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European Urology Today
EAU19 Congress News
T on hird da Ed y 1 iti 8 on M ar ch
34th Annual Congress of the European Association of Urology Barcelona, 15-19 March 2019
Breaking News: New PCa drugs and imaging
Is MRI-targeted biopsy enough?
By Loek Keizer
Opposing views on the efficacy and significance of MRI-targeted biopsy were presented during the first debate in Plenary Session 3: Imaging in prostate cancer: Is it time to change paradigms?, chaired by Dr. Jochen Walz (FR) and Prof. Dr. Francesco Montorsi (IT).
The results of two new studies were announced on the third day of EAU19: the eagerly awaited and possibly paradigm-changing ARAMIS study and new research into fast bi-parametric MRI. Delegates braved the early hours of Sunday morning to attend the Breaking News Session that was part of Plenary Session 3, on imaging in PCa. Prof. Teuvo Tammela (FI) presented the latest results of the ARAMIS study, which tested the effects of darolutamide on the PSA levels of men with non-metastatic castration-resistant prostate cancer (nmCRPC). “The latest results indicate that darolutamide significantly improves metastasis-free survival in men with nmCRPC. It elicits strong PSA declines and significantly delays PSA progression compared to placebo. Because it also has a favourable safety profile, we think darolutamide could be an attractive option for treating nmCRPC.” Prof. Peter Albers (DE) was on hand to place these findings in a wider context, first pointing out that the selection criteria were limited to patients with very short and aggressive doubling times. Albers: “The overall survival curves separate after about 18 months, so we have to wait longer. The study has a surrogate endpoint of metastatic-free survival.” “Darolutamide is a new and effective nextgeneration androgen receptor inhibitor,” Albers concluded. It has a better safety profile compared to enzalutamide and apalutamide, and will change practice if the advantage in metastasis-free survival leads to an overall survival advantage. It does however need strong selection criteria to prevent overtreatment.”
Plenary Session tackles the benefits and drawbacks By Erika de Groot
Prior to the deliberations, moderator Dr. Arnout Alberts (NL) asked the audience “Which biopsy strategy would you use in men with a clinical suspicion of PCa?”. The audience keyed in their answers via the EAU Events App. About 55% of the audience chose MRI (+targeted biopsy in case of positive MRI), always combined with TRUS biopsy; and 30% chose MRI (+targeted biopsy in case of positive MRI), TRUS biopsy depending on risk-stratification. The debate then commenced. In the presence of a positive MRI, Dr. Veeru Kasivisvanathan (GB) shared his insights on the advantages of MRI-targeted biopsy without TRUS biopsy. For example, patient burden and risk of (infectious) complications decrease when there are fewer biopsy cores per procedure. The detection rate of Grade Group (GG) 1 (Gleason 3+3) prostate cancer (PCa) is lower, and patients with a false negative MRI-targeted biopsy are not lost to follow up. In summary, the counter-arguments of Dr. Guillaume
Fast MRI Prof. Jelle Baretsz (NL) presented the latest results from a multi-centre study on 626 biopsy-naïve patients, hoping to convince the audience that a “fast” prostate MRI without contrast is cheap, non-invasive and can double prostate MRI capacity. The study compared contrast-enhanced multiparametric full MRI protocol (mpMRI, 16 minutes) to an unenhanced, bi-parametric MRI (bpMRI, 13 minutes) and a fast bpMRI protocol (8 minutes). The latest data showed that non-invasive fast bpMRI without contrast agent can accurately detect and rule-out csPCa. Additionally, bpMRI-fast can be performed at significantly lower (55%) costs. The full results will be published soon in European Urology. Prof. Briganti (IT) pointed out that the results depend largely on the availability of the highest quality MRI and most experienced radiologists, warning that fast bpMRI is possibly ready to replace mpMRI in all patients, but only at selected centres. Monday, 18 March 2019
