| General information |
| Database: | DB00281 |
| Objective: | To investigate the safety and activity of cetuximab in the preoperative treatment of squamous cell carcinoma of the head and neck (SCCHN). |
| Authors: | Schmitz S, et al |
| Title: | Tumour response and safety of cetuximab in a window preoperative study in patients with squamous cell carcinoma of the head and neck. |
| Journal: | Ann Oncol. |
| Year: | 2013 |
| PMID: | 23704200 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a singleinstitution, openlabel noncomparative study |
| Key Patients Feature: | Eligible patients were required to have an untreated histologically proven T1T4 SCC of the oral cavity, oropharynx, hypopharynx or larynx and ECOG performance status 0-1. Patients had to be selected for primary surgical treatment with curative intent following multidisciplinary discussion. |
| Biomarker: | (18)FDGPET; Delta maximal standardized uptake values (¦¤SUVmax); pEGFR and pERK |
| Biomark Analysis: | For patients with ¦¤SUVmax less than 25% or less than 50%, Ki67 was significantly decreased by cetuximab (P = 0.01 and 0.003). Cetuximab induced downregulation of pEGFR (P = 0.0004) and pERK (P = 0.003). |
| Control Group Info: | 5 untreated patients were included as controls. |
| Treatment Info: | Cetuximab was administered for 2 weeks before surgery to 33 treatmentna ve patients selected for primary surgical treatment. Tumour biopsies, 2[fluorine18]fluoro2deoxydglucose positron emission tomography ((18)FDGPET) and imaging were carried out at baseline and before surgery. |
| Primary End Point: | safety |
| Secondary End Point: | metabolical, radiological and pathological tumour response. |
| Patients Number: | 33 |
| Trial Results |
| DLT_MTD: | Cetuximab given 24 h before surgery was safe. |
| Objective Response Rate: | 90% of patients had (18)FDGPET partial response (EORTC guideline) in the cetuximab group versus 0% in the control group. Delta maximal standardized uptake values (¦¤SUVmax) were correlated with tumour cellularity on the surgical specimens (P < 0.0001). For patients with ¦¤SUVmax less than 25% or less than 50%, Ki67 was significantly decreased by cetuximab (P = 0.01 and 0.003). Cetuximab induced downregulation of pEGFR (P = 0.0004) and pERK (P = 0.003). |
| 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: | Shortcourse preoperative administration of cetuximab is safe and shows a high rate of (18)FDGPET response. (18)FDGPET response was correlated with residual tumour cellularity suggesting that (18)FDGPET deserves further investigation as a potential early marker of cetuximab activity in SCCHN. |