Cytoreductive surgery followed by chemotherapy versus chemotherapy alone for recurrent platinum- sensitive epithelial ovarian cancer (SOCceR trial):a multicenter randomised controlled study

BACKGROUND: Improvement in treatment for patients with recurrent ovarian cancer is needed. Standard therapy in patients with platinum-sensitive recurrent ovarian cancer consists of platinum-based chemotherapy. Median overall survival is reported between 18 and 35 months. Currently, the role of surgery in recurrent ovarian cancer is not clear. In selective patients a survival benefit up to 62 months is reported for patients undergoing complete secondary cytoreductive surgery. Whether cytoreductive surgery in recurrent platinum-sensitive ovarian cancer is beneficial remains questionable due to the lack of level I-II evidence. METHODS/DESIGN: Multicentre randomized controlled trial, including all nine gynecologic oncologic centres in the Netherlands and their affiliated hospitals. Eligible patients are women, with first recurrence of FIGO stage Ic-IV platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer, who meet the inclusion criteria. Participants are randomized between the standard treatment consisting of at least six cycles of intravenous platinum based chemotherapy and the experimental treatment which consists of secondary cytoreductive surgery followed by at least six cycles of intravenous platinum based chemotherapy. Primary outcome measure is progression free survival. In total 230 patients will be randomized. Data will be analysed according to intention to treat. DISCUSSION: Where the role of cytoreductive surgery is widely accepted in the initial treatment of ovarian cancer, its value in recurrent platinum-sensitive epithelial ovarian cancer has not been established so far. A better understanding of the benefits and patients selection criteria for secondary cytoreductive surgery has to be obtained. Therefore the 4(th) ovarian cancer consensus conference in 2010 stated that randomized controlled phase 3 trials evaluating the role of surgery in platinum-sensitive recurrent epithelial ovarian cancer are urgently needed. We present a recently started multicentre randomized controlled trial that will investigate the role of secondary cytoreductive surgery followed by chemotherapy will improve progression free survival in selected patients with first recurrence of platinum-sensitive epithelial ovarian cancer. TRIAL REGISTRATION: Netherlands Trial Register number: NTR3337

Physiological Correlates of Volunteering

We review research on physiological correlates of volunteering, a neglected but promising research field. Some of these correlates seem to be causal factors influencing volunteering. Volunteers tend to have better physical health, both self-reported and expert-assessed, better mental health, and perform better on cognitive tasks. Research thus far has rarely examined neurological, neurochemical, hormonal, and genetic correlates of volunteering to any significant extent, especially controlling for other factors as potential confounds. Evolutionary theory and behavioral genetic research suggest the importance of such physiological factors in humans. Basically, many aspects of social relationships and social activities have effects on health (e.g., Newman and Roberts 2013; Uchino 2004), as the widely used biopsychosocial (BPS) model suggests (Institute of Medicine 2001). Studies of formal volunteering (FV), charitable giving, and altruistic behavior suggest that physiological characteristics are related to volunteering, including specific genes (such as oxytocin receptor [OXTR] genes, Arginine vasopressin receptor [AVPR] genes, dopamine D4 receptor [DRD4] genes, and 5-HTTLPR). We recommend that future research on physiological factors be extended to non-Western populations, focusing specifically on volunteering, and differentiating between different forms and types of volunteering and civic participation

Frequently asked questions about chlorophyll fluorescence, the sequel

[EN] Using chlorophyll (Chl) a fluorescence many aspects of the photosynthetic apparatus can be studied, both in vitro and, noninvasively, in vivo. Complementary techniques can help to interpret changes in the Chl a fluorescence kinetics. Kalaji et al. (Photosynth Res 122: 121-158, 2014a) addressed several questions about instruments, methods and applications based on Chl a fluorescence. Here, additionalChl a fluorescence-related topics are discussed again in a question and answer format. Examples are the effect of connectivity on photochemical quenching, the correction of F-V/F-M values for PSI fluorescence, the energy partitioning concept, the interpretation of the complementary area, probing the donor side of PSII, the assignment of bands of 77 K fluorescence emission spectra to fluorescence emitters, the relationship between prompt and delayed fluorescence, potential problems when sampling tree canopies, the use of fluorescence parameters in QTL studies, the use of Chl a fluorescence in biosensor applications and the application of neural network approaches for the analysis of fluorescence measurements. The answers draw on knowledge fromdifferent Chl a fluorescence analysis domains, yielding in several cases new insights.Kalaji, H.; Schansker, G.; Brestic, M.; Bussotti, F.; Calatayud, A.; Ferroni, L.; Goltsev, V.... (2017). Frequently asked questions about chlorophyll fluorescence, the sequel. 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High incidence of erysipelas after surgical treatment for vulvar carcinoma: An observational study

