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Article of the Week: LCA – EuRECA study

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Every week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Oncological outcomes and complication rates after laparoscopic-assisted cryoablation: a European Registry for Renal Cryoablation (EuRECA) multi-institutional study

Tommy K. Nielsen*, Brunolf W. Lagerveld†, Francis Keeley‡, Giovanni Lughezzani§, Seshadri Sriprasad, Neil J. Barber**, Lars U. Hansen*,††, Nicole M. Buffi§, Giorgio Guazzoni§, Johan A. van der Zee†, Mohamed Ismail‡, Khaled Farrag,Amr M. Emara**,‡‡, Lars Lund††,§§, Øyvind Østraat* and Michael Borre*

 

*Department of Urology, Aarhus University Hospital, Aarhus, Denmark, †Department of Urology, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands, ‡Bristol Urological Institute, Bristol, UK, §Department of Urology, Istituto Clinico Humanitas IRCCS, Clinical and Research Hospital, Milano, Rozzano, Italy, Department of Urology, Darent Vally Hospital, Dartford, **Department of Urology, Frimley Park Hospital, Camberley, UK, ††Department of Urology, Odense University Hospital, Odense, Denmark, ‡‡Department of Urology, Ain Shams University, Cairo, Egypt, and §§Department of Urology, Viborg Regional Hospital, Viborg, Denmark

 

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Abstract

Objective

To assess complication rates and intermediate oncological outcomes of laparoscopic-assisted cryoablation (LCA) in patients with small renal masses (SRMs).

Patients and Methods

A retrospective review of 808 patients treated with LCA for T1a SRMs from 2005 to 2015 at eight European institutions. Complications were analysed according to the Clavien–Dindo classification. Kaplan–Meier analyses were used to estimate 5- and 10-year disease-free survival (DFS) and overall survival (OS).

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Results

The median [interquartile (IQR)] age was 67 (58–74) years. The median (IQR) tumour size was 25 (19–30) mm. The transperitoneal approach was used in 77.7% of the patients. The median postoperative hospital stay was 2 days. In all, 514 patients with a biopsy-confirmed renal cell carcinoma (RCC) were available for survival analyses. The median (IQR) follow-up for the RCC-cohort was 36 (14–56) months. A total of 32 patients (6.2%) were diagnosed with treatment failure. The 5-/10-year DFS was 90.4%/80.0% and 5-/10-year OS was 83.2%/64.4%, respectively. A total of 134 postoperative complications (16.6%) were reported, with severe complications (grade ≥III) in 26 patients (3.2%). An American Society of Anesthesiologists score of 3 was associated with an increased risk of overall complications (odds ratio 2.85, 95% confidence interval 1.32–6.20; P = 0.005).

Conclusions

This large series of LCA demonstrates satisfactory long-term oncological outcomes for SRMs. However, although LCA is considered a minimally invasive procedure, risk of complications should be considered when counselling patients.

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Editorial: Laparoscopic renal mass cryoablation: an operation in search of an indication

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In this issue of BJUI, Nielsen et al. [1] report the oncological and surgical outcomes from a multi-institutional cohort of patients receiving laparoscopic cryoablation (LCA) as primary therapy for solitary renal masses <4 cm in size (cT1a). This work represents the latest addition to a growing body of literature in an important oncological space that lacks prospective/randomized evidence to guide practitioners counselling patients with kidney cancer. Although the article does not advance the discussion toward higher levels of evidence, the results are nonetheless provocative and several strengths and weaknesses deserve comment.

While nephron-sparing surgery has become the recognized standard of care for cT1a renal lesions [2, 3], the reality remains that certain patients carry unacceptable risk profiles for partial nephrectomy, making less invasive options preferable. Such indications might include being elderly or frail, having hereditary kidney cancer syndromes prone to metachronous renal tumours, or having a solitary kidney. For such patients, focal renal mass ablative techniques have emerged as a safe alternative to extirpation that avoids the permanent nephron loss associated with radical nephrectomy. From an oncological perspective, however, cryotherapy, radiofrequency ablation and microwave ablation (by any approach) all have yet to be studied against partial nephrectomy in a prospective fashion. Numerous retrospective analyses have attempted to fill the void [4], yet the general consensus among most academic kidney surgeons is that renal mass ablation offers acceptable but inferior cancer control compared with surgery [5].

