Sentinel lymph node mapping in endometrial cancer - robotic vs. laparoscopic detection system.

OBJECTIVE: Comparison of systems to detect sentinel lymph node in endometrial carcinoma using indocyanine green. Robotic Firefly Da Vinci fluorescence imaging system (Intuitive Surgical Inc., Sunnyvale, CA, USA) vs. laparoscopic Novadaq Pinpoint near-infrared imaging system (Novadaq, Ontario, Canada). MATERIAL AND METHOD: Fifteen patients with stage I endometrial cancer underwent sentinel lymph node biopsy after intracervical application of indocyanine green. For all of them, the detection was performed sequentially using both evaluated devices. The detection rate, identification match and extent of imaging of the lymphatic system were evaluated. RESULTS: The detection rate of both systems verified on a set of patients was identical, the detected sentinel nodes were identical, and the lymphatic system was shown to the same extent. The quality of the display and overall user-friendliness is different due to the applied technologies. CONCLUSION: Both systems used in minimally invasive surgery provide excelent perioperative imaging of the lymphatic system.

Dendritic cell-based immunotherapy (DCVAC/OvCa) combined with second-line chemotherapy in platinum-sensitive ovarian cancer (SOV02): A randomized, open-label, phase 2 trial.

OBJECTIVE: DCVAC/OvCa is an active cellular immunotherapy designed to stimulate an immune response against ovarian cancer. We explored the safety and efficacy of DCVAC/OvCa plus carboplatin and gemcitabine in platinum-sensitive ovarian cancer. METHODS: In this open-label, parallel-group, phase 2 trial (ClinicalTrials.gov number NCT02107950), patients with platinum-sensitive ovarian cancer relapsing after first-line chemotherapy were randomized to DCVAC/OvCa and chemotherapy or chemotherapy alone. DCVAC/OvCa was administered every 3-6 weeks (10 doses). Endpoints included safety, progression-free survival (PFS; primary efficacy endpoint) and overall survival (OS; secondary efficacy endpoint). RESULTS: Between November 2013 and May 2015, 71 patients were randomized to chemotherapy in combination with DCVAC/OvCa or to chemotherapy alone. Treatment-emergent adverse events related to DCVAC/OvCa, leukapheresis and chemotherapy occurred in six (16.2%), two (5.4%), and 35 (94.6%) patients in the DCVAC/OvCa group. Chemotherapy-related events occurred in all patients in the chemotherapy group. Seven patients in the DCVAC/OvCa group were excluded from primary efficacy analyses due to failure to receive ≥1 dose of DCVAC/OvCa. PFS was not improved (hazard ratio [HR] 0.73, 95% confidence interval [CI] 0.42-1.28, P = 0.274, data maturity 78.1%). Median OS was significantly prolonged (by 13.4 months) in the DCVAC/OvCa group (HR 0.38, 95% CI 0.20-0.74, P = 0.003; data maturity 56.3%). A signal for enhanced surrogate antigen-specific T-cell activity was seen with DCVAC/OvCa. CONCLUSIONS: DCVAC/OvCa combined with chemotherapy had a favorable safety profile in patients with platinum-sensitive ovarian cancer. DCVAC/OvCa did not improve PFS, but the exploratory analyses revealed OS prolongation and enhanced surrogate antigen-specific T-cell activity.

Cervical tuberculosis in a postmenopausal patient.

OBJECTIVE: Description of a case of extrapulmonary genital tuberculosis of the uterine cervix in a postmenopausal patient. CASE REPORT: A 66-year-old patient with a history of metrorrhagia, an ulcerated process in the area of the uterine cervix and vagina, with infiltration of parametria, serosanguinolent discharge and progressive cachectization was admitted to the oncogynecological center of the Hospital of Ceské Budejovice, a.s. As part of the dia-gnostics, physical examination, colposcopy, targeted bio-psy, polymerase chain reaction (PCR) and microbio-logical examination, oncogynecological ultrasound and CT examination were performed. Clinically, the lesion acted as an advanced tumor. However, no malignant cells were detected in the bio-psy and the histopathological finding corresponded to a granulomatous inflammatory condition with giant cell histiocytic elements. Bacterial DNA of Mycobacterium tuberculosis complex was detected by PCR testing. The patient underwent controlled antituberculosis treatment with regular gynecological examinations. CONCLUSION: Tuberculosis of the uterine cervix occurs rarely. Its clinical manifestation may mimic the tumor process. Dia-gnosis is based on the identification of the causative agent and treatment consists of long-term controlled administration of antituberculotics, and in rare cases, combination with surgical  treatment.

Comparison of complications in very obese women undergoing hysterectomy - Abdominal vs laparoscopic approach with short- and long-term follow-up.

