ORBi: Hubert Pascale - Phase I/IIclinical trial of local GM-CSF application in patients with cervical HPV-associated low grade squamous intraepithelial lesions

Reference : Phase I/IIclinical trial of local GM-CSF application in patients with cervical HPV-assoc...


	Document type :	Scientific congresses and symposiums : Unpublished conference
	Discipline(s) :	Human health sciences : Reproductive medicine (gynecology, andrology, obstetrics)
	To cite this reference:	http://hdl.handle.net/2268/70232

Title :	Phase I/IIclinical trial of local GM-CSF application in patients with cervical HPV-associated low grade squamous intraepithelial lesions
Language :	English
Author, co-author :	Hubert, Pascale [Université de Liège - ULg > Département des sciences biomédicales et précliniques > Anatomie et cytologie pathologiques >]
	Doyen, Jean [Université de Liège - ULg > > Gynécologie-Obstétrique CHR >]
	Chapelle, X. [ > > ]
	Evrard, Brigitte [Université de Liège - ULg > Département de pharmacie > Pharmacie galénique >]
	Gerday, Colette [Université de Liège - ULg > > Gynécologie-Obstétrique CHR >]
	Boniver, Jacques [Université de Liège - ULg > Département des sciences biomédicales et précliniques > Anatomie et cytologie pathologiques >]
	Foidart, Jean-Michel [Université de Liège - ULg > Département des sciences cliniques > Gynécologie - Obstétrique - Labo de biologie des tumeurs et du développement >]
	Jacobs, Nathalie [Université de Liège - ULg > Département des sciences biomédicales et précliniques > Anatomie et cytologie pathologiques >]
Publication date :	2007
Audience :	International
Event name :	24th International Papillomavirus Conference and Clinical Workshops
Event date :	3-7 novembre 2007
Event place (city) :	Bejing
Event country :	China
Abstract :	[en] Background: Quantitative and functional alterations of professional antigen-presenting cells (APC) in SIL suggest that these lesions may have a diminished capacity to capture viral antigens. Moreover, GM-CSF (whose production is decreased in HPV-transformed keratinocytes) is an essential factor for the migration of APC in cervical (pre)neoplastic lesions formed in vitro and transplanted in vivo on mouse. In this study we performed a phase I/II clinical trial in order to determine whether a local application of GM-CSF on cervical low-grade squamous intraepithelial lesions (LSIL) might increase the recruitment of APC into the epithelium and indirectly the viral antigen presentation to the immune system. Methods: Fifteen patients with LSIL (10 GM-CSF and 5 placebo) were enrolled in this study. Patients received 4 GM-CSF applications (or placebo gel) and were followed during 6-7 months. APC infiltration was quantified by immunostaining with anti-CD1a mAb. Cellular immune response was evaluated by using an IFN-gamma intracellular staining on PBMC stimulated in vitro with the E7 HPV16 protein and L1 HPV16 Virus-like particles (VLP). Hybrid capture was performed to semi-quantify the viral DNA in cervical brush specimens. Results: GM-CSF applications were well tolerated in all patients. No difference in the cytological/histological and viral parameters assessed at 2 and 6 months after the last application was observed between the GM-CSF and the placebo group. An increased number of CD1a+ APC was observed in 6/10 patients treated by GM-CSF compared to 1/5 patient in the placebo group. There was an increased immune response against HPV in the GM-CSF group showed by NK and T cells producing IFN-gamma.
Funders :	Région wallonne : Direction générale des Relations extérieures - DGRE ; Fonds de la Recherche Scientifique (Communauté française de Belgique) - F.R.S.-FNRS
Target :	Researchers ; Students
Permalink :	http://hdl.handle.net/2268/70232

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