Fertility-Sparing Surgery versus Radical Hysterectomy in Early Cervical Cancer : A Propensity Score Matching Analysis and Noninferiority Study

Fertility-sparing surgery (FSS) is the treatment of choice for patients with early cervical cancer (ECC) and fertility desire, but survival rates compared to radical hysterectomy (RH) have been scarcely reported. The aim of this study was to analyse the oncological outcomes of FSS compared to a balanced group of standard RH. A retrospective multicentre study of ECC patients who underwent FSS or RH was carried out in 12 tertiary hospitals in Spain between January 2005 and January 2019. The experimental group included patients who underwent a simple and radical trachelectomy, and the control group included patients who underwent RH. Optimal 1:1 propensity score (PS) matching analysis was performed to balance the series. The study included 222 patients with ECC; 111 (50%) were treated with FSS, and 111 (50%) were treated with RH. After PS matching, a total of 38 patients in the FSS group and 38 patients in the RH group were analysed. In both groups, the overall survival (HR 2.5; CI 0.89, 7.41) and recurrence rates (28.9% in the FSS group vs. 13.2% in RH group) were similar. The rate of disease-free survival at 5 years was 68.99% in the FSS group and 88.01% in the RH group (difference of −19.02 percentage points; 95% CI −32.08 to −5.96 for noninferiority). In the univariate analysis, only tumour size reached statistical significance. FSS offers excellent disease-free and overall survival in women with ECC with fertility desire and is not inferior compared to RH

Fertility-Sparing Surgery versus Radical Hysterectomy in Early Cervical Cancer: A Propensity Score Matching Analysis and Noninferiority Study

Objective: Fertility-sparing surgery (FSS) is the treatment of choice for patients with early cervical cancer (ECC) and fertility desire, but survival rates compared to radical hysterectomy (RH) have been scarcely reported. The aim of this study was to analyse the oncological outcomes of FSS compared to a balanced group of standard RH. Methods: A retrospective multicentre study of ECC patients who underwent FSS or RH was carried out in 12 tertiary hospitals in Spain between January 2005 and January 2019. The experimental group included patients who underwent a simple and radical trachelectomy, and the control group included patients who underwent RH. Optimal 1:1 propensity score (PS) matching analysis was performed to balance the series. Results: The study included 222 patients with ECC; 111 (50%) were treated with FSS, and 111 (50%) were treated with RH. After PS matching, a total of 38 patients in the FSS group and 38 patients in the RH group were analysed. In both groups, the overall survival (HR 2.5; CI 0.89, 7.41) and recurrence rates (28.9% in the FSS group vs. 13.2% in RH group) were similar. The rate of disease-free survival at 5 years was 68.99% in the FSS group and 88.01% in the RH group (difference of −19.02 percentage points; 95% CI −32.08 to −5.96 for noninferiority). In the univariate analysis, only tumour size reached statistical significance. Conclusion: FSS offers excellent disease-free and overall survival in women with ECC with fertility desire and is not inferior compared to RH

Present status of sentinel lymph node biopsy in cervical cancer

Cervical cancer is the fourth most common cancer in women, and seventh overall. This disease represents a medical, economic and social burden. In early FIGO stage patients (IA, IB1 and IIA1), nodal involvement is the most important prognostic factor. Imaging evaluation of nodal metastasis is of limited value. In order to determine lymph node involvement, allow loco-regional control of the disease, define the need for adjuvant radiotherapy and improve survival, standard surgery for early disease is radical hysterectomy with systematic pelvic lymphadenectomy. However, this surgical treatment has risks and complications: longer operative time, larger blood loss, neurovascular or ureteral injury, lower-limb lymphedema, symptomatic lymphocysts, hydronephrosis. A method that allows to define the presence of regional metastasis with less morbidity and equal or greater precision is particularly relevant. The use of the sentinel lymph node biopsy is intended to reach that purpose. The present study reviews recent literature on the role of sentinel lymph node biopsy in cervical cancer, analyzing its indications and contraindications, injection and detection techniques, tracers used, surgical and pathological approaches and its applicability in up-to-date clinical practice

Bedeutung der operativen Tumorreduktion bei Patientinnen mit Ovarialkarzinom und suboptimalem Debulking

