| General information |
| Database: | DB00795 |
| Objective: | Inhibitors of the epidermal growth factor receptor (EGFR) tyrosine kinase have demonstrated modest anticancer activity in advanced bronchioloalveolar carcinoma (BAC). they conducted a phase II study to evaluate cetuximab for the treatment of advanced BAC. |
| Authors: | Ramalingam SS, et al |
| Title: | Cetuximab for the treatment of advanced bronchioloalveolar carcinoma (BAC): an Eastern Cooperative Oncology Groupphase II study (ECOG 1504). |
| Journal: | J Clin Oncol. |
| Year: | 2011 |
| PMID: | 21422434 |
| Trial Design |
| Clinical Trial Id: | NCT00103207 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | lung cancer |
| Cancer Subtype: | advanced bronchioloalveolar carcinoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II study |
| Key Patients Feature: | Patients with advancedstage pure BAC or adenocarcinoma with BAC features, fetheyr than two prior chemotherapy regimens, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 were eligible. |
| Biomarker: | EGFR and KRAS mutations |
| Biomark Analysis: | Only one of the six patients with an EGFR mutation and one of the seven patients with a KRAS mutation had a partial response. |
| Control Group Info: | single arm |
| Treatment Info: | Cetuximab was given as a weekly intravenous infusion at 250 mg/m(2) after an initial loading dose of 400 mg/m(2) in week 1. |
| Primary End Point: | determination of response rate. |
| Secondary End Point: | NA |
| Patients Number: | 68 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | 7% |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 3.3 months |
| Median OS A vs. C: | 17.9 months (95% CI, 10.6 to 31.5 months) and 13 months (95% CI, 8 to 24 months) respectively for patients with pathology confirmation and all treated patients represents the PFS outcomes with cetuximab therapy. |
| Adverse Event(agent arm): | Twentyfour patients had grade 3 toxicity and three patients had grade 4 toxicities. The most common toxicity was skin rash (15%; grade 3). Twentysix percent of the patients had grade 1 or 2 hypomagnesemia. |
| Conclusions: | Cetuximab was associated with modest efficacy in patients with advanced BAC, despite a low response rate. EGFR and KRAS mutations were not predictive of response to cetuximab. |