| General information |
| Database: | DB00944 |
| Objective: | Patients with advanced pancreas cancer present with disease that is poorly responsive to conventional therapies. Preclinical and early clinical evidence has supported targeting the epidermal growth factor receptor (EGFR) signaling pathway in patients with pancreas cancer. This trial was conducted to evaluate the contribution of an EGFRtargeted agent to standard gemcitabine therapy. Cetuximab is a monoclonal antibody against the ligandbinding domain of the receptor. |
| Authors: | Philip PA, et al |
| Title: | Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Souththeyst Oncology Groupdirected intergroup trial S0205. |
| Journal: | J Clin Oncol. |
| Year: | 2010 |
| PMID: | 20606093 |
| Trial Design |
| Clinical Trial Id: | NCT00075686 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | pancreatic cancer |
| Cancer Subtype: | advanced pancreatic cancer. |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | gemcitabine + cetuximab |
| Study Type: | Phase III study |
| Key Patients Feature: | Patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | gemcitabine plus cetuximab versus gemcitabine |
| Treatment Info: | patients were randomly assigned to receive gemcitabine alone or gemcitabine plus cetuximab. |
| Primary End Point: | overall survival. |
| Secondary End Point: | progression free survival, time to treatment failure, objective response, and toxicity. |
| Patients Number: | 745 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 14% of patients treated with gemcitabine alone compared with 12% of patients treated with the combination. |
| Disease Control Rate: | 44% and 49% of patients who received gemcitabine alone and the combination, respectively. |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.0 months on the gemcitabine arm and 3.4 months on the gemcitabine plus cetuximab arm (HR = 1.07; 95% CI, 0.93 to 1.24; P = .18). |
| Median OS A vs. C: | 6.3 months for the gemcitabine plus cetuximab arm v 5.9 months for the gemcitabine alone arm; hazard ratio = 1.06; 95% CI, 0.91 to 1.23; P = .23, onesided |
| Adverse Event(agent arm): | Seven hundred sixteen patients were evaluable for toxicity assessment. Table 3 compares the frequency of adverse events between the two arms of the study. Sixteen percent and 11% of patients experienced grade 4 or 5 toxicities on the gemcitabine plus cetuximab and gemcitabine alone arms, respectively. Eight grade 5 toxicities were reported, seven on the gemcitabine plus cetuximab arm and one on the gemcitabine arm. |
| Conclusions: | In patients with advanced pancreas cancer, the antiEGFR monoclonal antibody cetuximab did not improve the outcome compared with patients treated with gemcitabine alone. Alternate targets other than EGFR should be evaluated for new drug development. |