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Table 4 Comparison with other studies

From: Long-term results of a phase II study of hypofractionated proton therapy for prostate cancer: moderate versus extreme hypofractionation

Study

Dose (Gy)/fx

EQD2 (Gy)

OTT (weeks)

No. of patients

Median

FU

Risk group (%) (ADT)

RT methods

BCFFS/DFS (%)

Grade ≥ 2 toxicity (%)

Acute

Late

a/b = 1.5 Gy

a/b = 3 Gy

a/b = 4 Gy

Low

Intermediate

High

Low

Intermediate

High

All

P=

GI

GU

GI

GU

Randomized controlled trials: MHF vs. conventional fractionation

Pollack et al. [13]

76.0/38

70.2/26

76.0

84.4

76.0

80.0

76.0

78.4

7.6

5.2

152

152

68 mo

0

66

(20%,

4 mo)

34

(100%,

24 mo)

IMRT

at 5-years

80.5/85.0

82.2/73.8

(no ADT/ADT)

73.9

67.9

78.6

76.7

.268

22.5

18.1

14.6

15.3

Not reported

13.4

21.5

RTOG 0415 [14]

73.8/41

70.0/28

69.6

80.0

70.8

77.0

71.3

75.8

8.2

5.6

542

550

70 mo

100

(no ADT)

0

0

3D-CRT/

IMRT

   

85.3

86.3

NI a

10.3

10.7

27.2

27.0

13.9

22.2

22.5

29.5

HYPRO [15]

78.0/39

64.6/19

78.0

90.4

78.0

82.7

78.0

79.7

7.8

6.5

397

407

60 mo

0

27

(67%, 34 mo)

73

IMRT

   

77.1

80.5

.36

31.2

42.0

57.8

60.5

17.7

21.9

19.0

12.9

CHHiP [16]

74.0/37

60.0/20

57.0/19

74.0

77.1

73.3

74.0

72.0

68.4

74.0

70.0

66.5

7.4

4.0

3.8

1065

1074

1077

62 mo

15

73

(97%, 3–6 mo)

12

IMRT

96.7

96.6

90.9

86.8

90.2

86.0

86.5

84.2

78.3

88.3

90.6

85.9

NI a

25

38

38

46

49

46

13.7

11.9

11.3

9.1

11.7

6.6

PROFIT [17]

78.0/39

60.0/20

78.0

77.1

78.0

72.0

78.0

70.0

7.8

4.0

598

608

72 mo

0

100

(no ADT)

0

3D-CRT/

IMRT

   

85.0

85.0

.16

10.4

16.3

30.6

30.4

13.9

9.9

22.4

22.0

EHF single arm studies

Katz and Kang [22]

35.0–36.25/5

85.0–90.6

70.0–74.3

64.2–68.0

1.0

given daily

515

72 mo

63

(8%)

30

(16%)

7

(55%)

SBRT

at 7-years

95.6

89.6

68.5

  

4

4

4

9.1

King et al. [19]

35.0–36.25/5

85.0–90.6

70.0–74.3

64.2–68.0

1.0–1.5

1100

36 mo

58

(8%, 3mo)

30

(15%, 4 mo)

11

(38%, 4mo)

SBRT

at 5-years

95

84

81

  

Not assessed

Loblaw et al. [18]

35.0/5b

85.0

70.0

64.2

4.0

84

55 mo

100

(no ADT)

0

0

SBRT

98

  

10

20

8

5

Current trial: prospective phase II study comparing MHF vs. EHF

Current trial

MHF

77.1–83.3

71.3–72.4

68.2–70.0

4.4–4.7

52

90 mo

34

45

(no ADT)

21

PBT

at 7-years

90.5

83.5

41.7

76.2

.005

0

4

19

12

EHF

85.0

70.0

64.2

2.0–4.0

30

57.1

42.9

40.0

46.2

 

0

7

13

7

  1. aEQD2 equivalent dose in 2-Gy (see Supplementary Appendix of reference 6), OTT overall treatment time, FU follow-up, ADT androgen deprivation therapy (% of patients received ADT, duration in months), RT radiotherapy, BCFFS biochemical failure-free survival, DFS disease-free survival, MHF moderate hypofractionation, EHF extreme hypofractionation, GI gastrointestinal, GU genitourinary, IMRT intensity-modulated radiotherapy, 3D-CRT 3-dimensional conformal radiotherapy, SBRT stereotactic body radiotherapy, PBT proton beam therapy, NI non-inferior, bTreated once a week