Preliminary outcome of a treatment strategy based on perioperative chemotherapy and surgery in patients with locally advanced colon cancer

Aim

Preoperative chemotherapy followed by radical surgery is an attractive treatment for locally advanced colon cancer (LACC) given the promising results of this approach in other locally advanced tumours. The study evaluates the outcome and treatment‐related complications of perioperative oxaliplatin‐ and capecitabine‐based chemotherapy and surgery for clinical Stage III colon cancer.

Method

Twenty‐two consecutive patients with a CT‐staged LACC were included. All were staged at baseline and before surgery. Surgery‐related complications and oncological outcome were determined.

Results

Toxicity was manageable, with 19/22 patients completing the planned chemotherapy protocol. The median time from initial diagnosis to surgery was 65.5 days. The median time from the end of chemotherapy to surgery was 22 days. After neoadjuvant treatment, tumour reduction of 69.5% was observed by CT scan and a 59.9% decrease of SUV_max (standard uptake value) was achieved on positron emission tomography/CT. No progressive disease was reported during preoperative chemotherapy and surgery was performed in all 22 patients. Four patients developed postoperative complications. After a median postoperative follow‐up of 14.4 months, the actuarial overall and disease‐free survival rates were 100 and 90%.

Conclusion

Neoadjuvant chemotherapy followed by surgery and chemotherapy for LACC is safe without apparent increase of early and medium‐term complications.

     

Accuracy of administrative coding data in colorectal cancer resections and short‐term outcomes

Background

Administrative data are routinely captured for each hospital admission and may serve as an alternative source for populating databases. This study aims to determine the accuracy of administrative data to provide tumour characteristics and short‐term post‐operative outcomes, after a colorectal cancer (CRC) resection, compared with clinical data.

Methods

A retrospective study of all CRC resections at a single hospital from 1 January 2008 to 31 December 2013 was conducted. Local administrative data were coded as per ICD‐10‐AM (International Classification of Diseases, Tenth Revision, Australian Modification) and Australian Classification of Health Interventions. Clinical data for all patients were extracted from the medical charts and compared with administrative data. Code combinations and algorithms were used to improve the accuracy of administrative data.

Results

A total of 436 patients were identified. The accuracy of algorithms combining tumour location and type of operation for right colon, left colon and rectum were 93, 89 and 88%, respectively. The accuracy of histological type was 89%, lymph node status 92% and metastasis status 88%. The accuracy of return to theatre and in‐hospital mortality was 100%.

Conclusion

Administrative data can provide reliable information on tumour details and short‐term post‐operative outcomes. The potential for administrative data to validate data captured in registries and be used independently for audit and research should be further explored.

     

Evaluating the predictive accuracy and the clinical benefit of a nomogram aimed to predict survival in node‐positive prostate cancer patients: External validation on a multi‐institutional database

Objectives

To assess the predictive accuracy and the clinical value of a recent nomogram predicting cancer‐specific mortality‐free survival after surgery in pN1 prostate cancer patients through an external validation.

Methods

We evaluated 518 prostate cancer patients treated with radical prostatectomy and pelvic lymph node dissection with evidence of nodal metastases at final pathology, at 10 tertiary centers. External validation was carried out using regression coefficients of the previously published nomogram. The performance characteristics of the model were assessed by quantifying predictive accuracy, according to the area under the curve in the receiver operating characteristic curve and model calibration. Furthermore, we systematically analyzed the specificity, sensitivity, positive predictive value and negative predictive value for each nomogram‐derived probability cut‐off. Finally, we implemented decision curve analysis, in order to quantify the nomogram's clinical value in routine practice.

Results

External validation showed inferior predictive accuracy as referred to in the internal validation (65.8% vs 83.3%, respectively). The discrimination (area under the curve) of the multivariable model was 66.7% (95% CI 60.1–73.0%) by testing with receiver operating characteristic curve analysis. The calibration plot showed an overestimation throughout the range of predicted cancer‐specific mortality‐free survival rates probabilities. However, in decision curve analysis, the nomogram's use showed a net benefit when compared with the scenarios of treating all patients or none.