BACKGROUND: Surgical treatment of obese female patients represents a real challenge. Over the last decade, minimally invasive techniques for hysterectomy have emerged. These approaches reduce the invasiveness of standard surgical procedures while maintaining efficacy and feasibility. OBJECTIVE: To evaluate the rates of perioperative, early, mid-term and late postoperative complications in very obese [body mass index (BMI) ≥ 35 and < 40 kg/m2] and severely obese (BMI ≥ 40 kg/m2) women who underwent total (non-radical) hysterectomy. DESIGN: A prospective comparative multi-centre non-randomized study. METHODS: In total, 328 consecutive total (non-radical) hysterectomies were performed at seven teaching gynaecological centres. Of these, 153 (46.6%) were performed using an open laparotomy (LT) approach and 175 (53.4%) were performed laparoscopically (LS). All data were collected by medical specialists at the pre-operative examination prior to surgery, during surgery and three times postoperatively (during hospital stay, at 6-week follow-up and 6 months following surgery). Another analysis considered a total of 206 women who underwent laparoscopic hysterectomy. The subjects were divided according to BMI into 120 very obese women (BMI ≥ 35 and < 40 kg/m2) and 86 severely obese women (BMI ≥ 40 kg/m2). RESULTS: The total number of composite perioperative complications was significantly lower in the LS group (p = 0.006). Composite complications occurred significantly more often in patients in the LT group compared with the LS group in the early (p < 0.001) and mid-term (p < 0.001) postoperative periods. In the late postoperative period, the total number of composite postoperative complications did not differ significantly between the groups (p < 0.396). Among 206 patients who underwent laparoscopic hysterectomy, the number of complications was generally low; the rates of composite perioperative (p = 0.393), early (p = 0.642), mid-term (p = 0.738) and late (p = 1) postoperative complications were generally low; and frequency did not differ significantly with BMI. CONCLUSION: The LS approach does not increase intra-operative morbidity associated with surgery, and has significantly better outcomes in terms of the postoperative complication rate.

Safety and efficacy of dendritic cell-based immunotherapy DCVAC/OvCa added to first-line chemotherapy (carboplatin plus paclitaxel) for epithelial ovarian cancer: a phase 2, open-label, multicenter, randomized trial.

BACKGROUND: Most patients with epithelial ovarian cancer (EOC) relapse despite primary debulking surgery and chemotherapy (CT). Autologous dendritic cell immunotherapy (DCVAC) can present tumor antigens to elicit a durable immune response. We hypothesized that adding parallel or sequential DCVAC to CT stimulates antitumor immunity and improves clinical outcomes in patients with EOC. Based on the interim results of sequential DCVAC/OvCa administration and to accommodate the increased interest in maintenance treatment in EOC, the trial was amended by adding Part 2. METHODS: Patients with International Federation of Gynecology and Obstetrics stage III EOC (serous, endometrioid, or mucinous), who underwent cytoreductive surgery up to 3 weeks prior to randomization and were scheduled for first-line platinum-based CT were eligible. Patients, stratified by tumor residuum (0 or <1 cm), were randomized (1:1:1) to DCVAC/OvCa parallel to CT (Group A), DCVAC/OvCa sequential to CT (Group B), or CT alone (Group C) in Part 1, and to Groups B and C in Part 2. Autologous dendritic cells for DCVAC were differentiated from patients' CD14+ monocytes, pulsed with two allogenic OvCa cell lines (SK-OV-3, OV-90), and matured in the presence of polyinosinic:polycytidylic acid. We report the safety outcomes (safety analysis set, Parts 1 and 2 combined) along with the primary (progression-free survival (PFS)) and secondary (overall survival (OS)) efficacy endpoints. Efficacy endpoints were assessed in the modified intention-to-treat (mITT) analysis set in Part 1. RESULTS: Between November 2013 and March 2016, 99 patients were randomized. The mITT (Part 1) comprised 31, 29, and 30 patients in Groups A, B, and C, respectively. Baseline characteristics and DCVAC/OvCa exposure were comparable across the treatment arms. DCVAC/OvCa showed a good safety profile with treatment-emergent adverse events related to DCVAC/OvCa in 2 of 34 patients (5.9%) in Group A and 2 of 53 patients (3.8%) in Group B. Median PFS was 20.3, not reached, and 21.4 months in Groups A, B, and C, respectively. The HR (95% CI) for Group A versus Group C was 0.98 (0.48 to 2.00; p=0.9483) and the HR for Group B versus Group C was 0.39 (0.16 to 0.96; p=0.0336). This was accompanied by a non-significant trend of improved OS in Groups A and B. Median OS was not reached in any group after a median follow-up of 66 months (34% of events). CONCLUSIONS: DCVAC/OvCa and leukapheresis was not associated with significant safety concerns in this trial. DCVAC/OvCa sequential to CT was associated with a statistically significant improvement in PFS in patients undergoing first-line treatment of EOC. TRIAL REGISTRATION NUMBER: NCT02107937, EudraCT2010-021462-30.