RESUMEN
PURPOSE: Evaluate the antitumor activity and safety profile of the combination of mirvetuximab soravtansine and bevacizumab in patients with platinum-resistant ovarian cancer. METHODS: Patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, whose most recent platinum-free interval was ≤6 months, were administered mirvetuximab soravtansine (6 mg/kg adjusted ideal body weight) and bevacizumab (15 mg/kg), intravenously, once every 3 weeks. Eligibility included FRα expression by immunohistochemistry (IHC; ≥25% of cells with ≥2+ intensity). Prior bevacizumab and/or PARP inhibitor (PARPi) treatment were permitted. The primary endpoint was confirmed objective response rate (ORR). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), and safety. RESULTS: Ninety-four patients received combination treatment with mirvetuximab soravtansine and bevacizumab. Median age was 62 years (range, 39-81). Fifty-two percent had ≥3 prior therapies; 59% had prior bevacizumab; and 27% had prior PARPi. ORR was 44% (95% CI 33, 54) with 5 complete responses, median DOR 9.7 months (95% CI 6.9, 14.1), and median PFS 8.2 months (95% CI 6.8, 10.0). Treatment-related adverse events were consistent with the profiles of each agent, with the most common being blurred vision (all grades 57%; grade 3, 1%), diarrhea (54%; grade 3, 1%), and nausea (51%; grade 3, 1%). CONCLUSION: The mirvetuximab soravtansine plus bevacizumab doublet is an active and well-tolerated regimen in patients with FRα-expressing platinum-resistant ovarian cancer. Promising activity was observed for patients regardless of level of FRα expression or prior bevacizumab. These data underscore the potential for mirvetuximab soravtansine as the combination partner of choice for bevacizumab in this setting.
Asunto(s)
Antineoplásicos , Inmunoconjugados , Neoplasias Ováricas , Humanos , Femenino , Persona de Mediana Edad , Bevacizumab/uso terapéutico , Neoplasias Ováricas/patología , Receptor 1 de Folato , Resistencia a Antineoplásicos , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Antineoplásicos/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológicoRESUMEN
BACKGROUND: Treatment options for patients with platinum-resistant/refractory ovarian cancers are limited and only marginally effective. The development of novel, more effective therapies addresses a critical unmet medical need. Olvimulogene nanivacirepvec (Olvi-Vec), with its strong immune modulating effect on the tumor microenvironment, may provide re-sensitization to platinum and clinically reverse platinum resistance or refractoriness in platinum-resistant/refractory ovarian cancer. PRIMARY OBJECTIVE: The primary objective is to evaluate the efficacy of intra-peritoneal Olvi-Vec followed by platinum-based chemotherapy and bevacizumab in patients with platinum-resistant/refractory ovarian cancer. STUDY HYPOTHESIS: This phase III study investigates Olvi-Vec oncolytic immunotherapy followed by platinum-based chemotherapy and bevacizumab as an immunochemotherapy evaluating the hypothesis that such sequential combination therapy will prolong progression-free survival (PFS) and bring other clinical benefits compared with treatment with platinum-based chemotherapy and bevacizumab. TRIAL DESIGN: This is a multicenter, prospective, randomized, and active-controlled phase III trial. Patients will be randomized 2:1 into the experimental arm treated with Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab or the control arm treated with platinum-doublet chemotherapy and bevacizumab. MAJOR INCLUSION/EXCLUSION CRITERIA: Eligible patients must have recurrent, platinum-resistant/refractory, non-resectable high-grade serous, endometrioid, or clear-cell ovarian, fallopian tube, or primary peritoneal cancer. Patients must have had ≥3 lines of prior chemotherapy. PRIMARY ENDPOINT: The primary endpoint is PFS in the intention-to-treat population. SAMPLE SIZE: Approximately 186 patients (approximately 124 patients randomized to the experimental arm and 62 to the control arm) will be enrolled to capture 127 PFS events. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Expected complete accrual in 2024 with presentation of primary endpoint results in 2025. TRIAL REGISTRATION: NCT05281471.
