In the Phase III PATRICIA study (NCT00122681), the human papillomavirus (HPV)‐16/18 AS04‐adjuvanted vaccine (Cervarix®, GlaxoSmithKline Biologicals) was highly efficacious against HPV‐16/18 infections and precancerous lesions in women HPV‐16/18 deoxyribose nucleic acid (DNA) negative and seronegative at baseline. We present further data on vaccine efficacy (VE) against HPV‐16/18 in the total vaccinated cohort including women who may have been exposed to HPV‐16/18 infection before vaccination. In women with no evidence of current or previous HPV‐16/18 infection (DNA negative and seronegative), VE was 90.3% (96.1% confidence interval: 87.3–92.6) against 6‐month persistent infection (PI), 91.9% (84.6–96.2) against cervical intraepithelial neoplasia (CIN)1+ and 94.6% (86.3–98.4) against CIN2+ [97.7% (91.1–99.8) when using the HPV type assignment algorithm (TAA)]. In women HPV‐16/18 DNA negative but with serological evidence of previous HPV‐16/18 infection (seropositive), VE was 72.3% (53.0–84.5) against 6‐month PI, 67.2% (10.9–89.9) against CIN1+, and 68.8% (−28.3–95.0) against CIN2+ [88.5% (10.8–99.8) when using TAA]. In women with no evidence of current HPV‐16/18 infection (DNA negative), regardless of their baseline HPV‐16/18 serological status, VE was 88.7% (85.7–91.1) against 6‐month PI, 89.1% (81.6–94.0) against CIN1+ and 92.4% (84.0–97.0) against CIN2+ [97.0% (90.6–99.5) when using TAA]. In women who were DNA positive for one vaccine type, the vaccine was efficacious against the other vaccine type. The vaccine did not impact the outcome of HPV‐16/18 infections present at the time of vaccination. Vaccination was generally well tolerated regardless of the woman's HPV‐16/18 DNA or serological status at entry.

A mature cystic teratoma should be treated as early as possible. Tumor stage and optimal debulking are critical to survival. Unlike SCCs of the uterine cervix, postoperative adjuvant chemotherapy may produce a better result than adjuvant radiotherapy for advanced-stage cases.

We evaluated the efficacy of the human papillomavirus (HPV)−16/18 AS04‐adjuvanted vaccine in preventing HPV‐related disease after surgery for cervical lesions in a post‐hoc analysis of the PApilloma TRIal against Cancer In young Adults (PATRICIA; NCT00122681). Healthy women aged 15–25 years were randomized (1:1) to receive vaccine or control at months 0, 1 and 6 and followed for 4 years. Women were enrolled regardless of their baseline HPV DNA status, HPV‐16/18 serostatus, or cytology, but excluded if they had previous or planned colposcopy. The primary and secondary endpoints of PATRICIA have been reported previously; the present post‐hoc analysis evaluated efficacy in a subset of women who underwent an excisional procedure for cervical lesions after vaccination. The main outcome was the incidence of subsequent HPV‐related cervical intraepithelial neoplasia grade 2 or greater (CIN2+) 60 days or more post‐surgery. Other outcomes included the incidence of HPV‐related CIN1+, and vulvar or vaginal intraepithelial neoplasia (VIN/VaIN) 60 days or more post‐surgery. Of the total vaccinated cohort of 18,644 women (vaccine = 9,319; control = 9,325), 454 (vaccine = 190, control = 264) underwent an excisional procedure during the trial. Efficacy 60 days or more post‐surgery for a first lesion, irrespective of HPV DNA results, was 88.2% (95% CI: 14.8, 99.7) against CIN2+ and 42.6% (−21.1, 74.1) against CIN1+. No VIN was reported and one woman in each group had VaIN2+ 60 days or more post‐surgery. Women who undergo surgical therapy for cervical lesions after vaccination with the HPV‐16/18 vaccine may continue to benefit from vaccination, with a reduced risk of developing subsequent CIN2+.

BackgroundThe control arm of PATRICIA (PApillomaTRIal against Cancer In young Adults, NCT00122681) was used to investigate the risk of progression from cervical HPV infection to cervical intraepithelial neoplasia (CIN) or clearance of infection, and associated determinants.Methods and FindingsWomen aged 15-25 years were enrolled. A 6-month persistent HPV infection (6MPI) was defined as detection of the same HPV type at two consecutive evaluations over 6 months and clearance as ≥2 type-specific HPV negative samples taken at two consecutive intervals of approximately 6 months following a positive sample. The primary endpoint was CIN grade 2 or greater (CIN2+) associated with the same HPV type as a 6MPI. Secondary endpoints were CIN1+/CIN3+ associated with the same HPV type as a 6MPI; CIN1+/CIN2+/CIN3+ associated with an infection of any duration; and clearance of infection. The analyses included 4825 women with 16,785 infections (3363 womenwith 6902 6MPIs). Risk of developing a CIN1+/CIN2+/CIN3+ associated with same HPV type as a 6MPI varied with HPV type and was significantly higher for oncogenic versus non-oncogenic types. Hazard ratios for development of CIN2+ were 10.44 (95% CI: 6.96-15.65), 9.65 (5.97-15.60), 5.68 (3.50-9.21), 5.38 (2.87-10.06) and 3.87 (2.38-6.30) for HPV-16, HPV-33, HPV-31, HPV-45 and HPV-18, respectively. HPV-16 or HPV-33 6MPIs had ~25-fold higher risk for progression to CIN3+. Previous or concomitant HPV infection or CIN1+ associated with a different HPV type increased risk. Of the different oncogenic HPV types, HPV-16 and HPV-31 infections were least likely to clear.ConclusionsCervical infections with oncogenic HPV types increased the risk of CIN2+ and CIN3+. Previous or concomitant infection or CIN1+ also increased the risk. HPV-16 and HPV-33 have by far the highest risk of progression to CIN3+, and HPV-16 and HPV-31 have the lowest chance of clearance.

C ervical cancer is the fourth most common cancer among women, with estimates from 2012 indicating that there are 528,000 new cases and 266,000 deaths each year worldwide (1). It is now established that persistent infection (PI) with human papillomavirus (HPV) is a prerequisite for cervical cancer (2). Approximately 70% of cervical cancer cases are attributable to highrisk (hr) with HPV