Conclusions

In an external setting, the nomogram showed inferior predictive accuracy and suboptimal calibration characteristics as compared to that reported in the original population. However, decision curve analysis showed a clinical net benefit, suggesting a clinical implication to correctly manage pN1 prostate cancer patients after surgery.

     

Chemotherapy for metastatic testicular cancer: The first nationwide multi‐institutional study by the Cancer Registration Committee of the Japanese Urological Association

Objectives

To assess clinicopathological data and oncological outcomes focused on metastatic testicular cancer patients, who received chemotherapy as the initial treatment, in the nationwide multi‐institutional study by the Cancer Registration Committee of the Japanese Urological Association.

Methods

A testicular cancer survey was carried out by the Japanese Urological Association in 2011 to register newly diagnosed testicular cancers in 2005 and 2008. Among 1121 registered patients, 278 patients with metastases who received chemotherapy as the initial treatment and could be categorized by the Japanese Urological Association classification were eligible for the analysis.

Results

As first‐line chemotherapy, bleomycin, etoposide and cisplatin, and etoposide and cisplatin therapies were chosen for 260 patients (93.5%). As second‐line therapy, vinblastine, ifosfamide and cisplatin/etoposide, ifosfamide and cisplatin; and paclitaxel, ifosfamide and cisplatin/paclitaxel, ifosfamide and nedaplatin therapies were carried out in 23 out of 63 (36.5%) and 29 out of 63 (46.0%) patients, respectively. The response rate and serum tumor marker normalization rate were 93.4% and 81.3% at first line, 75.4% and 60.7% at second line, and 41.7% and 16.7% at third line, respectively. The Japanese Urological Association classification (≥IIIB2 vs ≤IIIB1) and choriocarcinoma component in primary histology were independent prognostic factors of overall survival before starting chemotherapy. Furthermore, in patients with non‐seminomatous germ cell tumors, serum tumor marker normalization was an independent factor that was associated with better outcome of overall survival after completion of the initial series of chemotherapies.

Conclusions

The initial accurate diagnosis and risk stratification is an important prognostic factor to achieve better oncological outcomes. In patients with non‐seminomatous germ cell tumors, aiming for serum tumor marker normalization with continuous sequential chemotherapy could improve overall survival.

     

Prostate‐specific antigen screening impacts on biochemical recurrence in patients with clinically localized prostate cancer

Objective

To clarify the impact of prostate‐specific antigen screening on surgical outcomes of prostate cancer.

Methods

Patients who underwent radical prostatectomy were divided into two groups according to prostate‐specific antigen testing opportunity (group 1, prostate‐specific antigen screening; group 2, non‐prostate‐specific antigen screening). Perioperative clinical characteristics were compared using the Wilcoxon rank‐sum and χ²‐tests. Cox proportional hazards models were used to identify independent predictors of postoperative biochemical recurrence‐free survival.

Results

In total, 798 patients (63.2%) and 464 patients (36.8%) were categorized into groups 1 and 2, respectively. Group 2 patients were more likely to have a higher prostate‐specific antigen level and age at diagnosis and larger prostate volume. Clinical T stage, percentage of positive cores and pathological Gleason score did not differ between the groups. The 5‐year biochemical recurrence‐free survival rate was 83.9% for group 1 and 71.0% for group 2 (P < 0.001). On multivariate analysis, prostate‐specific antigen testing opportunity (hazard ratio 2.530; P < 0.001) was an independent predictive factor for biochemical recurrence after surgery, as well as pathological T stage, pathological Gleason score, positive surgical margin and lymphovascular invasion. Additional analyses showed that prostate‐specific antigen screening had a greater impact on biochemical recurrence in a younger patients, patients with a high prostate‐specific antigen level, large prostate volume and D'Amico high risk, and patients meeting the exclusion criteria of the Prostate Cancer Research International Active Surveillance study.

