Introduction/Background High-risk strains of HPV are well established as the causative agents for... more Introduction/Background High-risk strains of HPV are well established as the causative agents for cervical dysplasia and cervical cancer. It is also well known that pre-cancerous cervical lesions persist longer and progress quickly in women infected by high-risk HPV than in women with non-oncogenic HPV strains. The aim of this study was to evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- in repairing HPV-dependent cervical lesions (ASCUS/LSIL) in three groups of patients according to the oncogenic potential of HPV strains. Methodology Randomized, open-label, parallel-group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were randomized into 3 groups. Primary endpoint of the Paloma Clinical trial: percentage of patients with normal cytology and concordant colposcopy image at 6 months, evaluated in total population, high-risk subpopulation (16,18,31,33,35,39,45,51,52,56,58,59,68) subpopulation and the subpopulation infected by any combination of 16, 18 and 31, is presented. Pap smear evaluation was being centrally-conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this per-protocol analysis. Results A total of 84, 66 and 29 patients corresponding to total population, and high-risk and 16-18-31 subpopulations were evaluated, respectively. At 6 months, normal cytology and concordant colposcopy image was observed in 85% (45/53), 88% (36/41) and 73% (11/15) of patients treated with Papilocare® vs 65% (20/31), 56% (14/25) and 43% (6/14) of patients in control group, in the total population, and high-risk and 16-18-31 subpopulations (p=0.0311; p=0.0034; p=0.0959, chi-square test; figure1) respectively. Conclusion While the spontaneous normalizations of HPV-dependent cervical lesions clearly decreased according to the risk of HPV strains (Total population = 65%, HR-HPV=56%, and HPV-16-18-31=42%), the robust efficacy of Papilocare in normalizing cervical lesions was maintained in the 3 patients groups with statistically significant difference versus control. Disclosure Nothing to disclose. Abstract P158 Figure 1 Papilocare® on repairing HPV-dependent cervical lesions (ASCUS/LSIL) at 6 months in three groups o
Background The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 ... more Background The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 years in women with FIGO 2009 stage IB1 cervical cancer. The aim of this study was to compare the use of adjuvant therapy in these women, depending on the method used to diagnose lymphatic node metastasis. Patients and Methods We used data from the SUCCOR cohort, which collected information from 1049 women with FIGO 2009 stage IB1 cervical cancer who were operated on between January 2013 and December 2014 in Europe. We calculated the adjusted proportion of women who received adjuvant therapy depending on the lymph node diagnosis method and compared disease free and overall survival using Cox proportional-hazards regression models. Inverse probability weighting was used to adjust for baseline potential confounders. Results The adjusted proportion of women who received adjuvant therapy was 33.8% in the sentinel node biopsy + lymphadenectomy (SNB+LA) group and 44.7% in the LA group (p = 0.0...
ObjectiveIt has been suggested that the manipulation of neoplastic tissue during hysteroscopy may... more ObjectiveIt has been suggested that the manipulation of neoplastic tissue during hysteroscopy may lead to dissemination of tumor cells into the peritoneal cavity and worsen prognosis and overall survival. The goal of this study was to assess the oncological safety comparing hysteroscopy to Pipelle blind biopsy in the presurgical diagnosis of patients with endometrial cancer.MethodsWe performed a retrospective multicentric study among patients who had received primary surgical treatment for endometrial cancer. A multivariate statistical analysis model was used to compare relapse and survival rates in patients who had been evaluated preoperatively either by hysteroscopy or Pipelle biopsy. The relapse rate, disease-free survival, and overall survival were assessed as the main outcomes. The histological type, tumor size, myometrial invasion, International Federation of Gynecology and Obstetrics (FIGO) stage, surgical approach, use of a uterine manipulator, and adjuvant treatment were al...
Objective Based on the SUCCOR study database, our primary objective was to identify the independe... more Objective Based on the SUCCOR study database, our primary objective was to identify the independent clinical pathological variables associated with the risk of relapse in patients with stage IB1 cervical cancer who underwent a radical hysterectomy. Our secondary goal was to design and validate a risk predictive index (RPI) for classifying patients depending on the risk of recurrence. Methods Overall, 1116 women were included from January 2013 to December 2014. We randomly divided our sample into two cohorts: discovery and validation cohorts. The test group was used to identify the independent variables associated with relapse, and with these variables, we designed our RPI. The index was applied to calculate a relapse risk score for each participant in the validation group. Results A previous cone biopsy was the most significant independent variable that lowered the rate of relapse (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.17–0.60). Additionally, patients with a tumor dia...
