| General information |
| Database: | DB00027 |
| Objective: | To determine whether adding cetuximab to irinotecan prolongs survival in patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin |
| Authors: | Sobrero AF, et al |
| Title: | EPIC:phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. |
| Journal: | J Clin Oncol |
| Year: | 2008 |
| PMID: | 18390971 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | colorectal cancer |
| Cancer Subtype: | advanced colorectal cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab+irinotecan |
| Study Type: | a multicenter, openlabel, phase III study |
| Key Patients Feature: | patients with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine and oxaliplatin |
| Biomarker: | epidermal growth factor receptorexpressing |
| Biomark Analysis: | as in the conclusion |
| Control Group Info: | irinotecan alone |
| Treatment Info: | randomly assigned patients with epidermal growth factor receptorexpressing mCRC who had experienced firstline fluoropyrimidine and oxaliplatin treatment failure to cetuximab (400 mg/m(2) day 1 followed by 250 mg/m(2) weekly) plus irinotecan (350 mg/m(2) every 3 weeks) or irinotecan alone |
| Primary End Point: | overall survival (OS); |
| Secondary End Point: | progression free survival (PFS), response rate (RR), and quality of life (QOL). |
| Patients Number: | 1298 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | RR (16.4% v 4.2%; P <0.0001) |
| Disease Control Rate: | NA |
| Median Time to Progression: | resulted in significantly better scores in the QOL analysis of global health status (P =0.047). |
| Median PFS A vs. C: | Cetuximab added to irinotecan significantly improved PFS (median, 4.0 v 2.6 months; HR, 0.692; 95% CI, 0.617 to 0.776; P |
| Median OS A vs. C: | Median OS was comparable between treatments: 10.7 months (95% CI, 9.6 to 11.3) with cetuximab/irinotecan and 10.0 months (95% CI, 9.1 to 11.3) with irinotecan alone (hazard ratio [HR], 0.975; 95% CI, 0.854 to 1.114; P = .71). This lack of difference may have been due to posttrial therapy: 46.9% of patients assigned to irinotecan eventually received cetuximab (87.2% of those who did, received it with irinotecan). |
| Adverse Event(agent arm): | Cetuximab did not exacerbate toxicity, except for acneform rash, diarrhea, hypomagnesemia, and associated electrolyte imbalances. Neutropenia was the most common severe toxicity across treatment arms. |
| Conclusions: | Cetuximab and irinotecan improved PFS and RR, and resulted in better QOL versus irinotecan alone. OS was similar bettheyen study groups, possibly influenced by the large number of patients in the irinotecan arm who received cetuximab and irinotecan poststudy. |