all ic-bfm 2009 - tphd · 2017-11-29 · all-ic-bfm 2009 draft report 4/2016 missing data are...

1

ALL IC-BFM 2009 Study Report 4/2016

This report is based on the data entered by

the participating groups in the common study database This report provides data on patients registered up to december, 31, 2015

Prepared by M. Zimmermann

ALL-IC-BFM 2009 Draft report 4/2016

Missing data are marked by '.'

1

Total

Eligible for study

Not eligible Eligible

N N % N %

Total

3908 123 3.1 3785 96.9Total

Group

518 3 0.6 515 99.4Chile

Argentina GATLA 1239 31 2.5 1208 97.5

Uruguay 67 . . 67 100

Argentina SAHOP 474 37 7.8 437 92.2

Hungary 249 3 1.2 246 98.8

Poland 525 36 6.9 489 93.1

Croatia 57 . . 57 100

Cuba 95 1 1.1 94 98.9

Slovakia 90 2 2.2 88 97.8

Slovenia 47 2 4.3 45 95.7

Moscow 38 . . 38 100

Serbia 344 7 2.0 337 98.0

Greece 165 1 0.6 164 99.4


2

N

Diagnosis

Total2010 2011 2012 2013 2014 2015

Total

168 379 722 944 918 654 3785Total

Group

. 59 114 119 117 106 515Chile 100

Argentina (total) 210 115 199 204 246 259 185 1208

Uruguay 30 . . 13 20 17 17 67

Argentina SAHOP . 38 96 104 111 88 437

Hungary 60 . 22 60 60 58 46 246

Poland 220 . 5 133 206 143 2 489

Croatia 30 . 1 8 14 16 18 57

Cuba 30 . . 15 22 35 22 94

Slovakia 30 1 . . 28 28 31 88

Slovenia 30 . . 11 8 12 14 45

Moscow 30 7 6 8 8 8 1 38

Serbia 60 45 49 60 62 48 73 337

Greece . . . 47 66 51 164


3

Eligible for study Not eligible

Total

Reason for ELIG=No

. I/E criteria not fulfilled

Preexisting disease/ALL is sec. mal.

Significant previous

treatment Essential

data missingWrong

diagnosis Previous disease Other

N N % N % N % N % N % N % N % N %

Total

123 32 26.0 10 8.1 3 2.4 47 38.2 8 6.5 6 4.9 2 1.6 15 12.2 Total

Group

3 . . . . . . 3 100 . . . . . . . . Chile

Argentina GATLA 31 1 3.2 5 16.1 . . 17 54.8 2 6.5 1 3.2 . . 5 16.1

Argentina SAHOP 37 1 2.7 1 2.7 2 5.4 23 62.2 2 5.4 1 2.7 2 5.4 5 13.5

Hungary 3 . . 1 33.3 . . 1 33.3 . . 1 33.3 . . . .

Poland 36 29 80.6 1 2.8 1 2.8 2 5.6 3 8.3 . . . . . .

Cuba 1 . . . . . . . . . . 1 100 . . . .

Slovakia 2 . . . . . . . . . . 2 100 . . . .

Slovenia 2 . . 2 100 . . . . . . . . . . . .

Serbia 7 . . . . . . 1 14.3 1 14.3 . . . . 5 71.4

Greece 1 1 100 . . . . . . . . . . . . . .


4

Total

Diagnosis

2010 2011 2012 2013 2014 2015

N N % N % N % N % N % N %

#

3785 168 4.4 379 10.0 722 19.1 944 24.9 918 24.3 654 17.3 Total

Group

515 . . 59 11.5 114 22.1 119 23.1 117 22.7 106 20.6 Chile

Argentina GATLA 1208 115 9.5 199 16.5 204 16.9 246 20.4 259 21.4 185 15.3

Uruguay 67 . . . . 13 19.4 20 29.9 17 25.4 17 25.4

Argentina SAHOP 437 . . 38 8.7 96 22.0 104 23.8 111 25.4 88 20.1

Hungary 246 . . 22 8.9 60 24.4 60 24.4 58 23.6 46 18.7

Poland 489 . . 5 1.0 133 27.2 206 42.1 143 29.2 2 0.4

Croatia 57 . . 1 1.8 8 14.0 14 24.6 16 28.1 18 31.6

Cuba 94 . . . . 15 16.0 22 23.4 35 37.2 22 23.4

Slovakia 88 1 1.1 . . . . 28 31.8 28 31.8 31 35.2

Slovenia 45 . . . . 11 24.4 8 17.8 12 26.7 14 31.1

Moscow 38 7 18.4 6 15.8 8 21.1 8 21.1 8 21.1 1 2.6

Serbia 337 45 13.4 49 14.5 60 17.8 62 18.4 48 14.2 73 21.7

Greece 164 . . . . . . 47 28.7 66 40.2 51 31.1


5

Total

Pharmacogenomic studies (extra toxicity sheets!)

. No Yes

N N % N % N %

#

3785 1668 44.1 1731 45.7 386 10.2Total

Group

515 1 0.2 514 99.8 . .Chile

Argentina GATLA 1208 644 53.3 542 44.9 22 1.8

Uruguay 67 54 80.6 13 19.4 . .

