Complete remission sustained 3 years from treatment initiation is a powerful surrogate for extended survival in multiple myeloma.
BACKGROUND
Complete response (CR) has been considered a necessary although not sufficient early clinical endpoint for extended survival in multiple myeloma.


METHODS
By using Total Therapy 2 (TT2) clinical outcome data in 668 patients, whether sustained CR (SUS-CR) was potentially a superior surrogate for survival than attaining CR status per se was evaluated.


RESULTS
Compared with not achieving CR (NON-CR) and especially achieving and subsequently losing CR status (LOS-CR) within a 3-year landmark from treatment initiation, SUS-CR was associated with highly superior postlandmark survival (P < .0001). These results were validated in 231 untreated patients enrolled in the predecessor trial, TT1 (hazard ratio [HR] = 0.54, P = .013) and in 1103 previously treated patients on other transplant protocols (HR = 0.49; P < .001).


CONCLUSIONS
In all 3 trial settings the survival benefit of SUS-CR was independent of metaphase abnormalities as a dominant adverse parameter. Given its bleak prognosis despite high CR rates, SUS-CR should be evaluated as a primary trial endpoint in high-risk myeloma.
Barlogie
Bart
B
Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, USA. barlogiebart@uams.edu
Anaissie
Elias
E
Haessler
Jeffrey
J
van Rhee
Fritz
F
Pineda-Roman
Mauricio
M
Hollmig
Klaus
K
Alsayed
Yazan
Y
Epstein
Joshua
J
Shaughnessy
John D
JD
Crowley
John
J
D000368:Aged; D006801:Humans; D009101:Multiple Myeloma / Q000453:epidemiology / Q000628:therapy*; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome