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Table 4 Oxaliplatin and fluoropyrimidine as second-line chemotherapy in advanced pancreatic cancer

From: FOLFOX as second-line chemotherapy in patients with pretreated metastatic pancreatic cancer from the FIRGEM study

Authors

Prospectives Studies

No. of Patients

First-line therapy

Regimen

ECOG Performance status (PS)

ORR

Median TTP

Median

OS

Main Toxicities grade 3-4

Androulakis N et al., 2005 [18]

Phase II

18

Gemcitabine-based, n=18

oxali 180 mg/m2 q3weeks

PS 0, n=4 PS 1, n=9 PS 2, n=5

0%

_

3.5 mo

Diarrhoea 5% Vomiting 5% (Neutropenia 0%)

Tsavaris N et al., 2005 [23]

Phase II

30

Gemcitabine, n=30

oxali 50 mg/m2 D1,Leucovorin 50 mg/m2 D1,5FU 500 mg/m2 D1,q1 week

KPS 100-80%, n=10 KPS 70-50%, n=20

23%

22 wks

25 wks

Leucopenia 16% Diarrhoea 14%

Mitry E et al., 2005 [19]

phase II

18

Oxaliplatin, n=10 5FU, n=8

oxaliplatin 130 mg/m2 D1,5FU 1000 mg/m2 D1-D4,q3weeks

PS 0-1, n=4PS 2, n=7 PS > 2, n=4 Unknown, n=3

0%

0.9 m

1.3 mo

Neutropenia 19% Anemia 25% Asthenia 56%

Xiong HQ et al., 2008 [20]

Phase II

41

_

oxaliplatin 110–130 mg/m2 D1,capecitabine 1.5-2 g/m2 D1-D14q3week

PS 0, n=4 PS 1, n=16 PS 2, n=8

3%

9.9 wks*

23 wks

Asthenia 13% Diarrhoea 5%

Pelzer U et al., 2009 [21]

Phase II

37

Gemcitabine, n=37

oxaliplatin 85 mg/m2 D8, 22 folinic acid 500 mg/m2 D1,8,15,225FU 2600 mg/m2 D1,8,15,22 q6weeks

KPS 90-60%, n=37

6%

12 wks

22 wks

Nausea/vomiting 11% Diarrhoea 12%

Novarino A et al., 2009 [22]

Phase II

23

Gem alone, n=13 Gem/5FU/cisplatin, n=5 Gem/5FU, n=4 Gem/oxaliplatin, n=1

oxaliplatin 40 mg/m2 D1,8,15 leucovorin 250 mg/m2 D1,8,15 5FU 500 mg/m2 D1,D8,15 q4weeks

PS 0, n=6 PS 1, n=11 PS 2, n=6

0%

11.6 wks

17.1 wks

Diarrhoea 9% (Neutropenia 0%)

Yoo C et al., 2009 [14]

Randomised phase II (versus FOLFIRI3)

30

Gem alone, n=2Gem/cap, n=26 Gem/erlotinib, n=2

oxaliplatin 85 mg/m2 D1 leucovorin 400 mg/m2 D1 5FU 2000 mg/m2 D1,D2 q2weeks

PS 0, n=5 PS 1, n=24 PS 2, n=1

7%

6 wks*

14.9 wks

Neutropenia 20% Asthenia 14%

Pelzer U et al., 2011 [8]

Randomised phase III (versus BSC)

23

Gemcitabine, n=23

oxaliplatin 85 mg/m2 D8, 22 folinic acid 200 mg/m2 D1,8,15,22 5FU 2000 mg/m2 D1,8,15,22 q6weeks

KPS 100-90%, n=12 KPS 80-70%, n=11

_

_

4.82 mo (vs 2.3 mo BSC)

Diarrhoea 9% (Neutropenia 0%)

  1. Abbreviations: ECOG Eastern Cooperative Oncology Group, KPS Karnofsky Performance status, BSC Best Supportive Care, TTP Time To Progression, PFS Progression Free Survival, OS Overall Survival.
  2. *Evaluation according to PFS.