RESUMO
Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a Coriolus-versicolor-based vaginal gel (Papilocare®) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study's duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild-moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare® vaginal gel than spontaneous regression rates reported in the literature.
RESUMO
In the PALOMA trial, Papilocare® demonstrated efficacy in repairing low-grade cervical lesions related to human papillomavirus (HPV). This sub-analysis aimed to evaluate its efficacy in repairing these cervical lesions and clearing HPV in women aged older than 40 years. This was a multicenter, randomized, open-label, parallel-group, controlled clinical trial. Patients with low-degree HPV-dependent cervical lesions receiving 6-month treatment with the vaginal gel were compared to those with a watchful waiting approach. Among the 41 women analyzed (aged 47.7 years), 31 presented high-risk (HR) oncogenic HPV subtypes, and 14 had 16-18-31 HPV genotypes. After 6 months, normalized cytology and concordant colposcopy were achieved by a greater percentage of treated women. The difference was significant in the total population (92.3% vs. 50.0%, p = 0.007), and HR-HPV subpopulation (90.5% vs. 33.3%, p = 0.003). In the HR HPVs-16-18-31 subpopulation, the values were 75.0% and 40.0% (p = 0.293). In the total population, 61.5% of treated patients obtained HPV clearance, compared to 50.0% in the control group. Regarding the HR-HPV subpopulation, these values were 66.7% and 44.4%, respectively. Papilocare® demonstrated significant efficacy in repairing low-degree HPV-related cervical lesions and a positive trend to clear HPV in women older than 40 years old in comparison to the watchful waiting approach.
RESUMO
Introducción: La cirugía ultrarradical (CU), que empezó a utilizarse para el tratamiento de cánceres gástricos, se está empleando en la actualidad como procedimiento quirúrgico en el cáncer de ovario. Consiste en el abordaje de las regiones del abdomen, la pelvis y retroperitoneales afectadas por el tumor. El objetivo de este estudio es revisar nuestra experiencia en este tipo de cirugía. Material y métodos: Se revisan de forma retrospectiva 14 casos de cáncer de ovario, tratados en el Institut Universitari Dexeus con CU entre octubre de 2003 y diciembre de 2005. Se describen diversos parámetros desde una aproximación descriptiva, utilizándose distribuciones de frecuencias y medidas de tendencia central. Resultados: En 3 pacientes la CU fue primaria, y en las 11 restantes se practicó por recidiva de la enfermedad. La citorreducción tumoral fue con un mínimo de tumor residual (inferior a 0,5 cm) y en 10 pacientes no había evidencias macroscópicas de lesión residual. Sólo una de las 4 pacientes de CU primaria recidivó a los 7 meses. La CU como segundo acto quirúrgico se produjo a los 21,5 meses de la intervención inicial. Se han producido 4 fallecimientos (36,4%), a un tiempo mediano de 8 meses (rango, 6-21). Conclusiones: En síntesis, se trata de una opción tarapéutica que en muchas ocasiones se aplica de forma paliativa. A pesar de que la casuística es escasa, la radicalidad puede aumentar la supervivencia respecto a otros actos quirúrgicos menos agresivos
Introduction: Ultraradical (UR) surgery, which was first used for the treatment of gastric cancer, is currently performed in ovarian cancer. This procedure consists of examination of all the abdominal, pelvic and retroperitoneal regions affected by the tumor. The objective of this study was to review our experience of this surgical technique. Material and methods: Fourteen cases of ovarian cancer treated in the Institut Universitari Dexeus from Barcelona (Spain), between October 2003 and December 2005 were retrospectively reviewed. The parameters were evaluated within a descriptive approach. Frequency distributions and central tendency measures were analyzed. Results: UR surgery was performed for primary tumors in three patients and for tumoral recurrence in the remaining 11 patients. Tumor reduction left minimal residual lesions (less than 0.5 cm) in 4 patients and there was no macroscopic evidence of residual lesions in 10 patients. Only one of the patients with primary UR surgery showed tumoral recurrence after 7 months. UR surgery as a second choice was performed 21.5 months after primary surgery. Four patients (36.4%) died at a median of 8 months after the second intervention (range, 6-21). Conclusions: UR surgery is a therapeutic choice that can be used as a palliative procedure. Although the number of patients in this study is small, UR surgery can improve survival in comparison with other surgical approaches