Asunto(s)
Neoplasias Ováricas , Vacunas Virales , Humanos , Femenino , Bevacizumab , Estudios Prospectivos , Carcinoma Epitelial de Ovario , Platino (Metal) , Neoplasias Ováricas/tratamiento farmacológico , Microambiente TumoralRESUMEN
OBJECTIVE: The Laparoscopic Approach to Cervical Cancer (LACC) trial found that minimally invasive radical hysterectomy compared to open radical hysterectomy compromised oncologic outcomes and was associated with worse progression-free survival (PFS) and overall survival (OS) in early-stage cervical carcinoma. We sought to assess oncologic outcomes at multiple centers between minimally invasive (MIS) radical hysterectomy and OPEN radical hysterectomy. METHODS: This is a multi-institutional, retrospective cohort study of patients with 2009 FIGO stage IA1 (with lymphovascular space invasion) to IB1 cervical carcinoma from 1/2007-12/2016. Patients who underwent preoperative therapy were excluded. Squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinomas were included. Appropriate statistical tests were used. RESULTS: We identified 1093 cases for analysis-715 MIS (558 robotic [78%]) and 378. OPEN procedures. The OPEN cohort had more patients with tumors >2 cm, residual disease in the hysterectomy specimen, and more likely to have had adjuvant therapy. Median follow-up for the MIS and OPEN cohorts were 38.5 months (range, 0.03-149.51) and 54.98 months (range, 0.03-145.20), respectively. Three-year PFS rates were 87.9% (95% CI: 84.9-90.4%) and 89% (95% CI: 84.9-92%), respectively (P = 0.6). On multivariate analysis, the adjusted HR for recurrence/death was 0.70 (95% CI: 0.47-1.03; P = 0.07). Three-year OS rates were 95.8% (95% CI: 93.6-97.2%) and 96.6% (95% CI: 93.8-98.2%), respectively (P = 0.8). On multivariate analysis, the adjusted HR for death was 0.81 (95% CI: 0.43-1.52; P = 0.5). CONCLUSION: This multi-institutional analysis showed that an MIS compared to OPEN radical hysterectomy for cervical cancer did not appear to compromise oncologic outcomes, with similar PFS and OS.
Asunto(s)
Laparoscopía , Neoplasias del Cuello Uterino , Supervivencia sin Enfermedad , Femenino , Humanos , Histerectomía/métodos , Laparoscopía/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Estadificación de Neoplasias , Estudios Retrospectivos , Neoplasias del Cuello Uterino/patologíaRESUMEN
Objective: To identify the pattern of recurrence and assess the clinicopathologic prognostic factors for survival after robotic radical hysterectomy (RRH) in the treatment of stage IB cervical cancer. Methods: From December 2008 to March 2018, 64 cervical cancer patients who underwent RRH with pelvic lymph node dissection by a single surgeon were enrolled in this retrospective historical cohort timeline study. The patient's status was estimated in terms of operative outcomes, pathologic results, and survival outcomes. Results: The median follow-up was 63 months. The recurrence rate was 9.4% (6/64). There were two recurrences at the vaginal vault, two in the pelvic cavity, and two at the peritoneum in the intraabdominal cavity. The overall survival rate was 95.3% (61/64). When patients were divided into three groups in order based on surgery date, the first surgical period showed significantly higher recurrence rate (21%) compared to both the second (10%) and the third period (0%) (p=0.037). Multivariate analysis showed that the early period of RRH (p=0.025) and clinical tumor size more than 3 cm (p=0.003) were prognostic factors related to the recurrence. Although there was no statistical significance, there has been no recurrence since a uterine manipulator was not used. Conclusion: The early surgical period and large tumor were related to the disease recurrence after RRH. We suggest that the achievement of proficiency and appropriate patient selection are critical for prognosis after RRH in stage IB cervical cancer.
Asunto(s)
Histerectomía/estadística & datos numéricos , Recurrencia Local de Neoplasia/epidemiología , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Neoplasias del Cuello Uterino/cirugía , Adulto , Femenino , Estudios de Seguimiento , Humanos , Histerectomía/métodos , Persona de Mediana Edad , Recurrencia Local de Neoplasia/prevención & control , Estadificación de Neoplasias , Supervivencia sin Progresión , Estudios Retrospectivos , Medición de Riesgo/métodos , Tasa de Supervivencia , Factores de Tiempo , Neoplasias del Cuello Uterino/diagnóstico , Neoplasias del Cuello Uterino/mortalidadRESUMEN
OBJECTIVE: Identify factors influencing the feasibility and safety of outpatient robotic-assisted hysterectomy for endometrial or cervical carcinoma. METHODS: A single-institution retrospective chart review of patients who underwent robotic hysterectomy for cervical or endometrial cancer between 2012 and 2016 was performed. Outcomes were measured by length of stay (LOS), which was categorized as an admit-to-discharge time of >12 h or <12 h. Past medical history, surgical history, social history, patient demographics, intraoperative course, and postoperative events were examined as possible factors associated with LOS >12 h. These factors were evaluated using multivariate logistic regression. Readmission rates were compared between the two groups using an independent-samples t-test. RESULTS: Of the 254 patients, 150 (59.1%) had a LOS >12 h and 104 (40.9%) had a LOS < 12 h. The factors associated with a LOS >12 h (p < 0.05) included: Postoperative emesis, inadequate pain control, operating room (OR) time > 180 min, uterine mass > 150 g, start time after 15:00, history of venous thromboembolism (VTE), age > 75 years, body mass index (BMI) 35-40, and post-operative VTE formation. Patients discharged in <12-hours were not more likely than those discharged in >12-hours to be re-admitted (p = 0.92). CONCLUSIONS: Robotic hysterectomy for the treatment of endometrial and cervical carcinoma is both feasible and safe in the outpatient setting, as >40% of patients were successfully discharged within 12 h with no increase in readmission. Multiple risk factors were identified for extended hospitalization, offering potential for the development of a risk stratification model to improve the efficacy of outpatient robotic hysterectomy.
