OPUS
Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer
Phase 2NCT00125034
- Population
- Previously untreated metastatic colorectal cancer (EGFR-expressing disease per the registry title)
- Design
- Randomised phase 2 study of first-line FOLFOX-4 with or without cetuximab in metastatic colorectal cancer. The 2011 report extended the biomarker analysis: KRAS status was available for 315 samples (93%), of which 179 tumours (57%) were KRAS wild type. The 2015 report re-analysed KRAS exon 2 wild-type tumours for other RAS mutations by BEAMing (cutoff of 5% mutant sequences) in 118 evaluable patients, finding other RAS mutations in 31 (26%). The 2015 report calls objective response (confirmed best overall response assessed by an independent review committee) the primary endpoint of OPUS and describes its own analysis as post hoc.
- Primary endpoint
- ORR
- Arms
- FOLFOX-4 (control): FOLFOX-4 (fluorouracil, folinic acid, oxaliplatin)
- Cetuximab plus FOLFOX-4 (experimental): Cetuximab plus FOLFOX-4
- People
- Bokemeyer C
PFSHR 0.567Δ ORR+29 points
Show the numbers
| Endpoint | Analysis | Cetuximab plus FOLFOX-4 | FOLFOX-4 | Effect |
|---|---|---|---|---|
| PFSKRAS wild-type tumours (179 of 315 KRAS-evaluable samples); biomarker reanalysis | exploratoryBokemeyer 2011 | — | — | HR 0.567P=0.0064Hazard ratio for progression-free survival, cetuximab plus FOLFOX-4 versus FOLFOX-4. The abstract also reports an odds ratio for response of 2.551 (P=0.0027) in this group and, in its words, a favourable effect on survival; no interval is given for either. |
| ORRRAS wild-type tumours in the extended analysis (n=87); biomarker reanalysis | exploratoryBokemeyer 2015 | 58% | 29% | P=0.0084Odds ratio 3.33 (95% CI 1.36-8.17). The abstract describes only trends for progression-free and overall survival in this group (n=87) and notes that small numbers limited precise estimates. |
| Endpoint | Analysis | Cetuximab plus FOLFOX-4 | FOLFOX-4 | Effect |
|---|---|---|---|---|
| PFSKRAS wild-type tumours (179 of 315 KRAS-evaluable samples); biomarker reanalysis | exploratoryBokemeyer 2011 | — | — | HR 0.567P=0.0064Hazard ratio for progression-free survival, cetuximab plus FOLFOX-4 versus FOLFOX-4. The abstract also reports an odds ratio for response of 2.551 (P=0.0027) in this group and, in its words, a favourable effect on survival; no interval is given for either. |
| ORRRAS wild-type tumours in the extended analysis (n=87); biomarker reanalysis | exploratoryBokemeyer 2015 | 58% | 29% | P=0.0084Odds ratio 3.33 (95% CI 1.36-8.17). The abstract describes only trends for progression-free and overall survival in this group (n=87) and notes that small numbers limited precise estimates. |
Appears in
Sources
Bokemeyer C, Bondarenko I, Hartmann JT, de Braud F, Schuch G, Zubel A, et al. Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study. Ann Oncol. 2011;22(7):1535-1546.
Bokemeyer C, Köhne CH, Ciardiello F, Lenz HJ, Heinemann V, Klinkhardt U, et al. FOLFOX4 plus cetuximab treatment and RAS mutations in colorectal cancer. Eur J Cancer. 2015;51(10):1243-52.