al. Bortezomib (VELCADE) in metastatic breast cancer: pharmacodynamics, biological effects, and prediction of clinical benefits. Ann Oncol. 2006;17:813–817
  33. Kozuch PS, Rocha-Lima CM, Dragovich T, et al. Bortezomib with or without irinotecan in relapsed or refractory colorectal cancer: results from a randomized phase II study. J Clin Oncol. 2008;26:2320–2326
  34. Alberts SR, Foster NR, Morton RF, et al. PS-341 and gemcitabine in patients with metastatic pancreatic adenocarcinoma: a North Central Cancer Treatment Group (NCCTG) randomized phase II study. Ann Oncol. 2005;16:1654–1661
  35. Fanucchi MP, Fossella FV, Belt R, et al. Randomized phase II study of Bortezomib alone and Bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006;24:5025–5033
  36. Uddin S, Ahmed M, Bavi , et al. Bortezomib (Velcade) induces p27Kip1 expression through S-phase kinase protein 2 degradation in colorectal cancer. Cancer Res. 2008;68:3379–3388
  37. Nozoe T, Rikimaru T, Mori E, Okuyama T, Takahashi I. Increase of both CEA and Ca 19–9 in sera is an independent prognostic indicator in colorectal carcinoma. J Surg Oncol. 2006;94:132–137
  38. Chen CC, Yang SH, Lin JK, et al. Is it reasonable to add preoperative serum level of CEA and CA 19–9 to staging for colorectal cancer?. J Surg Res. 2005;124:169–174
  39. Orlowski RZ. The ubiquitin proteasome pathway from bench to bedside. Hematol Am Soc Hematol Educ Progr; 2005:220–5.
  40. Cusack J, Wang F, Sloss C, Lu R, Xia L. EGFR activation and ERK signalling is triggered by proteasome inhibitors: implication for combining proteasome inhibitors with EGFR inhibitors. Eur J Cancer. 2006;4:[Abstract 179]
  41. Cascone T, Morelli MP, Morgillo F, et al. Synergistic anti-proliferative and pro-apoptotic activity of combined therapy with bortezomib, a proteasome inhibitor, with anti-epidermal growth factor receptor (EGFR) drugs in human cancer cells. J Cell Physiol. 2008;216:698–707

PII: S0959-8049(08)00640-0

doi: 10.1016/j.ejca.2008.08.011

European Journal of Cancer
Volume 45, Issue 1 , Pages 48-55 , January 2009