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Blood, 15 November 2007, Vol. 110, No. 10, pp. 3557-3560. Prepublished online as a Blood First Edition Paper on August 9, 2007; DOI 10.1182/blood-2006-08-036947. This Article Full Text (PDF) Supplemental Appendices All Versions of this Article: blood-2006-08-036947v1 110/10/3557    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Richardson, P. G. Articles by Anderson, K. C Search for Related Content PubMed PubMed Citation Articles by Richardson, P. G. Articles by Anderson, K. C Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted August 2, 2006 Accepted June 20, 2007 Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial Paul G. Richardson*, Pieter Sonneveld, Michael Schuster, David Irwin, Edward Stadtmauer, Thierry Facon, Jean-Luc Harousseau, Dina Ben-Yehuda, Sagar Lonial, Hartmut Goldschmidt, Donna Reece, Jesus San Miguel, Joan Blade, Mario Boccadoro, Jamie Cavenagh, Melissa Alsina, S Vincent Rajkumar, Martha Lacy, Andrzej Jakubowiak, William Dalton, Anthony Boral, Dixie-Lee Esseltine, David Schenkein, and Kenneth C Anderson Dana-Farber Cancer Institute, Boston, MA, United States University Hospital Rotterdam, Rotterdam, Netherlands NY-Presbyterian Hospital, New York, NY, United States Alta Bates Cancer Center, Berkeley, CA, United States University PA Cancer Center, Philadelphia, PA, United States Hosp Claude Huriez, Lille, France Hotel Dieu, CHU de Nantes, Nantes, France Hadassah University Hospital, Jerusalem, Israel Emory University School of Medicine, Atlanta, GA, United States University Heidelberg, Heidelberg, Germany Princess Margaret Hospital, Toronto, Canada Hospital Univ Salamanca, Salamanca, Spain University of Barcelona, Barcelona, Spain University of Torino, Torino, Italy St. Bartholomew's Hospital, London, United Kingdom H. Lee Moffitt Cancer Center, Tampa, FL, United States Mayo Clinic, Rochester, MN, United States University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, United States Millennium Pharmaceuticals, Inc., Cambridge, MA, United States Genentech, Inc., San Francisco, CA, United States * Corresponding author; email: paul_richardson{at}dfci.harvard.edu. Initial analysis of the Assessment of Proteasome Inhibition for Extending Remissions (APEX) trial of relapsed multiple myeloma patients showed significantly longer time to progression, higher response rate, and improved survival with single-agent bortezomib vs high-dose dexamethasone. In this updated analysis (median follow-up: 22 months) survival was assessed in both arms, and efficacy updated for the bortezomib arm. Median survival was 29.8 months for bortezomib vs 23.7 months for dexamethasone, a 6-month benefit, despite substantial crossover from dexamethasone to bortezomib. Overall/complete response rates with bortezomib were 43% and 9%, respectively; among responding patients, 56% improved response with longer therapy beyond initial response, leading to continued improvement in overall quality of response. Higher response quality (100% M-protein reduction) was associated with longer response duration; response duration was not associated with time to response. These data confirm the activity of bortezomib and support extended treatment in relapsed multiple myeloma patients tolerating therapy. This study is registered at http://clinicaltrials.gov (Study ID NCT00048230). CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: P. G. Richardson, E. Weller, S. Jagannath, D. E. Avigan, M. Alsina, R. L. Schlossman, A. Mazumder, N. C. Munshi, I. M. Ghobrial, D. Doss, et al. Multicenter, Phase I, Dose-Escalation Trial of Lenalidomide Plus Bortezomib for Relapsed and Relapsed/Refractory Multiple Myeloma J. Clin. Oncol., December 1, 2009; 27(34): 5713 - 5719. [Abstract] [Full Text] [PDF] J.-L. Harousseau, H. Avet-Loiseau, M. Attal, C. Charbonnel, F. Garban, C. Hulin, M. Michallet, T. Facon, L. Garderet, G. Marit, et al. Achievement of at Least Very Good Partial Response Is a Simple and Robust Prognostic Factor in Patients With Multiple Myeloma Treated With High-Dose Therapy: Long-Term Analysis of the IFM 99-02 and 99-04 Trials J. Clin. Oncol., December 1, 2009; 27(34): 5720 - 5726. [Abstract] [Full Text] [PDF] D. E. Reece, V. Sanchorawala, U. Hegenbart, G. Merlini, G. Palladini, J.-P. Fermand, R. A. Vescio, X. Liu, Y. A. Elsayed, A. Cakana, et al. Weekly and twice-weekly bortezomib in patients with systemic AL amyloidosis: results of a phase 1 dose-escalation study Blood, August 20, 2009; 114(8): 1489 - 1497. [Abstract] [Full Text] [PDF] P. Richardson, S. Jagannath, M. Hussein, J. Berenson, S. Singhal, D. Irwin, S. F. Williams, W. Bensinger, A. Z. Badros, R. Vescio, et al. