Adenoid cystic carcinoma of the Bartholin gland is not HPV-related: A case report and review of literature

Adenoid cystic carcinoma (ACC) of the Bartholin gland is a rare gynaecological entity. Despite its slow growth and inconspicuous presentation, vulvar ACC has a propensity for perineural invasion and is therefore associated with high local recurrence rates. We report a case of vulvar ACC in a 61-year-old woman with a prolonged swelling of the Bartholin gland. This patient presented with pulmonary metastases at the moment of histological diagnosis. The vulvar and the pulmonary lesions showed identical histology. Despite a history of human papilloma virus (HPV)-related usual type vulvar intra-epithelial neoplasia and cervical squamous cell carcinoma, the vulvar ACC was negative for both p16 immuno

Role of the PlasmaJet Surgical device during cytoreductive surgery for advanced stage ovarian cancer: PlaComOv-study: randomized controlled trial in the Netherlands

BACKGROUND Treatment of advanced stage ovarian cancer (ASOC) consists of surgery and chemotherapy. During surgery, it is important to remove all visible tumor (complete cytoreductive surgery (CRS)) because this improves survival compared to an optimal CRS (residual tumor: 0.1-1 cm3). If there are metastases at vulnerable structures such as the small intestine, it is difficult to achieve a complete CRS with conventional devices. GOAL During a multicenter randomized controlled trial, to investigate whether the use of the PlasmaJet during CRS is safe and effective to achieve a higher percentage of complete CRS in the treatment of women with ASOC. PROJECT DESIGN RESEARCH QUESTION Does the use of the PlasmaJet result to a higher percentage complete CRS in patients with ASOC? HYPOTHESIS Adding PlasmaJet to standard surgical equipment improves the rate of complete CRS by 15% STUDY DESIGN Single-blind, multicenter randomized controlled trial in the Netherlands STUDY POPULATION Inclusion criteria: ASOC FIGO stage IIIB-IV where radical surgery and chemotherapy is indicated and who are fit enough to undergo surgery (primary or interval CRS) Exclusion criteria: ovarian cancer FIGO stage I-IIIA, recurrent ovarian cancer, no epithelial ovarian cancer INTERVENTION Use of PlasmaJet during CRS USUAL CARE Use of standard surgical instruments during CRS RESULTS From February 2018-September 2020, 327 women with ASOC were included in the study. The intention-to-treat analysis demonstrates a percentage of complete CRS of 75.8% in the intervention group versus 67.6% in the control group (p=0.131). The per-protocol analysis, excluding women who did not undergo CRS, demonstrates a percentage complete CRS of 85.6% in the intervention group versus 71.5% in the control group (p=0.005). There was no significant differences in the secondary outcomes (complication rate, operative time, blood loss, hospitalization, colostomy). A difference in the percentage of colostomy is seen with 5.7% in the intervention group and 11.8% in the control group. The use of the PlasmaJet during CRS produces significantly less thermal damage than electrocoagulation treatment (0.15mm versus 0.33mm, p<0.001). The cost of treatment from diagnosis to the end of chemotherapy when using the PlasmaJet is significantly higher than when the PlasmaJet is not available with a difference of €1,249. Twelve months after surgery, women in the intervention group reported a higher QoL than women in the control group (p=0.005). As part of the implementation process, various training courses have been organized in a skills lab for surgeons and gynecologists. Intended results are the difference in disease-free and overall survival and a cost-effectiveness analysis. DISCUSSION We conclude that the use of the PlasmaJet improves the surgical outcome without an increase of the complication rate. We will wait for the long-term results (5 years after the last inclusion) to know whether the use of the PlasmaJet also results to a longer disease-free and overall survival. The main limitation of this study is that we did not randomize per-operatively, so all women with unresectable disease (shown during surgery) would be excluded from this study and we could really analyze the effect of the PlasmaJet. The data of the per-protocol analysis would be the final outcomes. An explanation for rejecting the hypothesis to show a 15% difference in complete CRS between the two groups is that surgery has become more extensive over time. This results in a higher percentage of complete CRS in the intervention group. Most results have been published in international journals. The results of QoL have been submitted

