Table 2.
Summary of safety in patients with metastatic colorectal cancer treated with FTD/TPI plus bevacizumab in second- or third-line settings.
| Study | Study design | Tx setting | Regimen | Sample size | Grade ≥ 3 AEs, % | % disc | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Neutropenia | FN | Diarrhea | Constipation | Nausea | Vomiting | Asthenia | Fatigue | ||||||
| Pfeiffer et al 8 | RCT | 2L+ | FTD/TPI + BEV | 46 | 67 | 6 | 9 | NA | 2 | 4 | NA | 7 | 2 |
| Takahashi et al46 | Non-RCT | 2L+ | FTD/TPI + BEV | 102 | 54 | 4 | 5 | NA | 5 | NA | NA | 1 | 9 |
| Kuboki et al7 | Non-RCT | 2L+ | FTD/TPI + BEV | 25 | 72 | 16 | 0 | NA | 0 | 0 | NA | 0 | 0 |
| Nose36 | Ret Obs | 2L+ | FTD/TPI + BEV | 32 | 53 | NA | 0 | NA | 0 | NA | NA | 6 | 0 |
| Satake37 | Non-RCT | 3L+ | FTD/TPI + BEV | 44 | 16 | 0 | 5 | NA | 7 | 0 | NA | 0 | 11 |
| Ishizaki43 | Non-RCT | 3L+ | FTD/TPI + BEV | 19 | 5 | NA | 0 | NA | 0 | 0 | NA | NA | 5 |
| Yoshida47 | Non-RCT | 3L+ | FTD/TPI + BEV | 32 | 47 | NA | 0 | NA | 6 | 0 | NA | 3 | 3 |
| Shibutani38 | Ret Obs | 3L+ | FTD/TPI + BEV | 36 | 39 | 0 | 0 | NA | 0 | 0 | NA | 3 | NA |
| Matsuhashi28 | Ret Obs | 3L+ | FTD/TPI + BEV | 17 | 41 | 0 | 0 | NA | 0 | 5 | NA | 0 | NA |
| Kotani27 | Ret Obs | 3L+ | FTD/TPI + BEV | 60 | 50 | 3 | 0 | NA | 0 | 0 | NA | 0 | NA |
Abbreviations: 2L, second line; 3L, third line; AE, adverse event; BEV, bevacizumab; disc, AE-related discontinuation; FN, febrile neutropenia; FTD/TPI, trifluridine/tipiracil; NA, not available; Non-RCT, nonrandomized controlled trial; RCT, randomized controlled trial; Ret Ob, retrospective observational study; Tx, treatment.