Objectives: Vulvar carcinoma is mainly treated surgically and has an overall good prognosis. Despite the development of minimally invasive surgical procedures in recent years, morbidity remains significant. The aim of the study was to determine the incidence and risk factors of erysipelas after surgical treatment for vulvar carcinoma. Methods: This retrospective observational study was performed within the Comprehensive Cancer Centre South. The study included patients (N = 116) who underwent surgery for primary vulvar carcinoma between 2005 and 2012. Patients with International Federation of Gynecology and Obstetrics stage IA and IV were excluded. Clinical and histopathological data were analyzed using logistic regression, χ2 tests, Fisher exact tests, independent t tests, and nonparametric tests. Primary outcome was the incidence of postoperative erysipelas and determination of risk factors for erysipelas. Secondary outcome included other comorbidities. Results: A total of 23 patients (20%) with vulvar carcinoma had 1 or more episodes of erysipelas. The risk of developing erysipelas was significantly higher in patients who underwent lymph node dissection than in those who underwent sentinel node biopsy (36% [n = 12] and 14% [n = 11], respectively, P = 0.008) and in patients with lymphedema than in those without (30% [n = 7] and 12% [n = 11], respectively, P = 0.048). Patients with diabetes tended to have a higher incidence of erysipelas than those without (28% vs 18%, P = 0.27). Conclusions: Erysipelas occurs frequently in patients who undergo surgical treatment for vulvar carcinoma. The risk of erysipelas is 3 times higher in patients who undergo lymph node dissection and in those with lymphedema than in those without, and it tends to be high in patients with diabetes

Comparing Blind and Ultrasound-Guided Retrobulbar Nerve Blocks in Equine Cadavers: The Training Effect

In standing ophthalmic surgery in horses, a retrobulbar nerve block (RNB) is often placed blindly for anesthesia and akinesia. The ultrasound (US)-guided RNB may have fewer complications, but the two techniques have only been compared once in equine cadavers. This study compares the techniques for success and complication rates and analyzes the effect of training on US guidance. Twenty-two equine cadavers were divided into three groups: blind RNBs were performed bilaterally in eight cadavers, US-guided RNBs were performed bilaterally in seven cadavers, and after US-guided training, blind RNBs were performed bilaterally in seven cadavers. All RNBs were performed by the same two inexperienced operators, and a combination of contrast medium (CM; 1.25 mL) and methylene blue dye (1.25 mL) were injected (2.5 mL total volume). Needle positioning in the periorbita and the distance of the CM to the optic foramen were assessed using computerized tomography (CT). Dye spreading was evaluated by dissection. In group 1, 37.5% of the injections were in the optimal central position in the periorbita; in group 2, 75% and in group 3, 71.4%. There was no significant difference between the groups regarding needle position (groups 1 and 2 p = 0.056; groups 1 and 3 p = 0.069, groups 2 and 3 p = 0.8). The mean CM distribution distance was not significantly different between all groups. Group 1 had 18.75% intraocular injections versus 0% in group 2 and 7.1% in group 3 (not significant). US guidance showed no significant increases in accuracy nor decreases in complications. However, the effects on accuracy showed a trend towards significant improvement, and larger scale follow-up studies might show significant training effects on US guidance

Comparing Blind and Ultrasound-Guided Retrobulbar Nerve Blocks in Equine Cadavers: The Training Effect

In standing ophthalmic surgery in horses, a retrobulbar nerve block (RNB) is often placed blindly for anesthesia and akinesia. The ultrasound (US)-guided RNB may have fewer complications, but the two techniques have only been compared once in equine cadavers. This study compares the techniques for success and complication rates and analyzes the effect of training on US guidance. Twenty-two equine cadavers were divided into three groups: blind RNBs were performed bilaterally in eight cadavers, US-guided RNBs were performed bilaterally in seven cadavers, and after US-guided training, blind RNBs were performed bilaterally in seven cadavers. All RNBs were performed by the same two inexperienced operators, and a combination of contrast medium (CM; 1.25 mL) and methylene blue dye (1.25 mL) were injected (2.5 mL total volume). Needle positioning in the periorbita and the distance of the CM to the optic foramen were assessed using computerized tomography (CT). Dye spreading was evaluated by dissection. In group 1, 37.5% of the injections were in the optimal central position in the periorbita; in group 2, 75% and in group 3, 71.4%. There was no significant difference between the groups regarding needle position (groups 1 and 2 p = 0.056; groups 1 and 3 p = 0.069, groups 2 and 3 p = 0.8). The mean CM distribution distance was not significantly different between all groups. Group 1 had 18.75% intraocular injections versus 0% in group 2 and 7.1% in group 3 (not significant). US guidance showed no significant increases in accuracy nor decreases in complications. However, the effects on accuracy showed a trend towards significant improvement, and larger scale follow-up studies might show significant training effects on US guidance

Comparing Blind and Ultrasound-Guided Retrobulbar Nerve Blocks in Equine Cadavers: The Training Effect

