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Table 4 Efficacy

From: Phase 2 study of canfosfamide in combination with pegylated liposomal doxorubicin in platinum and paclitaxel refractory or resistant epithelial ovarian cancer

Population

Intent-to-Treat (N = 39)

Efficacy Evaluable (N = 36)

 

n (%)

95% CI

n (%)

95% CI

Objective Response

10 (25.6)

13.0-42.1

10 (27.8)

14.2-45.2

   CR

1 (2.6)

0.1-13.5

1 (2.8)

0.1-14.5

   PR

9 (23.1)

11.1-39.3

9 (25.0)

12.1-42.2

   SD

20 (51.3)

34.8-67.6

19 (52.8)

35.5-69.6

   PD

8 (20.5)

9.3-36.5

7 (19.4)

8.2-36.0

   NE*

1 (2.6)

----

0

0

   DSR

30 (76.9)

60.7-88.9

29 (80.6)

64.0-91.8

Patients having SD ≥ 3 months

19 (48.7)

19 (52.8)

Objective Response by RECIST by Platinum Status (ITT)

Platinum Refractory or Primary Platinum Resistant

N = 15 n (%); [95% CI]

Secondary Platinum Resistant

N = 24 n (%); [95% CI]

   ORR

4 (26.7); [7.8-55.1]

6 (25.0); [9.8-46.7]

   CR

1 (6.7); [0.2-31.9]

0

   PR

3 (20.0); [4.3-48.1]

6 (25.0); [9.8-46.7]

   SD

8 (53.3); [26.6-78.7]

12 (50.0); [29.1-70.9]

   PD

3 (20.0); [4.3-48.1]

5 (20.8); [7.1-42.2]

   NE

0

1 (4.2); NA

Patients having SD ≥ 3 Months

7 (46.7)

12 (50.0)

 

ITT Population

n; Median

ITT Population

Q1-Q3

Duration of Response (Months)

10; 9.7

5.8-NA

   CR

1; NA

NA

   PR

9; 9.7

5.8-NA

Duration of SD

20; 6.4

4.3-13.9

Time to Objective Response

10; 2.9

2.3-3.9

 

Platinum Refractory or Primary Platinum Resistant

N = 15

Secondary Platinum Resistant

N = 24

All

N = 39

 

Median (Q1-Q3)

Median (Q1-Q3)

Median (Q1-Q3)

Time to Tumor Progression (Months)

6.4 (4.1-14.0)

6.0 (2.6-12.0)

6.2 (3.3-12.0)

Progression-free Survival (Months)

6.4 (4.1-14.0)

5.8 (2.3-11.6)

6.0 (2.6-12.0)

Overall Survival (Months)

17.8 (7.0-NA)

17.4 (8.1-NA)

17.8 (7.7-NA)

  1. Abbreviations: NE, not evaluable; CI, confidence interval