In this retrospective analysis by Nielsen et al., 808 patients underwent LCA between 2005 and 2015, 514 (63.4%) of whom had pre-procedural biopsy-proven RCC. The principal findings described in the present study include not only 5- and 10-year disease-free and overall survival, but also morbidity and mortality outcomes after LCA. The authors should be commended for the structure of their design, which included a high proportion of patients with available preoperative biopsy data. Additionally, clear definitions of treatment success, ‘residual unablated tumour’ and ‘local tumour progression’ are provided, and consistent follow-up imaging protocols were employed by the institutions involved. In each of these ways, Nielsen et al. overcome many of the pitfalls that have clouded the interpretation of results from previous reports.

Nevertheless, the oncological outcomes reported in this study, which are on a par with those for partial nephrectomy as well as other ablative techniques, must be approached with a degree of skepticism. As there is no alternative treatment cohort included in the study, omission of anatomical complexity data (in the form of nephrometry scoring) prohibits any meaningful comparison with patients having undergone ablative procedures or partial nephrectomy from other series. Availability of these data is essential for the reader to gauge the influence of selection bias in the interpretation of the results.

From a morbidity and mortality standpoint, the reported 16% overall complication rate, 3% rate of severe complications (defined as Clavien III–V) and three deaths within 30 days of the procedure might have been strengthened by the missing nephrometry data, as the rate of complications would be expected to increase with the complexity of the renal mass [6]. Also noticeably absent from the analysis are granular comorbidity and previous surgery data, both of which intuitively predispose patients to complications when undergoing minimally invasive surgery.

With these limitations in mind, the experienced kidney surgeon is not likely to see LCA as an equally effective or safer alternative to minimally invasive partial nephrectomy, which can be performed with similar complication rates and length of hospital stay without sacrificing oncological efficacy in most patients. Similarly, the question of why the practitioner should assume the risks of LCA when percutaneous cryoablation is readily available at many contemporary kidney cancer centres is unanswered by the present study. Indeed, with increasingly complex renal masses being managed via minimally invasive nephron-sparing surgery, and active surveillance of small renal masses gaining traction in the appropriate patient population, cryoablation via a laparoscopic approach unfortunately may represent another urological application without a well-defined indication going forward. We hope that the results presented by Nielsen et al. in this issue of BJUI encourage investigators to enroll patients in prospective trials aimed at comparing available ablative techniques or partial nephrectomy in matched cohorts to identify the ideal patient population for this operation and further clarify the oncological and clinical outcomes compared with surgical excision.

Daniel C. Parker and Brian W. Cross

 

Department of Urologic Oncology, University of Oklahoma Stephenson Cancer Center, Oklahoma City, OK, USA

 

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References

 

1 NielsenT, Lagerveld B, Keeley F et al. Oncologic outcomes and complication rates after laparoscopic-assisted cryoablation: a EuRECA multi-institutional study. BJU Int 2016. [Epub ahead of print].

 

2 Campbell SC, Novick AC, Belldegrun A et al. Guideline for management of the clinical T1 renal mass. J Urol 2009; 182: 1271–9

 

3 Ljungberg B, Bensalah K, Canfield S et al. EAU guidelines on renal cell carcinoma: 2014 update. Eur Urol 2015; 67: 913–24

 

4 Wagstaff P, Ingels A, Zondervan P et al. Thermal ablation in renal cell carcinoma management: a comprehensive review. Curr Opin Urol 2014; 24: 474–82

 

5 Kutikov A, Smaldone MC, Uzzo RG. Focal therapy for treatment of the small renal mass: dealer’s choice or a therapeutic gamble? Eur Urol 2015; 67: 260–1

