Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27-45 years of age compared to women 16-26 years of age: An open-label phase 3 study.

BACKGROUND: Efficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16-26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27-45 versus 16-26 years of age. METHODS: This international, open-label study (NCT03158220) was conducted in women 16-45 years of age. Participants (16-26 years, n = 570 and 27-45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study. RESULTS: At month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27-45 years were compared to those in women 16-26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27-45 years to 16-26 years) was 0.60-0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27-45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16-26 years, and 85.2% and 24.1% of women 27-45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study. CONCLUSIONS: The 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27-45 years compared with women 16-26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16-26 years to women 27-45 years of age. Clinical trial registration NCT03158220.

[Breast cancer mortality trend in Spain and its autonomous communities during the period 1980-2005]. / Mortalidad por cáncer de mama: evolución en España y sus comunidades autónomas durante el período 1980-2005.

BACKGROUND: Breast cancer is the most common cancer in women. The aim of this study is to describe the development of breast cancer mortality and its relation with the implementation of population screening programs in Spain and its Autonomous Communities (AC) from 1980 to 2005. METHODS: A breast cancer mortality trends analysis was done. We used the data from mortality of Ministry of Health and Social Policies. We calculated crude, standardized, specific and truncated mortality rates per 100,000 women. Trend analysis was done using a Joinpoint Regression Model to compute the Annual Percentage Change (APC). RESULTS: 131746 people died from breast cancer in Spain between 1980 and 2005. In Spain, mortality rates increased until 1992, when there was a change in the trend (APC = -0.1, -0.9, -0.8 for standard, specific and truncated rates respectively), CONCLUSIONS: Mortality from breast cancer in women in Spain indicates a general downward trend from 1992 to 2005 that was different among the different age groups. This downward trend was also observed in all the AC with some variability in the year that change occurs.