Dear Editor, In response to the letter by van der Velden J and Fons G, we appreciate their commen... more Dear Editor, In response to the letter by van der Velden J and Fons G, we appreciate their comments and we would like to thank them for their detailed critical review in order to improve the VULCAN study interpretation. Regarding their first comment, we are sure that after they read the full paper by Joura EA (reference 3) they noticed it refers to the correlation of vulvar intraepithelial neoplasm (VIN) with invasive vulvar cancer. The authors state an increase of VINrelated vulvar cancer in the last decades from 2% to 21%. In our opinion it could be caused by a higher detection rate at younger ages. In addition, data published posteriorly corroborate this finding, showing an increment in the VIN and vulvar cancer rates with a peak age at 40–50 years. We agree that the pioneers of conservative management in vulvar cancer reported it almost 40 years ago; however, it has been during the last decade when most of the groups have shifted to more conservative techniques with the implementation of wide excision instead of radical vulvectomy, and sentinel node biopsy instead of inguinal lymphadenectomy. We think it is proof of the general trend in gynecological oncology such as in cervical cancer and its nervesparing surgical treatment (reported for the first time 60 years ago by Kobayashi). With respect to Reference 8, we agree that we included it by mistake, we apologize for that. We would like to clarify that a professional health science statistician carried out all statistical analyses. Table 1 in the study is correct, and it reflects the data included by the researchers. In some cases the researchers included the FIGO stage but left nodal status missing, so even if the FIGO stage was III, we could not identify whether positive nodes were unilateral, contralateral, or bilateral. The differences between FIGO stage III for squamous cancers (356 patients) and nodal involvement (274 patients) correspond to missing data on nodal status, which do not invalidate these results. Concerning Tables 2 and 3 in the study, you are completely right, there were typographical errors in the columns that we did not notice at the time of undertaking several corrections. We unintentionally switched the HRs and 95% CIs of Tables 2 and 3. So the hazard ratios and confidence intervals from Table 2 corresponded to Table 3; and those from Table 3 corresponded to Table 2. We apologize for that mistake. The significance of each factor was correct, and the lack of administration of chemotherapy still remains one of the most important factors for local recurrence and overall survival. Please find included with this letter the corrected values of the tables (Tables 1 and 2). We hope that after these clarifications, the VULCAN study can help with a better understanding of the role of prognostic factors in squamous cell carcinoma of the vulva.
Objective The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor–... more Objective The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor–based vaginal gel, in repairing human papillomavirus (HPV)-related low-grade cervical lesions. Methods The study is a multicenter, open-label, randomized, parallel-group, watchful waiting approach-controlled trial involving 91 HPV-positive women with low-grade Pap smear alterations and consistent colposcopy. Results The percentage of patients with normal Pap smear and concordant colposcopy 3 and 6 months after receiving treatment (78.0% and 84.9%) was significantly higher than without treatment (54.8% and 64.5%), especially in high-risk HPV patients (79.5% and 87.8% vs 52.0% and 56.0%). At 6-month visit, overall HPV clearance was achieved by a greater number of patients receiving treatment (59.6%) compared with those without treatment (41.9%), especially high-risk HPV ones (62.5% vs 40.0%). The cervical re-epithelization score was significantly higher with treatment (mean = 4.5) than wit...
Background Inflammatory myofibroblastic tumour is an infrequent mesenchymal neoplasia of unknown ... more Background Inflammatory myofibroblastic tumour is an infrequent mesenchymal neoplasia of unknown aetiology and variable behaviour, ranging from rather benign lesions to locally aggressive and even metastatic disease. Its presence has been described in almost all organs; however, its location in the female genital tract has rarely been reported. Case presentation We present the case of a 47-year-old female, who was studied in our institution for a recent medical history of several weeks of dyspareunia and abdominal pain. She underwent pertinent studies including ultrasonography and CT scan. Under suspicion of degenerated leiomyoma, a total hysterectomy was performed. Unexpectedly, the pathological study of the surgical specimen showed very few tumour cells with focal fusiform morphology surrounded by an abundant inflammatory infiltrate; a thorough immunohistochemistry study lead to myofibroblastic tumour of the cervix diagnosis. A PET-CT scan did not show metastatic disease. The pati...
