Medium-term Oncological Outcomes Research Articles

SC82 - Medium term oncological outcomes in a large cohort of men treated with either focal- or hemi-ablation with HIFU for primary localized prostate cancer

SC82 - Medium term oncological outcomes in a large cohort of men treated with either focal- or hemi-ablation with HIFU for primary localized prostate cancer

Medium-term oncological outcomes in a large cohort of men treated with either focal or hemi-ablation using high-intensity focused ultrasonography for primary localized prostate cancer.

To report medium-term oncological outcomes in men receiving primary focal treatment with high-intensity focused ultrasonography ( HIFU) for prostate cancer (PCa). Consecutive patients with PCa treated with primary focal HIFU at two centres by six treating clinicians were assessed. Patients were submitted to either focal ablation or hemi-ablation using HIFU (Sonablate 500). The primary objective of the study was to assess medium-term oncological outcomes, defined as overall survival, freedom from biopsy failure, freedom from any further treatment and freedom from radical treatment after focal HIFU. The secondary objective was to evaluate the changes in pathological features among patients treated with focal HIFU over time. We also assessed the relationship between year of surgery and 5-year retreatment probability. A total of 1032 men treated between November 2005 and October 2017 were assessed. The median age was 65 years and median prostate-specific antigen level was 7 ng/mL. The majority of patients had a Gleason score of 3 + 4 or above (80.3%). The median (interquartile range) follow-up was 36 (14-64) months. The overall survival rates at 24, 60 and 96 months were 99%, 97% and 97%, respectively. Freedom from biopsy failure, defined as absence of Gleason 3 + 4 disease, was 84%, 64% and 54% at 24, 60 and 96 months. Freedom from any further treatment was 85%, 59% and 46% at 24, 60 and 96 months, respectively. Approximately 70% of patients who were retreated received a second focal treatment. Freedom from radical treatment was 98%, 91% and 81% at 24, 60 and 96 months. During the study period, we observed an increase in the proportion of patients undergoing focal HIFU with Gleason 3 + 4 disease and with T2 stage disease as defined by multiparametric magnetic resonance imaging. Finally, there was a reduction over time in the proportion of patients undergoing re-treatment within 5 years of first treatment. Focal HIFU for PCa is a feasible therapeutic strategy, with acceptable survival and oncological results and a reduction in the 5-year retreatment rates over the last decade. Re-do focal treatment is a feasible technique whose functional and oncological outcomes have still to be evaluated.

471 - Medium term oncological outcomes in a large cohort of men treated with either focal- or hemi-ablation with HIFU for primary localized prostate cancer

INTRODUCTION AND OBJECTIVES:To report medium-term oncological outcomes in patients receiving primary focal treatment with HIFU for PCa.METHODS:Consecutive men treated by means of primary focal HIFU...

Focal therapy for prostate cancer: concepts and future directions.

To present a perspective on the current status and future directions of focal therapy for prostate cancer (PCa). Focal therapy for localized PCa is a rapidly evolving field. Various recent concepts - the index lesion driving prognosis, the enhanced detection of clinically significant PCa using multiparametric MRI and targeted biopsy, improved risk-stratification using novel blood/tissue biomarkers, the recognition that reducing radical treatment-related morbidity (along with reducing pathologic progression) is a clinically meaningful end-point - have all led to a growing interest in focal therapy. Novel focal therapy modalities are being investigated, mostly in phase 1 and 2 studies. Recently, level I prospective randomized data comparing partial gland ablation with a standard-of-care treatment became available from one study. Recent developments in imaging, including 7-T MRI, functional imaging, radiomics and contrast-enhanced ultrasound show early promise. We also discuss emerging concepts in patient selection for focal therapy. PCa focal therapy has evolved considerably in the recent few years. Overall, these novel focal therapy treatments demonstrate safety and feasibility, low treatment-related toxicity and acceptable short-term and in some cases medium-term oncologic outcomes. As imaging techniques evolve, patient selection, detection of clinically significant PCa and noninvasive assessment of therapeutic efficacy will be further optimized. The aspirational goal of achieving oncologic control while reducing radical treatment-related morbidity will drive further innovation in the field.

