Quelle: Fachblatt The Lancet
THE LANCET: Press Release
(PATRICIA trial): FINAL
The final analysis of the PATRICIA
study shows that the
The study looked at women aged 15-25 years who were vaccinated at months 0, 1, and 6. Analyses were done in the according-to-protocol cohort for efficacy (ATP-E, which included all women who were given 3 vaccine doses, had normal pap smears or pap smears showing mild abnormalities at baseline, complied with the protocol and were evaluable for the primary endpoint; vaccine=8093, control=8069), the total vaccinated cohort (TVC, included all women who received at least one vaccine dose, regardless of their baseline HPV status; represents young sexually active population; vaccine=9319, control=9325), and TVC-naïve (no evidence of oncogenic HPV infection at baseline; represents women before sexual debut, vaccine=5822, control=5819).
The primary endpoint was to assess vaccine against cervical intraepithelial neoplasia 2+ (CIN2+)—the precancerous lesions that can eventually lead to full-blown cervical cancer.
The mean follow-up was just under three
years after the third dose.
Vaccine efficacy against CIN2+ that was associated with HPV-16/18
was 93% in the primary analysis and 98% in an analysis in which
causality to HPV type was assigned in lesions infected with multiple
oncogenic types. Vaccine efficacy against CIN2+ irrespective of
HPV type detected in lesions was 30% in the TVC and 70% in the TVC-naïve.
Corresponding values against CIN3+ (more serious precancer) were
33% in TVC and 87% in TVC-naïve, indicating the larger contribution
of HPV-16/18 to The vaccine was also shown to be protective against
other oncogenic (cancer causing) HPV types – most notably
HPV-31 (related to HPV-16) and HPV-45 (related to HPV-18).
The authors say: “The reduction in the number of lesions in the TVC and TVC-naïve was accompanied by a significant proportional reduction in the numbers of colposcopy referrals and cervical excision procedures. Reduction in the number of cervical excision procedures might be accompanied by a reduction in the numbers of preterm births and other adverse pregnancy outcomes because these outcomes have been shown to be associated with the treatment of CIN.”
The authors note the strengths and weaknesses
of the study. The strengths include its duration and size, plus
the diversity of the participants, which included a broadly representative
group of women from North America, Latin America, Europe, and Asia-Pacific
regions. However Africa and some other regions were not included,
but trials have since begun in these areas.
The authors conclude: “The HPV-16/18 AS04-adjvanted vaccine showed high efficacy against CIN2+ that was associated with HPV-16/18 and non-vaccine oncogenic HPV types, and substantial overall effect in cohorts that are relevant to universal mass vaccination and catch-up programmes.
“Although the importance of continued tests for pap or HPV in vaccinated and unvaccinated women must be emphasised, HPV vaccination has the potential to substantially reduce the incidence of cervical cancer and precancer, and the numbers of colposcopy referrals and cervical excision procedures.”
In an accompanying Comment, Dr Karin B. Michels, Harvard Medical School, Boston, USA and Dr Harald zur Hausen, German Cancer Research Centre, Heidelberg, Germany, say: “Currently, the targets for HPV vaccination are girls and young women aged 11-26 years prior to sexual debut. While good utilization of the program will reduce cervical cancer incidence in a couple of decades, this subgroup of the population at risk is too small to limit the spread of the virus. The only efficient way to stop the virus is to also vaccinate the other half of the sexually active population: boys and men.”
They conclude: “Women have shouldered responsibility for contraception since its inception. The goal to eradicate sexually transmitted carcinogenic viruses can be jointly carried by women and men and could be accomplished within a few decades.”
Dr Jorma Paavonen, University of Helsinki, Finland E) Jorma.Paavonen@hus.fi
Dr Karin B. Michels, Harvard Medical School, Boston, USA (currently in Europe) E) firstname.lastname@example.org
For full Article and Comment, see: http://press.thelancet.com/patriciafinal.pdf
Notes to editors: *the figure of 11—16% is found by calculating 37—54% of the 30% (30% of cervical cancers are from types of HPV other than 16 and 18)
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