| General information |
| Database: | DB01021 |
| Objective: | Use of cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), has the potential to increase survival in patients with advanced non small cell lung cancer. they therefore compared chemotherapy plus cetuximab with chemotherapy alone in patients with advanced EGFRpositive non small cell lung cancer |
| Authors: | Pirker R, et al |
| Title: | Cetuximab plus chemotherapy in patients with advanced non small cell lung cancer (FLEX): an openlabel randomisedphase III trial. |
| Journal: | Lancet. |
| Year: | 2009 |
| PMID: | 19410716 |
| Trial Design |
| Clinical Trial Id: | NCT00148798 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | non small cell lung cancer |
| Cancer Subtype: | advanced non small cell lung cancer |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab+chemotherapy |
| Study Type: | a multinational, multicentre, openlabel, phase III trial |
| Key Patients Feature: | chemotherapynaive patients (>or=18 years) with advanced EGFRexpressing histologically or cytologically proven stage theyt IIIB or stage IV non small cell lung cancer |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | chemotherapy plus cetuximab versus chemotherapy |
| Treatment Info: | patients were randomly assigned in a 1:1 ratio to chemotherapy plus cetuximab or just chemotherapy. Chemotherapy was cisplatin 80 mg/m(2) intravenous infusion on day 1, and vinorelbine 25 mg/m(2) intravenous infusion on days 1 and 8 of every 3week cycle) for up to six cycles. Cetuximabat a starting dose of 400 mg/m(2) intravenous infusion over 2 h on day 1, and from day 8 onwards at 250 mg/m(2) over 1 h per weekwas continued after the end of chemotherapy until disease progression or unacceptable toxicity had occurred |
| Primary End Point: | overall survival. Analysis was by intention to treat. |
| Secondary End Point: | NA |
| Patients Number: | 1125 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | chemotherapy and cetuximab vs. chemotherapy alone36% vs 29% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 4.8 months in both groups (4.2-5.3 for chemotherapy plus cetuximab, 4.4-5.4 for chemotherapy alone |
| Median OS A vs. C: | 11.3 months (9.4-12.4) in the chemotherapypluscetuximab group and 10.1 months (9.1-10.9) in the chemotherapy alone group |
| Adverse Event(agent arm): | The safety profiles of the study treatment combinations were consistent with the known pattern of sideeffects of the individual agents used. As expected with an antiEGFR antibody, acnelike skin rash grade 3 (10% vs <1%), diarrhoea grades 3 and 4 (5% vs 2%), and infusionrelated reactions grades 3 and 4 (4% vs <1%) were more common in patients given chemotherapy plus cetuximab. Similar proportions of patients had neutropenia and febrile neutropenia grade 4 in the two groups ( table 2). Grade 3 and 4 sepsis was more common in the chemotherapypluscetuximab group. however, treatmentrelated deaths were similar in both groups (15 [3%] of 548 vs 10 [2%] of 562). |
| Conclusions: | Addition of cetuximab to platinumbased chemotherapy represents a new treatment option for patients with advanced non small cell lung cancer. |