Argentina SAHOP 437 348 79.6 62 14.2 27 6.2

Hungary 246 . . . . 246 100

Poland 489 415 84.9 73 14.9 1 0.2

Croatia 57 28 49.1 28 49.1 1 1.8

Cuba 94 . . 94 100 . .

Slovakia 88 . . . . 88 100

Slovenia 45 17 37.8 27 60.0 1 2.2

Moscow 38 . . 38 100 . .

Serbia 337 . . 337 100 . .

Greece 164 161 98.2 3 1.8 . .


6

Total

Sex Age

Male Female Age <1 Y. Age 1-5 Y. Age 6-9 Y. Age 10-14 Y. Age 15-18 Y.

N N % N % N % N % N % N % N %

#

3785 2146 56.7 1639 43.3 39 1.0 2081 55.0 760 20.1 691 18.3 214 5.7 Total

Group

515 288 55.9 227 44.1 1 0.2 283 55.0 110 21.4 121 23.5 . . Chile

Argentina GATLA 1208 693 57.4 515 42.6 8 0.7 636 52.6 243 20.1 250 20.7 71 5.9

Uruguay 67 33 49.3 34 50.7 1 1.5 38 56.7 9 13.4 17 25.4 2 3.0

Argentina SAHOP 437 249 57.0 188 43.0 8 1.8 218 49.9 108 24.7 83 19.0 20 4.6

Hungary 246 134 54.5 112 45.5 1 0.4 137 55.7 62 25.2 29 11.8 17 6.9

Poland 489 283 57.9 206 42.1 . . 302 61.8 90 18.4 64 13.1 33 6.7

Croatia 57 25 43.9 32 56.1 . . 29 50.9 12 21.1 11 19.3 5 8.8

Cuba 94 56 59.6 38 40.4 5 5.3 46 48.9 15 16.0 17 18.1 11 11.7

Slovakia 88 52 59.1 36 40.9 2 2.3 52 59.1 15 17.0 13 14.8 6 6.8

Slovenia 45 27 60.0 18 40.0 . . 30 66.7 7 15.6 5 11.1 3 6.7

Moscow 38 13 34.2 25 65.8 . . 24 63.2 8 21.1 4 10.5 2 5.3

Serbia 337 198 58.8 139 41.2 13 3.9 183 54.3 58 17.2 48 14.2 35 10.4

Greece 164 95 57.9 69 42.1 . . 103 62.8 23 14.0 29 17.7 9 5.5


7

Total

WBC

miss. WBC < 20000 WBC 20000-

<100000 WBC 100000-

<200000 WBC >=200000

N N % N % N % N % N %

#

3785 14 0.4 2404 63.5 908 24.0 226 6.0 233 6.2Total

Group

515 . . 321 62.3 135 26.2 25 4.9 34 6.6Chile

Argentina GATLA 1208 7 0.6 785 65.0 282 23.3 73 6.0 61 5.0

Uruguay 67 1 1.5 49 73.1 14 20.9 1 1.5 2 3.0

Argentina SAHOP 437 . . 250 57.2 109 24.9 33 7.6 45 10.3

Hungary 246 2 0.8 153 62.2 61 24.8 14 5.7 16 6.5

Poland 489 1 0.2 334 68.3 102 20.9 26 5.3 26 5.3

Croatia 57 . . 39 68.4 12 21.1 1 1.8 5 8.8

Cuba 94 . . 63 67.0 21 22.3 9 9.6 1 1.1

Slovakia 88 2 2.3 57 64.8 19 21.6 5 5.7 5 5.7

Slovenia 45 . . 31 68.9 10 22.2 1 2.2 3 6.7

Moscow 38 1 2.6 25 65.8 12 31.6 . . . .

Serbia 337 . . 190 56.4 93 27.6 26 7.7 28 8.3

Greece 164 . . 107 65.2 38 23.2 12 7.3 7 4.3


8

Immunphenotype

. Non-T T-ALL

N % N % N %

#

91 2.4 3254 86.0 440 11.6Total

Group

5 1.0 463 89.9 47 9.1Chile

Argentina GATLA 16 1.3 1059 87.7 133 11.0

Uruguay 1 1.5 61 91.0 5 7.5

Argentina SAHOP . . 377 86.3 60 13.7

Hungary 7 2.8 211 85.8 28 11.4

Poland 37 7.6 397 81.2 55 11.2

Croatia 2 3.5 48 84.2 7 12.3

Cuba 18 19.1 61 64.9 15 16.0

Slovakia 1 1.1 76 86.4 11 12.5

Slovenia 1 2.2 35 77.8 9 20.0

Moscow 1 2.6 34 89.5 3 7.9

Serbia 2 0.6 285 84.6 50 14.8

Greece . . 147 89.6 17 10.4


9

Total

Cytogenetic category

. Done but without

results normal / +21 only

BCR-ABL/t(9;22)(q34;

q11)

MLL-AF4/t(4;11)(q21;q

23)

MLL-ENL/t(11;19)(q23

;p13)

N N % N % N % N % N % N %

#

3785 1031 27.2 600 15.9 843 22.3 40 1.1 20 0.5 8 0.2 Total

Group

515 30 5.8 133 25.8 112 21.7 . . . . . . Chile

Argentina GATLA 1208 217 18.0 304 25.2 394 32.6 . . 5 0.4 2 0.2

Uruguay 67 15 22.4 7 10.4 19 28.4 2 3.0 . . . .

