Post hoc analysis of the PATRICIA randomized trial of the efficacy of human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against incident and persistent infection with nonvaccine oncogenic HPV types using an alternative multiplex type-specific PCR assay for HPV DNA
Struyf F.,Glaxosmithkline |
Colau B.,Glaxosmithkline |
Wheeler C.M.,University of New Mexico |
Naud P.,Federal University of Rio Grande do Sul |
And 28 more authors.
Clinical and Vaccine Immunology | Year: 2015
The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV in the Papilloma Trial against Cancer in Young Adults (PATRICIA) was evaluated using a combination of the broad-spectrum L1-based SPF10 PCR-DNA enzyme immunoassay (DEIA)/line probe assay (LiPA25) system with type-specific PCRs for HPV-16 and -18. Broad-spectrum PCR assays may underestimate the presence of HPV genotypes present at relatively low concentrations in multiple infections, due to competition between genotypes. Therefore, samples were retrospectively reanalyzed using a testing algorithm incorporating the SPF10 PCR-DEIA/LiPA25 plus a novel E6-based multiplex type-specific PCR and reverse hybridization assay (MPTS12 RHA), which permits detection of a panel of nine oncogenic HPV genotypes (types 16, 18, 31, 33, 35, 45, 52, 58, and 59). For the vaccine against HPV types 16 and 18, there was no major impact on estimates of vaccine efficacy (VE) for incident or 6-month or 12-month persistent infections when the MPTS12 RHA was included in the testing algorithm versus estimates with the protocol-specified algorithm. However, the alternative testing algorithm showed greater sensitivity than the protocol-specified algorithm for detection of some nonvaccine oncogenic HPV types. More cases were gained in the control group than in the vaccine group, leading to higher point estimates of VE for 6-month and 12-month persistent infections for the nonvaccine oncogenic types included in the MPTS12 RHA assay (types 31, 33, 35, 45, 52, 58, and 59). This post hoc analysis indicates that the per-protocol testing algorithm used in PATRICIA underestimated the VE against some nonvaccine oncogenic HPV types and that the choice of the HPV DNA testing methodology is important for the evaluation of VE in clinical trials. (This study has been registered at ClinicalTrials.gov under registration no. NCT00122681.). Copyright © 2015, American Society for Microbiology.
PubMed | Lin Medical Center and Gynecological Oncology Unit
Type: | Journal: Gynecologic oncology reports | Year: 2015
We report a case of malignant cardiac tamponade secondary to ovarian carcinomaWe emphasize the quick and fatal outcome of such a complicationIt seems that aggressive treatment offers the longest overall survival.
Palsdottir K.,Karolinska University Hospital |
Fischerova D.,Charles University |
Franchi D.,Gynecological Oncology Unit |
Testa A.,Catholic University of the Sacred Heart |
And 2 more authors.
Ultrasound in Obstetrics and Gynecology | Year: 2015
Objectives: To determine how various objective two-dimensional (2D) and three-dimensional (3D) ultrasound parameters allow prediction of deep stromal tumor invasion and lymph node involvement, in comparison to subjective ultrasound assessment, in women scheduled for surgery for cervical cancer. Methods: This was a prospective multicenter trial including 104 women with cervical cancer at FIGO Stages IA2-IIB, verified histologically. Patients scheduled for surgery underwent a preoperative ultrasound examination. The value of various 2D (size, color score) and 3D (volume, vascular indices) ultrasound parameters was compared to that of subjective assessment in the prediction of deep stromal tumor invasion and lymph node involvement. Histology obtained from radical hysterectomy or trachelectomy and pelvic lymphadenectomy was considered as the gold standard for assessment. Results: All women underwent pelvic lymphadenectomy, with 99 (95%) undergoing subsequent radical surgery; five underwent only pelvic lymphadenectomy because of the presence of a positive sentinel lymph node. Women with deep stromal invasion or lymph node involvement had significantly larger tumors (diameter and volume) but there was no correlation with vascular indices measured on 3D ultrasound. Subjective evaluation was superior (AUC, 0.93; sensitivity, 90.5%; specificity, 97.2%) in the prediction of deep stromal invasionwhen compared to any objective measurement technique, with maximal tumor diameter at 20.5-mm cut-off (AUC, 0.83; sensitivity, 90.5%; specificity, 61.1%) and 3D tumor volume at 9.1-mm3 cut-off (AUC, 0.85; sensitivity, 79.4%; specificity, 83.3%) providing the best performance among the objective parameters. Both subjective assessment and objective measurements were poorly predictive of lymph node involvement. Conclusions: In women with cervical cancer, subjective ultrasound evaluation allowed better prediction of deep stromal invasion than did objective measurements; however, neither subjective evaluation nor objective parameters were adequate to predict lymph node involvement. 3D vascular indices were ineffective in the prediction of advanced stages of the disease. Copyright © 2014 ISUOG. Published by John Wiley & Sons Ltd.
Netzer I.,Gynecological Oncology Unit |
Sobeh S.,Technion - Israel Institute of Technology |
Keidar Z.,Technion - Israel Institute of Technology |
Keidar Z.,Rambam Health Care Campus |
And 6 more authors.
Medical Oncology | Year: 2013
Cervical cancer is one of the leading causes of death among women with gynecological malignancies. In early stages of the disease (IB-IIA), surgical treatment alone is usually the treatment of choice. However, some high-risk patients are referred for postoperative chemo-radiotherapy, leading to increased morbidity. Maximal Standardized Uptake Value (SUVmax) is a positron emission tomography-computed tomography (PET-CT)-derived semiquantitative measurement of fluorodeoxyglucose (FDG) uptake in a defined lesion and may reflect tumor aggressiveness. The purpose of this study was to determine whether preoperative high SUVmax values can be used for the selection of initial therapy, thus reducing the side effects resulting from bimodal treatment. PET-CT studies of 46 cervical cancer patients who underwent surgery were reviewed, and SUVmax data were collected. Statistical analyses were performed to determine the relationships between SUVmax values and clinical parameters, modalities of treatment, and outcomes. SUV max was found to correlate with depth of tumor invasion (r = 0.46, p < 0.003). A statistically significant correlation was also found between SUVmax and histological grade, with the mean and variance of SUV max significantly lower for grade one, as compared to grades two and three (mean 1.10, 11.06, and 8.88; variance 3.57, 45.60, and 29.79, respectively; p < 0.0001 and p = 0.076). A possible SUVmax cutoff value of 10.08 was identified as a potential indicator of increased risk for receiving bimodal treatment, with a sensitivity of 61.5 % and a specificity of 75.8 %. SUVmax can be used for differentiating early-stage cervical cancer patients who will need postoperative adjuvant treatment and therefore can serve as an additional modality to reduce the need for bimodal therapy in these patients. © 2013 Springer Science+Business Media New York.