Phase I-II on Radiochemotherapy Combined With Panitumumab in the Treatment of Localised Epidermoid Carcinoma of the Anus
Treatment is based on radiochemotherapy for locally advanced tumours. The objective of treatment is to provide a cure without resorting to abdominoperineal amputation, while preserving sphincter function. The prognosis is mainly related to tumour size and lymph node invasion. The large majority of patients do not show any spread remote from the tumour at the time of diagnosis (2). Recurrences are mainly of a local/regional nature and require abdominoperineal amputation. This type of intervention is not always possible or complete, which then gives rise to the particularly distressing risk of local progression, with survival at 3 years of approximately 30% (3). It is therefore very important to achieve a complete and permanent tumour response from initial treatment with radiochemotherapy. Furthermore, the use of an anti-EGFR antibody in combination with exclusive radiotherapy in ENT cancer was able to increase recurrence-free survival and overall survival in these patients. These data are in favour of the use of a combination of chemotherapy and anti-EGFR antibodies in epidermoid cancer of the anus.
• Histologically proven epidermoid carcinoma of the anus
• Locally advanced tumour without metastases
• Stage T2\>3 cm or T3 or T4, irrespective of N
• Stage N1-N3 irrespective of T stage (T1 to T4)
• General condition WHO 0-1
• Life expectancy \> 3 months
• Signed informed consent form
• Age \> 18 years
• Effective contraception in female and/or male patients having reached sexual maturity during treatment and up to 6 months after the end of treatment
• CD4 \> 400 / mm3
• Measureable tumor on at least one of the following exams : MRI, endoscopic ultrasonography, clinical exam