| General information |
| Database: | DB00324 |
| Objective: | non small cell lung cancer (non small cell lung cancer) commonly expresses the epidermal growth factor receptor (EGFR), which is associated with poor clinical outcome. Cetuximab is a chimerized monoclonal antibody that targets the EGFR and, in preclinical models, it demonstrates radiosensitization properties. They report a phase II trial testing the combination of cetuximab with chemoradiotherapy (CRT) in unresectable stage III non small cell lung cancer. |
| Authors: | Blumenschein GR Jr, et al. |
| Title: | Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non small cell lung cancer: RTOG 0324. |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21555682 |
| Trial Design |
| Clinical Trial Id: | NCT00081302 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | unresectable stage III non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 3 |
| Therapeutic Combination Content: | cetuximab + chemoradiation |
| Study Type: | Phase II Study |
| Key Patients Feature: | patients were eligible if they were 18 years of age with untreated pathologically confirmed inoperable stage IIIA or IIIB non small cell lung cancer, weight loss of less than 5%over the 3 months before registration, a Zubrod performance status (PS) of 0 to 1, forced expiratory ventilation in 1 second 1, 200 cm3, measurable disease byResponse Evaluation Criteria in Solid Tumors (RECIST), and adequate organ(bone marrow, kidney, liver, heart) function.2 |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | Patients received an initial dose of cetuximab (400 mg/m(2)) on day 1 of week 1 and then weekly doses of cetuximab (250 mg/m(2)) until completion of therapy (weeks 2 through 17). During week 2, patients started CRT (63 Gy in 35 fractions) with weekly carboplatin at area under the [concentrationtime] curve (AUC) 2 and six doses of paclitaxel at 45 mg/m(2) followed by carboplatin (AUC 6) and two cycles of paclitaxel (200 mg/m(2)) during weeks 12 through 17. |
| Primary End Point: | the feasibility as measured by safety and compliance; |
| Secondary End Point: | the treatment response rate, overall survival (OS), and time to disease progression. |
| Patients Number: | 93 |
| Trial Results |
| DLT_MTD: | Adverse events related to treatment included 20% grade 4 hematologic toxicities, 8% grade 3 esophagitis, and 7% grade 3 to 4 pneumonitis. There were five grade 5 events |
| Objective Response Rate: | Response rate was 62% (n 54), median survival was 22.7 months, and 24month overall survivalwas 49.3% |
| Disease Control Rate: | 0.27 |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 55.2% (95% CI, 44.6% to 65.7%) |
| Median OS A vs. C: | The 24month survival rate was49.3%(95% CI, 38.3% to 59.3%), andMS was 22.7 months (95% CI, 15.3 to 30.4 months). |
| Adverse Event(agent arm): | Adverse events related to treatment included 20% grade 4 hematologic toxicities, 8% grade 3 esophagitis, and 7% grade 3 to 4 pneumonitis. There were five grade 5 events. |
| Conclusions: | The combination of cetuximab with CRT is feasible and shows promising activity. The median and overall survival achieved with this regimen they were longer than any previously reported by the Radiation Therapy Oncology Group. |