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 Bladé, Mario Boccadoro, Jamie Cavenagh, Melissa Alsina, S. Vincent Rajkumar, Martha Lacy, Andrzej Jakubowiak, William DaltonAnthony Boral, Dixie Lee Esseltine, David Schenkein, Kenneth C. Anderson

Research output: Contribution to journalArticle

438 Scopus citations

Abstract

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).

Original languageEnglish (US)
Pages (from-to)3557-3560
Number of pages4
JournalBlood
Volume110
Issue number10
DOIs
StatePublished - Nov 15 2007

ASJC Scopus subject areas

  • Biochemistry
  • Immunology
  • Hematology
  • Cell Biology

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    Richardson, P. G., Sonneveld, P., Schuster, M., Irwin, D., Stadtmauer, E., Facon, T., Harousseau, J. L., Ben-Yehuda, D., Lonial, S., Goldschmidt, H., Reece, D., San Miguel, J., Bladé, J., Boccadoro, M., Cavenagh, J., Alsina, M., Rajkumar, S. V., Lacy, M., Jakubowiak, A., ... Anderson, K. C. (2007). Extended follow-up of a phase 3 trial in relapsed multiple myeloma: Final time-to-event results of the APEX trial. Blood, 110(10), 3557-3560. https://doi.org/10.1182/blood-2006-08-036947