Conclusions

Detection by screening results in favorable outcomes after surgery. Prostate‐specific antigen screening might contribute to reducing biochemical recurrence in patients with localized prostate cancer.

     

Prospective study of robotic partial nephrectomy for renal cancer in Japan: Comparison with a historical control undergoing laparoscopic partial nephrectomy

Objectives

To evaluate the outcomes of robotic partial nephrectomy compared with those of laparoscopic partial nephrectomy for T1 renal tumors in Japanese centers.

Methods

Patients with a T1 renal tumor who underwent robotic partial nephrectomy were eligible for inclusion in the present study. The primary end‐point consisted of three components: a negative surgical margin, no conversion to open or laparoscopic surgery and a warm ischemia time ≤25 min. We compared data from these patients with the data from a retrospective study of laparoscopic partial nephrectomy carried out in Japan.

Results

A total of 108 patients were registered in the present study; 105 underwent robotic partial nephrectomy. The proportion of patients who met the primary end‐point was 91.3% (95% confidence interval 84.1–95.9%), which was significantly higher than 23.3% in the historical data. Major complications were seen in 19 patients (18.1%). The mean change in the estimated glomerular filtration rate in the operated kidney, 180 days postoperatively, was ?10.8 mL/min/1.73 m² (95% confidence interval ?12.3–9.4%).

Conclusions

Robotic partial nephrectomy for patients with a T1 renal tumor is a safe, feasible and more effective operative method compared with laparoscopic partial nephrectomy. It can be anticipated that robotic partial nephrectomy will become more widely used in Japan in the future.

     

Influence of the neural microenvironment on prostate cancer

Background

Nerves are key factors in prostate cancer (PCa), but the functional role of innervation in prostate cancer is poorly understood. PCa induced neurogenesis and perineural invasion (PNI), are associated with aggressive disease.

Method

We denervated rodent prostates chemically and physically, before orthotopically implanting cancer cells. We also performed a human neoadjuvant clinical trial using botulinum toxin type A (Botox) and saline in the same patient, before prostatectomy.

Result

Bilateral denervation resulted in reduced tumor incidence and size in mice. Botox treatment in humans resulted in increased apoptosis of cancer cells in the Botox treated side. A similar denervation gene array profile was identified in tumors arising in denervated rodent prostates, in spinal cord injury patients and in the Botox treated side of patients. Denervation induced exhibited a signature gene profile, indicating translation and bioenergetic shutdown. Nerves also regulate basic cellular functions of non‐neoplastic epithelial cells.

Conclusion

Nerves play a role in the homeostasis of normal epithelial tissues and are involved in prostate cancer tumor survival. This study confirms that interactions between human cancer and nerves are essential to disease progression. This work may make a major impact in general cancer treatment strategies, as nerve/cancer interactions are likely important in other cancers as well. Targeting the neural microenvironment may represent a therapeutic approach for the treatment of human prostate cancer.

     

A five‐CpG DNA methylation score to predict metastatic‐lethal outcomes in men treated with radical prostatectomy for localized prostate cancer

Background

Prognostic biomarkers for localized prostate cancer (PCa) could improve personalized medicine. Our group previously identified a panel of differentially methylated CpGs in primary tumor tissue that predict disease aggressiveness, and here we further validate these biomarkers.

Methods

Pyrosequencing was used to assess CpG methylation of eight biomarkers previously identified using the HumanMethylation450 array; CpGs with strongly correlated (r >0.70) results were considered technically validated. Logistic regression incorporating the validated CpGs and Gleason sum was used to define and lock a final model to stratify men with metastatic‐lethal versus non‐recurrent PCa in a training dataset. Coefficients from the final model were then used to construct a DNA methylation score, which was evaluated by logistic regression and Receiver Operating Characteristic (ROC) curve analyses in an independent testing dataset.

