| General information |
| Database: | DB00792 |
| Objective: | Cetuximab has demonstrated improved efficacy in combination with chemotherapy and radiotherapy. they evaluated the integration of cetuximab in the combined modality treatment of stage III non small cell lung cancer (non small cell lung cancer). |
| Authors: | Ramalingam SS, et al |
| Title: | A multicenterphase II study of cetuximab in combination with chest radiotherapy and consolidation chemotherapy in patients with stage III non small cell lung cancer. |
| Journal: | Lung Cancer. |
| Year: | 2013 |
| PMID: | 23849982 |
| Trial Design |
| Clinical Trial Id: | NCT00492206 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | stage III non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | cetuximab + chest radiotherapy + consolidation chemotherapy |
| Study Type: | A multicenterphase II study |
| Key Patients Feature: | Patients with surgically unresectable stage IIIA or IIIB non small cell lung cancer |
| Biomarker: | EGFR gene copy number on baseline tumor tissues |
| Biomark Analysis: | EGFR gene copy number on baseline tumor tissues, analyzed by FISH, was not predictive of efficacy outcomes. |
| Control Group Info: | single arm |
| Treatment Info: | patients were treated with chest radiotherapy, 73.5 Gy (with lung and tissue heterogeneity corrections) in 35 fractions/7 weeks, once daily (63 Gy without heterogeneity corrections). Cetuximab was given weekly during radiotherapy and continued during consolidation therapy with carboplatin and paclitaxel up to a maximum of 26 weekly doses. |
| Primary End Point: | overall survival. |
| Secondary End Point: | NA |
| Patients Number: | 40 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 55% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 9.3 months (95% CI, 8.5-17.2) |
| Median OS A vs. C: | 19.4 months (95% CI, 15.4-26) |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of cetuximab to chest radiotherapy and consolidation chemotherapy was tolerated well and had modest efficacy in stage III non small cell lung cancer. Taken together with the lotheyr incidence of esophagitis, our results support evaluation of targeted agents instead of chemotherapy with concurrent radiotherapy in this setting. |