Phase 2 N=45 Treatment

Radiochemotherapy With Panitumumab in the Localised Epidermoid Carcinoma of the Anus

Epidermoid Carcinoma · Anus

Bottom Line

View on ClinicalTrials.gov: NCT01581840 ↗

Enrolled (actual)

Serious AEs

31.1%

Results posted

Jul 2024

Primary outcome: Primary: Percentage of Patients With Complete Response to Treatment — 30; 10; 0; 4 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: radiochemotherapy (Drug); Panitumumab (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Federation Francophone de Cancerologie Digestive
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Patients With Complete Response to Treatment	27; 9; 1; 7	—
SECONDARY Percentage of Patients With Complete Response to Treatment	27; 9; 1; 7	—
SECONDARY 3 Years Colostomy-free Survival (CFS)	68.8	—
SECONDARY Recurrence-free Survival (RFS) at 3 Years	62.2	—
SECONDARY Overall Survival (OS) at 12 Months	95.6	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Presence of metastases
Previous anti-EGFR therapy
Stage T1N0 or T2 1.5 times the upper limit of the normal range, transaminase (ASAT and ALAT) > 2.5 times the upper limit of the normal range, creatinine clearance < 50 mL/min (Cockcroft's formula Appendix x), Mg2+ < the lower limit of the normal range, Ca2+ < the lower limit of the normal range
Significant coronary artery disease or myocardial infarction in the past year
Follow-up not possible due to psychological or geographic reasons
History of interstitial pneumonitis or pulmonary fibrosis
History of malignant disease in the past five years apart from basocellular skin carcinoma or in situ cervical carcinoma having received adequate treatment
Pregnant or breast-feeding women, women of child-bearing potential not having taken a pregnancy test.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01581840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.