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sehr niedrige Qualita¨t der Evidenz Radiofrequenzablation bei Tumoren des Urogenitaltrakts (Nierenzellkarzinom, Prostatakarzinom, Leiomyome des Uterus) Schlussfolgerung und Empfehlung Aufgrund des unkontrollierten Studiendesigns der prospektiven Fallserien und der inadäquaten Vergleichsgruppe (HIFU) des RCTs bei der Behandlung uteriner Myome ist die Qualität der vorliegenden Evidenz gemäß GRADE als sehr niedrig zu bewerten. Insgesamt ist die vorhandene Evidenz nicht ausreichend, um die Wirksamkeit und Sicherheit der RFA zur Behandlung von Tumoren des Urogenitaltrakts im Vergleich zur chirurgischen Resektion beurteilen zu können. Die Aufnahme in den Leistungskatalog wird derzeit daher nicht empfohlen. 6 LBI-HTA | 2012
Executive Summary Background and research question Radiofrequency ablation (RFA) is a relatively new, minimally-invasive ablation method that destroys tumors by local application of heat. This systematic review evaluates the following indications of RFA for the treatment of benign and malignant tumors of the urogenital tract: renal cell carcinoma, prostate cancer and uterine leiomyoma. Methods A systematic literature search in various databases was supplemented by a handsearch (manually and by using Scopus). Additionally, RFAmanufacturers were contacted for further information. Two review authors independently screened and selected the literature and included eligible studies. In cases of disagreement, consensus was achieved through discussion or by involving a third person. The data was extracted by one author and checked by a second author. In the absence of (randomised) controlled trials (RCT) with an adequate control group (like surgical resection), prospective (uncontrolled) case-series were included as best available evidence and assessed the quality of evidence according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. Results Concerning RFA for the treatment of renal cell carcinoma, we identified 3 studies that included 359 patients aged 64-68 years. The average tumor size was 2-3 cm. The 5-year-survival rate was 85%, the recurrence rate in a subgroup of tumors was 10%. There was no significant difference in the quality of life after RFA compared to baseline values. RFA for renal cell carcinomas appears to be safe: major complications were not observed, while minor complications occurred in up to a quarter of patients. In terms of RFA for the treatment of prostate cancer, no studies were identified that met the inclusion criteria. It seems, that for this indication other experimental therapeutic options, such as high-intensity focussed ultrasound (HIFU), are more relevant than RFA. Concerning RFA for the treatment of uterine leiomyomas, we identified 6 studies: 1 RCT (however, with an inadequate control group: HIFU) and 5 case series. In total, 352 women aged 39-45 years with an average tumor size of 5 cm were treated with RFA. There was a consistently observed improvement in both quality of life and symptoms 6-24 months after RFA compared to baseline values. RFA appeared to be safe, as can be seen in the complication rates: major 0-9%; minor 0-34%; pain 2-13%; re-operation 0-4%. Conclusion and recommendation According to GRADE, the quality of evidence is very low due to the uncontrolled study design of the included case series and the inadequate control group of the included RCT (HIFU) of RFA for the treatment of uterine leiomyomas. Overall, the available evidence is insufficient to assess the efficacy RFA: minimallyinvasive, thermal destruction of tumors literature search + infos from manufacturers best available evidence are prospective caseseries and one RCT quality of evidence according to GRADE renal cell carcinoma: 3 studies, 359 patients, 64-68 years 5-year-survival: 85%, recurrence rate: 10%, relatively safe prostate cancer: no evidence uterine leioymoma: 1 RCT (RFA vs. HIFU), 5 case series improved quality of life and symptoms, relatively safe very low quality of evidence LBI-HTA | 2012 7
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Seite 4 und 5: Fu¨r den Inhalt verantwortlich: Pr
Seite 6 und 7: Abbildungsverzeichnis Abbildung 2.4
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Seite 12 und 13: Goldstandard der Therapie: chirurgi
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Seite 16 und 17: RFA relativ neu kleine Tumore und/o
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Seite 27 und 28: Datenextraktion Tabelle 4.1-1: Resu
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Seite 31 und 32: Datenextraktion Tabelle 4.1-2: Resu
Seite 33 und 34: Datenextraktion Author, year, refer
Seite 35 und 36: 5 Qualita¨t der Evidenz Zur Beurte
Seite 37: Qualita¨t der Evidenz Tabelle 5-2:
Seite 40 und 41: (R)CTs: RFA vs. OP bei Nierenzellka
Seite 43 und 44: 7 Empfehlung In Tabelle 7-1 ist das
Seite 45 und 46: 8 Literaturverzeichnis [1] Spornitz
Seite 47: Literaturverzeichnis [37] Park S, A
Seite 56: Radiofrequenzablation bei Tumoren d

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