Argentina SAHOP 437 10 2.3 68 15.6 83 19.0 16 3.7 6 1.4 3 0.7

Hungary 246 30 12.2 37 15.0 53 21.5 5 2.0 1 0.4 2 0.8

Poland 489 468 95.7 4 0.8 10 2.0 . . . . . .

Croatia 57 8 14.0 1 1.8 7 12.3 1 1.8 1 1.8 . .

Cuba 94 91 96.8 . . 1 1.1 . . . . . .

Slovakia 88 14 15.9 7 8.0 34 38.6 . . 1 1.1 . .

Slovenia 45 2 4.4 . . 11 24.4 3 6.7 . . 1 2.2

Moscow 38 6 15.8 9 23.7 17 44.7 . . . . . .

Serbia 337 135 40.1 24 7.1 38 11.3 12 3.6 6 1.8 . .

Greece 164 5 3.0 6 3.7 64 39.0 1 0.6 . . . .


10


MLL-AF9/t(9;11)(p22;q

23)

MLL other / 11q23 aberr

except (4;11),(9;11),(11;1

9) TEL-

AML1/t(12;21)

E2A-PBX1/t(1;19)(q23

;p13.3) Near Haploid (24-30 Chromosomes)

Low Hypodiploid (31-44

Chromosomes)

N % N % N % N % N % N %

#

3 0.1 10 0.3 263 6.9 73 1.9 3 0.1 25 0.7Total

Group

. . 1 0.2 72 14.0 18 3.5 . . 3 0.6Chile

Argentina GATLA 1 0.1 1 0.1 . . 17 1.4 . . 12 1.0

Uruguay . . . . 8 11.9 4 6.0 . . 1 1.5

Argentina SAHOP . . . . 60 13.7 22 5.0 . . 2 0.5

Hungary 1 0.4 4 1.6 32 13.0 1 0.4 . . 3 1.2

Poland . . 1 0.2 . . . . . . . .

Croatia . . . . 11 19.3 . . . . . .

Cuba . . . . . . . . . . 2 2.1

Slovakia . . . . 13 14.8 1 1.1 1 1.1 . .

Slovenia 1 2.2 1 2.2 16 35.6 . . . . . .

Moscow . . . . . . . . . . . .

Serbia . . . . 19 5.6 7 2.1 2 0.6 2 0.6

Greece . . 2 1.2 32 19.5 3 1.8 . . . .


11


High Hypodiploid (45

Chromosomes) Hyperdiploid (47-50 Chromosomes)

Hyperdiploid (>50

Chormosomes)

Near Triploid (69-81

Chromosomes 3n)

Near Tetraploid (82-94

Chromosomes 4n)

IGH-IL3/t(5;14)(q31;q

32)

N % N % N % N % N % N %

#

31 0.8 96 2.5 412 10.9 13 0.3 16 0.4 3 0.1Total

Group

6 1.2 19 3.7 75 14.6 3 0.6 1 0.2 . .Chile

Argentina GATLA 8 0.7 26 2.2 106 8.8 2 0.2 12 1.0 . .

Uruguay . . 6 9.0 5 7.5 . . . . . .

Argentina SAHOP 3 0.7 4 0.9 72 16.5 3 0.7 1 0.2 2 0.5

Hungary 1 0.4 9 3.7 33 13.4 1 0.4 . . . .

Poland . . . . . . . . . . . .

Croatia 3 5.3 8 14.0 13 22.8 . . . . . .

Cuba . . . . . . . . . . . .

Slovakia . . 3 3.4 13 14.8 . . . . . .

Slovenia . . . . 6 13.3 1 2.2 . . . .

Moscow 1 2.6 2 5.3 . . . . . . . .

Serbia 4 1.2 12 3.6 59 17.5 2 0.6 2 0.6 1 0.3

Greece 5 3.0 7 4.3 30 18.3 1 0.6 . . . .


12


IGH-MYC/t(8;14)(q24;

q32), t(2;8), t(8;22)

SIL-TAL1/del(1)(p32)

Non-Random aberrations

Complex (without other main

abnormality)

Random-Non recurrent

aberrations

N % N % N % N % N %

#

1 0.0 8 0.2 78 2.1 81 2.1 127 3.4Total

Group

1 0.2 . . 26 5.0 1 0.2 14 2.7Chile

Argentina GATLA . . . . 17 1.4 53 4.4 31 2.6

Uruguay . . . . . . . . . .

Argentina SAHOP . . 7 1.6 . . 4 0.9 71 16.2

Hungary . . . . 21 8.5 12 4.9 . .

Poland . . . . . . 1 0.2 5 1.0

Croatia . . . . . . 3 5.3 1 1.8

Cuba . . . . . . . . . .

