Page 182 - 2019_05-HaematologicaMondo-web

H.M. Blommestein et al.
Table 1. Data extraction of the included trials.
Trial reference Trial ID
NCT number
Facon 2006
IFM 95/01 n/r
Facon 2007
IFM 99–06 NCT00367185
Morgan 2013
MRCMIX
ISRCTN68454111 Rajkumar 2008
MM-003 NCT00057564
Ludwig 2009
NCT00205751
Palumbo 2008
GIMEMA NCT00232934
Hulin 2009
IFM 01/01 Trial
n/r
Waage 2010
NMSG NCT00218855 Beksac 2010
TMSG
Primary outcome
OS
OS
PFS, OS
TTP
Randomized / enrolled patients
500
447
856
470
289
331
232
363
122
344
135
Treatment Median N Median age research itt PFS
HRs (95% CI) {research vs. comparator treatment}
0.75 (0.62-0.91) {MP vs. D} 0.66 (0.53-0.81) {MD vs. D} 0.92 (0.76-1.11) {DI vs. D} 0.59 (0.44-0.78) {MPT vs. M100}
0.51 (0.39-0.66) {MPT vs. MP}
0.87 (0.68-1.1) {M100 vs. MP} 0.81 (0.69-0.94) {CTD(a) vs. MP}
0.5 (0.38-0.64) {TD vs. D}
1.3 (0.95-1.78)
{TD vs. MP}
0.63 (0.48-0.81) {MPT vs. MP}
0.61 (0.46-0.82)
{MPT vs. MP}
0.89 (0.7-1.13) {MPT vs. MP}
0.7 (0.42-1.17)
{MPT vs. MP}
0.79 (0.62-1) {MPT vs. MP}
0.67 (0.38-1.18)
{MPT vs. MP} 22
n/r
0.89 (0.48-1.64) {MPT vs. CTD} 1.1 (0.53-2.31) {TD vs. CTD} 0.73 (0.34-1.59)
Median Median OS follow up
33.4 82.8
1.15 (0.93-1.42) 34 82.8 {MP vs. MD}
1.45 (1.17-1.79) 39.6 82.8 {DI vs MD}
1.26 (1.04-1.53) 32 82.8
D
MP MD DI
MPT
MP
M100
MP
CTDa
TD D
TD
MP
MPT-T MP
MPT
MP
MPT-T MP MPT
MP MPT-T
MP
MPT
treatment years 95% CI (range)
70 127 12.2
(67-73) (10.2-14.2)
70 122 21.1 (68-72) (17.8-24.4) 69 118 22.9 (68-72) (19.0-26.8)
69 121 15.2
(67-72) (9.9-20.5) n/r 125 27.5 (65-751) (23.4-31.6)
n/r 196 17.8 (65-752) (15.1-20.5)
n/r 126 19.4 (65-753) (17.4-21.4)
73 423 12
(57-89) n/r 73 426 13 (58-87) n/r
64 235 14.9 (39-86) n/r 64 235 6.5 (31-84) n/r
72 145 16.7
(54-86) n/r 72 144 20.7 (55-86) n/r 72 167 21.8
(19.6-26.1)
72 164 14.5 (12.2-17)
79 115 24.1
(75-89) (19.4-29) 117 18.5
(14.6-21.3) 75 184 15
(12-19) 74 179 14
(11-18)
69 60 n/r
72 62 n/r
72 171 15 (65-87) n/r 73 173 11 (65-84) n/r 76 70 33 (66–89) n/r MP 79 65
{DI vs. MP}
PFS, tolerance
RR, PFS
OS
OS
Treatment
response, toxicities
EFS
n/r
n/r
51.6 51.5
33.2 51.5
38.3 51.5
32 70.8
34 70.8
NR 17 30 18
41.5 28.1
49.4 28.1
45 38.4 47.6 37.7
44 47.5
29.1 47.5
29 42 32 42 26 35
28 23 40 39
31 39
52 30
32 30
32.4 37.5
54.6 37.5
42 37.5
NCT00934154 Wijermans 2010
HOVON-49 ISRCTN90692740 Sacchi 2011
(68–88) Hungria2016 ORR 82 CTD 70 32 25.9 n/r NCT01532856 TD 72 18 21.5
n/r MPT 72 32 38.5
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