Background and objectives: Ovarian cancer (OC) is the main cause of mortality related to gynaecologic cancer worldwide. Surgical cytoreduction is the cornerstone of current treatment in patients with advanced primary disease. In contrast, the value of surgery in recurrent ovarian cancer (ROC) remains unclear. In the present study, we evaluate the role of postoperative tumor residual and tumor reduction in primary and recurrent ovarian cancer with survival as primary goal. Methods: All consecutive patients with primary or first relapsed OC who underwent tumor-debulking surgery at our institution were systematically analyzed with the help of an intraoperative documentation tool. We evaluated the tumor characteristics as well as the operative and clinical outcomes. Then we performed univariate and multivariate analyses to identify independent predictors for mortality and disease progression as well as predictors for complete tumor resection in both situations. Results: A total of 446 operations performed between 09/2000 and 04/2006 were included in the analysis (269 on patients with primary OC and 177 on patients with ROC). The median age at first diagnosis for the primary situation was 59 years. 71.7% of patients had tumor FIGO stage III-IV. Overall, 64.7% of patients were operated to be macroscopically tumor-free, 21.5% had residual disease ≤ 1cm, and 13.8% had >1 cm intra abdominal residual disease. In 26.0%, 4/5 of the tumor was removed, in 7.5 % less than 4/5 of the tumour was removed and 1.9% were considered to have unresectable disease. The postoperative morbidity rate was 28.5%, while the perioperative mortality rate was 3.0%. 75.5% of patients received adjuvant paclitaxel/carboplatin therapy. The median follow-up time was 18.4 months (range 0.1-74.5 months). In multivariate analysis, no tumor resection (HR 10.6), 4/5 tumor reduction (HR 5.4) and other tumor histology than serous (HR 2.7) were the most significant factors for mortality. The postoperative median survival (OS) could not be calculated and the median progression-free survival (PFS) was 13.0 months (range 0.1-72.9 months). Median OS was 32.2 months (95%CI 24.2-40.1), 15.5 months (95%CI 0.1-33.6) and 2.6 months (95 %CI 0.1-10.6) for patients with 4/5 tumor resection, less than 4/5 tumor resection and no tumor resection, respectively (p-value=0.002). For patients left with tumor residual of any size, OS was 27.1 months (95%CI 15.2-38.9). Threshold analysis illustrated a point between 0.5 and 1cm tumor residual where the survival KM graph diverges. Variables such as age (>60 years) (OR=0,36; 95%CI 0,2-0,94), small bowel metastasis (OR=0,27; 95% CI 0,17-0,64), tumor spread in the upper abdomen (OR=0,34; 95% CI 0,14-0,81) and systematic lymphadenectomy (OR 6.4 CI 95% 2.5-16.2) were identified as significant predictive factors for complete tumor reduction in primary OC. In ROC, 67.8% of patients were platinum-sensitive and 28.2% platinum-resistant. In 44.6%, a complete tumor resection was achieved; in another 26.0% postoperative tumor residuals were <1 cm. In 31.6%, 4/5 of the tumour was removed. The postoperative morbidity rate was 37.2% while the perioperative mortality rate was 8.2%. The median follow-up was 10.8 months (range 0.0-65.0 months). Median PFS was 8.4 months (range 0.0-55 months). In multivariate analysis, ascites (≥500ml HR 4.7 and <500 ml. HR 2.8 compared with no ascites), no tumor reduction (HR 4.7 compared with macroscopic tumor-free), tumor residual 1cm) and platinum- resistance (HR 2.7) were independent predictors for OS. Median OS for patients with complete tumor resection was 60.6 months (95%CI 21.3-99.8). Among patients with a tumor residual of any size, median OS was 29.5 (21.6-37.3) and 8.7 (4.1-13.2) for patients with residual of <1cm and ≥1cm, respectively (p value <0.001). Variables such as ascites less than 500ml (OR=0.3; 95% CI 0.1-0.8 p<0.05), small bowel metastasis (OR=0.22; 95% CI 0.07-0.71 p<0.05), tumor spread in the upper abdomen (OR 0.33 CI 95% 0.1-0.9 p <0.05), serous tumor histology (OR 5.8 95% CI 1.2-28.1 p<0.05) and platinum-sensitivity (platinum-resistance OR 0.1 95% CI 0.06-0.5 p< 0.01) were identified as significant predictive factors for complete tumor reduction. Age was not significant. Conclusion: Complete debulking to achieve no visible tumor residual must be considered the ultimate goal of primary ovarian cancer surgery. In patients with any residual tumor, improved survival was achieved by ascending tumor reduction percentages. Tumor residual ≤1cm (“optimal” cytoreduction) may not represent the best survival prognosis, but the threshold between a good and a poor survival prognosis. Procedures which have been described in recent years for primary cytoreduction may be also be applicable to secondary surgery. Complete tumor resection should also be the aim of ROC surgery, as it is associated with a prolonged survival. However, not only complete tumor resection but also “optimal” cytoreduction to tumor residuals of <1cm seem to contribute to a prognostic benefit. Therefore, operative efforts should be carried out fully in order to obtain maximum tumor resection, always considering the associated morbidity of course.Hindergrund und Ziele: Das Ovarialkarzinom ist weltweit die fuhrende Ursache der Mortalitat gynakologischer Malignome. Die chirurgische Zytoreduktion ist der Eckpfeiler in der heutigen Behandlung von Patienten in fortgeschrittenem Stadium des primaren Ovarialkarzinoms. Im Gegensatz hierzu ist der Stellenwert der chirurgischen