CAO / ARO / AIO 04
Präoperative Radiochemotherapie und postoperative Chemotherapie mit Fluorouracil und Oxaliplatin versus Fluorouracil allein bei local fortgeschrittenem Rektumkarzinom
50,4Gy RT
5-FU 1000mg/qm als Infusion d1—5, d29—33
50,4Gy RT
5-FU 250mg/qm als Infusion d1—5, d29—33
Oxaliplatin 50mg/qm d1,8,22,29
8x
Oxaliplatin 100 mg/qm d1 d15
5-FU 2400 mg/qm als Infusion d1 d2 d15 d16
Leucovorin 400 mg/qm d1 d15
| Kriterium | FU | FU+ Oxaliplatin | Statistik |
| pCR bei OP | 13% | 17% | p=0·04 |
| distante Metastasen bei OP | 6% | 4% | p=0·04 |
| Patienten | 623 | 613 |
Die Einschätzung des Chirurgen war nicht signifikant.
| Kriterium | TME | Bemerkungen | ||
| Mesorektal | Intramesorektal | Muscularis propria | ||
| Patienten | 930 (80.7%) |
169 (14.7%) |
53 (4.6%) |
|
| 3a-DFS | 73.1-78.8 | 61.6-76.0 | 55.6-81.3 | 95% CI; P = .01 |
| Lokale + distante Rezidive: Kumulative Inzidenz |
2.0-4.5 | 1.2-8.1 | 2.5-20.5 | 95% CI; P < .001 |
| OS | 88.3-92.3 | 79.7-91.0 | 81.6-98.7 | 95% CI; P < .02 |
- lokal fortgeschritten
- bis 12cm ab ano
- T3 oder T4 oder N+
| Arm | FU + Ox | FU | Bemerkungen |
| Stadium II | 145 (24%) | 156 (25%) | |
| cT1–2 N1–2 | 25 (4%) | 35 (6%) | |
| cT3–4 N1–2 | 423 (69%) | 409 (66%) |
Teil von
Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial.
The Lancet Oncology 13(2012):679-687
2.) Rödel C, et al. on behalf of the German Rectal Cancer Study Group:
Oxaliplatin added to fluorouracil-based preoperative chemoradiotherapy and postoperative chemotherapy of locally advanced rectal cancer (the German CAO/ARO/AIO-04 study): final results of the multicentre, open-label, randomised, phase 3 trial.
Lancet Oncol 2015; 16: 979–89
3.) Kitz J, et al. for the German Rectal Cancer Study Group:
Association of Plane of Total Mesorectal Excision With Prognosis of Rectal Cancer. Secondary Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial.
JAMA Surg 2018; 153(8): e181607.
doi: 10.1001/jamasurg.2018.1607
PMCID: PMC6142959
PMID: 29874375