Results

Five CpGs were technically validated and all were retained (P < 0.05) in the final model. The 5‐CpG and Gleason sum coefficients were used to calculate a methylation score, which was higher in men with metastatic‐lethal progression (P = 6.8 × 10^?6) in the testing dataset. For each unit increase in the score there was a four‐fold increase in risk of metastatic‐lethal events (odds ratio, OR = 4.0, 95%CI = 1.8–14.3). At 95% specificity, sensitivity was 74% for the score compared to 53% for Gleason sum alone. The score demonstrated better prediction performance (AUC = 0.91; pAUC = 0.037) compared to Gleason sum alone (AUC = 0.87; pAUC = 0.025).

Conclusions

The DNA methylation score improved upon Gleason sum for predicting metastatic‐lethal progression and holds promise for risk stratification of men with aggressive tumors. This prognostic score warrants further evaluation as a tool for improving patient outcomes.

     

Systematic overview and critical appraisal of meta‐analyses of interventions in intensive care medicine

Rationale

Meta‐analysed intervention effect estimates are perceived to represent the highest level of evidence. However, such effects and the randomized clinical trials which are included in them need critical appraisal before the effects can be trusted.

Objective

Critical appraisal of a predefined set of all meta‐analyses on interventions in intensive care medicine to assess their quality and assessed the risks of bias in those meta‐analyses having the best quality.

Methods

We conducted a systematic search to select all meta‐analyses of randomized clinical trials on interventions used in intensive care medicine. Selected meta‐analyses were critically appraised for basic scientific criteria, (1) presence of an available protocol, (2) report of a full search strategy, and (3) use of any bias risk assessment of included trials. All meta‐analyses which qualified these criteria were scrutinized by full “Risk of Bias in Systematic Reviews” ROBIS evaluation of 4 domains of risks of bias, and a “Preferred Reporting Items for Systematic Reviews and Meta‐Analyses” PRISMA evaluation.

Results

We identified 467 meta‐analyses. A total of 56 meta‐analyses complied with these basic scientific criteria. We scrutinized the risks of bias in the 56 meta‐analyses by full ROBIS evaluation and a PRISMA evaluation. Only 4 meta‐analyses scored low risk of bias in all the 4 ROBIS domains and 41 meta‐analyses reported all 27 items of the PRISMA checklist.

Conclusion

In contrast with what might be perceived as the highest level of evidence only 0.9% of all meta‐analyses were judged to have overall low risk of bias.

     

A two‐drug combination simulation study for metastatic castrate resistant prostate cancer

Background

Prostate cancer often evolves resistance to androgen deprivation therapy leading to a lethal metastatic castrate‐resistant form. Besides androgen independence, subpopulations of the tumor are genetically heterogeneous. With the advent of tumor genome sequencing we asked which has the greater influence on reducing tumor size: genetic background, heterogeneity, or drug potency?

Methods

A previously developed theoretical evolutionary dynamics model of stochastic branching processes is applied to compute the probability of tumor eradication with two targeted drugs. Publicly available data sets were surveyed to parameterize the model.

Results

Our calculations reveal that the greatest influence on successful treatment is the genetic background including the number of mutations overcoming resistance. Another important criteria is the tumor size at which it is still possible to achieve tumor eradication, for example, 2‐4 cm large tumors have at best a 10% probability to be eradicated when 50 mutations can confer resistance to each drug.

Conclusion

Overall, this study finds that genetic background and tumor heterogeneity are more important than drug potency in treating mCRPC. It also points toward identifying metastatic sites early using biochemical assays and/or dPET.

     

Radiotherapy for the treatment of distant nodes metastases from oligometastatic urothelial cancer: A retrospective case series

Objectives

To investigate the efficacy of stereotactic body radiotherapy in oligometastatic urothelial carcinoma with node‐only involvement.