Therapie bei rezidiviertem Ovarialkarzinom unklar. In der vorliegenden Untersuchung untersuchen wir die Rolle des postoperativen Tumorrests sowie der Tumorreduktion bei primarem und rezidiviertem Ovarialkarzinom, hierbei gilt als primarer Endpunkt das Uberleben. Methoden: Samtliche Patienten mit Primar- oder Erstrezidiv-Ovarialkarzinom, die in unserer Klinik einer Tumor-Debulking-Operation unterzogen wurden, wurden systematisch auf der Basis eines intraoperativen Dokumentations-Verfahrens untersucht. Hierbei wurden Tumorcharakteristik, Muster der Tumor- Disseminierung und operatives und klinisches Outcome untersucht. Uni- und multivariate Analysen wurden duchgefuhrt, um unabhangige Pradiktivfaktoren fur Mortalitat und Progression sowie Pradiktoren einer kompletten Tumor-Resektion in beiden klinischen Situationen zu identifizieren. Ergebnisse: Zwischen 09/2000 und 04/2006 wurden insgesamt 446 Operationen in die Analyse eingeschlossen, 269 davon in Patienten mit primaerem Ovarialkarzinom und 177 in Rezidivsituation. Bei primaerem Ovarialkarzinom lag der Altersmedian bei 59 Jahren. 71,7% der Patienten hatten Tumorstadium FIGO III-IV. Insgesamt konnten 64,7% der Patienten makroskopisch tumorfrei operiert werden, 21,5% hatten einen Tumorrest 1 cm intraabdominalen Tumorrest auf. In 26% wurden 4/5, in 7,5% weniger als 4/5 des Tumors entfernt und in 1,9% war der Tumor nicht resektabel. Die postoperative Morbiditat lag bei 28,5% und die perioperative Mortalitat bei 3%. 75,5% erhielten eine adjuvante Paclitaxel/Carboplatin- Therapie. Die mediane Nachbeobachtungszeit lag bei 18,4 Monaten (0,1-74,5 Monate). In der multivariaten Analyse zeigten sich als Faktoren mit hochster Signifikanz fur erhohte Mortalitat: keine Tumorresektion (Hazard-Ratio (HR) 10,6), 4/5 Tumor-Reduktion (HR 5,4) und nicht-serose Tumor- Histologie (HR 2,7). Das postoperative mediane Uberleben konnte nicht berechnet werden und das mediane progressionsfreie Intervall (PFS) lag bei 13 Monaten (0,1- 72,9 Monate). Das mediane Gesamtuberleben lag bei 32,2 Monaten (95% KI 24,2- 40,1),15,5 Monaten (95% KI 0,1- 33,6) und 2,6 Monaten (95% KI 0,1- 10,6 ) fur Patienten mit 4/5 Tumorresektion, weniger als 4/5 Tumorresektion und Patienten ohne erzielte Tumorresektion (p-Wert= 0,002). Fur Patienten mit Residualtumor jedweder Grose lag das Gesamtuberleben bei 27,1 Monaten (95% KI 15,2-38,9). Eine Schwellenwert- Analyse zeigte fur einen Wert zwischen 0,5cm und 1cm Tumorrest einen Unterschied in der Kaplan-Meier- Uberlebenskurve. Variablen wie Alter (> 60 Jahre) (Odds Ratio (OR)= 0,36; 95% KI 0,2-0,94), Dunndarmmetastasierung (OR=0,27; 95% KI 0,17-0,64), Tumorausbreitung im oberen Abdomen (OR= 0,34; 95% KI 0,14- 0,81) und systematische Lymphadenektomie (OR 6,4; 95% KI 2,5- 16,2) wurden als signifikante Pradiktivfaktoren einer kompletten Tumorentfernung im primarem Ovarialkarzinom identifiziert. Beim rezidivierten Ovarialkarzinom zeigten sich 67,8% der Patienten Platin- sensibel und 28,2% Platin- resistent. In 44,6% konnte eine komplette Tumor-Resektion erreicht werden; in weiteren 26% war der postoperative Tumorrest < 1cm. In 31,6% konnten 4/5 des Tumors entfernt werden. Die postoperative Morbiditat lag bei 37,2%, die perioperative Mortalitat bei 8,2%. Die mediane Nachbeobachtungsdauer waren 10,8 Monate (0,0- 65 Monate). Das mediane PFS lag bei 8,4 Monaten (0- 55 Monate). In der multivariaten Analyse waren unabhangige Faktoren des Gesamtuberlebens: Aszites (.500ml HR 4,7 und <500ml HR 2,8 verglichen mit keinem Aszites), nicht erreichte Tumorreduktion (HR 4,7 verglichen mit makroskopischer Tumorfreiheit), Tumorrest 1cm) und Platin-Resistenz (HR 2,7). Das mediane Gesamtuberleben von Patienten mit kompletter Tumorresektion lag bei 60,6 Monaten (95% KI 21,3- 99,8). Fur Patienten mit Tumorrest jedweder Grose lag das mediane Gesamtuberleben bei 29,5 (21,6- 37,3) Monaten fur Tumorrest < 1cm und bei 8,7 (4,1- 13,2) Monaten fur Tumorrest . 1cm (p-Wert < 0,001). Variablen wie Aszitesmenge <500ml (OR=0,3; 95% KI 0,1-0,8; p<0,05), Dunndarmmetastasierung (OR=0,22; 95% KI 0,07-0,71), Tumorausbreitung im oberen Abdomen (OR 0,33 KI95% 0,1-0,9; p<0,005), serose Tumorhistologie (OR 5,8; 95%KI 1,2.-28,1) und Platin- Sensibilitat (Platin-Resistenz OR 0,1 95%KI 0,06-0,5; p<0,01) konnten als signifikante Pradiktivfaktoren einer kompletten Tumorreduktion identifiziert werden. Alter war nicht signifikant. Schlussfolderung: Das komplette "Debulking" mit Erreichen eines makroskopisch nicht sichtbaren Tumorrestes muss als absolutes Ziel in der Operation des primaren Ovarialkarzinoms angesehen werden. In Patienten mit Tumorrest jedweder Grösse wurde eine Verlangerung des Uberlebens in Korrelation mit erhohten Prozentzahlen der Tumorreduktion erzielt. Ein Tumorrest <=1cm ("optimale" Zytoreduktion) bedeutet nicht die beste Prognose, sicher aber einen Schwellenwert zwischen guter und schlechter Uberlebens-Prognose. Traditionell fur die primare Zytoreduktion beschriebene (operative) Verfahren konnen ebenso in Situationen einer sekundaren Operation angewandt werden. Eine komplette Tumorresektion sollte auch in der Chirurgie des rezidivierten Ovarialkarzinoms angestrebt werden, da sie mit verlangertem Uberleben assoziiert ist. Nicht nur die komplette Tumorresektion sondern ebenso eine "optimale" Zytoreduktion mit Tumorresten < 1cm scheinen einen prognostischen Nutzen zu haben. Deshalb sollte das operative Bemuhen immer auf die maximal erreichbare Tumorreduktion abzielen, wobei die perioperative Morbiditat berucksichtigt werden muss

