Table 1.
Patient characteristics and cohorts in the CRYSTAL trial (NCT00154102)
| Treatment arm | Cohort FOLFIRI plus cetuximab | Cohort FOLFIRI alone |
|---|---|---|
| No. | Dataset CRC-FCHQ: 116 patients | Dataset CRC-FHQ: 129 patients |
| Dataset CRC-FCSD: 186 patients | Dataset CRC-FSD: 236 patients | |
| Tumor characteristics | ||
| Tumor type | CRC | CRC |
| Stage | Advanced | Advanced |
| Lesion(s) segmented | Liver metastases | Liver metastases |
| Clinical trial characteristics | ||
| Biomarker | KRAS* WT mutational status | KRAS* WT mutational status |
| Treatment regimen | ||
| Chemotherapy | FOLFIRI | FOLFIRI |
| Anti-EGFR | Cetuximab (anti-EGFR mAb) | None |
| Primary endpoint | ||
| Outcome | OS, PFS | OS, PFS |
| Sensitivity to anti-EGFR mAb | OS benefit compared with FOLFIRI alone | N/A |
| Time of completion of CT scans | Baseline and 8 weeks | Baseline or 8 weeks |
| Clinical trial no. | NCT00154102 | NCT00154102 |
*
KRAS status and not RAS status was evaluated post hoc in the CRYSTAL clinical trial. CRC = colorectal cancer; F = FOLFIRI; FC = FOLFIRI+cetuximab; HQ = High computed tomography quality; SD = Standard computed tomography quality; mAb = monoclonal antibody.