Primary Whole-gland Cryoablation for Prostate Cancer: Biochemical Failure and Clinical Recurrence at 5.6 Years of Follow-up

We retrospectively evaluated complications and functional and oncologic outcomes of 94 consecutive men who underwent primary whole-gland cryoablation for localized prostate cancer (PCa) from 2002 to 2012. Kaplan-Meier and multivariable Cox regression analyses were performed using a landmark starting at 6 mo of follow-up. In total, 75% patients had D’Amico intermediate- (48%) or high- (27%) risk PCa. Median follow-up was 5.6 yr. Median time to prostate-specific antigen (PSA) nadir was 3.3 mo, and 70 patients reached PSA <0.2ng/ml postcryoablation. The 90-d high-grade (Clavien Grade IIIa) complication rate was 3%, with no rectal fistulas reported. Continence and potency rates were 96% and 11%, respectively. The 5-yr biochemical failure-free survival (PSA nadir+2ng/ml) was 81% overall and 89% for low-, 78% for intermediate-, and 80% for high-risk PCa (p=0.46). The median follow-up was 5.6 and 5.1 yr for patients without biochemical failure and with biochemical failure, respectively. The 5-yr clinical recurrence-free survival was 83% overall and 94% for low-, 84% for intermediate-, and 69% for high-risk PCa (p=0.046). Failure to reach PSA nadir <0.2ng/ml within 6 mo postcryoablation was an independent predictor for biochemical failure (p=0.006) and clinical recurrence (p=0.03). The 5-yr metastases-free survival was 95%. Main limitation is retrospective evaluation. Primary whole-gland cryoablation for PCa provides acceptable medium-term oncologic outcomes and could be an alternative for radiation therapy or radical prostatectomy. Patient summaryCryoablation is a safe, minimally-invasive procedure that uses cold temperatures delivered via probes through the skin to kill prostate cancer (PCa) cells. Whole-gland cryoablation may offer an alternative treatment option to surgery and radiotherapy. We found that patients had good cancer outcomes 5 yr after whole-gland cryoablation, and those with a prostate-specific antigen value ≥0.2ng/ml within 6 mo after treatment were more likely to have PCa recurrence.

Positive surgical margins and biochemical recurrence following minimally-invasive radical prostatectomy \u2013 An analysis of outcomes from a UK tertiary referral centre

BackgroundPositive surgical margins are a strong prognostic marker of disease outcome following radical prostatectomy, though prior evidence is largely from a PSA-screened population. We therefore aim to evaluate the biochemical recurrence in men with positive surgical margins (PSM) after minimally-invasive radical prostatectomy (MIRP) in a UK tertiary centre.MethodsRetrospective study of men undergoing laparoscopic or robotic-assisted radical prostatectomy between 2002 and 2014. Men with positive surgical margins (PSM) were identified and their biochemical recurrence (BCR) rate compared with men without PSM. The primary outcome measures were BCR rates and time to BCR. Cox regression was used to estimate adjusted hazard ratios for biochemical recurrence rate (BCR), accounting for potential confounders.ResultsFive hundred ninety-two men were included for analysis. Pre-operative D’Amico risk stratification showed 37.5%, 53.3% and 9.3% of patients in the low, intermediate and high-risk groups, respectively. On final pathological analysis, the proportion of patients with local staging pT2, pT3a and pT3b was 68.8%, 25.2% and 6.1% respectively. Overall positive margin rate was 30.6%. On multivariate analysis, the only pre-operative factor associated with PSM was age >65years. Patients with PSM were more likely to have higher tumour volume and more advanced pathological local stage. The BCR rate was 10.7% in margin-positive patients and 5.1% in margin-negative patients, at median 4.4-year follow-up. Upon multivariate analysis, high pre-operative PSA and high Gleason group were the only significant predictors of BCR (P<0.05).ConclusionsIn comparison to patients with negative surgical margins, those with PSM do not translate into worse medium-term oncological outcomes in the majority of cases amongst our cohort. We found that high pre-operative PSA and high Gleason group were the only significant predictors of BCR.

Oncological Outcomes After Robotic Proctectomy for Rectal Cancer: Analysis of a Prospective Database.