Bedeutung der operativen Tumorreduktion bei Patientinnen mit Ovarialkarzinom und suboptimalem Debulking

Background and objectives: Ovarian cancer (OC) is the main cause of mortality related to gynaecologic cancer worldwide. Surgical cytoreduction is the cornerstone of current treatment in patients with advanced primary disease. In contrast, the value of surgery in recurrent ovarian cancer (ROC) remains unclear. In the present study, we evaluate the role of postoperative tumor residual and tumor reduction in primary and recurrent ovarian cancer with survival as primary goal. Methods: All consecutive patients with primary or first relapsed OC who underwent tumor-debulking surgery at our institution were systematically analyzed with the help of an intraoperative documentation tool. We evaluated the tumor characteristics as well as the operative and clinical outcomes. Then we performed univariate and multivariate analyses to identify independent predictors for mortality and disease progression as well as predictors for complete tumor resection in both situations. Results: A total of 446 operations performed between 09/2000 and 04/2006 were included in the analysis (269 on patients with primary OC and 177 on patients with ROC). The median age at first diagnosis for the primary situation was 59 years. 71.7% of patients had tumor FIGO stage III-IV. Overall, 64.7% of patients were operated to be macroscopically tumor-free, 21.5% had residual disease ≤ 1cm, and 13.8% had >1 cm intra abdominal residual disease. In 26.0%, 4/5 of the tumor was removed, in 7.5 % less than 4/5 of the tumour was removed and 1.9% were considered to have unresectable disease. The postoperative morbidity rate was 28.5%, while the perioperative mortality rate was 3.0%. 75.5% of patients received adjuvant paclitaxel/carboplatin therapy. The median follow-up time was 18.4 months (range 0.1-74.5 months). In multivariate analysis, no tumor resection (HR 10.6), 4/5 tumor reduction (HR 5.4) and other tumor histology than serous (HR 2.7) were the most significant factors for mortality. The postoperative median survival (OS) could not be calculated and the median progression-free survival (PFS) was 13.0 months (range 0.1-72.9 months). Median OS was 32.2 months (95%CI 24.2-40.1), 15.5 months (95%CI 0.1-33.6) and 2.6 months (95 %CI 0.1-10.6) for patients with 4/5 tumor resection, less than 4/5 tumor resection and no tumor resection, respectively (p-value=0.002). For patients left with tumor residual of any size, OS was 27.1 months (95%CI 15.2-38.9). Threshold analysis illustrated a point between 0.5 and 1cm tumor residual where the survival KM graph diverges. Variables such as age (>60 years) (OR=0,36; 95%CI 0,2-0,94), small bowel metastasis (OR=0,27; 95% CI 0,17-0,64), tumor spread in the upper abdomen (OR=0,34; 95% CI 0,14-0,81) and systematic lymphadenectomy (OR 6.4 CI 95% 2.5-16.2) were identified as significant predictive factors for complete tumor reduction in primary OC. In ROC, 67.8% of patients were platinum-sensitive and 28.2% platinum-resistant. In 44.6%, a complete tumor resection was achieved; in another 26.0% postoperative tumor residuals were <1 cm. In 31.6%, 4/5 of the tumour was removed. The postoperative morbidity rate was 37.2% while the perioperative mortality rate was 8.2%. The median follow-up was 10.8 months (range 0.0-65.0 months). Median PFS was 8.4 months (range 0.0-55 months). In multivariate analysis, ascites (≥500ml HR 4.7 and <500 ml. HR 2.8 compared with no ascites), no tumor reduction (HR 4.7 compared with macroscopic tumor-free), tumor residual 1cm) and platinum- resistance (HR 2.7) were independent predictors for OS. Median OS for patients with complete tumor resection was 