PlaComOv-study: randomized controlled trial in the Netherlands

BACKGROUND Treatment of advanced stage ovarian cancer (ASOC) consists of surgery and chemotherapy. During surgery, it is important to remove all visible tumor (complete cytoreductive surgery (CRS)) because this improves survival compared to an optimal CRS (residual tumor: 0.1-1 cm3). If there are metastases at vulnerable structures such as the small intestine, it is difficult to achieve a complete CRS with conventional devices. GOAL During a multicenter randomized controlled trial, to investigate whether the use of the PlasmaJet during CRS is safe and effective to achieve a higher percentage of complete CRS in the treatment of women with ASOC. PROJECT DESIGN RESEARCH QUESTION Does the use of the PlasmaJet result to a higher percentage complete CRS in patients with ASOC? HYPOTHESIS Adding PlasmaJet to standard surgical equipment improves the rate of complete CRS by 15% STUDY DESIGN Single-blind, multicenter randomized controlled trial in the Netherlands STUDY POPULATION Inclusion criteria: ASOC FIGO stage IIIB-IV where radical surgery and chemotherapy is indicated and who are fit enough to undergo surgery (primary or interval CRS) Exclusion criteria: ovarian cancer FIGO stage I-IIIA, recurrent ovarian cancer, no epithelial ovarian cancer INTERVENTION Use of PlasmaJet during CRS USUAL CARE Use of standard surgical instruments during CRS RESULTS From February 2018-September 2020, 327 women with ASOC were included in the study. The intention-to-treat analysis demonstrates a percentage of complete CRS of 75.8% in the intervention group versus 67.6% in the control group (p=0.131). The per-protocol analysis, excluding women who did not undergo CRS, demonstrates a percentage complete CRS of 85.6% in the intervention group versus 71.5% in the control group (p=0.005). There was no significant differences in the secondary outcomes (complication rate, operative time, blood loss, hospitalization, colostomy). A difference in the percentage of colostomy is seen with 5.7% in the intervention group and 11.8% in the control group. The use of the PlasmaJet during CRS produces significantly less thermal damage than electrocoagulation treatment (0.15mm versus 0.33mm, p<0.001). The cost of treatment from diagnosis to the end of chemotherapy when using the PlasmaJet is significantly higher than when the PlasmaJet is not available with a difference of €1,249. Twelve months after surgery, women in the intervention group reported a higher QoL than women in the control group (p=0.005). As part of the implementation process, various training courses have been organized in a skills lab for surgeons and gynecologists. Intended results are the difference in disease-free and overall survival and a cost-effectiveness analysis. DISCUSSION We conclude that the use of the PlasmaJet improves the surgical outcome without an increase of the complication rate. We will wait for the long-term results (5 years after the last inclusion) to know whether the use of the PlasmaJet also results to a longer disease-free and overall survival. The main limitation of this study is that we did not randomize per-operatively, so all women with unresectable disease (shown during surgery) would be excluded from this study and we could really analyze the effect of the PlasmaJet. The data of the per-protocol analysis would be the final outcomes. An explanation for rejecting the hypothesis to show a 15% difference in complete CRS between the two groups is that surgery has become more extensive over time. This results in a higher percentage of complete CRS in the intervention group. Most results have been published in international journals. The results of QoL have been submitted

Survival in advanced-stage epithelial ovarian cancer patients with cardiophrenic lymphadenopathy who underwent cytoreductive surgery

Purpose: To evaluate the clinical outcomes of enlarged cardiophrenic lymph node (CPLN) in advanced-stage epithelial ovarian cancer (AEOC) patients who underwent cytoreductive sur-gery. Methods: The Embase

Adult but not childhood onset asthma is associated with the metabolic syndrome, independent from body mass index

Introduction: Adult-onset asthma (AOA) is usually more severe compared to childhood onset asthma (CoA). Given the increasing evidence that AoA is associated with obesity, we investigated the relationship of other related metabolic comorbid conditions with AoA compared to CoA. Study design and methods: This cross-sectional study compared the metabolic syndrome and lipid derived inflammatory markers in patients with AoA, CoA and age- and sex-matched control subjects without asthma. Participants were asthma patients visiting the outpatient clinic of two teaching hospitals in Rotterdam, The Netherlands. All participants underwent lung function tests, blood tests and physical activity tracking. AoA was defined as asthma age of onset after the age of 18 years. Metabolic syndrome was defined according to the international joint interim statement criteria. Results: Eighty-one participants were included (27 AoA, 25 CoA, 29 controls). AoA was associated with the metabolic syndrome (Odds Ratio = 3.64 95% CI (1.16–11.42) p = 0.03, Nagelkerke R2 = 0.26), adjusted for age, sex, body mass index and smoking habits. AoA patients had higher median serum IL-6 and leptin-adiponectin (LA) ratio compared to controls (IL-6 (pg/mL): 3.10 [1.11–4.30] vs. 1.13 [0.72–1.58], p = 0.002 and LA ratio (pg/mL): 6.21 [2.45–14.11] vs. 2.24 [0.67–4.71], p = 0.0390). This was not observed in CoA and controls. Conclusion: AoA was associated with the metabolic syndrome and its related pro-inflammatory endocrine and cytokine status. This may suggest adipose tissue derived inflammatory markers play a role in the pathophysiology of AoA.</p