Clínica e Investigación en Ginecología y Obstetricia, 2021
Resumen Objetivo Evaluar el porcentaje de aclaramiento de la infeccion por el virus del papiloma ... more Resumen Objetivo Evaluar el porcentaje de aclaramiento de la infeccion por el virus del papiloma humano (VPH) de alto riesgo en las mujeres sometidas a una conizacion cervical, asi como analizar los genotipos de VPH mas prevalentes en nuestro medio. Material y metodos Estudio longitudinal, observacional, retrospectivo, descriptivo y analitico. Se revisaron las conizaciones realizadas en el Area 7 del Hospital Clinico San Carlos de Madrid entre octubre de 2015 y octubre de 2016. Resultados De 291 conizaciones practicadas durante 12 meses, se realizo determinacion de VPH-AR pre-conizacion a 138 pacientes. En 247 pacientes la indicacion del tratamiento escisional fue por resultado de biopsia HSIL/CIN 2-3, y en 44 por LSIL/CIN una persistente mas de dos anos. Sesenta y una de las 138 mujeres presentaron uno o varios VPH-AR distintos al 16/18/31 antes de la conizacion (61/138), mientras que en 77 pacientes se diagnosticaron VPH-AR 16/18/31 (77/138). Si desglosamos, el VPH 16 estuvo presente en 58/138 de los casos, el VPH 31 en 15/138 y el VPH 18 en 4/138. En el primer control post-conizacion, en 126 pacientes la determinacion de VPH-AR fue negativa (126/138). El VPH 16 se aclaro en 49 pacientes (49/58), el VPH 31 en 15 (15/15) y el VPH 18 en uno (1/4). Conclusiones El genotipo 16 fue el VPH-AR mas frecuente en mujeres conizadas en nuestro estudio, seguido por el 31 y el 18. Tras la conizacion cervical, se consigue un aclaramiento de la infeccion por VPH-AR en un 91,4% de las pacientes.
Introduction/Background High-risk strains of HPV are well established as the causative agents for... more Introduction/Background High-risk strains of HPV are well established as the causative agents for cervical dysplasia and cervical cancer. It is also well known that pre-cancerous cervical lesions persist longer and progress quickly in women infected by high-risk HPV than in women with non-oncogenic HPV strains. The aim of this study was to evaluate the efficacy of Papilocare® -a Coriolus versicolor-based vaginal gel- in repairing HPV-dependent cervical lesions (ASCUS/LSIL) in three groups of patients according to the oncogenic potential of HPV strains. Methodology Randomized, open-label, parallel-group, controlled clinical trial (Paloma Clinical Trial). HPV+ women aged between 30 and 65 with cytology of ASCUS or LSIL with concordant colposcopy image were randomized into 3 groups. Primary endpoint of the Paloma Clinical trial: percentage of patients with normal cytology and concordant colposcopy image at 6 months, evaluated in total population, high-risk subpopulation (16,18,31,33,35,39,45,51,52,56,58,59,68) subpopulation and the subpopulation infected by any combination of 16, 18 and 31, is presented. Pap smear evaluation was being centrally-conducted at the IECM laboratory (Lugo, Spain). Papilocare® arms (A+B) were combined for this per-protocol analysis. Results A total of 84, 66 and 29 patients corresponding to total population, and high-risk and 16-18-31 subpopulations were evaluated, respectively. At 6 months, normal cytology and concordant colposcopy image was observed in 85% (45/53), 88% (36/41) and 73% (11/15) of patients treated with Papilocare® vs 65% (20/31), 56% (14/25) and 43% (6/14) of patients in control group, in the total population, and high-risk and 16-18-31 subpopulations (p=0.0311; p=0.0034; p=0.0959, chi-square test; figure1) respectively. Conclusion While the spontaneous normalizations of HPV-dependent cervical lesions clearly decreased according to the risk of HPV strains (Total population = 65%, HR-HPV=56%, and HPV-16-18-31=42%), the robust efficacy of Papilocare in normalizing cervical lesions was maintained in the 3 patients groups with statistically significant difference versus control. Disclosure Nothing to disclose. Abstract P158 Figure 1 Papilocare® on repairing HPV-dependent cervical lesions (ASCUS/LSIL) at 6 months in three groups o
Background The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 ... more Background The SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 years in women with FIGO 2009 stage IB1 cervical cancer. The aim of this study was to compare the use of adjuvant therapy in these women, depending on the method used to diagnose lymphatic node metastasis. Patients and Methods We used data from the SUCCOR cohort, which collected information from 1049 women with FIGO 2009 stage IB1 cervical cancer who were operated on between January 2013 and December 2014 in Europe. We calculated the adjusted proportion of women who received adjuvant therapy depending on the lymph node diagnosis method and compared disease free and overall survival using Cox proportional-hazards regression models. Inverse probability weighting was used to adjust for baseline potential confounders. Results The adjusted proportion of women who received adjuvant therapy was 33.8% in the sentinel node biopsy + lymphadenectomy (SNB+LA) group and 44.7% in the LA group (p = 0.0...
