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Table 3 Objective tumor response resultsa

From: Assessment of denosumab treatment effects and imaging response in patients with giant cell tumor of bone

 

Overall best response

RECIST 1.1

EORTC

ICDS

Proportion of responders, n/N (%)

 Overall

136/190 (71.6)

47/187 (25.1)

25/26 (96.2)

134/176 (76.1)

  Study 1

20/27 (74.1)

3/27 (11.1)

15/16 (93.8)

18/23 (78.3)

  Study 2

116/163 (71.2)

44/160 (27.5)

10/10 (100.0)

116/153 (75.8)

   Cohort 1

76/114 (66.7)

36/113 (31.9)

4/4 (100.0)

76/105 (72.4)

   Cohort 2

40/49 (81.6)

8/47 (17.0)

6/6 (100.0)

40/48 (83.3)

Median time to first OTR, months (95% CI)b

3.1 (2.89–3.65)

NE (20.9–NE)

2.7 (1.64–2.79)

3.0 (2.79–3.48)

Patients with sustained OTR, n/N (%)

 Overall

  ≥ 4 weeks

102/153 (66.7)

32/150 (21.3)

18/20 (90.0)

101/143 (70.6)

  ≥ 12 weeks

98/144 (68.1)

32/141 (22.7)

16/17 (94.1)

97/135 (71.9)

  ≥ 24 weeks

76/111 (68.5)

26/109 (23.9)

11/12 (91.7)

76/102 (74.5)

 Study 1

  ≥ 4 weeks

15/24 (62.5)

2/24 (8.3)

11/13 (84.6)

13/20 (65.0)

  ≥ 12 weeks

14/20 (70.0)

2/20 (10.0)

10/11 (90.9)

13/17 (76.5)

  ≥ 24 weeks

12/17 (70.6)

2/17 (11.8)

8/9 (88.9)

12/14 (85.7)

 Study 2

  ≥ 4 weeks

87/129 (67.4)

30/126 (23.8)

7/7 (100.0)

88/123 (71.5)

  ≥ 12 weeks

84/124 (67.7)

30/121 (24.8)

6/6 (100.0)

84/118 (71.2)

  ≥ 24 weeks

64/94 (68.1)

24/92 (26.1)

3/3 (100.0)

64/88 (72.7)

  Cohort 1

   ≥ 4 weeks

59/91 (64.8)

25/90 (27.8)

3/3 (100.0)

60/85 (70.6)

   ≥ 12 weeks

56/87 (64.4)

25/86 (29.1)

3/3 (100.0)

57/81 (70.4)

   ≥ 24 weeks

49/73 (67.1)

22/73 (30.1)

2/2 (100.0)

50/67 (74.6)

  Cohort 2

   ≥ 4 weeks

28/38 (73.7)

5/36 (13.9)

4/4 (100.0)

28/38 (73.7)

   ≥ 12 weeks

28/37 (75.7)

5/35 (14.3)

3/3 (100.0)

27/37 (73.0)

   ≥ 24 weeks

15/21 (71.4)

2/19 (10.5)

1/1 (100.0)

14/21 (66.7)

 Patients with tumor controlc, %

  ≥ 4 weeks

148/153 (96.7)

145/150 (96.7)

19/20 (95.0)

139/143 (97.2)

  ≥ 12 weeks

139/144 (96.5)

137/141 (97.2)

17/17 (100.0)

131/135 (97.0)

  ≥ 24 weeks

109/111 (98.2)

108/109 (99.1)

12/12 (100.0)

101/102 (99.0)

  1. RECIST Response Evaluation Criteria in Solid Tumors, EORTC European Organisation for Research and Treatment of Cancer, ICDS inverse Choi density/size; NE not estimable, OTR objective tumor response
  2. aPatients with at least one evaluable time point assessment
  3. bKaplan-Meier estimate
  4. cDefined as CR + PR + SD
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World Journal of Surgical Oncology

ISSN: 1477-7819

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