| General information |
| Database: | DB00265 |
| Objective: | Treatment with cisplatin or cetuximab combined with radiotherapy each yield superior survival in locally advanced squamous cell head and neck cancer (LASCCHN) compared with radiotherapy alone. Eastern Cooperative Oncology Group Trial E3303 evaluated the triple combination. |
| Authors: | Egloff AM, et al |
| Title: | Phase II study of cetuximab in combination with cisplatin and radiation in unresectable, locally advanced head and neck squamous cell carcinoma: Eastern cooperative oncology group trial E3303. |
| Journal: | Clin Cancer Res. |
| Year: | 2014 |
| PMID: | 25107914 |
| Trial Design |
| Clinical Trial Id: | NCT00096174 |
| 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: | 3 |
| Therapeutic Combination Content: | Cetuximab +Cisplatin + Radiation |
| Study Type: | a phase II study |
| Key Patients Feature: | Eligible patients had pathologically confirmed stage IV, unresectable locally advanced SCCHN (LASCCHN) (excluding nasopharynx, paranasal sinus, parotid gland). Eligibility also required ECOG performance status (PS) of 0-1 and adequate hematologic, hepatic and renal function. |
| Biomarker: | Patient tumor and blood correlates, including tumor human papillomavirus (HPV) status. |
| Biomark Analysis: | HPV was evaluable in 29 tumors; 10 (all oropharyngeal) were HPV positive. HPV(+) patients had significantly longer OS and PFS (P = 0.004 and P = 0.036, respectively). |
| Control Group Info: | single arm |
| Treatment Info: | pts received a loading dose of cetuximab (400 mg/m(2)) followed by 250 mg/m(2)/week and cisplatin 75 mg/m(2) q 3 weeks ¡Á3 cycles concurrent with standard fractionated radiotherapy. In the absence of disease progression or unacceptable toxicity, patients continued maintenance cetuximab for 6 to 12 months. |
| Primary End Point: | 2year PFS rate. |
| Secondary End Point: | OS, response rate (RR), and toxicity. |
| Patients Number: | 69 |
| Trial Results |
| DLT_MTD: | NA |
| Objective Response Rate: | Response rate was 66.7%. |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | Median PFS was 19.4 months, 2year PFS 47% [95%(CI), 33%61%]. HPV(+) patients had significantly longer PFS (P = 0.036). |
| Median OS A vs. C: | Twoyear overall survival (OS) was 66% (95% CI, 53%77%); median OS was not reached. Only tumor HPV status was significantly associated with survival. HPV(+) patients had significantly longer OS (P = 0.004). |
| Adverse Event(agent arm): | Most common grade more than and equal to 3 toxicities included mucositis (55%), dysphagia (46%), and neutropenia (26%); one attributable grade 5 toxicity occurred. |
| Conclusions: | Concurrent cetuximab, cisplatin, and radiotherapy they were well tolerated and yielded promising 2year PFS and OS in LASCCHN with improved survival for patients with HPV(+) tumors. |