Table 2.
Summary of safety for 5-FU and oxaliplatin-based therapy
| Treatment | Author/year | N | Grade 3–4 clinically relevant toxicities > 10% in any trial | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Diarrhea | Neutropenia | Anemia | Neurotoxicity | Fatiguea | Vomiting | Thrombocytopenia | |||
| OFF | Pelzer 2009 [28] | 37 | 8.1 | NR | NR | 10.8 | NR | 13.5 | 0 |
| OFF | Pelzer 2011 [27] | 23 | 8.7 | NR | NR | NR | NR | NR | NR |
| OFF | Oettle 2014 [14] | 76 | 1.3 | NR | 3.9 | NR | NR | 1.3 | 1.3 |
| 5-FU/OXA-based | Tsavaris 2005 [29] | 30 | 14.2 | NR | 3.2 | 4.2 | 0 | 0 | 3.2 |
| FOLFOX | Gebbia 2007 [30] | 42 | NR | 17 | 14 | 12 | NR | NR | 7 |
| FOLFOX | Yoo 2009 [31] | 30 | 0 | 20 | 3 | 0 | 14 | 10 | 3 |
| FOLFOX | Zaanan 2014 [24] | 27 | 0 | 7.4 | 7.4 | 7.4 | 14.8 | 0 | 11.1 |
| FOLFOX | Gill 2016 [16] | 49 | 2 | 32.7 | 2 | 4.1 | 14.2 | 4.1 | 8.2 |
| FOLFOX | Berk 2012 [32] | 46 | 2 | 22 | 0 | NR | NR | 2 | 7 |
| OFF | El-Hadaad 2013 [33] | 30 | 3.3 | 23.2 | 6.6 | 6.6 | NR | 3.3 | 6.6 |
| FOLFOX | Chung 2017 [15] | 62 | 6.5 | NR | 3.2 | 0 | 12.9 | 4.8 | NR |
| Evaluable patients for each AE, n | 410 | 224 | 392 | 307 | 198 | 387 | 367 | ||
| Weighted average (%) | 4.2 | 21.5 | 4.5 | 5.3 | 11.7 | 4.1 | 4.9 | ||
Abbreviations: 5-FU 5-fluorouracil, AE adverse event, FOLFOX leucovorin/5-fluorouracil/oxaliplatin, N patients in each study, n evaluable patients for each AE, NR not reported, OFF oxaliplatin/5-fluorouracil/leucovorin, OXA oxaliplatin
aFatigue includes reported terms of fatigue and asthenia