 

6 Simhan J, Smaldone MC, Tsai KJ et al. Objective measures of renal mass anatomic complexity predict rates of major complications following partial nephrectomy. Eur Urol 2011; 60: 724–30

 

Article of the week: Out of the COLD: cryoablation for locally advanced PCa

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one

Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the Cryo-On-Line Database (COLD) Registry

John F. Ward, Christopher J. DiBlasio*, Christopher Williams†, Robert Given‡ and J. Stephen Jones

§The University of Texas MD Anderson Cancer Center, Houston, TX, *Urology, Mount Sinai School of Medicine, Huntington, NY, †Urology, University of Florida and Shands Medical Center, Jacksonville, FL, ‡Urology, Eastern Virginia Medical School, Norfolk, VA, and §Urology, Cleveland Clinic Lerner College of Medicine, Cleveland, OH, USA

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OBJECTIVE

• To assess the oncological and functional outcomes of primary prostate cryoablation for men with clinical stage T3 (cT3) prostate cancer, as although radical prostatectomy (RP) or external beam radiotherapy (EBRT) are the standard treatments for locally advanced cT3 prostate cancer some patients opt for nonextirpative prostate cryoablation instead.

PATIENTS AND METHODS

• The Cryo-On-Line Database (COLD) Registry was queried to identify patients with cT3 prostate cancer treated with whole-gland cryoablation (366 patients).

• We assessed biochemical disease-free survival (bDFS) using the Phoenix definition and determined reported rates of urinary incontinence and retention, sexual activity, and rectourethral fistulisation after treatment.

• Patients were subsequently assessed according to whether they were administered neoadjuvant androgen-deprivation therapy or not (ADT; 115 patients, 31.4%).

RESULTS

• For the entire cohort, the 36- and 60-month bDFS rates were 65.3% and 51.9%, respectively.

• Patients who received neoadjuvant ADT had statistically nonsignificantly higher 36- and 60-month bDFS rates (68.0% and 55.4%, respectively) than patients who did not receive neoadjuvant ADT (55.3% and 36.9%, respectively).

• The after treatment urinary incontinence rate was 2.6%; urinary retention rate, 6.0%; sexual activity rate, 30.4%; and rectourethral fistulisation rate, 1.1%.

CONCLUSIONS

• Cryoablation for patients with cT3 prostate cancer leads to less favourable bDFS than that after RP or RT for the same group of men.

• The after treatment rectourethral fistulisation rates for patients with cT3 disease are higher than in those with organ-confined prostate cancer treated with cryoablation; however, urinary dysfunction and sexual activity rates are similar for men with cT3 to those reported from this same registry in men with cT2 disease.

• The addition of neoadjuvant ADT (though not studied prospectively here) should be strongly considered if a patient with cT3 prostate cancer is to be treated with cryoablation.

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Editorial: Cryosurgery for clinical T3 prostate cancer

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There are limited data available on the outcomes of cryosurgery for clinical T3 prostate cancer, and as such, the role of cryosurgery for clinical T3 disease is currently undetermined [1]. Modern cryosurgery of the prostate, utilizing gas-based third-generation technology, a real-time monitoring system with ultrasonography and thermocouples, is associated with a low complication rate [7], although comparative outcomes of the different treatment modalities and long-term follow-up data remain to be seen.

Several aspects of cryosurgery can make it difficult to adequately control locally advanced prostate cancer. First, cryosurgery for clinical T3 cancer requires unique surgical expertise to control local disease while minimizing side-effects. Secondly, staging of locally advanced prostate cancer is challenging – it is difficult to accurately identify the extent of extracapsular extension, seminal vesicle involvement and/or lymph node metastasis. Thirdly, challenges in managing clinical T3 disease include the requirement of a more extensive ablation technique to appropriately target the extraprostatic disease and seminal vesicle involvement as well as treatment for possible microscopic metastasis, which might not be clinically detectable.

