Table I.
Trial | Year | Ref | CNS-directed therapy |
---|---|---|---|
A: TIT versus IT therapy | |||
*CCG-1952 | 1996 | 11 | DITa × 1 + IT MTX × 1 R: TITa × 14 (f) or 18 (m) v IT MTX × 14 (f) or 18 (m) |
B: Radiotherapy plus IT therapy versus extra IT therapy | |||
a Radiotherapy v IT therapy | |||
CCG-161 | 1978 | 12 | IT MTX × 6 R: 18 Gy CRT v IT MTX × 8 |
CCG-105 | 1983 | 13 | IT MTX × 6 R: 18 Gy CRT v IT MTX × 8 (f) or 14 (m) |
INEN-P83 | 1983 | IT MTX × 5 R: 18 Gy CRT v IT MTX × 12 | |
CCG-1882 | 1989 | 14 | IT MTX × 14 (f) or 18 (m) + IT AraC × 1 R: 18 Gy CRT v IT MTX × 7 |
b Radiotherapy (+ IT) v DIT or TIT therapy | |||
†SWOG 7623/AlinC12 | 1976 | 15 | R: 24 Gy CRT + IT MTX × 5 v TITa × 22 |
LAL 7/78 | 1978 | 16 | R: 24 Gy CRT + IT MTX × 6 v DITa × 10 |
INS 84 | 1984 | 17 | TITa × 6 R: 18Gy CRT v TITa × 12 |
INEN-P85 | 1985 | R: 18 Gy CRT + IT MTX × 5 v TITa × 17 | |
c Radiotherapy + DIT v TIT therapy | |||
*DFCI ALL 95-001 | 1996 | 18 | IT AraC × 1 + TITa × 2 R: 18Gy CRT + DITa × 6 v TITa × 12 |
C: Addition of IV methotrexate to long-term IT therapy or radiotherapy with IT therapy | |||
a TIT therapy +/- IV methotrexate | |||
SJCRH Total XIIIA | 1991 | 19 | TITa × 13 or 17 + 2 g/m2IV MTX × 9 or 10 R: ± 1 g/m2 IV MTX × 1 |
*POG 9005 | 1991 | 20 | 1 g/m2 IV mp × 17–19 + TITA × 16 R: ± 1 g/m2 IV MTX × 12 |
FRALLE 93 LR | 1993 | 21 | TITc × 16 R: ± 1·5 g/m2 IV MTX × 6 |
FRALLE 93 IR | 1993 | 21 | TITc × 18 R: ± 8 g/m2 IV MTX × 4 |
*SJCRH Total XIIIB | 1994 | 22 | 1 g/m2 IV mp + TITa × 13 or 15 + 2 g/m2 IV MTX × 10 R: ± 1 g/m2 IV MTX × 1 |
b IT therapy +/- IV methotrexate | |||
CCG-139 | 1984 | 23 | IT MTX × 15 (f) or 20 (m) R: ± 0·5 g/m2 IV MTX × 24 (f) or 33 (m) |
DFCI 87001 | 1987 | 24 | IT AraC × 1 + IT MTX × 10 (HR: + 18 Gy CRT) R: ± 4 g/m2 IV MTX × 1 |
UKALLXI LWCC | 1990 | 25 | IT MTX × 16 R: ± 6–8 g/m2 IV MTX × 3 |
c Radiotherapy with IT therapy +/- IV methotrexate | |||
DFCI 81001 | 1981 | 26 | 18 or 28 Gy CSCRT + IT AraC × 1 + IT MTX × 8 R: ± 4 g/m2IV MTX × 1 |
*POG 9404 | 1994 | 27 | TITa × 11 + 18 Gy CRT R: ± 5 g/m2 IV MTX × 4 |
D: IV methotrexate + IT therapy v TIT | |||
*POG8035/8036 | 1981 | 28 | TITa × 6 R: 1 g/m2 IV MTX × 17 + IT MTX × 4 v TITa × 17 |
E: Addition of IT therapy to radiotherapy plus short-term IT therapy | |||
†CALGB-7113 | 1971 | 29 | 24 Gy CRT + IT MTX × 12 R: ± IT MTX × 3 |
CCG-162 | 1978 | 30 | 18 Gy CRT + IT MTX × 6 R: ± IT MTX × 8 |
UKALLVII | 1979 | 31 | 18 or 24 Gy CRT + IT MTX × 5 R: ± IT MTX × 8 |
F: Radiotherapy plus IT therapy v IV methotrexate plus IT therapy | |||
CLB 7611 | 1976 | 32 | IT MTX × 6 R: 24 Gy CRT v 0·5 g/m2 IV MTX × 3 |
†NCI 77-02 | 1980 | 33 | R: 18–24 Gy CRT + IT MTX × 5 v 33·6 g/m2 IV MTX × 10 |
ALL-BFM-81 | 1981 | 34 | IT MTX × 6 R: 12–18 Gy CRT v 0·5 g/m2 IV MTX × 4 |
Jena ALL VII 81 | 1981 | 35 | IT MTX × 8 R: 18 Gy CRT v 0·5 g/m2 IV MTX × 4 |
JCCLSG L-874 | 1987 | 36 | DITb × 3 R: 18 Gy CRT v 2 g/m2 IV MTX × 3 + DITb × 6 |
JCCLSG I-874 | 1987 | 36 | (2 g/m2 × 1 + 4·5 g/m2 × 20) IV MTX + DITb × 1 R: 18 Gy CRT + DITb × 2 v 4·5 g/m2 IV MTX × 3 |
GCMTLA | 1988 | 37 | TITb × 6 R: 12–18 Gy CRT v 0·5 g/m2 IV MTX × 4 + TITb × 6 |
