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Table 3 Efficacy data reported in 11 trials of Gliadel wafers combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma

From: Gliadel wafer implantation combined with standard radiotherapy and concurrent followed by adjuvant temozolomide for treatment of newly diagnosed high-grade glioma: a systematic literature review

Clinical trial

Treatments/arms

ND HGG (n)

Gliadel wafer plus RT/TMZ (n)

Median OS (months)

OS, 1 year (%)

OS, 2 years (%)

Median PFS (months)

PFS, 6 months (%)

PFS, 1 year (%)

Aoki et al. [27]

Resection + Gliadel wafer + RT/TMZ

16

16

20.2a

100.0 %

68.8 %, 44.4%a

NA

75.0 %

62.5 %

Bock et al. [28]

Resection + Gliadel wafer + RT/TMZ

44

44

12.7

58.0 %

13.0 %

7

63.0 %

35.0 %

Burri et al. [29]

Resection + Gliadel wafer + early TMZ (day 4) + RT/TMZ

46

46

18

76.0 %

33.0 %

8.5

72.0 %

33.0 %

Duntze et al. [30]

Resection + Gliadel wafer + RT/TMZ

92

65

18.8

70.0 %

37.0 %

10.5

74 %

41.0 %

McGirt et al. [31]

(1) Resection + Gliadel wafer + RT/TMZ

33

33

21.3

NA

36.0 %

NA

93.0 %

NA

(2) Resection + Gliadel wafer + RT

78

12.4b

NA

NA

NA

NA

NA

(3) Resection/biopsy + RT/TMZ

45

14.7c

NA

NA

NA

NA

NA

Menei et al. [32]

(1) Resection + Gliadel wafer + RT/TMZ

43

43

17

NA

NA

NA

NA

NA

(2) Resection + Gliadel wafer + other regimens

40

NA

NA

NA

NA

NA

NA

Miglierini et al. [33]

Resection + Gliadel wafer + RT/TMZ

24

22

19.2

78.0 %

24.0 %

12.3

81.50 %

52.0 %

Noel et al. [34]

(1) Resection + Gliadel wafer + RT/TMZ

28

28

20.6

78.6 %

40.9 %

12.9

NA

52.0 %

(2) Resection/biopsy + RT/TMZ

37

20.8

78.4%d

33.3 %

14

NA

55.0%e

Pan et al. [35]

Resection + Gliadel wafer + RT/TMZ

21

21

17

NA

39.0 %

8.5

71.0 %

NA

Pavlov et al. [36]

Resection + Gliadel wafer + RT/TMZ

83

61

19.5

NA

NA

8.5

NA

NA

Salvati et al. [37]

Resection + Gliadel wafer + RT/TMZ

32

32

NA

100 %

NA

NA

100 %

NA

  1. EOR extent of resection, ND HGG newly diagnosed high-grade glioma, OS overall survival, PFS progression-free survival, RT/TMZ radiotherapy + temozolomide regimen, NA not available
  2. aGlioblastoma patients only
  3. bGliadel plus RT/TMZ versus Gliadel wafer alone, p = 0.005
  4. cGliadel plus RT/TMZ versus RT/TMZ, p < 0.001
  5. dGliadel plus RT/TMZ versus RT/TMZ, log-rank test for overall survival, p = 0.81
  6. eGliadel plus RT/TMZ versus RT/TMZ, log-rank test for progression-free survival, p = 0.89