Methods

We retrospectively collected data on the outcomes of patients who underwent stereotactic body radiotherapy for metastatic node lesions from oligometastatic urothelial carcinoma at Radiotherapy Unit of University Hospital of Parma, Parma, Italy. The investigated outcomes were lesion size, standardized uptake value, overall response rate, lesion control rate, lesion progression‐free interval, progression‐free survival and overall survival.

Results

Among seven patients included in the study, a total of 14 node metastatic lesions were treated with stereotactic body radiotherapy. The mean total dose of stereotactic body radiotherapy was 32 Gy (range 25–40 Gy). At first imaging evaluation, a mean variation of ?4% (P = 0.427) in major diameter, ?16% (P = 0.048) in minor diameter and –76% in standardized uptake value (P < 0.001) were documented. The overall response rate and lesion control rate were 43% and 100%, respectively. Median lesion progression‐free interval, progression‐free survival and overall survival were 11.4 months (95% CI 3.4–19.4), 2.9 months (95% CI 2.6–3.1) and 14.9 months (95% CI 12.3–17.5), respectively. Stereotactic body radiotherapy was effective in delaying the beginning of a systemic chemotherapy in four patients.

Conclusions

The present findings generate the hypothesis of a possible role for the use of stereotactic body radiotherapy in selected patients with distant node metastases from oligometastatic urothelial carcinoma.

     

Correlations of SELENOF and SELENOP genotypes with serum selenium levels and prostate cancer

Background

Selenium status is inversely associated with the incidence of prostate cancer. However, supplementation trials have not indicated a benefit of selenium supplementation in reducing cancer risk. Polymorphisms in the gene encoding selenoprotein 15 (SELENOF) are associated with cancer incidence/mortality and present disproportionately in African Americans. Relationships among the genotype of selenoproteins implicated in increased cancer risk, selenium status, and race with prostate cancer were investigated.

Methods

Tissue microarrays were used to assess SELENOF levels and cellular location in prostatic tissue. Sera and DNA from participants of the Chicago‐based Adiposity Study Cohort were used to quantify selenium levels and genotype frequencies of the genes for SELENOF and the selenium‐carrier protein selenoprotein P (SELENOP). Logistic regression models for dichotomous patient outcomes and regression models for continuous outcome were employed to identify both clinical, genetic, and biochemical characteristics that are associated with these outcomes.

Results

SELENOF is dramatically reduced in prostate cancer and lower in tumors derived from African American men as compared to tumors obtained from Caucasians. Differing frequency of SELENOF polymorphisms and lower selenium levels were observed in African Americans as compared to Caucasians. SELENOF genotypes were associated with higher histological tumor grade. A polymorphism in SELENOP was associated with recurrence and higher serum PSA.

Conclusions

These results indicate an interaction between selenium status and selenoprotein genotypes that may contribute to the disparity in prostate cancer incidence and outcome experienced by African Americans.

     

Cerebrovascular autoregulation monitoring and patient‐centred outcomes after cardiac surgery: a systematic review

Background

Impaired cerebrovascular autoregulation (CVAR) is observed in up to 20% of cardiac surgical patients. This systematic review aims to evaluate the association between impaired CVAR, measured by current monitoring techniques, and patient‐centred outcomes in adults following cardiac surgery.

Methods

MEDLINE, EMBASE, PubMed, MEDLINE In‐Process and Cochrane Library were systematically searched through 8 December 2017. Studies were included if they assessed associations between CVAR and patient‐centred outcomes in the adult cardiac surgical population. The primary outcome of this systematic review was mortality. Secondary outcomes were stroke, delirium and acute kidney injury. Risk of bias was systematically assessed, and the GRADE methodology was used to evaluate the quality of evidence across outcomes.

Results

Eleven observational studies and no randomised controlled trials met the inclusion criteria. Due to methodological heterogeneity, meta‐analysis was not possible. There was a high risk of bias within individual studies and low quality of evidence across outcomes. Of the included studies, one assessed mortality, five assessed stroke, four assessed delirium, and three assessed acute kidney injury. No reliable conclusions can be drawn from the one study assessing mortality. Interpretation of studies investigating CVAR and stroke, delirium and acute kidney injury was complicated by the lack of standardisation of monitoring techniques as well as varying definitions of impaired CVAR.