60.6 months (95%CI 21.3-99.8). Among patients with a tumor residual of any size, median OS was 29.5 (21.6-37.3) and 8.7 (4.1-13.2) for patients with residual of <1cm and ≥1cm, respectively (p value <0.001). Variables such as ascites less than 500ml (OR=0.3; 95% CI 0.1-0.8 p<0.05), small bowel metastasis (OR=0.22; 95% CI 0.07-0.71 p<0.05), tumor spread in the upper abdomen (OR 0.33 CI 95% 0.1-0.9 p <0.05), serous tumor histology (OR 5.8 95% CI 1.2-28.1 p<0.05) and platinum-sensitivity (platinum-resistance OR 0.1 95% CI 0.06-0.5 p< 0.01) were identified as significant predictive factors for complete tumor reduction. Age was not significant. Conclusion: Complete debulking to achieve no visible tumor residual must be considered the ultimate goal of primary ovarian cancer surgery. In patients with any residual tumor, improved survival was achieved by ascending tumor reduction percentages. Tumor residual ≤1cm (“optimal” cytoreduction) may not represent the best survival prognosis, but the threshold between a good and a poor survival prognosis. Procedures which have been described in recent years for primary cytoreduction may be also be applicable to secondary surgery. Complete tumor resection should also be the aim of ROC surgery, as it is associated with a prolonged survival. However, not only complete tumor resection but also “optimal” cytoreduction to tumor residuals of <1cm seem to contribute to a prognostic benefit. Therefore, operative efforts should be carried out fully in order to obtain maximum tumor resection, always considering the associated morbidity of course.Hindergrund und Ziele: Das Ovarialkarzinom ist weltweit die fuhrende Ursache der Mortalitat gynakologischer Malignome. Die chirurgische Zytoreduktion ist der Eckpfeiler in der heutigen Behandlung von Patienten in fortgeschrittenem Stadium des primaren Ovarialkarzinoms. Im Gegensatz hierzu ist der Stellenwert der chirurgischen Therapie bei rezidiviertem Ovarialkarzinom unklar. In der vorliegenden Untersuchung untersuchen wir die Rolle des postoperativen Tumorrests sowie der Tumorreduktion bei primarem und rezidiviertem Ovarialkarzinom, hierbei gilt als primarer Endpunkt das Uberleben. Methoden: Samtliche Patienten mit Primar- oder Erstrezidiv-Ovarialkarzinom, die in unserer Klinik einer Tumor-Debulking-Operation unterzogen wurden, wurden systematisch auf der Basis eines intraoperativen Dokumentations-Verfahrens untersucht. Hierbei wurden Tumorcharakteristik, Muster der Tumor- Disseminierung und operatives und klinisches Outcome untersucht. Uni- und multivariate Analysen wurden duchgefuhrt, um unabhangige Pradiktivfaktoren fur Mortalitat und Progression sowie Pradiktoren einer kompletten Tumor-Resektion in beiden klinischen Situationen zu identifizieren. Ergebnisse: Zwischen 09/2000 und 04/2006 wurden insgesamt 446 Operationen in die Analyse eingeschlossen, 269 davon in Patienten mit primaerem Ovarialkarzinom und 177 in Rezidivsituation. Bei primaerem Ovarialkarzinom lag der Altersmedian bei 59 Jahren. 71,7% der Patienten hatten Tumorstadium FIGO III-IV. Insgesamt konnten 64,7% der Patienten makroskopisch tumorfrei operiert werden, 21,5% hatten einen Tumorrest 1 cm intraabdominalen Tumorrest auf. In 26% wurden 4/5, in 7,5% weniger als 4/5 des Tumors entfernt und in 1,9% war der Tumor nicht resektabel. Die postoperative Morbiditat lag bei 28,5% und die perioperative Mortalitat bei 3%. 