Asunto(s)
Atención Ambulatoria/métodos , Neoplasias Endometriales/cirugía , Neoplasias del Cuello Uterino/cirugía , Adulto , Anciano , Procedimientos Quirúrgicos Ambulatorios/efectos adversos , Procedimientos Quirúrgicos Ambulatorios/métodos , Estudios de Factibilidad , Femenino , Humanos , Histerectomía/efectos adversos , Histerectomía/métodos , Persona de Mediana Edad , Alta del Paciente , Estudios Retrospectivos , Factores de Riesgo , Procedimientos Quirúrgicos Robotizados/efectos adversos , Procedimientos Quirúrgicos Robotizados/métodosRESUMEN
This surgical film describes the steps of a novel minimally invasive surgical technique for the treatment of early-stage cervical cancer that prioritizes tumor containment and minimizes tumor seeding. Total Intracorporeal Robotic Radical Hysterectomy with Vaginal Cerclage and without uterine manipulator (TIRRHVC) is a C1 nerve sparing procedure that minimizes tumor seeding by eliminating the use of a uterine manipulator and maximizes tumor containment by placing circumferential sutures distal to the tumor, completely occluding it from the vagina. This surgical film demonstrates the relevant anatomy, dissection techniques and unique steps to accomplish a TIRRHVC, including the use of the robotic third arm for optimal traction and vaginal cerclage for complete circumferential occlusion of the cervical tumor.
RESUMEN
Introduction: Minimally invasive radical hysterectomy (MIRH) has been reported to have a four-fold increase in recurrence compared to open radical hysterectomy (ORH) for the treatment of early-stage cervical cancer. The cause for the inferior outcomes with MIRH is unclear. However, the use of a uterine manipulator and the lack of tumor containment strategies may contribute to tumor seeding in previous MIRH approaches. Objective: Determine the feasibility and early oncologic outcomes of a novel robotic-assisted surgical technique for the treatment of early-stage cervical cancer, Total Intracorporeal Robotic Radical Hysterectomy with Vaginal Cerclage (TIRRHVC). Methods: Retrospective cohort study. Results: Twenty-six patients between 2018 and 2022 underwent the TIRRHVC procedure after being counseled on the risks and benefits of ORH and TIRRHVC; these 26 patients' demographics, clinical, surgical, and oncologic outcomes were reviewed retrospectively. Seventeen patients (65.4 %) had clinical stage IB1 and 9 (34.6 %) were IB2 cervical cancer according to FIGO 2018 guidelines. Following hysterectomy and lymphadenectomy, 4 patients were upstaged. The average pathologic tumor size was 2.66 cm (0 cm - 5.6 cm); 65 % of tumors were > 2 cm. There were no intraoperative complications. There were 13 postoperative complications, including 10 urinary tract infections. Eleven patients (42.3 %) received adjuvant therapy. The average follow-up period was 2.8 years (IQR 2.3-3.6). Only one patient has recurred at 3.6 years. One patient expired from causes unrelated to gynecologic cancer. The 3-year disease free survival is 95.5 %. Conclusion: These promising early oncologic outcomes are encouraging that TIRRHVC may be a treatment option that offers the benefits of minimally invasive surgery without compromising oncologic outcomes.