Slovakia . . 1 1.1 . . . . . .

Slovenia . . . . 1 2.2 2 4.4 . .

Moscow . . . . 1 2.6 1 2.6 1 2.6

Serbia . . . . 10 3.0 1 0.3 1 0.3

Greece . . . . 2 1.2 3 1.8 3 1.8


13

Weight (kg) Height (cm) Body surface (m2)

N Q1 Q2 Q3 N Q1 Q2 Q3 N Q1 Q2 Q3

#

3670 15 20 34 3546 98.0 113.0 138.0 3716 0.6 0.8 1.1Total

Group

514 15 20 34 515 97.0 112.0 136.0 515 0.6 0.8 1.2Chile

Argentina GATLA 1197 15 20 35 1075 99.0 113.0 140.0 1200 0.6 0.8 1.2

Uruguay 67 16 18 35 67 98.0 113.0 150.0 67 0.6 0.8 1.2

Argentina SAHOP 434 15 20 31 436 97.0 112.0 133.0 434 0.6 0.8 1.2

Hungary 185 14 19 31 185 98.0 113.0 138.0 214 0.6 0.8 1.1

Poland 479 15 19 30 479 98.0 111.0 133.0 478 0.6 0.8 1.0

Croatia 55 16 21 43 56 106.0 123.5 150.0 54 0.7 0.8 1.2

Cuba 94 16 20 38 88 100.0 114.0 150.0 93 0.7 0.8 1.2

Slovakia 84 16 20 32 84 99.5 115.0 138.5 84 0.6 0.8 1.1

Slovenia 45 16 20 27 45 102.0 111.0 127.0 45 0.7 0.8 1.0

Moscow 15 17 30 48 15 104.0 125.0 160.0 31 0.6 0.7 1.0

Serbia 337 15 19 33 337 98.0 113.0 141.0 337 0.6 0.8 1.1

Greece 164 15 19 31 164 98.0 110.0 135.0 164 0.6 0.8 1.1


14

Platelets (/mikroL) Hb (g/dl) % blasts (PB)

N Q1 Q2 Q3 N Q1 Q2 Q3 N Q1 Q2 Q3

#

3771 22000 49000 105000 3746 6.5 8.1 9.9 3699 11.0 46.0 80.0Total

Group

515 22000 48000 103000 515 6.0 7.7 9.3 515 5.0 39.0 77.0Chile

Argentina GATLA 1202 20000 46000 100000 1198 6.2 7.9 9.4 1194 11.0 50.0 81.0

Uruguay 67 18000 44000 103000 67 6.4 8.2 9.6 53 20.0 59.0 88.0

Argentina SAHOP 437 21000 44000 100000 437 5.9 7.5 9.3 435 18.0 54.0 85.0

Hungary 244 28000 52300 104500 226 5.8 7.9 9.5 240 19.0 50.0 80.0

Poland 487 19000 51000 96000 486 6.9 8.5 10.2 458 10.0 47.5 77.0

Croatia 57 30000 50000 93000 57 8.3 9.5 10.7 57 10.0 33.0 78.0

Cuba 94 20000 45500 136000 94 7.3 8.9 10.5 93 9.0 33.0 60.0

Slovakia 86 24000 69000 120000 86 7.9 9.1 10.9 74 14.0 47.0 64.0

Slovenia 45 29000 73000 143000 45 8.1 9.1 10.3 45 12.0 29.0 70.0

Moscow 36 86 18500 51500 35 8.4 10.0 12.2 36 10.0 39.5 68.0

Serbia 337 27000 57000 130000 337 7.6 9.8 13.4 335 17.0 45.0 78.0

Greece 164 33500 69000 141500 163 6.6 8.3 10.4 164 7.5 38.0 75.0


15

% BM blasts at diagnosis BM blasts day 15 (%)

N Q1 Q2 Q3 N Q1 Q2 Q3

#

3685 80.0 90.0 95.0 3589 0.0 2.0 5.0Total

Group

499 86.0 95.0 98.0 515 0.0 2.0 9.0Chile

Argentina GATLA 1199 85.0 90.0 96.0 1163 0.0 1.0 4.0

Uruguay 53 71.0 85.0 91.0 50 1.0 3.0 7.0

Argentina SAHOP 435 80.0 90.0 94.0 424 1.0 3.0 6.0

Hungary 218 76.0 88.0 95.0 226 0.0 1.0 4.0

Poland 468 80.0 90.1 95.0 462 0.8 2.4 5.0

Croatia 57 66.0 87.0 95.0 45 0.0 0.0 2.0

Cuba 93 90.0 92.0 97.0 47 0.0 4.0 10.0

Slovakia 86 57.0 76.0 86.0 85 0.0 2.0 6.0

Slovenia 43 78.0 90.0 95.0 45 0.0 3.0 7.0

Moscow 35 84.0 89.0 95.0 35 0.0 1.0 7.0

Serbia 336 75.0 85.0 93.0 329 0.0 2.0 5.0

Greece 163 85.0 90.0 95.0 163 0.0 0.0 3.0


16

Total

Pred.resp.

