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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 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 Citation Map 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. Related Collections Neoplasia Brief Reports Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  CLINICAL TRIALS AND OBSERVATIONS Brief Report Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial Paul G. Richardson1, Pieter Sonneveld2, Michael Schuster3, David Irwin4, Edward Stadtmauer5, Thierry Facon6, Jean-Luc Harousseau7, Dina Ben-Yehuda8, Sagar Lonial9, Hartmut Goldschmidt10, Donna Reece11, Jesus San Miguel12, Joan Bladé13, Mario Boccadoro14, Jamie Cavenagh15, Melissa Alsina16, S. Vincent Rajkumar17, Martha Lacy17, Andrzej Jakubowiak18, William Dalton16, Anthony Boral19, Dixie-Lee Esseltine19, David Schenkein20, and Kenneth C. Anderson1 1 Dana-Farber Cancer Institute, Boston, MA; 2 University Hospital Rotterdam, Rotterdam, The Netherlands; 3 New York-Presbyterian Hospital, New York City; 4 Alta Bates Cancer Center, Berkeley, CA; 5 University of Pennsylvania Cancer Center, Philadelphia; 6 Hospital Claude Huriez, Lille, France; 7 Hotel Dieu, Centre Hospitalier Universitaire de Nantes, Nantes, France; 8 Hadassah University Hospital, Jerusalem, Israel; 9 Emory University, Atlanta, GA; 10 University of Heidelberg, Heidelberg, Germany; 11 Princess Margaret Hospital, Toronto, ON; 12 Hospital University of Salamanca, Salamanca, Spain; 13 University of Barcelona, Barcelona, Spain; 14 University of Torino, Torino, Italy; 15 St Bartholomew's Hospital, London, United Kingdom; 16 H. Lee Moffitt Cancer Center, Tampa, FL; 17 Mayo Clinic, Rochester, MN; 18 University of Michigan Comprehensive Cancer Center, Ann Arbor; 19 Millennium Pharmaceuticals, Cambridge, MA; and 20 Genentech, San Francisco, CA 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 versus 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 versus 23.7 months for dexamethasone, a 6-month benefit, despite substantial crossover from dexamethasone to bortezomib. Overall and 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 [ClinicalTrials.gov] ). CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: 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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