title: Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial.
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.
authors: Dana-Farber Cancer Institute, Boston, MA 02115, USA. paul_richardson@dfci.harvard.edu
authors: Paul G
authors: PG
authors: Richardson
authors: Pieter
authors: P
authors: Sonneveld
authors: Michael
authors: M
authors: Schuster
authors: David
authors: D
authors: Irwin
authors: Edward
authors: E
authors: Stadtmauer
authors: Thierry
authors: T
authors: Facon
authors: Jean-Luc
authors: JL
authors: Harousseau
authors: Dina
authors: D
authors: Ben-Yehuda
authors: Sagar
authors: S
authors: Lonial
authors: Hartmut
authors: H
authors: Goldschmidt
authors: Donna
authors: D
authors: Reece
authors: Jesus San
authors: JS
authors: Miguel
authors: Joan
authors: J
authors: Bladé
authors: Mario
authors: M
authors: Boccadoro
authors: Jamie
authors: J
authors: Cavenagh
authors: Melissa
authors: M
authors: Alsina
authors: S Vincent
authors: SV
authors: Rajkumar
authors: Martha
authors: M
authors: Lacy
authors: Andrzej
authors: A
authors: Jakubowiak
authors: William
authors: W
authors: Dalton
authors: Anthony
authors: A
authors: Boral
authors: Dixie-Lee
authors: DL
authors: Esseltine
authors: David
authors: D
authors: Schenkein
authors: Kenneth C
authors: KC
authors: Anderson
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001897:Boronic Acids / Q000009:adverse effects / Q000627:therapeutic use*; D000069286:Bortezomib; D003907:Dexamethasone / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000401:mortality; D011719:Pyrazines / Q000009:adverse effects / Q000627:therapeutic use*; D012008:Recurrence; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib; D003907:Dexamethasone