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2015 ; 126
(11
): 1294-301
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gab.com Text
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English Wikipedia
Melphalan, prednisone, and thalidomide vs melphalan, prednisone, and lenalidomide
(ECOG E1A06) in untreated multiple myeloma
#MMPMID26157076
Stewart AK
; Jacobus S
; Fonseca R
; Weiss M
; Callander NS
; Chanan-Khan AA
; Rajkumar SV
Blood
2015[Sep]; 126
(11
): 1294-301
PMID26157076
show ga
This phase 3 trial (Eastern Cooperative Oncology Group [ECOG] E1A06) compared
melphalan, prednisone, and thalidomide (MPT-T) with melphalan, prednisone, and
lenalidomide (mPR-R) in patients with untreated multiple myeloma (MM). A
noninferiority design was used, and inferiority was defined as a progression-free
survival (PFS) hazard ratio (HR) of MPT-T/mPR-R ?0.82. A total of 306 patients
enrolled, with a median age of 75.7 years. Median follow-up was 40.7 months.
Median time on therapy was 12.1 months and 23.1 months for the 46.6% of treated
patients who received maintenance, with no differences by arm. Median PFS was 21
months on MPT-T and 18.7 months on mPR-R (HR, 0.84; 95% confidence interval,
0.64-1.09). Overall survival was 52.6 months (MPT-T) vs 47.7 months (mPR-R) (P =
.476). Per-protocol response rates were 63.6% (MPT-T) and 59.9% (mPR-R) (P =
.557). Grade ?3 nonhematologic toxicity was 59.5% for MPT-T vs 40.0% for mPR-R (P
= .001). Second malignancies were observed in 18 MPT-T patients vs 14 mPR-R
patients. Quality-of-life analysis favored mPR-R by induction end (P = .007). Use
of MPT-T or mPR-R in elderly patients with untreated MM demonstrates no
statistical or clinically relevant differences in response rates, PFS, and OS;
however, quality of life at end of induction was improved and lower toxicity
reported with mPR-R. This trial was registered at www.clinicaltrials.gov as
#NCT00602641.