The aim of this study is to evaluate the oncological outcomes of robotic total mesorectal excision (TME) at an NCI designated cancer center. The effectiveness of laparoscopic TME could not be established, but the robotic-assisted approach may hold some promise, with improved visualization and ergonomics for pelvic dissection. Oncological outcome data is presently lacking. Patients who underwent total mesorectal excision or tumor-specific mesorectal excision for rectal cancer between April 2009 and April 2016 via a robotic approach were identified from a prospective single-institution database. The circumferential resection margin (CRM), distal resection margin, and TME completeness rates were determined. Kaplan-Meier analysis of disease-free survival and overall survival was performed for all patients treated with curative intent. A total of 276 patients underwent robotic proctectomy during the study period. Robotic surgery was performed initially by 1 surgeon with 3 additional surgeons progressively transitioning from open to robotic during the study period with annual increase in the total number of cases performed robotically. Seven patients had involved circumferential resection margins (2.5%), and there were no positive distal or proximal resection margins. One hundred eighty-six patients had TME quality assessed, and only 1 patient (0.5%) had an incomplete TME. Eighty-three patients were followed up for a minimum of 3 years, with a local recurrence rate of 2.4%, and a distant recurrence rate of 16.9%. Five-year disease-free survival on Kaplan-Meier analysis was 82%, and 5-year overall survival was 87%. Robotic proctectomy for rectal cancer can be performed with good short and medium term oncological outcomes in selected patients.

PTH-279 Medium term oncological outcomes of single incision laparoscopic surgery for rectal cancer

Introduction Conventional laparoscopic surgery for rectal cancer management is now widely accepted as a suitable alternative to open surgery; bestowing specific advantages, without causing detriment to oncological outcome. Evolving from this, single-incision laparoscopic surgery (SILS) has been successfully utilised for the removal of colonic tumours. However, the literature lacks data analysing the suitability of SILS for rectal cancer resection, particularly in terms of oncological outcome. We report medium term oncological outcomes from a prospective observational study of SILS for rectal cancer, including both high and low anterior resections. Method A prospective electronic database was collated of all patients undergoing SILS rectal cancer resection in our institution, between 2009 and 2014. In addition to patient, tumour and operative data, histo-pathological and medium term oncological outcomes were recorded. Kaplan Meier curves were used to analyse survival, performed using SPSS® Statistics version 21.0 for Windows ® (IBM, Armonk, New York, USA). Results Sixty-one patients underwent SILS for rectal cancer: high anterior resection (34); Total Mesorectal Excision (TME) (24) and TME with hand sewn colo-anal anastomosis (3). Median operative time was 105 min (37–280 mins) and 92% of cases were completed via SILS. Mean time to diet was 11 h and median length of stay was 2 days (1–8 days). Median number of lymph nodes harvested was 18 (6–44) and all were R0 resections. After a median follow-up of 46 months (16–64 months), 8 patients developed further disease (13.1%), of whom 5 had liver metastases (8.2%) and 3 developed widespread metastatic disease and local recurrence (4.9%). Three patients have died (4.9%), all of whom had metastases. The mean time to recurrent disease diagnosis was 7 months (2–17months) and post-operative survival of those who died was 29 months, 33 months and 53 months respectively. Kaplan Meier Survival Curves for disease free survival (including local recurrence, metastases and death) are shown in Figure 1. Conclusion Anterior resection and TME for rectal cancer can be safely performed by the SILS technique, with appropriate histo-pathological results and, crucially, good oncological outcomes. SILS rectal cancer surgery may confer additional advantages over conventional multiport surgery, such as reduced operating time and length of hospital stay. Disclosure of interest None Declared.

Improving standard of care through introduction of laparoscopy for the surgical management of gynecological malignancies.

This study aimed to evaluate the impact on perioperative and medium-term oncologic outcomes of the implementation of laparoscopy into a preexisting oncologic setting. Data from consecutive 736 patients undergoing surgery for apparent early stage gynecological malignancies (endometrial, cervical, and adnexal cancers) between 2000 and 2011 were reviewed. Complications were graded per the Accordion classification. Survival outcomes within the first 5 years were analyzed using Kaplan-Meier method. Overall, 493 (67%), 162 (22%), and 81 (11%) had surgery for apparent early stage endometrial, cervical, and adnexal cancer. We assisted at an increase of the number of patients undergoing surgery via laparoscopy through the years (from 10% in the years 2000-2003 to 82% in years 2008-2011; P < 0.001 for trend); while the need to perform open surgery decreased dramatically (from 83% to 10%; P < 0.001). Vaginal approach was nearly stable over the years (from 7% to 8%; P = 0.76). A marked reduction in estimated blood loss, length of hospital stay, blood transfusions as well as grade greater than or equal to 3 postoperative complications over the years was observed (P < 0.001). Surgical radicality assessed lymph nodes count was not influenced by the introduction of laparoscopic approach (P > 0.05). The introduction of laparoscopy did not adversely affect medium-term (within 5 years) survival outcomes of patients undergoing surgery for apparent early stage cancers of the endometrium, uterine cervix, and adnexa (P > 0.05 log-rank test). The introduction of laparoscopy into a preexisting oncologic service allows an improvement of standard of care due to a gain in perioperative results, without detriments of medium-term oncologic outcomes.

