Table 3 Univariate progression-free survival analysis

From: A phase II trial of weekly nab-paclitaxel for progressive and symptomatic desmoid tumors

 

Intention-to-treat population (n = 40)

Intention-to-treat sub-population (n = 35)

30 months-central PFS

P value

30 months-CR PFS*

P value

30 months-central PFS

P value

30 months-CR PFS*

P value

Median age (years):

 

0.11

 

0.057

 

0.15

 

0.051

 18–38

94% (83–100)

 

77% (58–97)

 

93% (79–100)

 

80% (59–100)

 

 >38

77% (56–97)

 

46% (20–73)

 

76% (55–97)

 

45% (19–71)

 

Age (years):

 

<0.001

 

0.25

 

<0.001

 

0.33

 18–50

93% (83–100)

 

66% (48–83)

 

92% (81–100)

 

65% (46–84)

 

 >50

57% (20–94)

 

57% (20–94)

 

57% (20–94)

 

57% (20–94)

 

Sex (M/F):

 

0.23

 

0.093

 

0.2

 

0.15

 Male

77% (53–100)

 

48% (21–75)

 

73% (47–99)

 

69% (47–91)

 

 Female

91% (78–100)

 

72% (52–92)

 

90% (76–100)

 

50% (22–78)

 

Median time diagnosis to enrollment (range):

 

0.85

 

0.93

 

0.62

 

0.95

 0–17

84% (67–100)

 

62% (39–84)

 

81% (61–100)

 

61% (36–86)

 

 >17

87% (71–100)

 

64% (40–88)

 

87% (70.100)

 

63% (39–87)

 

Previous relapses:

 

0.37

 

0.81

 

0.41

 

0.9

 No

79% (58–100)

 

65% (40–91)

 

78% (56–100)

 

62% (35–89)

 

 Yes

90% (77–100)

 

61% (39–83)

 

89% (74–100)

 

62% (39–85)

 

Previous surgery:

 

0.64

 

0.38

 

0.62

 

0.58

 No

83% (65–100)

 

73% (53–93)

 

81% (61–100)

 

70% (48–92)

 

 Yes

88% (75–100)

 

52% (27–77)

 

87% (70–100)

 

55% (29–81)

 

Previous chemotherapy:

 

0.37

 

0.6

 

0.37

 

0.44

 No

83% (70–97)

 

63% (45–81)

 

81% (67–93)

 

63% (44–82)

 

 Yes

100% (NA)

 

60% (17–100)

 

100% (NA)

 

50% (1–99)

 

Location:

 

0.15

 

<0.001

 

0.16

 

<0.001

 Head and neck & Proximal upper extremity

71% (43–100)

 

20% (0–51)

 

71% (43–100)

 

20% (0–51)

 

 Other

90% (77–100)

 

81% (63–98)

 

90% (77–100)

 

80% (63–98)

 

ECOG baseline:

 

0.32

 

0.18

 

0.22

 

0.43

 0

79% (59–100)

 

80% (60–100)

 

74% (49–99)

 

75% (50–99)

 

 1

90% (77–100)

 

50% (27–73)

 

89% (76–100)

 

54% (30–77)

 

Local response:

 

0.72

 

0.28

 

0.72

 

0.35

 PR

90% (71–100)

 

80% (55–100)

 

89% (68–100)

 

78% (51–100)

 

 SD

84% (69–99)

 

56% (36–76)

 

82% (66–98)

 

56% (35–78 f)

 

Central response:

 

<0.001

 

<0.001

 

<0.001

 

<0.001

 PR

100% (NA)

 

100% (NA)

 

100% (NA)

 

100% (NA)

 

 SD

84% (69–98)

 

53% (33–73)

 

83% (67–98)

 

54% (33–75)

 

 PD

0% (NA)

 

0% (NA)

 

0% (NA)

 

0% (NA)

 

Change in T2 enhance sequence (MRI)a:

 

0.23

 

0.13

 

0.17

 

0.056

 0–7.5

94% (82–100)

 

79% (57–100)

 

94% (82–100)

 

79% (57–100)

 

 >7.5

77% (57–97)

 

54% (30–78)

 

73% (51–96)

 

46% (20–71)

 

New score:

 

0.63

 

0.42

 

0.53

 

0.25

 No change

100% (NA)

 

67% (13–100)

 

100% (NA)

 

67% (13–100)

 

 0–4

90% (71–100)

 

80% (55–100)

 

90% (71–100)

 

80% (55–100)

 

 5–9

100% (NA)

 

100% (NA)

 

100% (NA)

 

100% (NA)

 

 >10

77% (57–97)

 

54% (30–78)

 

73% (51–96)

 

46% (20–71)

 

Reduction in pain (BPI worst pain reduction)

 

0.98

 

0.73

 

0.45

 

0.37

 At least −2

87% (65–100)

 

56% (17–95)

 

85% (72–99)

 

50% (1–99)

 

 <−2

85% (72–99)

 

65% (47–83)

 

75% (32–100)

 

65% (47–83)

 
  1. aChange in T2: defined as the percentage in changes of the fibrous component of the tumor in T2-enhanced sequence during therapy. Two-sided Fisher’s exact test. Multiple comparisons were not used for this analysis.
  2. PFS progression-free survival, CR PFS clinical/radiological PFS, M male, F female, PR partial response, SD stable disease, PD progressive disease, BPI Brief Pain Inventory.