Two recent randomized trials compared outcomes of external beam radiation therapy with those of cryosurgery (including cT3 diseases with use of neo-adjuvant androgen deprivation therapy [ADT]), with contrasting results [2, 3]. Chin et al. [2] reported superiority of biochemical disease-free survival favouring external beam radiation therapy in relatively more advanced (bulky) disease, while Donnelly et al. [3] reported significantly fewer positive biopsy rates favouring cryosurgery in the relatively less advanced disease. These findings could suggest that more advanced bulky cases that require wider local control of bulky extraprostatic diseases are not suitable for cryosurgery, while in appropriately selected cases with fewer extraprostatic diseases, cryosurgery is an acceptable option (when combined with neo-adjuvant ADT). Although appropriately extended cryo-lesions that achieve lethal temperatures can control extraprostatic disease, there is a certain limitation in the extension of cryo-lesions without injury to vital peri-prostate organs, such as the urinary sphincter, rectal wall, bladder wall and ureters.

Evolving accuracy of preoperative diagnostic imaging to assess extraprostatic disease can enhance outcomes, and staging tissue sampling from suspected extraprostatic disease could also identify actual microscopic extension of the extraprostatic disease [4]. A recently updated nomogram predicting lymph node invasion [5] suggests that the probability of lymph node invasion in patients with cT3, PSA level >10 ng/mL, and biopsy primary Gleason grade 4 is 20% or greater. Clearly, the preoperative risk assessment of lymph node involvement using such a modern calculator is pertinent for appropriate patient selection. Finally, management decision should be made by a multidisciplinary team.

When combined with radiotherapy, neo-adjuvant ADT for high-risk and locally advanced prostate cancer has been associated with clinical benefit; however, when combining neo-adjuvant ADT with prostatectomy, there is pathological down-staging and reduction in the surgical positive margin but minimal improvement in overall or disease-free survival [6]. The role of neo-adjuvant and adjuvant ADT when combined with cryosurgery is still unknown. Clearly, a prospective study is needed to determine the optimal duration and method of ADT (whether to use LHRH analogue or combined blockade) and to analyse the side-effects, the quality of life and the cost-effectiveness of a combination of cryosurgery with ADT for cT3a and cT3b prostate cancer.

Osamu Ukimura, Andre Luis de Castro Abreu, Andrew J. Hung and Inderbir S. Gill
USC Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA

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References

  1. Babaian RJ, Donnelly B, Bahn D et al. Best practice statement on cryosurgery for the treatment of localized prostate cancer. J Urol 2008; 180: 1993–2004
  2. Chin JL, Al-Zahrani AA, Autran-Gomez AM, Williams AK, Bauman G. Extended followup oncologic outcome of randomized trial between cryoablation and external beam therapy for locally advanced prostate cancer (T2c-T3b). J Urol 2012; 188: 1170–1175
  3. Donnelly BJ, Saliken JC, Brasher PM et al. A randomized trial of external beam radiotherapy versus cryoablation in patients with localized prostate cancer. Cancer 2010; 116: 323–330
  4. Ukimura O, Coleman JA, de la Taille A et al. Contemporary role of systematic prostate biopsies: indications, techniques, and implications for patient care. Eur Urol 2013; 63: 214–230
  5. Briganti A, Larcher A, Abdollah F et al. Updated nomogram predicting lymph node invasion in patients with prostate cancer undergoing extended pelvic lymph node dissection: the essential importance of percentage of positive cores. Eur Urol 2012; 61: 480–487
  6. Shelley MD, Kumar S, Wilt T, Staffurth J, Coles B, Mason MD. A systematic review and meta-analysis of randomised trials of neo-adjuvant hormone therapy for localised and locally advanced prostate carcinoma. Cancer Treat Rev 2009; 35: 9–17
  7. Ward JF, DiBlasio CJ, Williams C, Given R, Jones JS. Cryoablation for locally advanced clinical stage T3 prostate cancer: a report from the Cryo-On-Line Database (COLD) Registry. BJU Int 2014; 113: 714–718

 

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