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Table 2 Multivariate analyses of disease control rate, progression-free survival, and overall survival in 76 treatment-naïve patients (N = 76)

From: Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naïve study

 

DCR (SD ≥ 6mos/PR/CR) (N = 68)

Progression-free Survival (N = 76)

Overall Survival (N = 76)

Parameters

Univariate

Multivariate

Univariate

Multivariate

Univariate

Multivariate

N

Rate

P value

OR (95% CI)

P value

N

Median (months)

P value

HR (95% CI)

P value

N

Median (months)

P value

HR (95% CI)

P value

Age, years

 ≥63

36

44%

> 0.99

--

--

38

4.5

0.47

--

--

38

15.6

0.18

--

--

 < 63

32

44%

   

38

4.3

   

38

NR

   

Gender

 Men

29

48%

0.63

--

--

36

4.3

0.75

--

--

36

17.3

0.50

--

--

 Women

39

41%

   

40

4.3

   

40

14.7

   

Treatment

 Matched

48

54%

0.02

2.57 (0.65-10.21)

0.18

54

5.7

0.007

0.61 (0.31-1.19)

0.14

54

17.7

0.27

--

--

 Unmatched

20

20%

   

22

2.1

   

22

15.6

   

Matching Score

 ≥ 60%

25

68%

0.005

3.31 (1.01-10.83)

0.048

27

11.6

0.008

0.55 (0.28-1.07)

0.08

27

18.7

0.053

0.42 (0.21-0.85)

0.02

 < 60%

43

30%

   

49

2.8

   

49

11.6

   

Number of drugs

 ≥ 2 drugs

56

45%

> 0.99

--

--

62

4.3

0.88

--

--

62

14.3

0.14

2.87 (1.00-8.23)

0.050

 Single drug

12

42%

   

14

5.7

   

14

23.0

   

GI or HPB cancer

 Yes

34

38%

0.46

--

--

39

3.1

0.41

--

--

39

17.3

0.74

--

--

 No

34

50%

   

37

5.7

   

37

15.6

   

CUP

 Yes

10

60%

0.32

--

--

10

4.3

0.74

--

--

10

8.3

0.57

--

--

 No

58

41%

   

66

4.3

   

66

15.6

   

Breast cancer

 Yes

3

67%

0.58

--

--

3

NR

0.20

--

--

3

14.7

0.42

--

--

 No

65

43%

   

73

4.3

   

73

16.0

   
  1. *Variables with P < 0.15 in the univariate were entered into the multivariate analysis
  2. Eight patients were not evaluable for the SD ≥ 6mos/PR/CR analysis because they had ongoing SD < 6 months or were too early; all patients were evaluable for PFS and OS. After data cutoff date, a re-analysis of the data showed that, included in the analysis, were two patients without target lesions by RECIST, but with evaluable disease (one with progressive disease and one with prolonged stable disease) and one patient who achieved a PR who had a baseline scan outside the four week window
  3. Includes colorectal, GI-non-colorectal, appendiceal, hepatobiliary, and pancreatic cancers