Conclusions

There is a paucity of high quality evidence for CVAR monitoring and its associations with outcome measures in post‐cardiac surgical patients, highlighting the need for future studies.

     

Premenopausal women with recurrent urinary tract infections have lower quality of life

Objectives

To examine the impact on quality of life of recurrent acute uncomplicated urinary tract infection among premenopausal Singaporean women, and to determine the risk factors for lower quality of life among these patients.

Methods

A total of 85 patients with recurrent acute uncomplicated urinary tract infection who were referred to the Urology Department at the National University Hospital, Singapore, were prospectively recruited over a 3‐year period to complete the validated Short Form 36 Health Survey version 1. In addition, demographic and clinical details including symptomology and medical history were analyzed for factors impacting quality of life. Short Form 36 Health Survey version 1 results were compared with published population norms.

Results

After adjusting for age, gender and race, recurrent acute uncomplicated urinary tract infection patients had significantly lower quality of life on seven out of eight Short Form 36 Health Survey version 1 domains when compared with age‐, gender‐ and race‐adjusted population norms for Singapore. Among those with recurrent acute uncomplicated urinary tract infection, those who also reported caffeine consumption had significantly lower Short Form 36 Health Survey version 1 scores than those who did not. Those who reported chronic constipation also had consistently lower Short Form 36 Health Survey version 1 scores across all domains.

Conclusions

Recurrent acute uncomplicated urinary tract infection has a negative impact on the quality of life of premenopausal, otherwise healthy women. Recurrent acute uncomplicated urinary tract infection patients who also have chronic constipation or consume caffeine have lower quality of life than those who do not. More studies are required to understand the relationships between these common problems and risk factors.

     

Epigenetic markers in circulating cell‐free DNA as prognostic markers for survival of castration‐resistant prostate cancer patients

Background

: Noninvasive biomarkers to guide personalized treatment for castration‐resistant prostate cancer (CRPC) are needed. In this study, we analyzed hypermethylation patterns of two genes (GSTP1 and APC) in plasma cell‐free DNA (cfDNA) of CRPC patients. The aim of this study was to analyze the cfDNA concentrations and levels of the epigenetic markers and to assess the value of these biomarkers for prognosis.

Methods

: In this prospective study, patients were included before starting new treatment after developing CRPC. The blood samples were collected prior to start of the treatment and at three time points thereafter. cfDNA was extracted from 1.5 mL of plasma and before performing a methylation‐specific PCR, bisulfate modification was carried out.

Results

: The median levels of cfDNA, GSTP1, and APC copies in the baseline samples of CRPC patients (n = 47) were higher than in controls (n = 30). In the survival analysis, the group with baseline marker levels below median had significant less PCa‐related deaths (P‐values <0.02) and did not reach the median survival point. The survival distributions for the groups were statistically significant for the cfDNA concentration, GSTP1 and APC copies, as well as PSA combined with GSTP1 + APC (P‐values <0.03). Furthermore, there were strong positive correlations between PSA and marker response after starting treatment (P‐values <0.04).

Conclusions

: In conclusion, this study showed the kinetics of methylated cfDNA (GSTP1 and APC) in plasma of CRPC patients after starting treatment. Furthermore, the value of the markers before treatment is prognostic for overall survival. These results are promising for developing a test to guide treatment‐decision‐making for CRPC patients.

     

The efficacy and safety of cold‐induced lipolysis in the treatment of pseudogynecomastia

Background

The treatment options for pseudogynecomastia have been limited. Cold‐induced lipolysis provides a noninvasive, localized subcutaneous adipocyte destruction by inducing adipocyte apoptosis.

Objective

This study has been designed to evaluate the efficacy of cold‐induced lipolysis as a treatment modality for pseudogynecomastia.