75,5% erhielten eine adjuvante Paclitaxel/Carboplatin- Therapie. Die mediane Nachbeobachtungszeit lag bei 18,4 Monaten (0,1-74,5 Monate). In der multivariaten Analyse zeigten sich als Faktoren mit hochster Signifikanz fur erhohte Mortalitat: keine Tumorresektion (Hazard-Ratio (HR) 10,6), 4/5 Tumor-Reduktion (HR 5,4) und nicht-serose Tumor- Histologie (HR 2,7). Das postoperative mediane Uberleben konnte nicht berechnet werden und das mediane progressionsfreie Intervall (PFS) lag bei 13 Monaten (0,1- 72,9 Monate). Das mediane Gesamtuberleben lag bei 32,2 Monaten (95% KI 24,2- 40,1),15,5 Monaten (95% KI 0,1- 33,6) und 2,6 Monaten (95% KI 0,1- 10,6 ) fur Patienten mit 4/5 Tumorresektion, weniger als 4/5 Tumorresektion und Patienten ohne erzielte Tumorresektion (p-Wert= 0,002). Fur Patienten mit Residualtumor jedweder Grose lag das Gesamtuberleben bei 27,1 Monaten (95% KI 15,2-38,9). Eine Schwellenwert- Analyse zeigte fur einen Wert zwischen 0,5cm und 1cm Tumorrest einen Unterschied in der Kaplan-Meier- Uberlebenskurve. Variablen wie Alter (> 60 Jahre) (Odds Ratio (OR)= 0,36; 95% KI 0,2-0,94), Dunndarmmetastasierung (OR=0,27; 95% KI 0,17-0,64), Tumorausbreitung im oberen Abdomen (OR= 0,34; 95% KI 0,14- 0,81) und systematische Lymphadenektomie (OR 6,4; 95% KI 2,5- 16,2) wurden als signifikante Pradiktivfaktoren einer kompletten Tumorentfernung im primarem Ovarialkarzinom identifiziert. Beim rezidivierten Ovarialkarzinom zeigten sich 67,8% der Patienten Platin- sensibel und 28,2% Platin- resistent. In 44,6% konnte eine komplette Tumor-Resektion erreicht werden; in weiteren 26% war der postoperative Tumorrest < 1cm. In 31,6% konnten 4/5 des Tumors entfernt werden. Die postoperative Morbiditat lag bei 37,2%, die perioperative Mortalitat bei 8,2%. Die mediane Nachbeobachtungsdauer waren 10,8 Monate (0,0- 65 Monate). Das mediane PFS lag bei 8,4 Monaten (0- 55 Monate). In der multivariaten Analyse waren unabhangige Faktoren des Gesamtuberlebens: Aszites (.500ml HR 4,7 und <500ml HR 2,8 verglichen mit keinem Aszites), nicht erreichte Tumorreduktion (HR 4,7 verglichen mit makroskopischer Tumorfreiheit), Tumorrest 1cm) und Platin-Resistenz (HR 2,7). Das mediane Gesamtuberleben von Patienten mit kompletter Tumorresektion lag bei 60,6 Monaten (95% KI 21,3- 99,8). Fur Patienten mit Tumorrest jedweder Grose lag das mediane Gesamtuberleben bei 29,5 (21,6- 37,3) Monaten fur Tumorrest < 1cm und bei 8,7 (4,1- 13,2) Monaten fur Tumorrest . 1cm (p-Wert < 0,001). Variablen wie Aszitesmenge <500ml (OR=0,3; 95% KI 0,1-0,8; p<0,05), Dunndarmmetastasierung (OR=0,22; 95% KI 0,07-0,71), Tumorausbreitung im oberen Abdomen (OR 0,33 KI95% 0,1-0,9; p<0,005), serose Tumorhistologie (OR 5,8; 95%KI 1,2.-28,1) und Platin- Sensibilitat (Platin-Resistenz OR 0,1 95%KI 0,06-0,5; p<0,01) konnten als signifikante Pradiktivfaktoren einer kompletten Tumorreduktion identifiziert werden. Alter war nicht signifikant. Schlussfolderung: Das komplette "Debulking" mit Erreichen eines makroskopisch nicht sichtbaren Tumorrestes muss als absolutes Ziel in der Operation des primaren Ovarialkarzinoms angesehen werden. In Patienten mit Tumorrest jedweder Grösse wurde eine Verlangerung des Uberlebens in Korrelation mit erhohten Prozentzahlen der Tumorreduktion erzielt. Ein Tumorrest <=1cm ("optimale" Zytoreduktion) bedeutet nicht die beste Prognose, sicher aber einen Schwellenwert zwischen guter und schlechter Uberlebens-Prognose. Traditionell fur die primare Zytoreduktion beschriebene (operative) Verfahren konnen ebenso in Situationen einer sekundaren Operation angewandt werden. Eine komplette Tumorresektion sollte auch in der Chirurgie des rezidivierten Ovarialkarzinoms angestrebt werden, da sie mit verlangertem Uberleben assoziiert ist. Nicht nur die komplette Tumorresektion sondern ebenso eine "optimale" Zytoreduktion mit Tumorresten < 1cm scheinen einen prognostischen Nutzen zu haben. Deshalb sollte das operative Bemuhen immer auf die maximal erreichbare Tumorreduktion abzielen, wobei die perioperative Morbiditat berucksichtigt werden muss

