Table 4.
Oxaliplatin and fluoropyrimidine as second-line chemotherapy in advanced pancreatic cancer
| 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%) |
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.
*Evaluation according to PFS.