. Good Poor

N N % N % N %

#

3785 125 3.3 3254 86.0 406 10.7Total

Group

515 . . 468 90.9 47 9.1Chile

Argentina GATLA 1208 25 2.1 1056 87.4 127 10.5

Uruguay 67 14 20.9 51 76.1 2 3.0

Argentina SAHOP 437 6 1.4 370 84.7 61 14.0

Hungary 246 22 8.9 202 82.1 22 8.9

Poland 489 34 7.0 402 82.2 53 10.8

Croatia 57 6 10.5 49 86.0 2 3.5

Cuba 94 1 1.1 80 85.1 13 13.8

Slovakia 88 8 9.1 78 88.6 2 2.3

Slovenia 45 1 2.2 37 82.2 7 15.6

Moscow 38 3 7.9 31 81.6 4 10.5

Serbia 337 5 1.5 285 84.6 47 13.9

Greece 164 . . 145 88.4 19 11.6


17

Total

BM Day 15 M2/M3 Day 33

. BM-15: 0 - 4 % BM-15: 5 - 24 % BM-15: >=25

% . No Yes

N N % N % N % N % N % N % N %

#

3785 196 5.2 2580 68.2 663 17.5 346 9.1 205 5.4 3485 92.1 95 2.5 Total

Group

515 . . 321 62.3 147 28.5 47 9.1 1 0.2 504 97.9 10 1.9 Chile

Argentina GATLA 1208 45 3.7 887 73.4 138 11.4 138 11.4 59 4.9 1112 92.1 37 3.1

Uruguay 67 17 25.4 32 47.8 13 19.4 5 7.5 11 16.4 54 80.6 2 3.0

Argentina SAHOP 437 13 3.0 285 65.2 107 24.5 32 7.3 21 4.8 408 93.4 8 1.8

Hungary 246 20 8.1 175 71.1 34 13.8 17 6.9 26 10.6 213 86.6 7 2.8

Poland 489 27 5.5 342 69.9 80 16.4 40 8.2 44 9.0 441 90.2 4 0.8

Croatia 57 12 21.1 35 61.4 8 14.0 2 3.5 7 12.3 49 86.0 1 1.8

Cuba 94 47 50.0 32 34.0 6 6.4 9 9.6 10 10.6 80 85.1 4 4.3

Slovakia 88 3 3.4 55 62.5 22 25.0 8 9.1 4 4.5 82 93.2 2 2.3

Slovenia 45 . . 28 62.2 13 28.9 4 8.9 1 2.2 42 93.3 2 4.4

Moscow 38 3 7.9 25 65.8 7 18.4 3 7.9 3 7.9 33 86.8 2 5.3

Serbia 337 8 2.4 236 70.0 63 18.7 30 8.9 15 4.5 311 92.3 11 3.3

Greece 164 1 0.6 127 77.4 25 15.2 11 6.7 3 1.8 156 95.1 5 3.0


18

Immunphenotype .

Total

Risk group 2002 calculated Risk group 2009 calculated

SR IR HR SR IR HR

N N % N % N % N % N % N %

#

91 35 38.5 46 50.5 10 11.0 5 5.5 70 76.9 16 17.6 Total

Group

5 1 20.0 3 60.0 1 20.0 . . 4 80.0 1 20.0 Chile

Argentina GATLA 16 7 43.8 8 50.0 1 6.3 3 18.8 11 68.8 2 12.5

Uruguay 1 1 100 . . . . . . 1 100 . .

Hungary 7 3 42.9 4 57.1 . . . . 7 100 . .

Poland 37 16 43.2 17 45.9 4 10.8 2 5.4 28 75.7 7 18.9

Croatia 2 . . 2 100 . . . . 1 50.0 1 50.0

Cuba 18 6 33.3 8 44.4 4 22.2 . . 14 77.8 4 22.2

Slovakia 1 . . 1 100 . . . . . . 1 100

Slovenia 1 . . 1 100 . . . . 1 100 . .

Moscow 1 . . 1 100 . . . . 1 100 . .

Serbia 2 1 50.0 1 50.0 . . . . 2 100 . .