Adjuvant Use of PlasmaJet Device During Cytoreductive Surgery for Advanced-Stage Ovarian Cancer: Results of the PlaComOv-study, a Randomized Controlled Trial in The Netherlands

Objective Standard surgical treatment of advanced-stage ovarian carcinoma with electrosurgery cannot always result in complete cytoreductive surgery (CRS), especially when many small metastases are found on the mesentery and intestinal surface. We investigated whether adjuvant use of a neutral argon plasma device can help increase the complete cytoreduction rate. Patients and Methods 327 patients with FIGO stage IIIB-IV epithelial ovarian cancer (EOC) who underwent primary or interval CRS were randomized to either surgery with neutral argon plasma (PlasmaJet) (intervention) or without PlasmaJet (control group). The primary outcome was the percentage of complete CRS. The secondary outcomes were duration of surgery, blood loss, number of bowel resections and colostomies, hospitalization, 30-day morbidity, and quality of life (QoL). Results Complete CRS was achieved in 119 patients (75.8%) in the intervention group and 115 patients (67.6%) in the control group (risk difference (RD) 8.2%, 95% confidence interval (CI) -0.021 to 0.181; P = 0.131). In a per-protocol analysis excluding patients with unresectable disease, complete CRS was obtained in 85.6% in the intervention group and 71.5% in the control group (RD 14.1%, 95% CI 0.042 to 0.235; P = 0.005). Patient-reported QoL at 6 months after surgery differed between groups in favor of PlasmaJet surgery (95% CI 0.455-8.350; P = 0.029). Other secondary outcomes did not differ significantly. Conclusions Adjuvant use of PlasmaJet during CRS for advanced-stage ovarian cancer resulted in a significantly higher proportion of complete CRS in patients with resectable disease and higher QoL at 6 months after surgery. (Funded by ZonMw, Trial Register NL62035.078.17.

Bacterial lysate add-on therapy to reduce exacerbations in severe asthma

Background: Asthma exacerbations are frequently induced by respiratory tract infections (RTIs). Bacterial lysates have been described to possess immune-modulatory effects and reduce RTIs as well as asthma symptoms in children. However, whether bacterial lysates have similar effects in adult asthma patients is unknown. Aims: To reduce asthma exacerbations by add-on bacterial lysate therapy in adults with severe asthma and to characterize the clinical and immune-modulatory effects of this treatment. Methods: Asthma patients (GINA 4) with ≥2 annual exacerbations in the previous year were included. The intervention regimen consisted of OM-85/placebo for 10 consecutive days per month for 6 months during two winter seasons. Primary end-point was the number of severe asthma exacerbations within 18 months. The study was approved by the national and local ethical review board and registered in the Dutch Trial Registry (NL5752). All participants provided written informed consent. Results: Seventy-five participants were included (38 OM-85; 37 placebo). Exacerbation frequencies were not different between the groups after 18 months (incidence rate ratio 1.07, 95%CI [0.68–1.69], p = 0.77). With the use of OM-85, FEV1% increased by 3.81% (p = 0.04) compared with placebo. Nasopharyngeal swabs taken during RTIs detected a virus less frequently in patients using OM-85 compared to placebo (30.5% vs. 48.0%, p = 0.02). In subjects with type 2 inflammation adherent to the protocol (22 OM-85; 20 placebo), a non-statistically significant decrease in exacerbations in the OM-85 group was observed (IRR = 0.71, 95%CI [0.39–1.26], p = 0.25). Immune-modulatory effects included an increase in several plasma cytokines in the OM-85 group, especially IL-10 and interferons. Peripheral blood T- and B cell subtyping, including regulatory T cells, did not show differences between the groups. Conclusion: Although OM-85 may have immune-modulatory effects, it did not reduce asthma exacerbations in this heterogeneous severe adult asthma group. Post hoc analysis showed a potential clinical benefit in patients with type 2 inflammation.</p