Focal cryotherapy of localized prostate cancer: a systematic review of the literature

Radical/whole gland treatment for prostate cancer has significant side-effects. Therefore focal treatments such as cryotherapy have been used to treat localized lesions whilst aiming to provide adequate cancer control with minimal side-effects. We performed a systematic review of Pubmed/Medline and Cochrane databases' to yield 9 papers for primary focal prostate cryotherapy and 2 papers for focal salvage treatment (radio-recurrent). The results of 1582 primary patients showed biochemical disease-free survival between 71–93% at 9–70 months follow-up. Incontinence rates were 0–3.6% and ED 0–42%. Recto-urethral fistula occurred in only 2 patients. Salvage focal cryotherapy had biochemical disease-free survival of 50–68% at 3 years. ED occurred in 60–71%. Focal cryotherapy appears to be an effective treatment for primary localized prostate cancer and compares favorably to radical/whole gland treatments in medium-term oncological outcomes and side-effects. Although more studies are needed it is also effective for radio-recurrent cancer with a low complications rates.

Robotic versus laparoscopic total mesorectal excision for rectal cancer: a meta-analysis

BackgroundRobotic surgery has been used successfully in many branches of surgery; but there is little evidence in the literature on its use in rectal cancer (RC). We conducted this meta-analysis that included randomized controlled trials and nonrandomized controlled trials of robotic total mesorectal excision (RTME) versus laparoscopic total mesorectal excision (LTME) to evaluate whether the safety and efficacy of RTME in patients with RC are equivalent to those of LTME. Materials and methodsPubmed, Embase, Cochrane Library, Ovid, and Web of Science databases were searched. Studies clearly documenting a comparison of RTME with LTME for RC were selected. Operative and recovery outcomes, early postoperative morbidity, and oncological parameters were evaluated. ResultsEight studies were identified that included 1229 patients in total, 554 (45.08%) in the RTME and 675 (54.92%) in the LTME. Meta-analysis suggested that the conversion rate to open surgery in RTME was significantly lower than in LTME (P = 0.0004). There were no significant differences in operation time, estimated blood loss, recovery outcome, postoperative morbidity and mortality, length of hospital stay, and the oncological accuracy of resection and local recurrence between the two groups. The positive rate of circumferential resection margins (P = 0.04) and the incidence of erectile dysfunction (P = 0.002) were lower in RTME compared with LTME. ConclusionsRTME for RC is safe and feasible, and the short- and medium-term oncological and functional outcomes are equivalent or preferable to LTME. It may be an alternative treatment for RC. More multicenter randomized controlled trials investigating the long-term oncological and functional outcomes are required to determine the advantages of RTME over LTME in RC.

A Comparative Study of Short- and Medium-term Outcomes Comparing Emergent Surgery and Stenting as a Bridge to Surgery in Patients With Acute Malignant Colonic Obstruction

