| General information |
| Database: | DB00267 |
| Objective: | They investigated whether expression of epidermal growth factor receptor (EGFR) was associated with survival and disease control in this secondary analysis of a phase II trial of cetuximab+chemoradiation for stage III non small cell lung cancer. |
| Authors: | Komaki R, et al |
| Title: | EGFR expression and survival in patients given cetuximab and chemoradiation for stage III non small cell lung cancer: a secondary analysis of RTOG 0324. |
| Journal: | Radiother Oncol. |
| Year: | 2014 |
| PMID: | 25042878 |
| Trial Design |
| Clinical Trial Id: | NCT00081302 |
| 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+chemoradiation |
| Study Type: | a phase II trial |
| Key Patients Feature: | patients must have had histologically or cytologically documented stage III non small cell lung cancer with good performance status (Zubrod 0-1) and adequate hematologic, hepatic, and renal function. |
| Biomarker: | expression of epidermal growth factor receptor (EGFR) |
| Biomark Analysis: | EGFR protein expression was not related to pretreatment characteristics or OS; FISHpositive disease was associated with better performance status but not with OS, PFS, or TTP. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received cetuximab weekly before and during radiation (63 Gy/35 fractions/7 weeks) with weekly carboplatin + paclitaxel. They analyzed EGFR expression by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in pretreatment biopsy specimens and compared findings with overall and progression free survival (OS, PFS) and time to progression (TTP). |
| Primary End Point: | potential associations between EGFR expression and OS and disease progression after cetuximab and concurrent chemoradiation. |
| Secondary End Point: | NA |
| Patients Number: | 87 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | patients without IHC data had worse TTP [HR = 1.99, P = 0.01] than those with IHC data.FISHpositive disease was associated with better performance status but not with TTP. |
| Median PFS A vs. C: | patients without IHC data had worse PFS (HR = 1.88, P = 0.008) than those with IHC data; FISHpositive disease was associated with better performance status but not with PFS. |
| Median OS A vs. C: | patients without IHC data had worse OS (HR = 1.63, P = 0.05) than those with IHC data; EGFR protein expression was not related to pretreatment characteristics or OS; FISHpositive disease was associated with better performance status but not with OS. |
| Adverse Event(agent arm): | NA |
| Conclusions: | Surprisingly, outcomes differed not by EGFR expression but by the availability of samples for analysis, underscoring the importance of obtaining biopsy samples in such trials. |