Tumor Size and Oncological Outcomes in Patients with Early Cervical Cancer Treated by Fertility Preservation Surgery : A Multicenter Retrospective Cohort Study

As cervical cancer is increasingly diagnosed in women who still intend to have children, fertility-sparing surgery is arising as a treatment option for those women with early-stage cervical cancer. The aim of this study was to analyze surgical, oncological and obstetrical outcomes of fertility-sparing surgery in early cervical cancer in Spain. In our study, the tumor size was the most important negative prognostic factor in fertility-sparing surgery (FSS) in cervical cancer. Selection criteria for fertility preservation should be rigorous, especially for patients with a tumor > 2 cm, due to the worse oncological outcomes associated with such tumors. Patients with an early cervical cancer tumor > 2 cm and a desire for pregnancy should be advised against primary FSS. Background: The aim of this study was to analyze the impact of tumor size > 2 cm on oncological outcomes of fertility-sparing surgery (FSS) in early cervical cancer in a Spanish cohort. Methods: A multicenter, retrospective cohort study of early cervical cancer (stage IA1 with lymphovascular space invasion -IB1 (FIGO 2009)) patients with gestational desire who underwent FSS at 12 tertiary departments of gynecology oncology between 01/2005 and 01/2019 throughout Spain. Results: A total of 111 patients were included, 82 (73.9%) with tumors < 2 cm and 29 (26.1%) with tumors 2-4 cm. Patients' characteristics were balanced except from lymphovascular space invasion. All were intraoperative lymph node-negative. Median follow-up was 55.7 and 30.7 months, respectively. Eleven recurrences were diagnosed (9.9%), five (6.0%) and six (21.4%) (p < 0.05). The 3-year progression-free survival (PFS) was 95.7% (95%CI 87.3-98.6) and 76.9% (95% CI 55.2-89.0) (p = 0.011). Only tumor size (<2 cm vs. 2-4 cm) was found to be significant for recurrence. After adjusting for the rest of the variables, tumor size 2-4 cm showed a Hazard Ratio of 5.99 (CI 95% 1.01-35.41, p = 0.036). Conclusions: Tumor size ≥ 2 cm is the most important negative prognostic factor in this multicenter cohort of patients with early cervical cancer and gestational desire who underwent FSS in Spain