The use of self-expanding metal stents as a bridge to surgery in the setting of malignant colorectal obstruction has been advocated as an acceptable alternative to emergency surgery. However, concerns about the safety of stenting have been raised following recent randomized studies. The aim of the current study was to compare outcomes. This was an observational, comparative study. This study was conducted at a tertiary referral center and university teaching hospital. Patients with malignant colonic obstruction (n = 49) treated by either emergency surgery (n = 26) or with stent placement (n = 23) as a bridge to surgery were identified and followed. Short-term outcomes including stoma rates and postoperative morbidity and medium-term oncological outcomes were compared based on an "intention-to-treat" analysis. Patients in both groups were well matched on clinicopathological parameters. Technical and clinical successful stent deployment was achieved in 91% and 83%. This did not adversely impact cancer-specific and overall survival (log rank = nonsignificant). No difference was observed in stoma rates, primary anastomosis rates, perioperative mortality rates, or reoperation rates between the 2 groups. Significantly fewer patients underwent total colectomy in the stent group in comparison with the emergency surgery group (1/23 vs 6/26: p = 0.027). There was no difference in postoperative morbidity (59% vs 66%: p = 0.09). There was a significant reduction in readmission rates in the stent group (5/26 vs 0/23: p = 0.038). The small sample size of this study could lead to type II error. In addition, the study was nonrandomized and demonstrated a limited length of follow-up. Despite a high rate of technical and clinical success in selected patients with colonic obstruction, stenting has no impact on stoma rates. Despite concerns about the rate of stent-associated perforation, stenting does not adversely impact disease progression or survival. Future comparative trials are essential to better define the role of stenting in this setting and to ensure that we are not using costly technology to create an elective operative situation without concomitant patient benefits.

Minimally invasive cystectomy approaches in the treatment of bladder cancer

Bladder cancer is the most frequently occurring tumor of the urinary system, with over 10,000 new diagnoses each year in the UK. Approximately 70% of these are non-muscle-invasive and limited to the mucosa (Ta) or submucosa (T1). These tumors are generally managed with transurethral resection followed by adjuvant intravesical chemo- or immuno-therapy and regular cystoscopic surveillance. The principal end points in the management of these tumors are prevention of recurrence and progression. Muscle-invasive bladder cancer is a life-threatening disease with overall 5-year mortality of 50%. Neoadjuvant chemotherapy, where possible followed by radical surgery, is currently considered the best standard of care. Open radical cystectomy is the gold-standard treatment for muscle-invasive or high-risk non-muscle-invasive (multifocal or recurrence after intravesical therapy) bladder cancer. Historically, this procedure has carried significant morbidity, although mortality of open radical cystectomy has reduced to 1–2% owing to improvements in anesthesia and intensive care facilities. Over the last 15 years, minimally invasive techniques in radical cystectomy have evolved, with the aim of reducing morbidity. In this article, we review the development of laparoscopic radical cystectomy and robot-assisted radical cystectomy, along with current evidence on perioperative morbidity and medium-term oncological outcomes.

25 Years of Experience With 1,000 Neobladders: Long-Term Complications

We analyzed the long-term complications (greater than 90 days postoperatively) in a large, single center series of patients who underwent cystectomy and substitution with an ileal neobladder. A total of 1,540 radical cystectomies were performed at our center between January 1986 and September 2008. Of the patients 1,013 received an ileal neobladder. Only the 923 patients with followup longer than 90 days (median 72 months, range 3 to 267) were included in analysis. All long-term complications were identified. The complication rate was calculated using the Kaplan-Meier method. The overall survival rate was 65.5%, 49.8% and 28.3% at 5, 10 and 20 years, respectively. The overall long-term complication rate was 40.8% with 3 neobladder related deaths. Hydronephrosis, incisional hernia, ileus or small bowel obstruction and feverish urinary tract infection were observed in 16.9%, 6.4%, 3.6% and 5.7% of patients, respectively, 20 years postoperatively. Subneovesical obstruction in 3.1% of cases was due to local tumor recurrence in 1.1%, neovesicourethral anastomotic stricture in 1.2% and urethral stricture in 0.9%. Chronic diarrhea was noted in 9 patients. Vitamin B12 was substituted in 2 patients. Episodes of severe metabolic acidosis occurred in 11 patients and 307 of 923 required long-term bicarbonate substitution. Rare complications included cutaneous neobladder fistulas in 2 cases, and intestinal neobladder fistulas, iatrogenic neobladder perforation, spontaneous perforation and necrotizing pyocystis in 1 each. Even in experienced hands the long-term complication rate of radical cystectomy and neobladder formation are not negligible. Most complications are diversion related. The challenge of optimum care for these elderly patients with comorbidities is best mastered at high volume hospitals by high volume surgeons.

Robotic radical cystectomy: Medium-term oncologic follow-up.

