| General information |
| Database: | DB00337 |
| Objective: | a phase III trial demonstrated that cetuximab is the first agent in 30 years to improve survival when added to platinumbased chemotherapy (platinumfluorouracil) first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). This analysis of the trial assessed the impact of treatment on quality of life (QoL). |
| Authors: | Mes¨ªa R, et al |
| Title: | Quality of life of patients receiving platinumbased chemotherapy plus cetuximab first line for recurrent and/or metastatic squamous cell carcinoma of the head and neck. |
| Journal: | Ann Oncol. |
| Year: | 2010 |
| PMID: | 20335368 |
| 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: | platinumbased chemotherapy plus cetuximab |
| Study Type: | an analysis of results from a phase III study |
| Key Patients Feature: | Patients with histologically or cytologically confirmed recurrent and/ormetastatic SCCHN (excluding nasopharyngeal carcinoma) not suitable forlocal therapy and a Karnofsky performance score (KPS) of 70 |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:cetuximab + platinumfluorouracil B:platinumfluorouracil |
| Treatment Info: | The European Organisation for Research and Treatment of Cancer QoL QuestionnaireCore 30 (QLQC30) and QLQHead and Neck 35 (QLQH&N35) module were used to assess QoL. |
| Primary End Point: | the effects of treatment on overall survival. |
| Secondary End Point: | QoL |
| Patients Number: | 442 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | For QLQH&N35, the mean score for the cetuximab arm was not significantly worsethan that for the chemotherapy arm for all symptom scales at all postbaseline visits. At cycle 3, some symptom scoressignificantly favored the cetuximab arm (pain, swallowing, speech problems, and social eating). |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | NA |
| Conclusions: | Adding cetuximab to platinumfluorouracil does not adversely affect the QoL of patients with recurrent andor metastatic SCCHN. |