Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy.
Fiche publication
Date publication
février 2011
Auteurs
Membres identifiés du Cancéropôle Est :
Pr BALDAUF Jean-Jacques, Pr CLAVEL Christine, Dr DALSTEIN Véronique, Pr DOUVIER Serge
Tous les auteurs :
Brun JL, Dalstein V, Leveque J, Mathevet P, Raulic P, Baldauf JJ, Scholl S, Huynh B, Douvier S, Riethmuller D, Clavel C, Birembaut P, Calenda V, Baudin M, Bory JP
Lien Pubmed
Résumé
OBJECTIVE: We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16-related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months. STUDY DESIGN: In all, 21 patients with HPV 16-related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy. RESULTS: Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA +/- DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up. CONCLUSION: These promising data warrant further development of TG4001 in CIN 2/3 treatment.
Référence
Am J Obstet Gynecol. 2011 Feb;204(2):169.e1-8.