ObjectiveIt has been suggested that the manipulation of neoplastic tissue during hysteroscopy may... more ObjectiveIt has been suggested that the manipulation of neoplastic tissue during hysteroscopy may lead to dissemination of tumor cells into the peritoneal cavity and worsen prognosis and overall survival. The goal of this study was to assess the oncological safety comparing hysteroscopy to Pipelle blind biopsy in the presurgical diagnosis of patients with endometrial cancer.MethodsWe performed a retrospective multicentric study among patients who had received primary surgical treatment for endometrial cancer. A multivariate statistical analysis model was used to compare relapse and survival rates in patients who had been evaluated preoperatively either by hysteroscopy or Pipelle biopsy. The relapse rate, disease-free survival, and overall survival were assessed as the main outcomes. The histological type, tumor size, myometrial invasion, International Federation of Gynecology and Obstetrics (FIGO) stage, surgical approach, use of a uterine manipulator, and adjuvant treatment were al...
Objective Based on the SUCCOR study database, our primary objective was to identify the independe... more Objective Based on the SUCCOR study database, our primary objective was to identify the independent clinical pathological variables associated with the risk of relapse in patients with stage IB1 cervical cancer who underwent a radical hysterectomy. Our secondary goal was to design and validate a risk predictive index (RPI) for classifying patients depending on the risk of recurrence. Methods Overall, 1116 women were included from January 2013 to December 2014. We randomly divided our sample into two cohorts: discovery and validation cohorts. The test group was used to identify the independent variables associated with relapse, and with these variables, we designed our RPI. The index was applied to calculate a relapse risk score for each participant in the validation group. Results A previous cone biopsy was the most significant independent variable that lowered the rate of relapse (odds ratio [OR] 0.31, 95% confidence interval [CI] 0.17–0.60). Additionally, patients with a tumor dia...
Dear Editor, In response to the letter by van der Velden J and Fons G, we appreciate their commen... more Dear Editor, In response to the letter by van der Velden J and Fons G, we appreciate their comments and we would like to thank them for their detailed critical review in order to improve the VULCAN study interpretation. Regarding their first comment, we are sure that after they read the full paper by Joura EA (reference 3) they noticed it refers to the correlation of vulvar intraepithelial neoplasm (VIN) with invasive vulvar cancer. The authors state an increase of VINrelated vulvar cancer in the last decades from 2% to 21%. In our opinion it could be caused by a higher detection rate at younger ages. In addition, data published posteriorly corroborate this finding, showing an increment in the VIN and vulvar cancer rates with a peak age at 40–50 years. We agree that the pioneers of conservative management in vulvar cancer reported it almost 40 years ago; however, it has been during the last decade when most of the groups have shifted to more conservative techniques with the implementation of wide excision instead of radical vulvectomy, and sentinel node biopsy instead of inguinal lymphadenectomy. We think it is proof of the general trend in gynecological oncology such as in cervical cancer and its nervesparing surgical treatment (reported for the first time 60 years ago by Kobayashi). With respect to Reference 8, we agree that we included it by mistake, we apologize for that. We would like to clarify that a professional health science statistician carried out all statistical analyses. Table 1 in the study is correct, and it reflects the data included by the researchers. In some cases the researchers included the FIGO stage but left nodal status missing, so even if the FIGO stage was III, we could not identify whether positive nodes were unilateral, contralateral, or bilateral. The differences between FIGO stage III for squamous cancers (356 patients) and nodal involvement (274 patients) correspond to missing data on nodal status, which do not invalidate these results. Concerning Tables 2 and 3 in the study, you are completely right, there were typographical errors in the columns that we did not notice at the time of undertaking several corrections. We unintentionally switched the HRs and 95% CIs of Tables 2 and 3. So the hazard ratios and confidence intervals from Table 2 corresponded to Table 3; and those from Table 3 corresponded to Table 2. We apologize for that mistake. The significance of each factor was correct, and the lack of administration of chemotherapy still remains one of the most important factors for local recurrence and overall survival. Please find included with this letter the corrected values of the tables (Tables 1 and 2). We hope that after these clarifications, the VULCAN study can help with a better understanding of the role of prognostic factors in squamous cell carcinoma of the vulva.