RESUMEN
OBJECTIVES: Treatment for atypical endometrial hyperplasia (AEH) is based on pathologic diagnosis. About 40% of AEH is found to be carcinoma at surgery. This study's objective is to derive an objective characterization of nuclei from cases diagnosed as AEH or superficially invasive endometrial cancer (SIEC). METHODS: Cases from GOG study 167A were classified by a central pathology committee as AEH (n=39) or SIEC (n=39). High resolution digitized images of cell nuclei were recorded. Features of the nuclear chromatin pattern were computed. Classification rules were derived by discriminant analysis. RESULTS: Nuclei from cases of AEH and SIEC occupy the same range on a progression curve for endometrial lesions. Cases of AEH and SIEC both comprise nuclei of two phenotypes: hyperplastic characteristics and premalignant/neoplastic characteristics. The principal difference between AEH and SIEC is the percentage of premalignant/neoplastic nuclei. When this percentage approaches 50-60% superficial invasion is likely. SIEC may develop already from lesions at the low end of the progression curve. CONCLUSIONS: AEH comprises cases which may constitute a low risk group involving <40% of AEH cases. These cases hold a percentage of <20% of nuclei of a preneoplastic phenotype. AEH cases from the central and high end of progression have >40% of nuclei of preneoplastic phenotype. Nuclei of the preneoplastic phenotype in AEH lesions are almost indistinguishable from nuclei in SIEC, where this percentage exceeds 60%. The percentage of nuclei of the preneoplastic phenotype in AEH esions might serve as criterion for assessment of risk for the development of invasive disease.
Asunto(s)
Núcleo Celular/ultraestructura , Cromatina/ultraestructura , Hiperplasia Endometrial/patología , Neoplasias Endometriales/patología , Cariometría , Análisis Discriminante , Progresión de la Enfermedad , Neoplasias Endometriales/ultraestructura , Femenino , Humanos , Invasividad Neoplásica , Fenotipo , Estudios Prospectivos , Medición de RiesgoRESUMEN
To evaluate safety of quick discharge after robotic radical hysterectomy (RRH) in a tertiary hospital which has the enhanced recovery after surgery (ERAS) protocol. Among 94 consecutive cervical cancer patients who had undergone RRH, operative outcomes and the rate of unexpected visit after surgery were analyzed retrospectively. Patients were categorized as a surgery-to-discharge time of ≤12 h (early discharge [ED]) or >12 h (late discharge [LD]). About 77% (n = 72) of analyzed 94 patients discharged within 12 h after RRH. The ED group had significant correlation with shorter duration for urinary catheter required, less operative blood loss, and less voiding difficulty after long-term follow up compared to the LD group. There was no difference of perioperative complications and unexpected visit between the two groups. Performing nerve sparing (NS) RRH was only independent predictor for ED (p = 0.043, hazard ratio for LD = 0.22, confidence interval = 0.05-0.95). In conclusion, the ED within 12 h after RRH was safe in the setting of ERAS protocol. The NS-RRH could avoid the delay of genitourinary function recovery after surgery which caused LD. It can become the reasonable clinical pathway to discharge early patients who undergo NS-RRH with ERAS protocol.
RESUMEN
Variations in vascular anatomy are of great concern to surgeons, as proper identification of aberrant arteries can reduce the risk of iatrogenic injury and improve patient outcomes. Several studies have highlighted the irregular branching pattern of pelvic arteries, with a recent focus on the obturator artery (OA). The OA has an inconstant origin from the internal iliac artery, external iliac artery, or inferior epigastric artery. Within the pelvis, the OA can give off muscular branches and nutrient vessels to the ilium and pubis. Though occasionally described in text, few resources employ images of human donors that depict branches arising from the OAs. Out of the 34 hemisected pelves studied, we identified 1 individual with a substantial nutrient vessel branching unilaterally from the OA. Herein, we present the first image of this unconventional nutrient artery. This vessel should be highlighted given that its size and course make it particularly vulnerable during intrapelvic surgeries such as pelvic lymph node dissection or in procedures requiring arterial embolization of the OA.
