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Table 2 Review of the literature: prospective trials.

From: Chemo-radiation with or without mandatory split in anal carcinoma: experiences of two institutions and review of the literature

study

n

Stage

total

RT dose (Gy) pelvic

inguinal

Split

CT

OS (%)

LC (%)

CFS (%)

toxicity overall

skin

diarrhea

BM

adherence (%)

prospective, randomized

               

Ajani (2008)

324

T2-4

55-59

45

45

cont

MMC, 5-FU

75 (5 y)

87 (5 y)1

90 (5 y)

87

48

23

61

 

RTOG 98-11

320

T2-4

55-59

45

45

cont

Cispl., 5-FU

70 (5 y)

81 (5 y)1

81 (5 y)

83

41

24

42

 

Flam (1996)

146

T1-4N0-3

45-50.4

30,6

30.6-45

split (4 w)

MMC, 5-FU

74 (4 y)

84 (4 y)

71 (4 y)

262

73

 

18

 

RTOG 87-04/ECOG 1289

  

(59.4*)

 

(54*)

          

UKCCR (1997)

283

>T1N0

604

45

e (45)

split (6 w)

MMC, 5-FU

65 (3 y)

61 (3 y)

 

27

17

5

4

 

Bartelink (1997)

52

T3-4N0-3

60 - 65

45

e (60-65)

split (6 w)

MMC, 5-FU

65 (5 y)

69* (5 y)

71 (5 y)

 

56

19

  

EORTC

 

T1-2N1-3

             

prospective, non-randomized

               

John (1996), Konsky (2008)

20

T1-4N0-3

59,6

30.6 - 455

30.6-45

cont

MMC, 5-FU

85 (5 y)

90 (5 y)

75 (5 y)

    

80

RTOG 92-08

46

T1-4N0-3

59,6

30.6 - 455

30.6-45

split (2 w)

MMC, 5-FU

67 (5 y)

73 (5 y)

58 (5 y)

63

32

9

40*

87

Cummings (1991)

192

T1-4N0-3

506

50

50

cont

MMC, 5-FU

75

88

 

75

    

PMH

 

T1-4N0-3

506

50

50

split

MMC, 5-FU

65

93

 

50

    
  

T1-4N0-3

48

48

48

split

MMC, 5-FU

65

85

 

36

    

Bosset (2003)

43

T2-4N0-3

59,4

36

e (36)

split (2 w)

MMC, 5-FU

81 (3 y)

88 (3 y)

81 (3 y)

 

28

12

2

93

EORTC

 

(>4 cm)

             

Vuong (2003)

30

T2-4N0-3

54

27-30

27

cont

MMC, 5-FU

64 (4 y)

91 (4 y)

  

20

3

13

100

McGill

               

Schneider (1992)

46

T0-4N0-3

50 (56-68)7

50

50

cont

MMC, 5-FU

84 (5 y)

83 (5 y)

80 (5 y)

 

35

24

28-35

 

Erlangen

               

Sischy (1989)

79

T1-4N0-3

40,8

40,8

40,8

cont

MMC, 5-FU

73 (3 y)

71 (3 y)8

  

19

1

3

51

RTOG

               
  1. EBRT = external beam radiotherapy, RT = radiotherapy, CT = chemotherapy, T = tumor stage, N = nodal stage, w = week, mo = months, y = years, OS = overall survival, LC = local control, CFS = colostomy-free survival, cont = continuous, e = elective, 1 = first event, 2 = grade 4/5, 3 = non-hematological, 4 = alternatively, surgery after 45 Gy, 5 = field reduction after 30.6 Gy from L4/5 to lower sacro-iliac joint, 6 = 2.5 Gy per fraction, 7 = 28% had an EBRT or brachytherapy boost of 6-18 Gy, 8 = locoregional. References: Ajani [1], Flam [2], UKCCR [3], Bartelink [4], John [6], Konsky [8], Cummings [5], Bosset [7], Vuong [9], Schneider [20], Sischy [30]