Methods

In this 28‐week prospective trial, a total of 12 male pseudogynecomastia patients (Korean) were treated twice with cold‐induced lipolysis. Efficacy was determined by chest circumference, ultrasonographic measurement of fat thickness, Simon's Gynecomastia class (SGC), photographic assessment, and the patient's satisfaction (baseline, weeks 4, 8, 16, and 28). Using a questionnaire, safety was evaluated at each visit.

Results

For 10 subjects that completed the trial, chest circumference and fat thickness significantly improved by week 8. This same improvement was gradually noticed through week 28. The patients SGC scores continuously decreased after two sessions. Photographic assessment showed an improvement until week 28. The result of the patient's satisfaction score was also meaningful. While there were no adverse events observed, transient pain and bruising at the treatment site were noticed.

Limitations

We recruited a limited number of participants. Also, we could not exclude there might be other individual factors in association with the patients pseudogynecomastia.

Conclusion

Cold‐induced lipolysis is a safe, effective therapeutic option in the treatment of pseudogynecomastia. Lasers Surg. Med. 48:584–589, 2016. © 2016 The Authors. Lasers in Surgery and Medicine Published by Wiley Periodicals Inc.

     

Oral administration of cernitin pollen extract (Cernilton®) for 30 days might be useful to avoid unnecessary biopsy in prostate biopsy candidates: A preliminary study

Objectives

To assess the effect of cernitin pollen extract on serum prostate‐specific antigen level prostate biopsy candidates, and to develop an ideal protocol to avoid an unnecessary biopsy procedure.

Methods

A total of 61 patients were administrated cernitin pollen extract tablets (two tablets t.i.d.) for 30 days, and then underwent a prostate biopsy with ≥12 systematic and targeted biopsy cores obtained. Serum prostate‐specific antigen levels were examined before and after administration of the pollen extract, and the change in serum prostate‐specific antigen and the rate of change were analyzed in relation to negative and positive biopsy results for cancer.

Results

The mean change in serum prostate‐specific antigen and rate of change after administration of cernitin pollen extract in all patients were ?0.6 ± 1.4 ng/mL and ?7.6 ± 16.1%, respectively, which were significantly different from the baseline values (P = 0.0003 and P = 0.0005, respectively). When prostate‐specific antigen change values and rates were compared between patients negative and positive for cancer, a significant difference between those groups was observed (P = 0.04 and P = 0.03, respectively).

Conclusions

The present study is the first to show that an ideal protocol using cernitin pollen extract has the potential to avoid an unnecessary prostate biopsy procedure in patients with elevated prostate‐specific antigen, possibly caused by inflammation. Additional studies with greater numbers of participants are required to confirm our findings and develop an ideal protocol.

     

Purely off‐clamp robotic partial nephrectomy: Preliminary 3‐year oncological and functional outcomes

Objectives

To describe our surgical technique and to report perioperative, 3‐year oncological and functional outcomes of a single‐center series of purely off‐clamp robotic partial nephrectomy.

Methods

A prospective renal cancer institutional database was queried, and data of consecutive patients treated with purely off‐clamp robotic partial nephrectomy between 2010 and 2015 in a high‐volume center were collected. Perioperative complications, and 3‐year oncological and functional outcomes were assessed. Univariable and multivariable analyses were carried out to identify independent predictors of renal function deterioration.

Results

Out of 308 patients treated, 41 (13.3%) experienced perioperative complications, 2.9% of which were Clavien grade ≥3. The 3‐year local recurrence‐free survival and renal cell carcinoma‐specific survival rates were 99.5% and 97.9%, respectively. No patient with preoperative chronic kidney disease stage ≤3B developed severe renal function deterioration (chronic kidney disease stage 4) at 1‐year follow up. At multivariable analysis, preoperative estimated glomerular filtration rate (P = 0.005) was the only independent predictor of a new‐onset chronic kidney disease stage ≥3 in patients with preoperative chronic kidney disease stages 1 or 2.

