An Open-label, Randomized, Phase 3 Clinical Trial of ABX-EGF Plus Best Supportive Care Versus Best Supportive Care in Subjects With Metastatic Colorectal Cancer
Phase 3N = 463NCT00113763
- Population
- Metastatic colorectal cancer with 1% or more EGFR tumour cell membrane staining, measurable disease and radiologic progression during or within 6 months of the most recent chemotherapy
- Design
- Open-label randomised phase 3 trial: panitumumab 6 mg/kg every 2 weeks plus best supportive care versus best supportive care alone. Tumour assessments by blinded central review. Patients on best supportive care who progressed could receive panitumumab in a crossover study.
- Primary endpoint
- PFS
- Arms
- Panitumumab plus BSC (experimental, n = 231): Panitumumab 6 mg/kg every 2 weeks plus best supportive care
- Best supportive care (control, n = 232): Best supportive care alone
- People
- Van Cutsem E
PFSHR 0.54 (95% CI 0.44–0.66)Δ ORR+10 pointsOSHR 1.00 (95% CI 0.82–1.22)PFSHR 0.45 (95% CI 0.34–0.59)PFSHR 0.99 (95% CI 0.73–1.36)
Show the numbers
| Endpoint | Analysis | Panitumumab plus BSC | Best supportive care | Effect |
|---|---|---|---|---|
| PFSAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | — | — | HR 0.54 (95% CI 0.44–0.66)P<.0001Median progression-free survival was 8 weeks (95% CI 7.9 to 8.4) with panitumumab and 7.3 weeks (95% CI 7.1 to 7.7) with best supportive care; the schema records medians in months only, so the week values are given here. |
| ORRAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | 10% | 0% | P<.0001After a minimum follow-up of 12 months. |
| OSAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | — | — | HR 1.00 (95% CI 0.82–1.22)The authors state the overall survival comparison was confounded by crossover: 76% of best-supportive-care patients entered the crossover study. |
| PFSPatients with wild-type KRAS tumours | exploratoryAmado 2008 | — | — | HR 0.45 (95% CI 0.34–0.59)Median progression-free survival in the wild-type KRAS group was 12.3 weeks with panitumumab and 7.3 weeks with best supportive care. KRAS status was ascertained in 427 (92%) of 463 patients (208 panitumumab, 219 best supportive care); KRAS mutations were found in 43%. The treatment effect on progression-free survival in the wild-type group differed significantly from the mutant group (P<.0001). |
| PFSPatients with mutant KRAS tumours | exploratoryAmado 2008 | — | — | HR 0.99 (95% CI 0.73–1.36) |
| ORRPatients with wild-type KRAS tumours treated with panitumumab | exploratoryAmado 2008 | 17% | — | — |
| ORRPatients with mutant KRAS tumours treated with panitumumab | exploratoryAmado 2008 | 0% | — | — |
| Endpoint | Analysis | Panitumumab plus BSC | Best supportive care | Effect |
|---|---|---|---|---|
| PFSAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | — | — | HR 0.54 (95% CI 0.44–0.66)P<.0001Median progression-free survival was 8 weeks (95% CI 7.9 to 8.4) with panitumumab and 7.3 weeks (95% CI 7.1 to 7.7) with best supportive care; the schema records medians in months only, so the week values are given here. |
| ORRAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | 10% | 0% | P<.0001After a minimum follow-up of 12 months. |
| OSAll randomised patients (analysis population not stated in the abstract) | primaryVan 2007 | — | — | HR 1.00 (95% CI 0.82–1.22)The authors state the overall survival comparison was confounded by crossover: 76% of best-supportive-care patients entered the crossover study. |
| PFSPatients with wild-type KRAS tumours | exploratoryAmado 2008 | — | — | HR 0.45 (95% CI 0.34–0.59)Median progression-free survival in the wild-type KRAS group was 12.3 weeks with panitumumab and 7.3 weeks with best supportive care. KRAS status was ascertained in 427 (92%) of 463 patients (208 panitumumab, 219 best supportive care); KRAS mutations were found in 43%. The treatment effect on progression-free survival in the wild-type group differed significantly from the mutant group (P<.0001). |
| PFSPatients with mutant KRAS tumours | exploratoryAmado 2008 | — | — | HR 0.99 (95% CI 0.73–1.36) |
| ORRPatients with wild-type KRAS tumours treated with panitumumab | exploratoryAmado 2008 | 17% | — | — |
| ORRPatients with mutant KRAS tumours treated with panitumumab | exploratoryAmado 2008 | 0% | — | — |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| PFS | 0.54 | 0.44–0.66 |
| OS | 1 | 0.82–1.22 |
| PFS | 0.45 | 0.34–0.59 |
| PFS | 0.99 | 0.73–1.36 |
Appears in
Sources
Van Cutsem E, Peeters M, Siena S, Humblet Y, Hendlisz A, Neyns B, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol. 2007;25(13):1658-64.
Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008;26(10):1626-34.