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Table 1 Result summary of PA-018 therapeutic responses and toxicities

From: Novel patient-derived xenograft mouse model for pancreatic acinar cell carcinoma demonstrates single agent activity of oxaliplatin

Group

N

Treatment regimen

Median

Statistical significance

Mean BW

Deaths

Agent

mg/kg

Route

Schedule

TTE

TGD (T-C)

Chi square

P value

Summary

Nadir

TR

NTR

1

10

placebo

–

–

–

32.7

–

–

–

–

−0.1 % day 14

0

0

2

10

5-FU

100

ip

qwk × 3

37.3

4.6

0.3966

0.5288

ns

−5.9 % day 21

1

0

3

10

irinotecan

100

ip

qwk × 3

40.8

8.1

0.5419

0.4616

ns

−7.9 % day 21

0

0

4

10

oxaliplatin

10

ip

qwk × 3

74*

41.3*

14.82

0.0001

***

−9.8 % day 21

0

0

5

10

gemcitabine

120

ip

q3d × 4

37.8

5.1

1.265

0.2607

ns

−5.2 % Day 39

1

0

6

9

bevacizumab

5

ip

biwk × 5

68.8

36.1

4.165

0.0413

a

−4.3 % day 21

0

1

7

9

erlotinib

80

po

qd × 15

54.4

21.7

1.277

0.2585

ne

−15.3 % day 14

2

1

8

10

doxorubicin

3

iv

qwk × 3

65.8

33.1

2.525

0.112

ns

−5.1 % day 42

0

0

9

9

imatinib

100

po

qd × 28

33.3

0.6

0.09389

0.7593

ns

−0.8 % day 21

0

1

  1. The therapies used included DNA synthesis inhibitors (5-FU, gemcitabine), a DNA alkylating agent (oxaliplatin), a DNA intercalating agent (liposomal doxorubicin), a topoisomerase inhibitor (irinotecan), an EGFR inhibitor (erlotinib), a c-kit inhibitor (imatinib) and an angiogenesis inhibitor (bevacizumab). Therapies were delivered as indicated and tumor growth was continually observed after treatment regimen ceased in order to determine time-to-endpoint (TTE) and difference between median TTE of treated groups vs. placebo (T-C). Statistical significance was evaluated by logrank test, df = 1 with significance indicated by * and non-significance (ns) or not evaluable (ne). Body weight (BW) nadir was shown as percent change and deaths were divided into treatment-related deaths (TR) and non-treatment related deaths (NTR). The final sample size (n) was calculated by removing NTR deaths
  2. n number of animals in a group not dead from accidental or unknown causes, or euthanized for sampling, TTE time to endpoint, T-C difference between median TTE (days) of treated group versus control group, TR treatment-related death, NTR non-treatment-related death, Mean BW Nadir lowest group mean body weight, as  % change from day 1, ne not evaluable, ns not significant
  3. Statistical significance (Logrank test, df = 1): * P < 0.05, ** P < 0.01, *** P < 0.001, compared to Group 1
  4. aTime of sacrifice (74 days) was artificially used at TTE for oxaliplatin group