الفهرس 
MOLECULAR BIOLOGY
STAGINGOnly 14 pages are availabe for public view
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Abstract
SUMMARY AND CONCLUSION
Purpose:
T
he target of this study is to evaluate the preliminary efficacy and toxicity of a regimen combining targeted therapy in the form of cetuximab with an estsablished cisplatin-radiotherapy regimen for patients with locally advanced Head and neck squamous cell carcinoma.
Patients and materials:
Fifty patients with LA-HNC were recruited aiming at cure. IMRT was combined with cisplatin (30 mg/m2/week) and cetuximab (standard weekly regimen) therapy. The study was single armed but we divided our patients to different strata for extensive statistical analyses.
Results
Fifty patients were accrued in this study between December 2006 and April 2009 with last follow up in October 2010. Follow up ranged from 3 to 40 months, with a median of 22 months +/-8 month., Stage III patients were 6/50: 12%, while stage IV was 44/50: 88% , Patients with oropharyngeal carcinoma were 23/50 ; 46%, laryngeal carcinoma 16/50; 32%, hypopharyngeal carcinoma 11/50; 22%. All patients were evaluable for response, survival and toxicity. The response and survival were analysed according to different patient stratification including age, race, performance status as well tumor site, stage and grade.
The overall response rate was 72% (CR:28/50; 56%), (PR: 8/50; 16%) and median PFS was of 31 month and 2 year PFS rate of 69% while the median was 40 month with a 2 year OAS of 82.15%. In regard to acute toxicity mucositis was encountered in 58%,: 29/50; radiation dermatitis in 36% ;18/50 and acneform rash in 20%: 10/50. While in late toxicity weight loss was 18%;9/50, dyshphagia was 12%;6/50, and neck fibrosis was 12%; 6/50.
Conclusions:
This study showed that the weekly administration of cisplatin and cetuximab was safely combined with IMRT. It was well tolerated with acceptable toxicity profile and medically manageable side effects, with relatively similar response rate and survival to the previously reported similar studies.
The study also denotes that the principal itself is effective but more data has to be collected in order to alleviate the expected toxicity of such a regimen to achieve better quality of life.