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Percutaneous ethanol instillation therapy for hepatocellular carcinoma – a randomized controlled trial

Perkutane Alkohol-Instillationstherapie zur Behandlung des Hepatozellulären Karzinoms – eine randomisiert kontrollierte Studie

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Zusammenfassung

HINTERGRUND: Die perkutane Alkohol-Instillation (PEI) ist eine akzeptierte und häufig benutzte Therapie des Hepatozellulären Karzinoms (HCC). Ihr Einfluss auf das Überleben der behandelten Patienten wurde jedoch noch nie in einer randomisierten kontrollierten Studie gegen nicht invasive Behandlungsmodalitäten überprüft. STUDIENZIEL: Ziel der Studie was es, den klinischen Erfolg einer zusätzlichen PEI gegenüber keiner zusätzlichen Behandlung bei Patienten mit HCC zu überprüfen, die alle als Basistherapie eine hormonelle Behandlung mit langwirksamen Octreotide erhielten. METHODEN: 61 Patienten mit inoperablem HCC wurden einmal im Monat mit 30 mg lang wirksamen Octreotide i.m. behandelt. Nach Randomisierung erhielten 31 Patienten zusätzliche PEI-Therapien, 30 andere Patienten keine weiteren Therapiemaßnahmen. Die Anzahl der PEI-Therapien pro Patient wurde nach dem Tumordurchmesser zum Zeitpunkt der Diagnose stratifiziert: Bei Patienten mit einem Tumordurchmesser < 5 cm erfolgten 5 PEI Therapien in monatlichen Abständen, Patienten mit Tumoren zwischen 5 und 8 cm im DM erhielten 10 PEI-Therapien. Gesamtüberleben, progressionsfreies Intervall und Zeitspanne bis zum lokalen Tumorwachstum wurden zwischen den beiden Behandlungsgruppen verglichen. Die Gruppen waren hinsichtlich Alter, Geschlecht, Tumorstadium (BCLC), Child-Pugh-Stadium und Ätiologie der Lebererkrankung vergleichbar. ERGEBNISSE: Das mediane Überleben zwischen der Gruppe, die mit lang wirksamem Octreotide und PEI behandelt wurde (14 Monate; 95% CI: 9–28 Monate) und der Gruppe, die nur lang wirksames Octreotide erhielt (22 Monate; 95% CI: 10–30 Monate) war nicht unterschiedlich (log-Rank-Test: p = 0,9). Das progressionsfreie Überleben nach den RECIST-Kriterien war ebenfalls in beiden Gruppen nicht unterschiedlich (Median: 3 Monate [3–6 Monate 95% CI] vs. 6 Monate [3–7 Monate 95% CI], log Rank Test p = 0,63). Die Zeitspanne bis zur lokalen Tumorprogression war ebenfalls in beiden Gruppen nicht unterschiedlich (6 vs. 6 Monate). Der Verlauf von AFP und Lebensqualitätsparametern war in beiden Gruppen ähnlich. ZUSAMMENFASSUNG: Die zusätzliche Alkohol-Instillationstherapie bei Patienten mit HCC, die mit lang wirksamem Octreotide behandelt wurden, führte weder zu einem besseren Gesamtüberleben noch zu einem längeren progressionsfreien Überleben oder einer längeren Zeitspanne bis zur lokalen Tumorprogression.

Summary

BACKGROUND AND AIMS: The aim of the study was to compare the clinical outcome of additional percutaneous ethanol instillation (PEI) against no further treatment in patients with hepatocellular carcinoma receiving hormonal treatment with long-acting octreotide. METHODS: In a randomized controlled trial conducted in a tertiary care center, a total of 61 patients with inoperable hepatocellular carcinoma were treated with long-acting octreotide 30 mg i.m. once a month and randomly assigned to receive either PEI (31 patients) or no further treatment (30 patients). RESULTS: Median survival time did not significantly differ between the long-acting octreotide plus PEI group (14 months; 95% CI: 9–28 months) and the long-acting octreotide alone group (22 months; 95% CI: 10–30 months) (logrank test P = 0.9). Similarly, an analysis stratifying for tumor diameter (< 5 cm or 5–8 cm) showed no significant survival differences between PEI or non-PEI treatment (logrank test P = 0.68). Progression-free survival according to RECIST was similar in the two groups (median: 3 months [3–6 months 95% CI] vs. 6 months [3–7 months 95% CI], logrank test P = 0.63). Time of local tumor control did not significantly differ between the two groups (6 months vs. 6 months). The course of alpha-fetoprotein levels and the reported quality of life were similar in the two groups. CONCLUSIONS: The addition of PEI to treatment with long-acting octreotide in patients with hepatocellular carcinoma did not result in better overall survival, longer progression-free survival or longer time of local tumor control.

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Authors and Affiliations

  1. Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie, Medical University of Vienna, Austria

    Christian Müller, Maximilian Schöniger-Hekele, Barbara Renner, Markus Peck-Radosavljevic, Andrea Brichta, Peter Ferenci & Alfred Gangl

  2. Universitätsklinik für Radiodiagnostik, Medical University of Vienna, Austria

    Rüdiger Schernthaner

  3. Klinisches Institut für Pathologie, Medical University of Vienna, Austria

    Fritz Wrba

  4. Institut für Medizinische Statistik, Besondere Einrichtung für Medizinische Statistik und Informatik, Medical University of Vienna, Austria

    Martin Posch & Peter Bauer

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  1. Christian Müller
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  2. Maximilian Schöniger-Hekele
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  3. Rüdiger Schernthaner
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  4. Barbara Renner
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  11. Alfred Gangl
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Correspondence to Christian Müller.

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Müller, C., Schöniger-Hekele, M., Schernthaner, R. et al. Percutaneous ethanol instillation therapy for hepatocellular carcinoma – a randomized controlled trial. Wien Klin Wochenschr 120, 608–618 (2008). https://doi.org/10.1007/s00508-008-1086-2

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  • DOI: https://doi.org/10.1007/s00508-008-1086-2

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