Table 4.
Summary of clinical trials of FOLFOXIRI neoadjuvant therapy for rectal cancer
| Author (study name, year) | Trial phase | Study population | Treatment arms | No. of patients | PCR (%) | R0 resection (%) | Local recurrence rate | DFS |
|---|---|---|---|---|---|---|---|---|
| Rouanet et al. [26] (GRECCAR-4, 2020) | II |
Age ≥8 years ECOG PS 0–2 MRI staging T3c-4 or MRF+ >1 cm from the anal verge |
FOLFOXIRI 4 cycles | 10 | 10% | 100% | 0 | 5-DFS: 80% |
| Immediate surgery, if ≥75% tumor volume reduction by MRI | 19 | 58% | 100% | 0 | 5-DFS: 89.5% | |||
| Standard radiochemotherapy, if ≥75% tumor volume reduction by MRI | 52 | 13.5% | 83% | 1.9% | 5-DFS: 72.9% | |||
| Standard radiochemotherapy, if <75% tumor volume reduction by MRI | 49 | 20% | 88% | 7.8% | 5-DFS: 72.8% | |||
| Zhang et al. [24] (FORTUNE, 2019) | II |
Age of 18–70 years ECOG PS 0–1 MRI staging T3–4 or N+ <12 cm from the anal verge |
cmFOLFOXIRI 4–6 cycles, selective radiation after assessment by MRI | 103 | 20.4% | 99.0% | 7.8% |
2-DFS: 85.6% 3-DFS: 78.9% |
| Conroy et al. [25] (PRODIGE-23, 2020) | III |
Age of 18–75 years ECOG PS 0–1 MRI staging T3–4 <15 cm from the anal verge |
FOLFOXIRI 6 cycles, then radiochemotherapy, followed by surgery at an interval of 7 weeks | 231 | 27.8% | NR | 4.8% | 2-DFS: 75.7% |
| Capecitabine-based concurrent radiochemotherapy, followed by surgery at an interval of 7 weeks | 230 | 12.1% | NR | 7% | 3-DFS: 68.5% | |||
| Masi et al. [27] (TRUST, 2019) | II |
Age of 18–75 years ECOG PS 0–2 (18–70 years) ECOG PS 0 (71–75 years) MRI staging: high-risk T3 (MRF+, ≤6 cm from the anal verge, T3c∼3d), T4, or stage III <12 cm from the anal verge |
Induction FOLFOXIRI plus bevacizumab for 6 cycles, followed by chemoradiotherapy with capecitabine plus bevacizumab | 48 | 36.4% | 97.8% | NR | 2-DFS: 80.45% |
ECOG PS, Eastern Cooperative Oncology Group performance status; DFS, disease-free survival.