RESUMEN
GOAL: To determine the learning curve and surgical outcome for the first one hundred twenty-two robotic hysterectomy with lymphadenectomy patients in comparison to the first one hundred twenty-two patients who underwent the same procedure laparoscopically. MATERIALS AND METHODS: An analysis of the first 122 patients who underwent a robotic assisted hysterectomy with lymphadenectomy (RHBPPALND) was compared to the first 122 patients who underwent a total laparoscopic hysterectomy with lymphadenectomy (LHBPPALND). The learning curve of the surgical procedure was determined by measuring operative time with respect to chronological order of each patient who had undergone their respective procedure. Number of lymph nodes, estimated blood loss, days of hospitalization, and complications of all patients were also analyzed and compared. RESULTS: The learning curve of the surgical procedure was determined by measuring operative time with respect to chronological order of each patient who had undergone their respective procedure. Data were analyzed for mean age, body mass index, operative time, estimated blood loss, lymph node retrieval and complications for both surgical procedures. The mean operative time was 147.2±48.2 and 186.8±59.8 for RHBPPALND and LHBPPALND respectively. The mean EBL was statistically significant at 81.1±45.9 and 207.4±109.4 for RHBPPALND and LHBPPALND respectively. The total number of pelvic and aortic lymph nodes was 25.1±12.7 for RHBPPALND and 43.1±17.8 for LHBPPALND. The number of pelvic lymph node was 19.2±9.0 and 24.7±11.9 for RHBPPALND and LHBPPALND. The days of hospitalization of RHBPPALND and LHBPPALND were 1.5±0.9 and 3.2±2.3. The number of intraoperative complications for RHBPPALND, and LHBPPALND was 1 and 7, respectively. CONCLUSION: Robotic hysterectomy with lymphadenectomy has a faster learning curve in comparison to laparoscopic hysterectomy with lymphadenectomy. The adequacy of surgical staging was comparable between the two surgical methods. RHBPPALND is associated with shorter hospitalization, less blood loss and less intraoperative and major complications, and lower rate of conversion to open procedure.
Asunto(s)
Neoplasias Endometriales/cirugía , Histerectomía/métodos , Laparoscopía/métodos , Curva de Aprendizaje , Escisión del Ganglio Linfático/métodos , Robótica , Anciano , Neoplasias Endometriales/patología , Femenino , Humanos , Complicaciones Intraoperatorias/epidemiología , Metástasis Linfática , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
OBJECTIVE: The safety and efficacy of gemcitabine plus carboplatin (GC) or paclitaxel plus carboplatin (TC) induction regimens with or without paclitaxel consolidation therapy were assessed in ovarian cancer (OC). METHODS: Patients with stage IC-IV OC were randomized to either GC (gemcitabine 1,000 mg/m(2), days 1 and 8, plus carboplatin area under the curve [AUC] 5, day 1) or TC (paclitaxel 175 mg/m(2) plus carboplatin AUC 6, day 1) every 21 days for up to six cycles. Patients with complete response (CR) were allowed optional consolidation with paclitaxel 135 mg/m(2) every 28 days for ≤ 12 months. Patients without CR received single-agent crossover therapy at induction doses/schedules until CR, disease progression (PD), or unacceptable toxicity. PD or death in 636 patients was required to compare induction arms with 80% statistical power for progression-free survival (PFS), the primary endpoint. RESULTS: Randomized induction therapy was received by 820 of 919 patients enrolled; 352 patients with CR received paclitaxel consolidation whereas 155 patients without CR received single-agent crossover therapy. PFS was similar for GC and TC (median, 20.0 and 22.2 months, respectively; P=.199). Despite high censoring rates (>52%), overall survival was longer for TC (median, 57.3 versus 43.8 months for GC; P=.013). Controlling for patient characteristics including performance status, residual tumor size, and tumor stage, there was no statistical difference in a multivariate analysis (HR=1.22; 95% CI=0.99-1.52; P=.067). CONCLUSIONS: GC does not improve PFS over TC as first-line induction chemotherapy in OC. Although favoring TC, overall survival analyses were limited by the study design and high censoring rates.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Glandulares y Epiteliales/tratamiento farmacológico , Neoplasias Ováricas/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Carcinoma Epitelial de Ovario , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Supervivencia sin Enfermedad , Neoplasias de las Trompas Uterinas/tratamiento farmacológico , Neoplasias de las Trompas Uterinas/patología , Femenino , Humanos , Quimioterapia de Inducción , Persona de Mediana Edad , Estadificación de Neoplasias , Neoplasias Glandulares y Epiteliales/patología , Neoplasias Ováricas/patología , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Neoplasias Peritoneales/tratamiento farmacológico , Neoplasias Peritoneales/patología , Tasa de Supervivencia , Adulto Joven , GemcitabinaRESUMEN
