| General information |
| Database: | DB00269 |
| Objective: | To report results of a randomizedphase II trial (Radiation Therapy Oncology Group RTOG0234) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with highrisk pathologic features. |
| Authors: | Harari PM, et al |
| Title: | Postoperative chemoradiotherapy and cetuximab for highrisk squamous cell carcinoma of the head and neck: Radiation Therapy Oncology Group RTOG0234. |
| Journal: | J Clin Oncol. |
| Year: | 2014 |
| PMID: | 25002723 |
| Trial Design |
| Clinical Trial Id: | NCT00084318 |
| Agent: | cetuximab
|
| Target: | Epidermal growth factor receptor
|
| Cancer Type: | head and neck cancer |
| Cancer Subtype: | squamous cell carcinoma of the head and neck |
| Therapy Type: | com |
| Therapeutic Combination Type: | 6 |
| Therapeutic Combination Content: | postoperative chemoradiotherapy + cetuximab |
| Study Type: | a randomizedphase II trial (Radiation Therapy Oncology Group RTOG0IIIII4) |
| Key Patients Feature: | Eligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases. |
| Biomarker: | p16 status |
| Biomark Analysis: | Patients with p16positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16negative oropharynx tumors. HPV |
| Control Group Info: | radiotherapy plus either cisplatin(arm A) or docetaxel(arm B) |
| Treatment Info: | patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m(2) or docetaxel 15 mg/m(2) once per week. |
| Primary End Point: | diseasefree survival (DFS). |
| Secondary End Point: | overall survival (OS), locoregional failure, and distant metastasis (DM). |
| Patients Number: | 238 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | 2year DFS was 57% and 66%, respectively. DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG9501 trial (Phase III Intergroup Trial of Surgery followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck), which had a hazard ratio of 0.76 for the cisplatin arm versus control (P = .05) and 0.69 for the docetaxel arm versus control (P = .01), reflecting absolute improvement in 2year DFS of 2.5% and 11.1%, respectively. |
| Median OS A vs. C: | 2year overall survival (OS) was 69% for the cisplatin arm and 79% for the docetaxel arm; |
| Adverse Event(agent arm): | Grade 3 to 4 myelosuppression was observed in 28% of patients in the cisplatin arm and 14% in the docetaxel arm; mucositis was observed in 56% and 54%, respectively. |
| Conclusions: | The delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity. The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in aphase IIIII trial. |