| General information |
| Database: | DB00347 |
| Objective: | In this randomized, phase III study, quality of life (QoL) was assessed in patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) after highdose radiotherapy alone or in combination with cetuximab. |
| Authors: | Curran D, et al |
| Title: | Quality of life in head and neck cancer patients after treatment with highdose radiotherapy alone or in combination with cetuximab. |
| Journal: | J Clin Oncol. |
| Year: | 2007 |
| PMID: | 17538164 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | EGFR
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | advanced nonmetastatic and measurable squamous cell carcinoma of the oropharynx, hypopharynx, or larynx |
| Therapy Type: | com |
| Therapeutic Combination Type: | 4 |
| Therapeutic Combination Content: | highdose radiotherapy alone or + cetuximab |
| Study Type: | multicenter, openlabel, stratified, randomized, phase IIIstudy |
| Key Patients Feature: | atients with stage III or IV nonmetastatic and measurable squamous cell carcinoma of theoropharynx, hypopharynx, or larynx were eligible |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | A:radiotherapy alone B: radiotherapy + cetuximab |
| Treatment Info: | QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQC30) and EORTC QLQ Head and Neck CancerSpecific Module at baseline, week 4, and at months 4, 8, and 12 postbaseline. |
| Primary End Point: | the duration of locoregional control |
| Secondary End Point: | overall survival and QoL. |
| Patients Number: | 424 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Radiotherapy/cetuximab significantly improved locoregional control (P = .005) and overall survival (P = .03) compared with radiotherapy alone, without significantly increasing radiotherapyassociated adverse events. The current analysis focused on the impact of cetuximab on the QoL. Compliance with completion of QoL questionnaires was high in both arms. QoL worsened during treatment and improved after cessation of treatment, reaching baseline levels at 12 months. There were no significant differences in QoL scores between the treatment arms. This was particularly notable for global health status/QoL, social functioning, social eating, and social contact. Pretreatment global health status/QoL was identified as a significant prognostic variable in these patients |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | NA |
| Median OS A vs. C: | 49.0 and 29.3 months (P=0 .03). |
| Adverse Event(agent arm): | NA |
| Conclusions: | The addition of cetuximab to radiotherapy significantly improved locoregional control and increased overall survival without adversely affecting QoL. |