Table 4 Subsequent OS after CA 19-9 response (≥25%, ≥50%) within defined time-points after signature of ICF.

From: Predictive criteria for overall survival and treatment duration of 2nd-line chemotherapy in patients with advanced pancreatic adenocarcinoma (AIO-PAK-0216)

Time after baseline

OS after response months (95% CI)

P

No response

Response

NA

CA 19-9 decrease from baseline ≥25%

 1 month

n = 100

n = 10

n = 31

0.122

6.23 (4.82–7.84)

8.23 (0.68–18.48)

8.00 (3.17–10.33)

 2 months

(n = 63)

(n = 35)

(n = 28)

0.025

4.41 (3.32–6.61)

8.22 (5.23–10.78)

8.02 (4.08–9.89)

 3 months

(n = 43)

(n = 47)

(n = 26)

<0.001

3.11 (2.29–5.18)

7.91 (5.84–10.70)

7.12 (3.18–12.47)

 4 months

n = 34

n = 45

n = 22

<0.001

3.98 (1.82–5.26)

7.30 (5.17–11.93)

7.33 (4.97–13.15)

 5 months

(n = 27)

(n = 40)

(n = 19)

<0.001

3.18 (1.21–4.99)

6.70 (4.23–11.79)

6.89 (4.00–18.39)

CA 19-9 decrease from baseline ≥50%

 1 month

n = 107

n = 3

n = 31

0.028

6.23 (4.82–7.61)

18.48 (11.78–n.c.)

8.00 (3.17–10.33)

 2 months

(n = 83)

(n = 15)

(n = 28)

0.160

5.75 (4.11–7.26)

8.87 (2.86–17.48)

8.02 (4.08–9.89)

 3 months

(n = 63)

(n = 27)

(n = 26)

<0.001

4.72 (3.11–5.84)

8.30 (6.23–13.79)

7.12 (3.18–12.47)

 4 months

(n = 49)

(n = 30)

(n = 22)

<0.001

4.08 (2.41–5.33)

7.30 (5.23–12.79)

7.33 (4.97–13.15)

 5 months

(n = 41)

(n = 26)

(n = 19)

<0.001

3.84 (2.56–4.99)

7.78 (5.41–14.48)

6.89 (4.00–18.39)

  1. NA not applicable, n.c. not calculable.
  2. *CA 19-9 response classified as not applicable in patients with baseline CA 19-9 of 30 μ/ml or less. p-values are for comparison between “without response” and “with response” groups. End of respective time period after ICF signature was used as starting time-point for OS.
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