Tumor Size and Oncological Outcomes in Patients with Early Cervical Cancer Treated by Fertility Preservation Surgery: A Multicenter Retrospective Cohort Study

Background: The aim of this study was to analyze the impact of tumor size > 2 cm on oncological outcomes of fertility-sparing surgery (FSS) in early cervical cancer in a Spanish cohort. Methods: A multicenter, retrospective cohort study of early cervical cancer (stage IA1 with lymphovascular space invasion -IB1 (FIGO 2009)) patients with gestational desire who underwent FSS at 12 tertiary departments of gynecology oncology between 01/2005 and 01/2019 throughout Spain. Results: A total of 111 patients were included, 82 (73.9%) with tumors p p = 0.011). Only tumor size (p = 0.036). Conclusions: Tumor size ≥ 2 cm is the most important negative prognostic factor in this multicenter cohort of patients with early cervical cancer and gestational desire who underwent FSS in Spain

Voiding recovery after radical parametrectomy in cervical cancer patients: An international prospective multicentre trial – SENTIX

OBJECTIVE: Voiding dysfunctions represent a leading morbidity after radical hysterectomy performed in patients with early-stage cervical cancer. The aim of this study was to perform ad hoc analysis of factors influencing voiding recovery in SENTIX (SENTinel lymph node biopsy in cervIX cancer) trial. METHODS: The SENTIX trial (47 sites, 18 countries) is a prospective study on sentinel lymph node biopsy without pelvic lymphadenectomy in patients with early-stage cervical cancer. Overall, the data of 300 patients were analysed. Voiding recovery was defined as the number of days from surgery to bladder catheter/epicystostomy removal or to post-voiding urine residuum ≤50 mL. RESULTS: The median voiding recovery time was three days (5th–95th percentile: 0–21): 235 (78.3%) patients recovered in 30 days. In the multivariate analysis, only previous pregnancy (p = 0.033) and type of parametrectomy (p 7 days post-surgery. Type-B parametrectomy was associated with a higher risk of delayed voiding recovery than type-C1 (OR = 4.69; p = 0.023 vs. OR = 3.62; p = 0.052, respectively), followed by type-C2 (OR = 5.84; p = 0.011). Both previous pregnancy and type C2 parametrectomy independently prolonged time to voiding recovery by two days. CONCLUSIONS: Time to voiding recovery is significantly related to previous pregnancy and type of parametrectomy but it is not influenced by surgical approach (open vs minimally invasive), age, or BMI. Type B parametrectomy, without direct visualisation of nerves, was associated with longer recovery than nerve-sparing type C1. Importantly, voiding dysfunctions after radical surgery are temporary, and the majority of the patients recover in less than 30 days, including patients after C2 parametrectomy

Twelve years of experience with miglustat in the treatment of type 1 Gaucher disease: The Spanish ZAGAL project.

We report data from a prospective, observational study (ZAGAL) evaluating miglustat 100mg three times daily orally. in treatment-naïve patients and patients with type 1 Gaucher Disease (GD1) switched from previous enzyme replacement therapy (ERT). Clinical evolution, changes in organ size, blood counts, disease biomarkers, bone marrow infiltration (S-MRI), bone mineral density by broadband ultrasound densitometry (BMD), safety and tolerability annual reports were analysed. Between May 2004 and April 2016, 63 patients received miglustat therapy; 20 (32%) untreated and 43 (68%) switched. At the time of this report 39 patients (14 [36%] treatment-naïve; 25 [64%] switch) remain on miglustat. With over 12-year follow-up, hematologic counts, liver and spleen volumes remained stable. In total, 80% of patients achieved current GD1 therapeutic goals. Plasma chitotriosidase activity and CCL-18/PARC concentration showed a trend towards a slight increase. Reductions on S-MRI (p=0.042) with an increase in BMD (