Zusammenfassung
HINTERGRUND: In der 3 dimensionalen Radiotherapie des lokalisierten Prostatakarzinoms wird zur Fixierung der Prostata und zur Verminderung der Strahlendosis an der Rektumhinterwand ein Rektumballon verwendet. Ziel dieser Studie war die Evaluierung der klinischen Anwendbarkeit eines Rektumballonkatheters, dessen Patientenakzeptanz und Untersuchung des Einflusses von akuten rektalen Nebenwirkungen und prätherapeutisch detektierten Hämorrhoiden auf die Ballonverträglichkeit. MATERIAL UND METHODE: 442 Patienten mit lokalisiertem Prostatakarzinom wurden im Rahmen einer prospektiven österreichisch-deutschen Multicenter-Studie evaluiert. Die Gesamtherddosis betrug 70 bzw. 74 Gray. Die Ballonverträglichkeit (1. Keine Beschwerden; 2. Schmerzen bei/während der Applikation; 3. Zeichen von Blut am Ballonkatheter nach Applikation ohne Schmerzen; 4. Zeichen von Blut am Ballonkatheter nach Applikation und Schmerzen; 5. Abbruch der Ballonapplikation) und akuten rektalen Nebenwirkungen wurden während der Radiotherapie (Beginn/Mitte/Ende) ermittelt. 310 Patienten willigten in eine Rektoskopie vor Beginn der Therapie ein. RESULTATE: 429/442 der Patienten (97 %) wurden mit Rektumballon bestrahlt. Dabei berichteten 79 % über keine Beschwerden. Die Ballonapplikation musste bei nur 4 % der Patienten abgebrochen werden. Grad 0 akute rektale Nebenwirkungen fanden sich bei 52 %, Grad 1 bei 31 %, Grad 2 und 3 bei 17 % und 0,5 %. Es zeigte sich eine signifikante Korrelation zwischen Rektumballonbeschwerden und rektalen Nebenwirkungen (p < 0,01). Bei 36 % der Patienten fanden sich Hämorrhoiden ohne einen Einfluss auf die Ballonverträglichkeit zu zeigen. SCHLUSSFOLGERUNG: Der Rektumballon wird von einem Großteil der Patienten im Rahmen der 3-dimensionalen Strahlentherapie des lokalisierten Prostatakarzinoms gut vertragen und kann im klinischen Alltag sicher verwendet werden. Während Patienten mit akuten rektalen Nebenwirkungen signifikant häufiger über Beschwerden bzgl. des Rektumballonkatheters berichteten, zeigte das Vorliegen von Hämorrhoiden keinen Einfluss.
Summary
PURPOSE: Patients with localized prostate cancer are treated with 3D radiotherapy using a rectal balloon catheter for internal immobilization of the prostate, thereby reducing the radiation dose to the dorsal rectal wall. The purpose of the study was to investigate clinical feasibility and the influence of acute rectal side effects and pre-existing hemorrhoids on patients' acceptance of the rectal balloon catheter. METHODS AND MATERIALS: 442 patients who underwent primary radiation therapy for localized prostate cancer were included in this prospective Austrian-German multicenter trial. The total radiation dose was either 70 Gy or 74 Gy. Acute rectal side effects were documented using the EORTC/RTOG grading score (European Organisation for Research and Treatment of Cancer/Radiation Therapy 225 Oncology Group) at weeks 2, 4 and 7 of radiation treatment. Within the same time intervals patients were interviewed about their tolerance of the rectal balloon catheter, evaluating five categories of acceptance (1 = no major complaints, 2 = pain at/during application, 3 = signs of blood at the balloon catheter after application but without any pain, 4 = signs of blood at the balloon catheter after application and pain, 5 = balloon application had to be stopped). Voluntary rectoscopy prior to radiotherapy was performed in 310 patients. RESULTS: 429/442 patients (97 %) were treated with the balloon catheter. No major complaints were reported in 79 % of the patients and no acute rectal side effects were seen in 52 % of the patients. Grade 1 side effects were seen in 31 % patients, Grade 2 in 17 % and Grade 3 in 0.5 %. Balloon use had to be stopped in only 4 % of the patients. There was significant correlation between balloon discomfort and rectal side effects (p < 0.01). The presence of hemorrhoids in 36 % patients prior to irradiation had no influence on balloon tolerance. CONCLUSIONS: The rectal balloon can be used in 3D radiotherapy of localized prostate cancer with a high degree of acceptance by the patients. Use of the balloon is safe within daily clinical treatment. Patients reporting acute rectal side effects experienced significantly more balloon discomfort, but the presence of hemorrhoids was not found to influence acceptance of the balloon.
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Goldner, G., Geinitz, H., Wachter, S. et al. 3-D Conformal radiotherapy of localized prostate cancer within an Austrian–German multicenter trial: a prospective study of patients' acceptance of the rectal balloon during treatment. Wien Klin Wochenschr 118, 224–229 (2006). https://doi.org/10.1007/s00508-006-0588-z
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DOI: https://doi.org/10.1007/s00508-006-0588-z