STUDY OBJECTIVE: To determine the learning curve for robotic-assisted hysterectomy with lymphadenectomy for surgical treatment of endometrial cancer. DESIGN: An analysis of robotic-assisted hysterectomy with lymphadenectomy vs total laparoscopic hysterectomy with lymphadenectomy and laparotomy with total abdominal hysterectomy with lymphadenectomy (Canadian Task Force classification II-1). SETTING: Solo, experienced, minimally invasive gynecologic oncology practice in a tertiary hospital. PATIENTS: One hundred forty-eight patients including 56 patients who underwent robotic-assisted hysterectomy with bilateral pelvic and paraaortic lymph node dissection, 56 patients who underwent total laparoscopic hysterectomy with bilateral pelvic and paraaortic lymph node dissection, and 36 patients who underwent traditional total abdominal hysterectomy with bilateral pelvic and paraaortic lymph node dissection performed by the same surgeon for treatment of endometrial cancer. INTERVENTIONS: Robotic-assisted hysterectomy with bilateral lymphadenectomy, total laparoscopic hysterectomy with bilateral lymphadenectomy, and traditional total abdominal hysterectomy with bilateral lymphadenectomy were performed. Data were categorized by chronologic order of cases into groups of 20 patients each. The learning curve of the surgical procedure was estimated by measuring operative time with respect to chronologic order of each patient who had undergone the respective procedure. MEASUREMENTS AND MAIN RESULTS: For the 3 surgical procedures, data analyzed included mean age, body mass index, operative time, blood loss, lymph node retrieval, and complications. Mean (SD); 95% confidence interval [CI]) operative time for the 3 procedures was statistically significant: 162.5 (53) minutes (95% CI, 148.6-176.4]), 192.3 (55.5) minutes (95% CI, 177.6-207.0), and 136.9 (32.3) minutes (95% CI, 126.3-147.5), respectively. Analysis of operative time for robotic-assisted hysterectomy with bilateral lymph node dissection with respect to chronologic order of each group of 20 cases demonstrated a decrease in operative time: 183.2 (69) minutes (95% CI; 153.0-213.4) for cases 1 to 20, 152.7 (39.8) minutes (95% CI, 135.3-170.1) for cases 21 to 40, and 148.8 (36.7) minutes (95% CI, 130.8-166.8) for cases 41 to 56. For the groups with laparoscopic hysterectomy with lymphadenectomy and traditional total abdominal hysterectomy with lymphadenectomy, there was no difference in operative time with respect to chronologic group order of cases. There was a difference between the number of lymph nodes retrieved between robotic-assisted hysterectomy with bilateral lymphadenectomy (26.7 [12.8]; 95% CI, 23.3-30.1) compared with laparoscopic hysterectomy with bilateral lymphadenectomy (45.1 [20.9]; 95% CI, 39.6-50.6) and traditional total abdominal hysterectomy with lymphadenectomy (55.8 [23.4]; 95% CI, 48.2-63.4). The rate of intraoperative complications for laparoscopic hysterectomy with bilateral lymphadenectomy was 12.5% (7 of 56) compared with 0 % for robotic-assisted hysterectomy with bilateral lymphadenectomy. The rate of postoperative complications was 14.3% (8 of 56), 21.4% (12 of 56), and 19.4% (7 of 36), respectively, for the 3 groups. There was less blood loss with robotic-assisted hysterectomy with bilateral lymphadenectomy (89.3 [45.4]; 95% CI, 77.4-101.2) compared with laparoscopic hysterectomy with bilateral lymphadenectomy (209.1 [91.8]; 95% CI, 185.1-233.1) and traditional total abdominal hysterectomy with lymphadenectomy (266.0 [145.1]; 95% CI, 218.6-313.4). Duration of hospitalization was shorter in the group with robotic-assisted hysterectomy with bilateral lymphadenectomy (1.6 [0.7]; 95% CI, 1.4-1.8) compared with the groups who underwent laparoscopic hysterectomy with bilateral lymphadenectomy (2.6 [0.9]; 95% CI, 2.4-2.8) or traditional total abdominal hysterectomy with lymphadenectomy (4.9 [1.9]; 95% CI, (4.3-5.5). CONCLUSION: The learning curve for robotic-assisted hysterectomy with lymph node dissection seems to be easier compared with that for laparoscopic hysterectomy with lymph node dissection for surgical management of endometrial cancer.
