| General information |
| Database: | DB00319 |
| Objective: | The efficacy and safety of a novel combination of weekly paclitaxel and the epidermal growth factor receptor (EGFR) monoclonal antibody cetuximab for the firstline treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck were investigated. |
| Authors: | Hitt R, et al |
| Title: | Phase II study of the combination of cetuximab and weekly paclitaxel in the firstline treatment of patients with recurrent and/or metastatic squamous cell carcinoma of head and neck. |
| Journal: | Ann Oncol. |
| Year: | 2012 |
| PMID: | 21865152 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced head and neck squamous cell carcinoma |
| Therapy Type: | com |
| Therapeutic Combination Type: | 2 |
| Therapeutic Combination Content: | cetuximab and weekly paclitaxel |
| Study Type: | phase II study |
| Key Patients Feature: | Patients >18 years of age with histologically confirmed recurrent/metastatic squamous cell carcinoma of the larynx, pharynx and oralcavity and associated organs considered to be unlikely to derivesignificant benefit from conventional treatment (platinumbasedchemotherapy) were enrolled. Other eligibility criteria included:measurable disease (using RECIST), Karnofsky performance status (KPS) 70% and adequate hematologic, hepatic and renal functions. Priorsystemic chemotherapy was allowed if given as part of a multimodaltreatment of locally advanced disease, completed >6 months before studyentry |
| Biomarker: | EGFR expression or EGFR gene copy number |
| Biomark Analysis: | No association between tumor EGFR expression or EGFR gene copy number and response or survival was found. |
| Control Group Info: | single arm |
| Treatment Info: | Patients received paclitaxel (80 mg/m(2)) and cetuximab (400/250 mg/m(2)), weekly, until disease progression or unacceptable toxicity. |
| Primary End Point: | the objective tumor response rate. |
| Secondary End Point: | the duration of response, progression free survival (PFS), overall survival and safety. |
| Patients Number: | 46 |
| Trial Results |
| DLT_MTD: | Common grade 3/4 adverse events were acnelike rash (24%), asthenia (17%) and neutropenia (13%). |
| Objective Response Rate: | the overall response rate was 54% [95% confidence interval (CI) 39% to 69%], with 10 (22%) complete responses and a disease control rate of 80%. |
| Disease Control Rate: | 80%. |
| Median Time to Progression: | 4.2 (95% CI 2.95.5 months) |
| Median PFS A vs. C: | 8.1 months (95% CI 6.69.6 months). FISHnegative tumors vs FISHpositive tumors(3.8 versus 3.3 months, P = 0.874) |
| Median OS A vs. C: | 8.1 months (95% CI 6.6-9.6 months) . FISHnegative tumors vs FISHpositive tumors(7.3 versus 3.3 months, P = 0.796). |
| Adverse Event(agent arm): | Common grade 3/4 adverse events were acnelike rash (24%), asthenia (17%) and neutropenia (13%). Prior chemotherapy and the development of acnelike rash were associated with tumor response but not survival. No association between tumor EGFR expression or EGFR gene copy number and response or survival was found. |
| Conclusions: | The combination of cetuximab and weekly paclitaxel was active and well tolerated by these poor prognosis patients and may be an option for the treatment of medically unfit patients, particularly those for whom platinum is contraindicated. |