CAO/ARO/AIO-94
Preoperative versus postoperative chemoradiotherapy for rectal cancer (German Rectal Cancer Study Group, CAO/ARO/AIO-94)
Phase 3N = 823
- Population
- Patients with clinical stage T3 or T4 or node-positive rectal cancer (stage II to III)
- Design
- Randomised phase 3 trial: patients with clinical stage T3 or T4 or node-positive rectal cancer received fluorouracil-based chemoradiotherapy either before surgery (5040 cGy in 180 cGy fractions, then surgery six weeks later, then four cycles of fluorouracil) or after surgery (the same chemoradiotherapy plus a 540 cGy boost). 823 patients were randomised (421 preoperative, 402 postoperative); the 2012 update analysed 799 eligible patients (404 and 395).
- Primary endpoint
- OS
- Arms
- Postoperative chemoradiotherapy (control, n = 402): Surgery, then fluorouracil-based chemoradiotherapy with a 540 cGy boost
- Preoperative chemoradiotherapy (experimental, n = 421): Fluorouracil-based chemoradiotherapy (5040 cGy), surgery six weeks later, then adjuvant fluorouracil
- People
- Sauer R, German Rectal Cancer Study Group
Δ 60-month OS+2 pointsΔ 60-month Local recurrence−7 pointsΔ Grade 3-4 acute toxicity−13 pointsΔ 120-month OS−0.3 pointsΔ 120-month Local recurrence−3 pointsΔ 120-month Cumulative incidence of distant metastases+0.2 points
Show the numbers
| Endpoint | Analysis | Preoperative chemoradiotherapy | Postoperative chemoradiotherapy | Effect |
|---|---|---|---|---|
| OSRandomised patients (analysis population not stated in the abstract)Overall five-year survival rate (primary end point) | primarySauer 2004 | 76% at 5 y | 74% at 5 y | P=0.80 |
| Local recurrenceRandomised patients (analysis population not stated in the abstract)Five-year cumulative incidence of local relapse | primarySauer 2004 | 6% at 5 y | 13% at 5 y | P=0.006 |
| Grade 3-4 acute toxicityRandomised patients (analysis population not stated in the abstract)Proportion of patients with grade 3 or 4 acute toxic effects | primarySauer 2004 | 27% | 40% | P=0.001Long-term toxic effects: 14% with preoperative versus 24% with postoperative chemoradiotherapy (P=0.01). |
| OSIntention-to-treat analysis of 799 eligible patients (404 preoperative, 395 postoperative)Overall survival at 10 years | long term-updatemedian follow-up 134 monthsSauer 2012 | 59.6% at 10 y | 59.9% at 10 y | P=0.85 |
| Local recurrenceEligible patients (404 preoperative, 395 postoperative)Ten-year cumulative incidence of local relapse | long term-updatemedian follow-up 134 monthsSauer 2012 | 7.1% at 10 y | 10.1% at 10 y | P=0.048 |
| Cumulative incidence of distant metastasesEligible patients (404 preoperative, 395 postoperative)Ten-year cumulative incidence of distant metastases | long term-updatemedian follow-up 134 monthsSauer 2012 | 29.8% at 10 y | 29.6% at 10 y | P=0.9The abstract reports no significant difference in disease-free survival either (values not given). |
| Endpoint | Analysis | Preoperative chemoradiotherapy | Postoperative chemoradiotherapy | Effect |
|---|---|---|---|---|
| OSRandomised patients (analysis population not stated in the abstract)Overall five-year survival rate (primary end point) | primarySauer 2004 | 76% at 5 y | 74% at 5 y | P=0.80 |
| Local recurrenceRandomised patients (analysis population not stated in the abstract)Five-year cumulative incidence of local relapse | primarySauer 2004 | 6% at 5 y | 13% at 5 y | P=0.006 |
| Grade 3-4 acute toxicityRandomised patients (analysis population not stated in the abstract)Proportion of patients with grade 3 or 4 acute toxic effects | primarySauer 2004 | 27% | 40% | P=0.001Long-term toxic effects: 14% with preoperative versus 24% with postoperative chemoradiotherapy (P=0.01). |
| OSIntention-to-treat analysis of 799 eligible patients (404 preoperative, 395 postoperative)Overall survival at 10 years | long term-updatemedian follow-up 134 monthsSauer 2012 | 59.6% at 10 y | 59.9% at 10 y | P=0.85 |
| Local recurrenceEligible patients (404 preoperative, 395 postoperative)Ten-year cumulative incidence of local relapse | long term-updatemedian follow-up 134 monthsSauer 2012 | 7.1% at 10 y | 10.1% at 10 y | P=0.048 |
| Cumulative incidence of distant metastasesEligible patients (404 preoperative, 395 postoperative)Ten-year cumulative incidence of distant metastases | long term-updatemedian follow-up 134 monthsSauer 2012 | 29.8% at 10 y | 29.6% at 10 y | P=0.9The abstract reports no significant difference in disease-free survival either (values not given). |
Appears in
Sources
Sauer R, Becker H, Hohenberger W, Rödel C, Wittekind C, Fietkau R, et al. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004;351(17):1731-40.
Sauer R, Liersch T, Merkel S, Fietkau R, Hohenberger W, Hess C, et al. Preoperative versus postoperative chemoradiotherapy for locally advanced rectal cancer: results of the German CAO/ARO/AIO-94 randomized phase III trial after a median follow-up of 11 years. J Clin Oncol. 2012;30(16):1926-33.