Asunto(s)
Neoplasias Endometriales/cirugía , Histerectomía/educación , Curva de Aprendizaje , Escisión del Ganglio Linfático/educación , Robótica/educación , Anciano , Femenino , Humanos , Histerectomía/métodos , Laparoscopía/métodos , Laparotomía/métodos , Escisión del Ganglio Linfático/métodos , Persona de Mediana Edad , Robótica/métodosRESUMEN
BACKGROUND: To compare the return of bladder function and genitourinary complications after type C1 robotic nerve-sparing radical hysterectomy (C1-RRH) to type C2 robotic radical hysterectomy (C2-RRH) in gynecologic cancers. METHODS: A retrospective analysis between C1-RRH (nâ¯=â¯42) and C2-RRH (nâ¯=â¯43) was performed. Operative outcomes and perioperative genitourinary complications between the two groups were analyzed. RESULTS: The C1-RRH group had shorter hospitalization (0.7 vs. 1.7 days, pâ¯<â¯0.001) and shorter DUC (1 vs. 28 days, pâ¯<â¯0.001). About 76% of C1-RRH group required a catheter for less than 1 week while 84% of the C2-RRH group did for more than 1 week (54% for 1-6 weeks; 30%â¯>â¯6 weeks). In spite of the short stay after surgery (95% of C1-RRHâ¯≤â¯1 day), only two patients (4.8%) in C1-RRH group were admitted again because of urinary tract infection. C1-RRH was only independent predictor for early bladder function return within 1 week after surgery. CONCLUSION: The C1-RRH showed early bladder function return and feasible outcomes in spite of early discharge. It can be considered as the first surgical option in gynecologic cancer patients who need RH to preserve their bladder function.
Asunto(s)
Histerectomía/mortalidad , Fibras Nerviosas , Tratamientos Conservadores del Órgano/mortalidad , Recuperación de la Función , Procedimientos Quirúrgicos Robotizados/mortalidad , Sistema Urogenital/fisiopatología , Neoplasias del Cuello Uterino/cirugía , Adenocarcinoma/patología , Adenocarcinoma/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Escamosas/patología , Carcinoma de Células Escamosas/cirugía , Neoplasias Endometriales/patología , Neoplasias Endometriales/cirugía , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Tasa de Supervivencia , Urodinámica , Neoplasias del Cuello Uterino/patologíaRESUMEN
OBJECTIVE: Upper paraaortic lymph node dissection (UPALD) to the infrarenal level is one of the most challenging robotic procedures. Because robotic system has the limitation in robotic arm mobility. This surgical video introduces a novel robotic approach, lower pelvic port placement (LP3), to perform optimally and simultaneously both UPALD and pelvic procedures in gynecologic cancer patients using da Vinci Xi system. METHODS: The patient presented with high-grade endometrial cancer. She underwent robotic surgical staging operation. For the setup of the LP3, a line was drown between both anterior superior iliac spines. At 3 cm below this line, another line was drown and four robotic ports were placed on this line. RESULTS: After paraaortic lymph node dissection (PALD) was completed, the boom of robotic system was rotated 180° to retarget for the pelvic lateral displacement. Robotic ports were placed and docked again. The operation was completed robotically without any complication. CONCLUSION: The LP3 was feasible for performing simultaneously optimal PALD as well as procedures in pelvic cavity in gynecologic cancer patients. The advantage of LP3 technique is the robotic port placement that affords for multi-quadrant surgery, abdominal and pelvic dissection. The LP3 is facilitated by utilizing advanced technology of Xi system, including the patient clearance function, the rotating boom, and 'port hopping' that allows using every ports for a camera. The LP3 will enable surgeons to extend the surgical indication of robotic surgical system in the gynecologic oncologic field.
Asunto(s)
Neoplasias Endometriales/cirugía , Escisión del Ganglio Linfático/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Aorta , Femenino , Humanos , Escisión del Ganglio Linfático/instrumentación , Procedimientos Quirúrgicos Robotizados/instrumentaciónRESUMEN
Robotic surgery in the treatment of gynecologic diseases continues to evolve and has become accepted over the last decade. The advantages of robotic-assisted laparoscopic surgery over conventional laparoscopy are three-dimensional camera vision, superior precision and dexterity with EndoWristed instruments, elimination of operator tremor, and decreased surgeon fatigue. The drawbacks of the technology are bulkiness and lack of tactile feedback. As with other surgical platforms, the limitations of robotic surgery must be understood. Patient selection and the types of surgical procedures that can be performed through the robotic surgical platform are critical to the success of robotic surgery. First, patient selection and the indication for gynecologic disease should be considered. Discussion with the patient regarding the benefits and potential risks of robotic surgery and of complications and alternative treatments is mandatory, followed by patient's signature indicating informed consent. Appropriate preoperative evaluation-including laboratory and imaging tests-and bowel cleansing should be considered depending upon the type of robotic-assisted procedure. Unlike other surgical procedures, robotic surgery is equipment-intensive and requires an appropriate surgical suite to accommodate the patient side cart, the vision system, and the surgeon's console. Surgical personnel must be properly trained with the robotics technology. Several factors must be considered to perform a successful robotic-assisted surgery: the indication and type of surgical procedure, the surgical platform, patient position and the degree of Trendelenburg, proper port placement configuration, and appropriate instrumentation. These factors that must be considered so that patients can be appropriately prepared before and during the operation are described.
