| General information |
| Database: | DB00353 |
| Objective: | To evaluate the efficacy and safety of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinumbased chemotherapy in patients with platinumrefractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | Baselga J, et al |
| Title: | Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinumbased chemotherapy in patients with platinumrefractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. |
| Journal: | J Clin Oncol. |
| Year: | 2005 |
| PMID: | 16009950 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab + platinumbased chemotherapy |
| Study Type: | Phase II Multicenter Study |
| Key Patients Feature: | patients were eligible for entry onto the study if they fulfilled the following criteria: age 18 years (19 years in Austria); Karnofskyperformance status (KPS) 60%; histologically confirmed diagnosis of stage III and IV SCCHN stage (according to AmericanJoint Committee on Cancer staging system); not candidates forlocal therapy; measurable disease; documented progressive disease(PD) after a minimum of two and a maximum of four cycles ofcisplatinbased ( 60 mg/m2/cycle) or carboplatinbased ( 250mg/m2/cycle) chemotherapy, with baseline disease being documented in the 30 days before the start of the platinumbasedregimen the patient was taking on study entry; tumor tissue available for immunohistochemical staining to demonstrate EGFRexpression; and adequate hematologic, renal, and hepatic function. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | patients received cetuximab (initial dose of 400 mg/m2 followed by subsequent weekly doses of 250 mg/m2) followed by platinum chemotherapy at the same dose and schedule at which progressive disease was documented before entry onto the study. |
| Primary End Point: | the response rate; |
| Secondary End Point: | time to response, duration of response, time to progression, overall survival, symptomatic changes, changes in KPS, and quality of life. |
| Patients Number: | 96 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | The response rate, based on an independently read assessment, in the intenttotreatpopulation was 10%, with a disease control rate (complete response, partial response [PR], and stable disease) of 53%. |
| Disease Control Rate: | 0.53 |
| Median Time to Progression: | The median TTP for the 3 and 4week cycles were 88 days (95% CI, 72 to 154 days) and 65 days (95% CI, 55 to 115 days), respectively. |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | The median OS times for the 3 and 4week cycles were 191 days (95% CI, 158 to 247 days) and 179 days (95% CI, 132 to 212 days), respectively. |
| Adverse Event(agent arm): | Treatment was well tolerated. The most common cetuximabrelated adverse events were skin reactions, particularly an acnelike rash. |
| Conclusions: | The combination of cetuximab and platinum chemotherapy is an active and welltolerated approach to the treatment of this poorprognosis patient population with platinumrefractory recurrent or metastatic SCCHN for whom there are no recommended standard therapeutic options. |