Objective The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor–... more Objective The aim of the study was to evaluate the efficacy of Papilocare, a Coriolus versicolor–based vaginal gel, in repairing human papillomavirus (HPV)-related low-grade cervical lesions. Methods The study is a multicenter, open-label, randomized, parallel-group, watchful waiting approach-controlled trial involving 91 HPV-positive women with low-grade Pap smear alterations and consistent colposcopy. Results The percentage of patients with normal Pap smear and concordant colposcopy 3 and 6 months after receiving treatment (78.0% and 84.9%) was significantly higher than without treatment (54.8% and 64.5%), especially in high-risk HPV patients (79.5% and 87.8% vs 52.0% and 56.0%). At 6-month visit, overall HPV clearance was achieved by a greater number of patients receiving treatment (59.6%) compared with those without treatment (41.9%), especially high-risk HPV ones (62.5% vs 40.0%). The cervical re-epithelization score was significantly higher with treatment (mean = 4.5) than wit...
Background Inflammatory myofibroblastic tumour is an infrequent mesenchymal neoplasia of unknown ... more Background Inflammatory myofibroblastic tumour is an infrequent mesenchymal neoplasia of unknown aetiology and variable behaviour, ranging from rather benign lesions to locally aggressive and even metastatic disease. Its presence has been described in almost all organs; however, its location in the female genital tract has rarely been reported. Case presentation We present the case of a 47-year-old female, who was studied in our institution for a recent medical history of several weeks of dyspareunia and abdominal pain. She underwent pertinent studies including ultrasonography and CT scan. Under suspicion of degenerated leiomyoma, a total hysterectomy was performed. Unexpectedly, the pathological study of the surgical specimen showed very few tumour cells with focal fusiform morphology surrounded by an abundant inflammatory infiltrate; a thorough immunohistochemistry study lead to myofibroblastic tumour of the cervix diagnosis. A PET-CT scan did not show metastatic disease. The pati...
Clínica e Investigación en Ginecología y Obstetricia, 2021
Resumen Objetivo Evaluar el porcentaje de aclaramiento de la infeccion por el virus del papiloma ... more Resumen Objetivo Evaluar el porcentaje de aclaramiento de la infeccion por el virus del papiloma humano (VPH) de alto riesgo en las mujeres sometidas a una conizacion cervical, asi como analizar los genotipos de VPH mas prevalentes en nuestro medio. Material y metodos Estudio longitudinal, observacional, retrospectivo, descriptivo y analitico. Se revisaron las conizaciones realizadas en el Area 7 del Hospital Clinico San Carlos de Madrid entre octubre de 2015 y octubre de 2016. Resultados De 291 conizaciones practicadas durante 12 meses, se realizo determinacion de VPH-AR pre-conizacion a 138 pacientes. En 247 pacientes la indicacion del tratamiento escisional fue por resultado de biopsia HSIL/CIN 2-3, y en 44 por LSIL/CIN una persistente mas de dos anos. Sesenta y una de las 138 mujeres presentaron uno o varios VPH-AR distintos al 16/18/31 antes de la conizacion (61/138), mientras que en 77 pacientes se diagnosticaron VPH-AR 16/18/31 (77/138). Si desglosamos, el VPH 16 estuvo presente en 58/138 de los casos, el VPH 31 en 15/138 y el VPH 18 en 4/138. En el primer control post-conizacion, en 126 pacientes la determinacion de VPH-AR fue negativa (126/138). El VPH 16 se aclaro en 49 pacientes (49/58), el VPH 31 en 15 (15/15) y el VPH 18 en uno (1/4). Conclusiones El genotipo 16 fue el VPH-AR mas frecuente en mujeres conizadas en nuestro estudio, seguido por el 31 y el 18. Tras la conizacion cervical, se consigue un aclaramiento de la infeccion por VPH-AR en un 91,4% de las pacientes.
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