Asunto(s)
Procedimientos Quirúrgicos Ginecológicos/métodos , Cuidados Intraoperatorios/métodos , Cuidados Preoperatorios/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Femenino , Humanos , Selección de PacienteRESUMEN
OBJECTIVE: To compare perioperative outcomes between robotic-assisted benign hysterectomies and abdominal, vaginal, and laparoscopic hysterectomies when performed by high-volume surgeons. METHODS: A multicenter data analysis compared 30-day outcomes from consecutive robotic-assisted hysterectomies performed by high-volume surgeons (≥60 prior procedures) at nine centers with records retrieved from the Premier Perspective database for abdominal, vaginal, and laparoscopic hysterectomies performed by high-volume gynecologic surgeons. Data on benign hysterectomy disorders from January 1, 2012 to September 30, 2013 were included. RESULTS: Data from 2300 robotic-assisted, 9745 abdominal, 8121 vaginal, and 11 952 laparoscopic hysterectomies were included. The robotic-assisted patient cohort had a significantly higher rate of adhesive disease compared with the vaginal (P<0.001) and laparoscopic cohorts (P<0.001), a significantly higher rate of morbid obesity than the vaginal (P<0.001) or laparoscopic cohorts (P<0.001), and a significantly higher rate of large uteri (>250g) than the abdominal (P<0.001), vaginal (P<0.001), or laparoscopic cohorts (P=0.017). The robotic-assisted cohort experienced significantly fewer intraoperative complications than the abdominal (P<0.001) and vaginal cohorts (P<0.001), and experienced significantly fewer postoperative complications compared with all the comparator cohorts (P<0.001). CONCLUSION: When performed by gynecologic surgeons with relevant high-volume experience, robotic-assisted benign hysterectomy provided improved outcomes compared with abdominal, vaginal, and laparoscopic hysterectomy.
Asunto(s)
Histerectomía/métodos , Complicaciones Intraoperatorias/epidemiología , Laparoscopía , Complicaciones Posoperatorias/epidemiología , Procedimientos Quirúrgicos Robotizados , Abdomen/cirugía , Adulto , Femenino , Humanos , Persona de Mediana Edad , Estudios Retrospectivos , Resultado del Tratamiento , Estados Unidos , Vagina/cirugíaRESUMEN
PURPOSE: To evaluate risk factors for GI adverse events (AEs) within a phase III trial of bevacizumab in first-line ovarian cancer therapy. PATIENTS AND METHODS: Women with previously untreated advanced disease after surgery were randomly allocated to six cycles of platinum-taxane chemotherapy plus placebo cycles (C)2 to C22 (R1); chemotherapy plus bevacizumab C2 to C6 plus placebo C7 to C22 (R2); or chemotherapy plus bevacizumab C2 to C22 (R3). Patients were evaluated for history or on-study development of potential risk factors for GI AEs defined as grade ≥ 2 perforation, fistula, necrosis, or hemorrhage. RESULTS: Of 1,873 patients enrolled, 1,759 (94%) were evaluable, and 2.8% (50 of 1,759) experienced a GI AE: 10 of 587 (1.7%, R1), 20 of 587 (3.4%, R2), and 20 of 585 (3.4%, R3). Univariable analyses indicated that previous treatment of inflammatory bowel disease (IBD; P = .005) and small bowel resection (SBR; P = .032) or large bowel resection (LBR; P = .012) at primary surgery were significantly associated with a GI AE. The multivariable estimated relative odds of a GI AE were 13.4 (95% CI, 3.44 to 52.3; P < .001) for IBD; 2.05 (95% CI, 1.09 to 3.88; P = .026) for LBR; 1.95 (95% CI, 0.894 to 4.25; P = .093) for SBR; and 2.15 for bevacizumab exposure (aggregated 95% CI, 1.05 to 4.40; P = .036). CONCLUSION: History of treatment for IBD, and bowel resection at primary surgery, increase the odds of GI AEs in patients receiving first-line platinum-taxane chemotherapy for advanced ovarian cancer. After accounting for these risk factors, concurrent bevacizumab doubles the odds of a GI AE, but is not appreciably increased by continuation beyond chemotherapy.