19

Immunphenotype Non-T

Total


SR IR HR SR IR HR

N N % N % N % N % N % N %

#

3254 1152 35.4 1660 51.0 442 13.6 369 11.3 2257 69.4 628 19.3 Total

Group

463 152 32.8 266 57.5 45 9.7 20 4.3 352 76.0 91 19.7 Chile

Argentina GATLA 1059 367 34.7 543 51.3 149 14.1 134 12.7 725 68.5 200 18.9

Uruguay 61 24 39.3 31 50.8 6 9.8 2 3.3 52 85.2 7 11.5

Argentina SAHOP 377 104 27.6 211 56.0 62 16.4 39 10.3 258 68.4 80 21.2

Hungary 211 78 37.0 105 49.8 28 13.3 34 16.1 135 64.0 42 19.9

Poland 397 169 42.6 178 44.8 50 12.6 57 14.4 275 69.3 65 16.4

Croatia 48 19 39.6 26 54.2 3 6.3 9 18.8 29 60.4 10 20.8

Cuba 61 20 32.8 35 57.4 6 9.8 . . 54 88.5 7 11.5

Slovakia 76 29 38.2 41 53.9 6 7.9 11 14.5 55 72.4 10 13.2

Slovenia 35 20 57.1 7 20.0 8 22.9 9 25.7 18 51.4 8 22.9

Moscow 34 11 32.4 15 44.1 8 23.5 6 17.6 19 55.9 9 26.5

Serbia 285 97 34.0 135 47.4 53 18.6 29 10.2 182 63.9 74 26.0

Greece 147 62 42.2 67 45.6 18 12.2 19 12.9 103 70.1 25 17.0


20

Immunphenotype T-ALL

Total


SR IR HR SR IR HR

N N % N % N % N % N % N %

#

440 24 5.5 235 53.4 181 41.1 9 2.0 224 50.9 207 47.0 Total

Group

47 . . 25 53.2 22 46.8 . . 23 48.9 24 51.1 Chile

Argentina GATLA 133 6 4.5 72 54.1 55 41.4 3 2.3 72 54.1 58 43.6

Uruguay 5 1 20.0 2 40.0 2 40.0 1 20.0 2 40.0 2 40.0

Argentina SAHOP 60 3 5.0 30 50.0 27 45.0 1 1.7 26 43.3 33 55.0

Hungary 28 2 7.1 15 53.6 11 39.3 1 3.6 14 50.0 13 46.4

Poland 55 4 7.3 26 47.3 25 45.5 1 1.8 23 41.8 31 56.4

Croatia 7 . . 7 100 . . . . 7 100 . .

Cuba 15 1 6.7 7 46.7 7 46.7 . . 8 53.3 7 46.7

Slovakia 11 1 9.1 6 54.5 4 36.4 . . 6 54.5 5 45.5

Slovenia 9 2 22.2 5 55.6 2 22.2 1 11.1 6 66.7 2 22.2

Moscow 3 . . 3 100 . . . . 3 100 . .

Serbia 50 4 8.0 28 56.0 18 36.0 1 2.0 26 52.0 23 46.0

Greece 17 . . 9 52.9 8 47.1 . . 8 47.1 9 52.9


21

Total

FCM day 15 available

No Yes

N N % N %

#

3785 787 20.8 2998 79.2Total

Group

515 164 31.8 351 68.2Chile

Argentina GATLA 1208 327 27.1 881 72.9

Uruguay 67 37 55.2 30 44.8

Argentina SAHOP 437 45 10.3 392 89.7

Hungary 246 20 8.1 226 91.9

Poland 489 61 12.5 428 87.5

Croatia 57 12 21.1 45 78.9

Cuba 94 94 100 . .

Slovakia 88 5 5.7 83 94.3

Slovenia 45 2 4.4 43 95.6

Moscow 38 5 13.2 33 86.8

Serbia 337 15 4.5 322 95.5

Greece 164 . . 164 100


22

Immunphenotype .

Total

FCM day 15

FCM day 15<0.1%

FCM day 15<10%

FCM day 15>=10%

N N % N % N % #

37 11 29.7 19 51.4 7 18.9Total

Group

2 1 50.0 1 50.0 . .Chile

Argentina GATLA 8 3 37.5 4 50.0 1 12.5

Hungary 2 . . 2 100 . .

Poland 19 6 31.6 8 42.1 5 26.3

Croatia 2 1 50.0 1 50.0 . .

Slovakia 1 . . . . 1 100

Slovenia 1 . . 1 100 . .

Serbia 2 . . 2 100 . .


23

Immunphenotype Non-T

Total

FCM day 15

FCM day 15<0.1%

FCM day 15<10%

FCM day 15>=10%

N N % N % N % #

2643 872 33.0 1412 53.4 359 13.6Total

Group

340 61 17.9 213 62.6 66 19.4Chile

Argentina GATLA 784 340 43.4 337 43.0 107 13.6

Uruguay 25 6 24.0 17 68.0 2 8.0

Argentina SAHOP 339 114 33.6 183 54.0 42 12.4

Hungary 200 65 32.5 112 56.0 23 11.5

Poland 361 109 30.2 212 58.7 40 11.1

Croatia 39 14 35.9 18 46.2 7 17.9

Slovakia 72 18 25.0 47 65.3 7 9.7

Slovenia 33 13 39.4 15 45.5 5 15.2

Moscow 30 15 50.0 11 36.7 4 13.3

Serbia 273 71 26.0 162 59.3 40 14.7

Greece 147 46 31.3 85 57.8 16 10.9


24

Immunphenotype T-ALL

Total

FCM day 15

FCM day 15<0.1%

FCM day 15<10%

FCM day 15>=10%

N N % N % N % #

318 74 23.3 129 40.6 115 36.2Total

Group

9 3 33.3 . . 6 66.7Chile

Argentina GATLA 89 29 32.6 33 37.1 27 30.3

Uruguay 5 2 40.0 2 40.0 1 20.0

Argentina SAHOP 53 8 15.1 23 43.4 22 41.5

Hungary 24 2 8.3 11 45.8 11 45.8

Poland 48 11 22.9 18 37.5 19 39.6

Croatia 4 4 100 . . . .