In standing ophthalmic surgery in horses, a retrobulbar nerve block (RNB) is often placed blindly for anesthesia and akinesia. The ultrasound (US)-guided RNB may have fewer complications, but the two techniques have only been compared once in equine cadavers. This study compares the techniques for success and complication rates and analyzes the effect of training on US guidance. Twenty-two equine cadavers were divided into three groups: blind RNBs were performed bilaterally in eight cadavers, US-guided RNBs were performed bilaterally in seven cadavers, and after US-guided training, blind RNBs were performed bilaterally in seven cadavers. All RNBs were performed by the same two inexperienced operators, and a combination of contrast medium (CM; 1.25 mL) and methylene blue dye (1.25 mL) were injected (2.5 mL total volume). Needle positioning in the periorbita and the distance of the CM to the optic foramen were assessed using computerized tomography (CT). Dye spreading was evaluated by dissection. In group 1, 37.5% of the injections were in the optimal central position in the periorbita; in group 2, 75% and in group 3, 71.4%. There was no significant difference between the groups regarding needle position (groups 1 and 2 p = 0.056; groups 1 and 3 p = 0.069, groups 2 and 3 p = 0.8). The mean CM distribution distance was not significantly different between all groups. Group 1 had 18.75% intraocular injections versus 0% in group 2 and 7.1% in group 3 (not significant). US guidance showed no significant increases in accuracy nor decreases in complications. However, the effects on accuracy showed a trend towards significant improvement, and larger scale follow-up studies might show significant training effects on US guidance

Effect of HIPEC according to HRD/BRCAwt genomic profile in stage III ovarian cancer:Results from the phase III OVHIPEC trial

The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin to interval cytoreductive surgery improves recurrence-free (RFS) and overall survival (OS) in patients with stage III ovarian cancer. Homologous recombination deficient (HRD) ovarian tumors are usually more platinum sensitive. Since hyperthermia impairs BRCA1/2 protein function, we hypothesized that HRD tumors respond best to treatment with HIPEC. We analyzed the effect of HIPEC in patients in the OVHIPEC trial, stratified by HRD status and BRCAm status. Clinical data and tissue samples were collected from patients included in the randomized, phase III OVHIPEC-1 trial. DNA copy number variation (CNV) profiles, HRD-related pathogenic mutations and BRCA1 promotor hypermethylation were determined. CNV-profiles were categorized as HRD or non-HRD, based on a previously validated algorithm-based BRCA1-like classifier. Hazard ratios (HR) and corresponding 99% confidence intervals (CI) for the effect of RFS and OS of HIPEC in the BRCAm, the HRD/BRCAwt and the non-HRD group were estimated using Cox proportional hazard models. Tumor DNA was available from 200/245 (82%) patients. Seventeen (9%) tumors carried a pathogenic mutation in BRCA1 and 14 (7%) in BRCA2. Ninety-one (46%) tumors classified as BRCA1-like. The effect of HIPEC on RFS and OS was absent in BRCAm tumors (HR 1.25; 99%CI 0.48-3.29), and most present in HRD/BRCAwt (HR 0.44; 99%CI 0.21-0.91), and non-HRD/BRCAwt tumors (HR 0.82; 99%CI 0.48-1.42), interaction P value: 0.024. Patients with HRD tumors without pathogenic BRCA1/2 mutation appear to benefit most from treatment with HIPEC, while benefit in patients with BRCA1/2 pathogenic mutations and patients without HRD seems less evident.</p

Central radiology assessment of the randomized phase III open-label OVHIPEC-1 trial in ovarian cancer

INTRODUCTION: Hyperthermic intraperitoneal chemotherapy (HIPEC) improved investigator-assessed recurrence-free survival and overall survival in patients with stage III ovarian cancer in the phase III OVHIPEC-1 trial. We analyzed whether an open-label design affected the results of the trial by central blinded assessment of recurrence-free survival, and tested whether HIPEC specifically targets the peritoneal surface by analyzing the site of disease recurrence. METHODS: OVHIPEC-1 was an open-label, multicenter, phase III trial that randomized 245 patients after three cycles of neoadjuvant chemotherapy to interval cytoreduction with or without HIPEC using cisplatin (100 mg/m2). Patients received three additional cycles of chemotherapy after surgery. Computed tomography (CT) scans and serum cancer antigen 125 (CA125) measurements were performed during chemotherapy, and during follow-up. Two expert radiologists reviewed all available CT scans. They were blinded for treatment allocation and clinical outcome. Central revision included Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurements and peritoneal cancer index scorings at baseline, during treatment, and during follow-up. Time to centrally-revised recurrence was compared between study arms using Cox proportional hazard models. Subdistribution models compared time to peritoneal recurrence between arms, accounting for competing risks. RESULTS: CT scans for central revision were available for 231 patients (94%) during neoadjuvant treatment and 212 patients (87%) during follow-up. Centrally-assessed median recurrence-free survival was 9.9 months in the surgery group and 13.2 months in the surgery+HIPEC group (HR for disease recurrence or death 0.72, 95% CI 0.55 to 0.94; p=0.015). The improved recurrence-free survival and overall survival associated with HIPEC were irrespective of response to neoadjuvant chemotherapy and baseline peritoneal cancer index. Cumulative incidence of peritoneal recurrence was lower after surgery+HIPEC, but there was no difference in extraperitoneal recurrences. CONCLUSION: Centrally-assessed recurrence-free survival analysis confirms the benefit of adding HIPEC to interval cytoreductive surgery in patients with stage III ovarian cancer, with fewer peritoneal recurrences. These results rule out radiological bias caused by the open-label nature of the study