What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question?
Phase meta-analysis
- Population
- Patients with T3-4 rectal cancer from the two trials
- Design
- Pooled analysis of individual patient data from EORTC 22921 (1011 patients) and FFCD 9203 (756 patients), published by other authors. Meta-analysis methodology compared preoperative chemoradiotherapy with radiotherapy alone for overall survival, progression-free survival, local control and distant progression; weighted linear regression estimated trial-level association (R2) between treatment effects on pathological complete response, local control or distant progression and overall survival.
- Arms
- Preoperative radiotherapy alone (control, n = 881): Preoperative radiotherapy without concurrent fluorouracil and leucovorin (pooled from both trials)
- Preoperative chemoradiotherapy (experimental, n = 886): Preoperative radiotherapy with concurrent fluorouracil and leucovorin (pooled from both trials)
- People
- Bonnetain F
OSHR 1.04Δ 60-month OS+0.4 pointsLocal recurrenceHR 0.54 (95% CI 0.41–0.72)
Show the numbers
| Endpoint | Analysis | Preoperative chemoradiotherapy | Preoperative radiotherapy alone | Effect |
|---|---|---|---|---|
| OSPooled individual patient data (881 radiotherapy alone, 886 chemoradiotherapy)5-year overall survival in the pooled analysis | exploratorymedian follow-up 5.6 yearsBonnetain 2012 | 66.3% at 5 y | 65.9% at 5 y | HR 1.04The abstract prints the hazard ratio as 1.04 {0.88-1.21} without naming the interval level. Trial-level association with overall survival: R2 0.88 for progression-free survival, 0.17 for local control and 0.31 for distant progression. |
| Local recurrencePooled individual patient data (881 radiotherapy alone, 886 chemoradiotherapy)Local control reported as a hazard ratio below 1 for chemoradiotherapy versus radiotherapy alone; the abstract does not define the event | exploratorymedian follow-up 5.6 yearsBonnetain 2012 | — | — | HR 0.54 (95% CI 0.41–0.72) |
| Endpoint | Analysis | Preoperative chemoradiotherapy | Preoperative radiotherapy alone | Effect |
|---|---|---|---|---|
| OSPooled individual patient data (881 radiotherapy alone, 886 chemoradiotherapy)5-year overall survival in the pooled analysis | exploratorymedian follow-up 5.6 yearsBonnetain 2012 | 66.3% at 5 y | 65.9% at 5 y | HR 1.04The abstract prints the hazard ratio as 1.04 {0.88-1.21} without naming the interval level. Trial-level association with overall survival: R2 0.88 for progression-free survival, 0.17 for local control and 0.31 for distant progression. |
| Local recurrencePooled individual patient data (881 radiotherapy alone, 886 chemoradiotherapy)Local control reported as a hazard ratio below 1 for chemoradiotherapy versus radiotherapy alone; the abstract does not define the event | exploratorymedian follow-up 5.6 yearsBonnetain 2012 | — | — | HR 0.54 (95% CI 0.41–0.72) |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Local recurrence | 0.54 | 0.41–0.72 |
Appears in
Sources
Bonnetain F, Bosset JF, Gerard JP, Calais G, Conroy T, Mineur L, et al. What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question?. Eur J Cancer. 2012;48(12):1781-90.