288 Background: We report our experience with robot assisted radical cystectomy (RARC) with regard to medium-term (at least 2 year) oncologic outcomes. Methods: A total of 275 patients have undergone RARC and urinary diversion at two institutions for invasive bladder cancer between 2005-present. We performed a retrospective analysis of the 139 patients who underwent RARC with a minimum of 2 years follow-up. Medium term oncologic outcomes including recurrence rates, time to recurrence, recurrence free survival (RFS), disease specific survival (DSS) were analyzed. Follow-up was measured from time of surgery to time of most recent clinical follow-up. Results: This cohort of patients consisted of 108 men (78%) and 31 women (22%) at a mean age of 67.3 years (range 45-86 years). Sixty-one (44%) patients had ≤ pT2 disease, 38 (27%) pT3/T4 disease, and 40 (29%) N+ disease. The mean number of lymph nodes removed was 18 (range 3-41). The average clinical follow up in this case series was nearly 3 years with a mean of 35.9 months (range 24-64 months). At this follow-up, 39 patients have recurred, 27 patients died of disease, and 5 patients died of other causes giving an overall RFS, DSS, and OS rates of 80%, 71%, and 68%, respectively. The mean (median) time to recurrence was 12.3 months (10 months). These findings are consistent with prior reports of the oncologic outcomes for open radical cystectomy. Conclusions: The oncologic follow-up of patients undergoing RARC appears to be favorable with acceptable outcomes in the medium-term (mean – 3 years). As our follow-up increases, we should expect to truly define the long-term clinical appropriateness and oncologic success of this procedure. No significant financial relationships to disclose.

Oncological Outcomes After Radical Cystectomy for Bladder Cancer: Open Versus Minimally Invasive Approaches

The number of centers performing robotic assisted radical cystectomy has recently increased, spurring greater concerns about oncological outcomes. In this review we summarize the most comprehensive articles published on the oncological outcomes of laparoscopic assisted, robotic assisted and open radical cystectomy. A MEDLINE/PubMed literature search was conducted in March 2009 to review English language articles published from 1998 onward. Of 217 selected articles on the 3 techniques 19 studies were selected for this review. The laparoscopic series reported recurrence-free survival rates in the range of 83% to 85% at 1 to 2 years and 60% to 77% at 2 to 3 years, while the robotic assisted studies reported recurrence-free survival rates of 86% to 91% at 1 to 2 years. Large open surgery studies showed 62% to 68% recurrence-free survival at 5 years and 50% to 60% at 10 years, with overall survival of 59% to 66% at 5 years and 37% to 43% at 10 years. Overall survival in the laparoscopic cohorts was 90% to 100% at 1 to 2 years and 50% to 87% at 2 to 3 years. Publications reporting robotic cases demonstrated a 90% to 96% overall survival in 1 to 2 years of followup. Despite the surge of centers adopting minimally invasive approaches for radical cystectomy, the long-term effectiveness of these techniques has not yet been proven. This review of recent and landmark articles on open and minimally invasive procedures emphasizes the need for prospective controlled studies and long-term followup data to determine the proper use of laparoscopic and robotic assisted techniques in bladder cancer surgery.

Robotic assisted radical cystectomy: short to medium-term oncologic and functional outcomes

To report short- and medium-term oncological and functional outcomes of the first robotic-assisted laparoscopic radical cystectomy (RARC) series from the UK. Thirty patients underwent RARC between 2004 and 2007 at our unit. We report oncological and functional outcomes of this procedure in 20 patients (17 ileal conduit and three Studer Pouches), who have completed at least 6 months of follow up. There were 17 men and three women, median age 66 years (range 38-77 years). Median operating time was 330 min (range 295-510 min), and median blood loss 150 ml (range 100-1150 ml). There were two major complications (10%); a port site bleed and a rectal injury. The median follow up of this cohort is 23 months (range 7-44 months). One patient died of distant metastases at 8 months, and another developed a right ureteric tumour at 7 months. None of the patients had local pelvic or port site recurrence. The overall and disease-free survival are 95% and 90% respectively. Functional complications included a neovesico-urethral stricture at 3 months, a left upper ureteric stricture at 6 months and an incisional hernia at 12 months. Robotic-assisted laparoscopic radical cystectomy is an emerging minimally invasive procedure which at short- to medium-term follow up, in our experience, is oncologically and functionally equivalent to open radical cystectomy.