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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.
 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]
).
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