†TCCSG L89-12 | 1989 | 38 | TITa × 4 + DITa × 3 R: 18 Gy CRT v 3 g/m2 IV MTX |
UKALLXI HWCC | 1990 | 25 | IT MTX × 7 or 9 R: 24 Gy CRT v 6–8 g/m2 IV MTX × 3 + IT MTX × 8 or 9 |
†TCCSG L92-13 HR | 1992 | 38 | DITb × 4 + TITa × 3 R: 18 Gy CRT + DITb × 1 v 3 g/m2 IV MTX × 2 |
*MRC ALL97 | 1997 | 39 | IT MTX × 7 or 9 R: 24 Gy CRT v 6–8 g/m2 IV MTX × 3 + IT MTX × 8 or 9 |
G: Higher dose of IV methotrexate | |||
*POG 9405 | 1994 | 40 | TITa × 22 R: 2·5 g/m2 IV MTX × 12 v 1 g/m2 IV MTX × 12 |
*POG 9406 | 1994 | 40 | TITa × 18 + 1 g/m2 IV mp × 6 R: 2·5 g/m2 IV MTX × 6 v 1 g/m2 IV MTX × 6 |
H: Higher doses of radiotherapy | |||
UKALL V | 1976 | 41 | IT MTX × 5 R: 24 Gy v 21 Gy CRT |
UKALLVI(i) | 1978 | 42 | IT MTX × 8 or IT MTX × 6 + IT AraC × 2 + 0·5 g/m2 IV MTX × 3 R: 24 Gy v 21 Gy CRT |
UKALLVI(ii) | 1978 | 42 | IT MTX × 8 or IT MTX × 6 + IT AraC × 2 + 0·5 g/m2 IV MTX × 3 R: 24 Gy v 18 Gy CRT |
UKALLVII | 1979 | 31 | IT MTX × 5 R: 24 Gy v 18 Gy CRT |
GBTLI-80 | 1980 | 43 | IT MTX × 13 R: 24 Gy v 18 Gy CRT |
TCCSG L81-10 | 1981 | 44 | DITa × 5 R: 24 Gy v 18 Gy CRT |
ALL-BFM-83 | 1983 | 34 | IT MTX × 8 + 0·5 g/m2 IV MTX × 4 R: 18 Gy v 12 Gy CRT |
I: Addition of radiotherapy | |||
a Addition to IT | |||
†POG CNS2 | 1970 | 45 | IT MTX × 20 R: ± 24 Gy CRT |
†CLB 7111 | 1971 | 46 | IT MTX × 6 R: ± 24 Gy CRT |
†SWOG 690/691/Alinc9 | 1971 | 47 | TITa × 10 R: ± 18–24 Gy CRT |
†DFCI-SFCC | 1972 | 48 | IT MTX × 9 R: ± 24 Gy CRT |
†CLB 7411 | 1974 | 49 | IT MTX × 6 R: ± 24 Gy CRT |
CCG-101 | 1974 | 50 | IT MTX × 6 R: ± 24 Gy CRT |
*CCG-123 | 1983 | 51 | IT AraC × 1 + IT MTX × 6 R: ± 18Gy CRT |
b Addition to IV with IT | |||
EORTC 58832 | 1983 | 52 | 2·5 g/m2 IV MTX × 4 + IT MTX × 7 R: ± 16–20 Gy CRT |
J: Higher dose of IV methotrexate v more IT or DIT therapy | |||
FRALLE 87 | 1987 | 53 | DITc × 5 R: 8 g/m2 IV MTX × 4 v 3 g/m2 IV MTX × 4 + DITc × 5 |
FRALLE 89 | 1989 | 21 | IT MTX × 5 R: 8 g/m2IV MTX × 4 v 3 g/m2IV MTX × 4 + IT MTX × 5 |
K: Addition of IV methotrexate plus IT, DIT or TIT therapy to radiotherapy plus IT or TIT therapy and/or IV methotrexate | |||
Jena ALLVII 81 | 1981 | 35 | 12 or 18 Gy CRT + IT MTX × 8 R: ± 0·5 g/m2 IV MTX × 4 + IT MTX × 4 |
TCCSG L84-11 SR | 1984 | 38 | 18 Gy CRT + TITa × 5 + 0·5 g/m2 IV MTX × 4 + IT MTX × 4 R: ± 0·5 g/m2 IV MTX × 3 + DITb × 6 |
TCCSG L84-11 HR | 1984 | 38 | 24 Gy CRT + TITa × 5 + 0·5g/m2 IV MTX × 12 + DITb × 12 R: ± 0·5 g/m2 IV MTX × 3 + TITa × 6 |
Other comparisons without data | |||
†ALGB 6801 | 1968 | 54 | R: IT MTX × 15 |
†GATLA-70 | 1970 | 55 | R: ± 24 Gy CRT + IT MTX × 5 |
†NCI 72-1 | 1971 | 56 | 24 Gy CRT R: IT AraC × 38 v IT MTX × 35 |
†NCI-84-C-153A | 1984 | R: 33·6 g/m2 IV MTX × 10 v IT MTX × 8 |
Data not available;
Not in previous paper; AraC, cytosine arabinoside; CRT, cranial irradiation; CSCRT, craniospinal irradiation; DITa, IT MTX + IT AraC; DITb, IT MTX + IT Hc; DITc, IT MTX + IT P; Dx, dexamethasone; f, female; Hc, hydrocortisone; IT, intrathecal; m, male; mp, mercaptopurine; MTX, methotrexate; P, prednisone; R, randomization; TITa, IT MTX + IT AraC + IT Hc; TITb, IT MTX + IT AraC + IT Dx; TITc, IT MTX + IT AraC + IT P.