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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