Slovakia 10 2 20.0 6 60.0 2 20.0

Slovenia 9 4 44.4 3 33.3 2 22.2

Moscow 3 2 66.7 1 33.3 . .

Serbia 47 5 10.6 25 53.2 17 36.2

Greece 17 2 11.8 7 41.2 8 47.1


25

Total

Status

Death before CR

(initial Complic.)

Death before

CR (Toxic Death)

Nonresp. death

Nonresp. alive

LFU before

CR Relapse Death

in CCRSecond

Malignancy

LFU in

CCR CCR

N N % N % N % N % N % N % N % N % N % N %

Total

3785 50 1.3 2 0.1 8 0.2 18 0.5 2 0.1 280 7.4 124 3.3 4 0.1 44 1.2 3253 85.9Total

Group

515 2 0.4 . . 1 0.2 . . . . 77 15.0 18 3.5 1 0.2 2 0.4 414 80.4Chile

Argentina GATLA 1208 22 1.8 1 0.1 7 0.6 6 0.5 . . 92 7.6 46 3.8 1 0.1 14 1.2 1019 84.4

Uruguay 67 1 1.5 . . . . 1 1.5 . . 3 4.5 . . . . . . 62 92.5

Argentina SAHOP 437 11 2.5 . . . . 1 0.2 . . 35 8.0 29 6.6 . . 3 0.7 358 81.9

Hungary 246 4 1.6 . . . . 1 0.4 . . 14 5.7 9 3.7 1 0.4 2 0.8 215 87.4

Poland 489 . . 1 0.2 . . 3 0.6 . . 12 2.5 . . . . 4 0.8 469 95.9

Croatia 57 . . . . . . . . . . . . 1 1.8 . . . . 56 98.2

Cuba 94 6 6.4 . . . . . . . . 10 10.6 5 5.3 . . 1 1.1 72 76.6

Slovakia 88 . . . . . . 2 2.3 . . 9 10.2 2 2.3 . . . . 75 85.2

Slovenia 45 . . . . . . . . . . . . . . . . . . 45 100

Moscow 38 . . . . . . . . . . 1 2.6 . . . . 2 5.3 35 92.1

Serbia 337 4 1.2 . . . . 1 0.3 2 0.6 23 6.8 9 2.7 1 0.3 15 4.5 282 83.7

Greece 164 . . . . . . 3 1.8 . . 4 2.4 5 3.0 . . 1 0.6 151 92.1


26

Risk group 2009 calculated

SR IR HR

N % N % N %

Total 383 100 2551 100 851 100

Status

. . 30 1.2 20 2.4Death before CR (initial Complic.)

Death before CR (Toxic Death) . . 2 0.1 . .

Nonresp. death . . 1 0.0 7 0.8

Nonresp. alive . . 4 0.2 14 1.6

LFU before CR 1 0.3 1 0.0 . .

Relapse 14 3.7 171 6.7 95 11.2

Death in CCR 3 0.8 63 2.5 58 6.8

Second Malignancy . . 2 0.1 2 0.2

LFU in CCR 6 1.6 26 1.0 12 1.4

CCR 359 93.7 2251 88.2 643 75.6


27

Total

Relapse

isol. BM isol. CNS isol. Testes BM+CNS BM+Testes Other

N N % N % N % N % N % N %

#

280 166 59.3 30 10.7 21 7.5 31 11.1 18 6.4 14 5.0 Total

Group

77 41 53.2 6 7.8 8 10.4 9 11.7 11 14.3 2 2.6 Chile

Argentina GATLA 92 52 56.5 10 10.9 8 8.7 11 12.0 5 5.4 6 6.5

Uruguay 3 1 33.3 1 33.3 . . 1 33.3 . . . .

Argentina SAHOP 35 24 68.6 1 2.9 3 8.6 4 11.4 1 2.9 2 5.7

Hungary 14 6 42.9 2 14.3 2 14.3 1 7.1 1 7.1 2 14.3

Poland 12 7 58.3 2 16.7 . . 1 8.3 . . 2 16.7

Cuba 10 8 80.0 2 20.0 . . . . . . . .

Slovakia 9 7 77.8 1 11.1 . . 1 11.1 . . . .

Moscow 1 1 100 . . . . . . . . . .

Serbia 23 16 69.6 5 21.7 . . 2 8.7 . . . .

Greece 4 3 75.0 . . . . 1 25.0 . . . .

