Hochintensiver fokussierter Ultraschall bei Low-Risk Prostatakarzinom – Onkologisches Outcome und postinterventionelle Lebensqualität im direkten Vergleich eines erfahrenen und unerfahrenen Therapiezentrums

Zusammenfassung

Hintergrund:

Bei Patienten mit Low-Risk Prostatakarzinom (PCa) bergen die Standardtherapien das Risiko der Übertherapie mit möglicherweise vermeidbaren Nebenwirkungen, während zurückhaltende Therapiestrategien das Risiko der Krankheitsunterschätzung bergen. Alternativen bestehen u. a. in thermalen Verfahren wie dem hochintensiven fokussierten Ultraschall (HIFU).

Patienten und Methoden:

96 Patienten mit Low-Risk PCa (D’Amico) wurden an 2 HIFU-Zen­tren unterschiedlicher Expertise (n=48 erfahrenes Zentrum Lyon/Frankreich; n=48 unerfahrenes Zentrum Charité Berlin) im Sinne einer matched pairs Analyse hinsichtlich des Biochemischen Rezidivfreien Überlebens (BDFS) sowie funktioneller Parameter (Miktion, erektile Funktion) prä- und postinterventionell verglichen. Unterschieden wurde, ob eine alleinige HIFU oder eine HIFU plus transurethrale Prostataresektion (TURP) erfolgte. Die Patienten des Lyon-Kollektivs wurden retrospektiv aus der @-registry-Datenbank extrahiert. Die Berliner Patienten wurden prospektiv evaluiert. Hier wurde zusätzlich eine Lebensqualitätsanalyse vor und nach Therapie durchgeführt.

Ergebnisse:

Der postoperative PSA-Nadir war im Berliner Kollektiv für HIFU (0,007 vs. Lyon 0,34 ng/ml; p=0,037) und HIFU+TURP (0,25 vs. Lyon 0,42 ng/ml; p=0,003) niedriger. Die beiden Kollektive waren bei alleiniger HIFU hinsichtlich des BDFS vergleichbar (Berlin 4,77, Lyon 5,23 Jahre; p=0,741). Jedoch zeigte sich für die Patienten mit HIFU+TURP der Berliner Gruppe ein ungünstigeres BDFS (Berlin 3,02, Lyon 4,59 Jahre; p=0,05). In der Subgruppenanalyse wiesen diejenigen Pa­tienten mit HIFU+TURP in selber Narkose (n=4) eine ungünstigere Prognose auf (p=0,009). Das mediane Gesamt-Follow-up lag bei 3,36 Jahren für die alleinige HIFU und 2,26 Jahren für HIFU+TURP. Weder HIFU (p=0,117) noch HIFU+TURP (p=0,131) hatten einen Einfluss auf das Miktionsverhalten. Die erektile Funktion wurde negativ beeinflusst (HIFU: p=0,04; HIFU+TURP: p=0,036). Eine Veränderung der Lebensqualität durch die Therapie konnte nicht gefunden werden.

Schlussfolgerung:

Das 4-Jahres BDFS nach HIFU und HIFU+TURP ist mit dem der Standardtherapien vergleichbar. Die erektile Funktion wird nachhaltig negativ beeinflusst. Ein Einfluss auf das Miktionsverhalten sowie die Lebensqualität konnte nicht gefunden werden. Die Ergebnisse werden sowohl durch die geringe Patientenzahl als auch das kurze Follow-up erheblich eingeschränkt und bedürfen der Validierung in prospektiven multizentrischen Langzeitstudien mit größerer Fallzahl.

Abstract

Background:

In patients with low-risk prostate cancer (PCa) the standard therapies carry a risk of overtreatment with potentially preventable side effects whereas restrained therapeutic strategies pose a risk of underestimation of the individual cancer risk. Alternative treatment options include thermal ablation strategies such as high-intensity focused ultrasound (HIFU).

Patients and Methods:

96 patients with low-risk PCa (D’Amico) were treated at 2 HIFU centres with different expertise (n=48, experienced centre Lyon/France; n=48 inexperienced centre Charité Berlin/Germany). Matched pairs were formed and analysed with regard to biochemical disease-free survival (BDFS) as well as postoperative functional parameters (micturition, erectile function). The matched pairs were discriminated as to whether they had received HIFU treatment alone or a combination of HIFU with transurethral resection of the prostate (TURP). Patients of the Lyon group were retrospectively matched through the @-registry database whereas pa­tients of the Berlin group were prospectively evaluated. In the latter patients quality of life assessment was additionally inquired.

Results:

Postoperative PSA-Nadir was lower in the Berlin group for patients with HIFU only (0.007 vs. Lyon 0.34 ng/ml; p=0.037) and HIFU+TURP (0.25 vs. Lyon 0.42 ng/ml; p=0.003). BDFS was comparable in both groups for HIFU only (Berlin 4.77, Lyon 5.23 years; p=0.741) but patients with combined HIFU+TURP in the Berlin group showed an unfavourable BDFS as compared to the Lyon group (Berlin 3.02, Lyon 4.59 years; p=0.05). In an analysis of Berlin subgroups especially patients who had received HIFU and TURP (n=4) within the same narcosis had an unfavourable BDFS (p=0.009). Median follow-up was 3.36 years for HIFU only and 2.26 years for HIFU+TURP. Neither HIFU only (p=0.117) nor HIFU+TURP (p=0.131) showed an impact on postoperative micturition. Erectile function was negatively influenced (HIFU: p=0.04; HIFU+TURP: p=0.036). There was no measurable change in quality of life after the treatment.

Conclusion:

The 4-year BDFS after HIFU and HIFU+TURP is comparable to that of the standard therapies. The erectile function is sustainably negatively influenced whereas postoperative micturition and quality of life were not affected by HIFU or HIFU+TURP. These results are strongly limited by the low pa­tient count and the short follow-up period and require valida­tion in prospective multicentre studies with higher number of cases.

Schlüsselwörter

Low-Risk Prostatakarzinom - hochintensiver fokussierter Ultraschall (HIFU) - matched pairs - Lebensqualität

Key words

low-risk prostate cancer - high-intensity focussed ultrasound (HIFU) - matched pairs - quality of life

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