Ploussard (FR) included the significant learning curve associated with multi-parametric MRI (mpMRI) reading and MRI-targeted biopsy, the possible registration errors in MRI-targeted biopsy, and the 10 to 20% of GG ≥ 2 (Gleason ≥ 3+4) tumours that are missed. Tumour evaluation (e.g. multifocality, heterogeneity) can be suboptimal if MRI-targeted biopsy is performed without TRUS biopsy. Negative MRI, no TRUS biopsy needed Prof. Francesco Porpiglia (IT) agreed that in the presence of a negative MRI or native MRI-targeted biopsy, no TRUS-biopsy is needed due to the high negative predictive value (NPV) of up to 95% of MRI for GG ≥ 2 (Gleason ≥ 3+4) PCa. There is a 30% reduction
in biopsies, which means a decrease in patient burden and costs, with fewer complications. Additionally, the detection rate of GG1 (Gleason 3+3) PCa is lower. Dr. Christian Arsov (DE) raised opposing points such as the significant learning curve associated with mpMRI reading; a lack of mpMRI quality control; and 10 to 20% missed GG ≥ 2 (Gleason GG ≥ 3 + 4) tumours. Dr. Alberts considered the pros and cons discussed, and concluded that there is no single right answer to the question of whether MRI-targeted biopsy is enough. He stated that the way forward seems to be an individual strategy with upfront risk-stratification and the combination of MRI-targeted biopsy and TRUS biopsy in case of elevated risk.
Renal Cell Carcinoma: Controversies in care Debates on robotic approaches and treatment modalities By Jen Tidman “The only thing that is permanent in surgery is change,” remarked Prof. Alexandre Mottrie (BE), launching the first debate in Sunday morning’s packed plenary on renal cell carcinoma (RCC). He was arguing that the benefits of new technologies, including robotic-assisted partial nephrectomy (RAPN), are unlimited compared to classical surgery, which he said results in too many complications. In his view, RAPN spares more healthy tissue, avoids large painful incisions, and gives good oncological and functional outcomes.
Prof. Barentsz presenting new results
Experts deliberate on efficacy of MRI-targeted biopsy
However, Mottrie admitted that although robots do not cause problems, the people behind them can. He therefore emphasised the need for proficiency-based, standardised, and quality-assured education, and congratulated the EAU on certifying the first training programme in robotics, by ERUS. In counter-argument, Prof. Markus Kuczyk (DE) said RAPN results in decreased patient satisfaction, and in low-volume centres often leads to transfusions, positive margins, and conversions to open surgery. In these centres, doctors experienced in open surgery should stick with this or send patients to expert centres. In the second debate, moderator Prof. Peter Mulders (NL) presented the case of a small renal mass in a 42-year-old woman with a BMI of 31. Three experts then discussed her treatment. Prof. Charles Karim Bensalah (FR) felt PN was the primary option, with fewer complications and a comparable survival rate. PN can actually improve outcomes in obese patients and the only potential obstacle would be toxic fat, which can be surmounted with good training and ultrasound identification of the
tumour margin. He noted support from the EAU Guidelines (2019), which recommend offering PN to patients with P1 tumours (strong level of evidence). Dr. Umberto Capitanio (IT) favoured local tumour ablation (cryoablation, radiofrequency, microwaves, or irreversible electroporation), especially in a patient at high risk of PN complications. However, in view of the weaker evidence, more research is needed. Dr. Antonio Finelli (CA) suggested active surveillance (AS) rather than potentially unnecessary surgery. He noted that 80-90% of <4cm masses grow at only 0.22cm per year on average and that it is not
uncommon for <1cm tumours to disappear. In addition, as obesity is a risk for RCC, de novo tumours might develop after initial surgery. He therefore advocated AS (except in young and healthy patients with >4cm tumours) intervening only when the opportunity for cure exists and the risk of progression has been appreciated. In conclusion, the experts agreed that in this particular case, all modalities were valid, depending on biopsy results and discussion with the patient. As Mulders said, any treatment decision must be based on all factors known about the patient, the physician, the facility and new research.
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