ALL-IC-BFM 2009 Draft report 4/2016 Random 1 MR+HR, no Down, Survival min. 33 days, without Poland

28

Total

Randomization 1

No Yes

N N % N %

#

2622 451 17.2 2171 82.8Total

Group

436 44 10.1 392 89.9Chile

Argentina GATLA 873 129 14.8 744 85.2

Uruguay 50 2 4.0 48 96.0

Argentina SAHOP 371 33 8.9 338 91.1

Hungary 199 19 9.5 180 90.5

Croatia 50 49 98.0 1 2.0

Cuba 63 7 11.1 56 88.9

Slovakia 73 33 45.2 40 54.8

Slovenia 34 10 29.4 24 70.6

Moscow 32 24 75.0 8 25.0

Serbia 296 63 21.3 233 78.7

Greece 145 38 26.2 107 73.8

ALL-IC-BFM 2009 Draft report 4/2016 Random 1

29

Treatment assigned 1

x y

N % N %

#

1104 50.9 1067 49.1Total

Group

193 49.2 199 50.8Chile

Argentina GATLA 382 51.3 362 48.7

Uruguay 28 58.3 20 41.7

Argentina SAHOP 172 50.9 166 49.1

Hungary 89 49.4 91 50.6

Croatia . . 1 100.0

Cuba 28 50.0 28 50.0

Slovakia 20 50.0 20 50.0

Slovenia 13 54.2 11 45.8

Moscow 6 75.0 2 25.0

Serbia 118 50.6 115 49.4

Greece 55 51.4 52 48.6


30


x y

N % N %

#

1104 100.0 1067 100.0Total

Sex

642 58.2 631 59.1Male

Female 462 41.8 436 40.9

Age

8 0.7 17 1.6Age <1 Y.

Age 1-5 Y. 503 45.6 455 42.6

Age 6-9 Y. 265 24.0 285 26.7

Age 10-14 Y. 253 22.9 255 23.9

Age 15-18 Y. 75 6.8 55 5.2

Immunphenotype

15 1.4 15 1.4.

Non-T 933 84.5 896 84.0

T-ALL 156 14.1 156 14.6

WBC

7 0.6 1 0.1miss.

WBC < 20000 612 55.4 582 54.5

WBC 20000-<100000 322 29.2 325 30.5

WBC 100000-<200000 82 7.4 74 6.9

WBC >=200000 81 7.3 85 8.0


31


x y

N % N %

#

1104 100.0 1067 100.0Total

Pred.resp.

22 2.0 22 2.1.

Good 932 84.4 909 85.2

Poor 150 13.6 136 12.7

FCM day 15

215 19.5 199 18.7.

FCM day 15<0.1% 204 18.5 205 19.2

FCM day 15<10% 511 46.3 502 47.0

FCM day 15>=10% 174 15.8 161 15.1


6 0.5 3 0.3SR

IR 795 72.0 772 72.4

HR 303 27.4 292 27.4

ALL-IC-BFM 2009 Draft report 4/2016 Random 2 MR Non-T, no Down, Survival min. 78 days, without Poland

32

Total

Randomization 2

No Yes

N N % N %

#

1846 484 26.2 1362 73.8Total

Group

323 50 15.5 273 84.5Chile

Argentina GATLA 619 174 28.1 445 71.9

Uruguay 37 4 10.8 33 89.2

Argentina SAHOP 262 39 14.9 223 85.1

Hungary 142 29 20.4 113 79.6

Croatia 15 15 100.0 . .

Cuba 42 16 38.1 26 61.9

Slovakia 56 34 60.7 22 39.3

Slovenia 23 12 52.2 11 47.8

Moscow 15 4 26.7 11 73.3

Serbia 201 69 34.3 132 65.7

Greece 111 38 34.2 73 65.8


33


x y

N % N %

#

697 51.2 665 48.8Total

Group

141 51.6 132 48.4Chile

Argentina GATLA 230 51.7 215 48.3

Uruguay 12 36.4 21 63.6

Argentina SAHOP 113 50.7 110 49.3

Hungary 57 50.4 56 49.6

Cuba 12 46.2 14 53.8

Slovakia 12 54.5 10 45.5

Slovenia 4 36.4 7 63.6

Moscow 10 90.9 1 9.1

Serbia 69 52.3 63 47.7

Greece 37 50.7 36 49.3


34


x y

N % N %

#

697 100.0 665 100.0Total

Sex

379 54.4 380 57.1Male

Female 318 45.6 285 42.9

Age

7 1.0 4 0.6Age <1 Y.

Age 1-5 Y. 326 46.8 291 43.8

Age 6-9 Y. 183 26.3 183 27.5

Age 10-14 Y. 155 22.2 145 21.8

Age 15-18 Y. 26 3.7 42 6.3

Immunphenotype

8 1.1 9 1.4.

Non-T 688 98.7 647 97.3

T-ALL 1 0.1 9 1.4

WBC

1 0.1 3 0.5miss.

WBC < 20000 451 64.7 439 66.0

WBC 20000-<100000 207 29.7 181 27.2

WBC 100000-<200000 23 3.3 30 4.5

WBC >=200000 15 2.2 12 1.8


35


x y

N % N %

#

697 100.0 665 100.0Total

Pred.resp.

9 1.3 14 2.1.

Good 686 98.4 649 97.6

Poor 2 0.3 2 0.3

FCM day 15

111 15.9 123 18.5.

FCM day 15<0.1% 160 23.0 160 24.1

FCM day 15<10% 416 59.7 374 56.2

FCM day 15>=10% 10 1.4 8 1.2


4 0.6 4 0.6SR

IR 675 96.8 648 97.4

HR 18 2.6 13 2.0

all ic-bfm 2009 - tphd · 2017-11-29 · all-ic-bfm 2009 draft report 4/2016 missing data are...

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