Conclusions

Off‐clamp robotic partial nephrectomy is a safe surgical approach in tertiary referral centers, with adequate oncological outcomes and negligible impact on renal function.

     

Clinical complications in renal biopsy using two different needle gauges: The impact of large hematomas,a random clinical trial study

Objective

To compare complications of ultrasound‐guided percutaneous renal biopsy using two needle gauges (16‐G and 18‐G).

Methods

A total of 238 individuals with renal biopsy indication were included and randomly separated into two groups: ultrasound‐guided percutaneous renal biopsy procedure carried out with a 16‐G or 18‐G needle. The adequacy of biopsy samples and post‐procedure complications were compared between the two groups.

Results

The procedures carried out with a 16‐G needle collected fragments with a mean of 22.1 ± 10.8 glomeruli, and those carried out with an 18‐G needle had a mean of 17.5 ± 9.4 glomeruli. Patients submitted to renal biopsies with a 16‐G needle had a higher likelihood of having a complication (OR5.1, 95% CI 1.7–15.4, P = 0.001). The overall mean volume of post‐biopsy hematoma in patients with complications was significantly larger than those without complications (44 ± 56.1 mL vs 5.9 ± 6.6 mL; P < 0.001).

Conclusions

Renal biopsies carried out by ultrasonography using an 18‐G needle provide adequate histological analysis, showing a lower amount of glomeruli but with similar clinical quality as a 16‐G needle. Furthermore, it is associated with a lower risk of procedure‐related complications.

     

Primary whole‐gland ablation for localized prostate cancer with high‐intensity focused ultrasound: The important predictors of biochemical recurrence

Objectives

To identify predictive factors of biochemical recurrence for patients undergoing high‐intensity focused ultrasound treatment for localized prostate cancer.

Methods

We retrospectively identified patients receiving whole‐gland prostate ablation with high‐intensity focused ultrasound for localized prostate cancer from 2009 to 2015. All the patients received pre‐high‐intensity focused ultrasound radical transurethral resection of the prostate. We included perioperative parameters as follows: age, preoperative prostate volume, stage of operation, initial prostate‐specific antigen, T stage, postoperative prostate‐specific antigen nadir, Gleason score, time to prostate‐specific antigen nadir and the presence of prostate‐specific antigen biochemical recurrence. Multivariable Cox regression and Kaplan–Meier analysis were used for investigating predictors of recurrence, and receiver operating characteristic analysis was used for the cut‐off values of prostate‐specific antigen nadir.

Results

Among 182 patients, 26.9% had prostate‐specific antigen biochemical recurrence after high‐intensity focused ultrasound during the median follow‐up period of 32.21 months. Gleason score ≥7 (Gleason score 7, hazard ratio 2.877, P = 0.027), stage ≥T2b (T2b, hazard ratio 3.16, P = 0.027) and prostate‐specific antigen nadir (hazard ratio 1.11, P < 0.001) were statistically significant, whereas there was no significance in prostate volume and initial prostate‐specific antigen. We posit that a cut‐off level of prostate‐specific antigen nadir 0.43 ng/mL might be considered as an independent predictive factor for prostate‐specific antigen biochemical recurrence in high‐intensity focused ultrasound patients in multivariate analysis (P < 0.001, hazard ratio 7.39, 95% confidence interval 3.56–15.37), and created a new nadir‐related prediction model for biochemical recurrence prediction.

Conclusions

Postoperative prostate‐specific antigen nadir of 0.43 ng/mL can be considered an important predictive factor for biochemical recurrence in primary whole‐prostate gland high‐intensity focused ultrasound treatment, and the nadir‐related prediction model might provide a reference for early salvage treatment. Furthermore, Gleason score ≥7, stage ≥T2b might be associated with unfavorable outcomes, although prostate volume and higher initial prostate‐specific antigen appear not to be associated with biochemical recurrence for the high‐intensity focused ultrasound treatment.