| General information |
| Database: | DB00313 |
| Objective: | The primary objective of this study was to evaluate the response rate of 2 separate doses of cetuximab as monotherapy in patients with recurrent or metastatic HNSCC. The secondary objectives of this study were to determine the disease control rate, OS, PFS, safety, and tolerability |
| Authors: | Fury MG, et al |
| Title: | A randomizedphase II study of cetuximab every 2 weeks at either 500 or 750 mg/m2 for patients with recurrent or metastatic head and neck squamous cell cancer. |
| Journal: | J Natl Compr Canc Netw. |
| Year: | 2012 |
| PMID: | 23138167 |
| 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: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | Randomizedphase II |
| Key Patients Feature: | (less than and equal to 2 prior cytotoxic chemotherapy regimens for recurrent or metastatic disease; ECOG performance status less than and equal to 2) |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | cetuximab q2w at 500 mg/m2 (Group A); 750 mg/m2 (Group B) |
| Treatment Info: | pts were randomized to receive cetuximab q2w at 500 mg/m(2) (Group A) or 750 mg/m(2) (Group B). |
| Primary End Point: | response rate (RECIST 1.0). |
| Secondary End Point: | NA |
| Patients Number: | 61 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Median progression free survival (PFS) and median overall survival (OS) were similar for both groups (PFS, 2.2 and 2.0 months; OS, 7.0 and 9.4 months; Groups A and B, respectively). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2.2 and 2.0 months Groups A and B, respectively |
| Median OS A vs. C: | 7.0 and 9.4 months; Groups A and B, respectively |
| Adverse Event(agent arm): | The most common cetuximabrelated adverse events (all grades) among treated subjects included rash, fatigue, and hypomagnesemia. |
| Conclusions: | Partial responses occurred only among patients whose primary tumors were in the oral cavity or larynx. Median progression free survival (PFS) and median overall survival (OS) were similar for both groups (PFS, 2.2 and 2.0 months; OS, 7.0 and 9.4 months; Groups A and B, respectively). The most common cetuximabrelated adverse events (all grades) among treated subjects included rash, fatigue, and hypomagnesemia. Cetuximab, 500 mgm2, q2w achieves similar efficacy as conventional dosing for patients with recurrent or metastatic HNSCC. Escalating the dose to 750 mgm2?q2w offers no obvious therapeutic advantage. |