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma Blood, July 23, 2009; 114(4): 772 - 778. [Abstract] [Full Text] [PDF] P. G. Richardson, W. Xie, C. Mitsiades, A. A. Chanan-Khan, S. Lonial, H. Hassoun, D. E. Avigan, A. L. Oaklander, D. J. Kuter, P. Y. Wen, et al. Single-Agent Bortezomib in Previously Untreated Multiple Myeloma: Efficacy, Characterization of Peripheral Neuropathy, and Molecular Correlations With Response and Neuropathy J. Clin. Oncol., July 20, 2009; 27(21): 3518 - 3525. [Abstract] [Full Text] [PDF] T.-M. Yang, D. Barbone, D. A. Fennell, and V. C. Broaddus Bcl-2 Family Proteins Contribute to Apoptotic Resistance in Lung Cancer Multicellular Spheroids Am. J. Respir. Cell Mol. Biol., July 1, 2009; 41(1): 14 - 23. [Abstract] [Full Text] [PDF] J. Loeffler-Ragg, D. Mueller, G. Gamerith, T. Auer, S. Skvortsov, B. Sarg, I. Skvortsova, K. J. Schmitz, H.-J. Martin, J. Krugmann, et al. Proteomic identification of aldo-keto reductase AKR1B10 induction after treatment of colorectal cancer cells with the proteasome inhibitor bortezomib Mol. Cancer Ther., July 1, 2009; 8(7): 1995 - 2006. [Abstract] [Full Text] [PDF] D. J. Kuhn, S. A. Hunsucker, Q. Chen, P. M. Voorhees, M. Orlowski, and R. Z. Orlowski Targeted inhibition of the immunoproteasome is a potent strategy against models of multiple myeloma that overcomes resistance to conventional drugs and nonspecific proteasome inhibitors Blood, May 7, 2009; 113(19): 4667 - 4676. [Abstract] [Full Text] [PDF] S. Knop, C. Gerecke, P. Liebisch, M. S. Topp, U. Platzbecker, O. Sezer, C. Vollmuth, K. Falk, A. Glasmacher, U. Maeder, et al. Lenalidomide, adriamycin, and dexamethasone (RAD) in patients with relapsed and refractory multiple myeloma: a report from the German Myeloma Study Group DSMM (Deutsche Studiengruppe Multiples Myelom) Blood, April 30, 2009; 113(18): 4137 - 4143. [Abstract] [Full Text] [PDF] G. Bianchi, L. Oliva, P. Cascio, N. Pengo, F. Fontana, F. Cerruti, A. Orsi, E. Pasqualetto, A. Mezghrani, V. Calbi, et al. The proteasome load versus capacity balance determines apoptotic sensitivity of multiple myeloma cells to proteasome inhibition Blood, March 26, 2009; 113(13): 3040 - 3049. [Abstract] [Full Text] [PDF] J. Blade and L. Rosinol Changing paradigms in the treatment of multiple myeloma Haematologica, February 1, 2009; 94(2): 163 - 166. [Full Text] [PDF] J. R. Berenson, O. Yellin, R. Patel, H. Duvivier, Y. Nassir, R. Mapes, C. D. Abaya, and R. A. Swift A Phase I Study of Samarium Lexidronam/Bortezomib Combination Therapy for the Treatment of Relapsed or Refractory Multiple Myeloma Clin. Cancer Res., February 1, 2009; 15(3): 1069 - 1075. [Abstract] [Full Text] [PDF] H. Brenner, A. Gondos, and D. Pulte Expected long-term survival of patients diagnosed with multiple myeloma in 2006-2010 Haematologica, February 1, 2009; 94(2): 270 - 275. [Abstract] [Full Text] [PDF] P. G. Richardson, C. Mitsiades, J. Laubach, D. Chauhan, T. Hideshima, and K. Anderson Realizing the Anticancer Potential of Proteasome Inhibition: The Clinical Development of Bortezomib and Second-generation Proteasome Inhibitors ASCO Educational Book, January 1, 2009; 2009(1): 163 - 170. [Abstract] [Full Text] [PDF] P. Moreau, V. Coiteux, C. Hulin, X. Leleu, H. van de Velde, M. Acharya, and J.-L. Harousseau Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma Haematologica, December 1, 2008; 93(12): 1908 - 1911. [Abstract] [Full Text] [PDF] A. Chanan-Khan, P. Sonneveld, M. W. Schuster, E. A. Stadtmauer, T. Facon, J.-L. Harousseau, D. Ben-Yehuda, S. Lonial, H. Goldschmidt, D. Reece, et al. Analysis of Herpes Zoster Events Among Bortezomib-Treated Patients in the Phase III APEX Study J. Clin. Oncol., October 10, 2008; 26(29): 4784 - 4790. [Abstract] [Full Text] [PDF] J. F. San Miguel, R. Schlag, N. K. Khuageva, M. A. Dimopoulos, O. Shpilberg, M. Kropff, I. Spicka, M. T. Petrucci, A. Palumbo, O. S. Samoilova, et al. Bortezomib plus Melphalan and Prednisone for Initial Treatment of Multiple Myeloma N. Engl. J. Med., August 28, 2008; 359(9): 906 - 917. [Abstract] [Full Text] [PDF] R. Z. Orlowski and D. J. Kuhn Proteasome Inhibitors in Cancer Therapy: Lessons from the First Decade Clin. Cancer Res., March 15, 2008; 14(6): 1649 - 1657. [Abstract] [Full Text] [PDF]

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