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Clinical Trial
. 2016 Jul;192(7):449-57.
doi: 10.1007/s00066-016-0971-2. Epub 2016 May 25.

SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer : Toxicity and quality of life assessment

Monika Rucinska  1   2 , Anna Kieszkowska-Grudny  3 , Sergiusz Nawrocki  4
Affiliations
Clinical Trial

SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer : Toxicity and quality of life assessment

Monika Rucinska et al. Strahlenther Onkol. 2016 Jul.

Abstract
in English, German

Background: Quality of life (QoL) is one of the most significant issues in prostate cancer treatment decisions. This study aimed to investigate the toxicity of hypofractionated stereotactic radiotherapy (SBRT) and QoL after treatment in localized prostate cancer patients.

Materials and methods: A prospective single-center clinical study was performed in low- and intermediate-risk prostate cancer patients. Patients received 33.5 Gy in 5 fractions (SHARP regimen). Acute and late toxicity was assessed according to RTOG/EORTC score. Patients filled out EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires.

Results: The analysis included 68 prostate cancer patients (55-83 years, median 73) with clinical stage T1c-T2cN0M0, median combined Gleason score of 6 (3-8), and median prostate-specific antigen (PSA) level of 10 ng/mL (4-20 ng/mL). Neoadjuvant androgen deprivation therapy was given to 52 patients (76.5 %), and stopped in 31 patients (45.5 %) after 6 months; in 21 patients (31 %) after 2-3 years. Average and median follow-up was 24 months (18-45). Median nadir PSA level was 0.03 ng/mL for all patients and 0.6 ng/mL for patients without hormone treatment. No patients had PSA failure. There were no acute grade IV toxicities. One patient (1.5 %) developed grade III and 24 patients (35.3 %) grade II acute bladder toxicity. No one developed grade III and 7 patients (10.3 %) grade II acute rectal toxicity. No grade III or IV late gastrointestinal or genitourinary toxicities were reported. Grade II late urinary symptoms were observed in 8 patients (11.8 %) and gastrointestinal symptoms in 3 patients (4.4 %). Global health status/QoL was good and improved during the observational period.

Conclusion: SBRT for prostate cancer patients is a well-tolerated treatment in terms of toxicity and QoL, has no negative impact on functioning and everyday life, with the important benefit of a short treatment period. However, long-term follow-up data are needed.

Hintergrund: Die Lebensqualität (QoL) ist zu einem der wichtigsten Schwerpunkte bei der Wahl der Prostatakarzinombehandlung geworden. Das Thema dieser Studie war die Untersuchung der Toxizität der hypofraktionierten stereotaktischen Radiotherapie (SBRT) und der QoL nach Behandlung des lokal begrenzten Prostatakarzinoms.

Materialien und Methoden: Die prospektive, monozentrische, klinische Studie wurde bei Prostatakarzinompatienten mit niedrigem bis mittlerem Risiko durchgeführt. Die Patienten erhielten 33,5 Gy in 5 Fraktionen (SHARP-Behandlungsschema). Akute und späte Toxizität wurden nach den Kriterien des RTOG/EORTC-Scores klassifiziert. Die Patienten füllten das EORTC-QLQ-C30- und das prostatakarzinomspezifische QLQ-PR25-Formular aus.

Ergebnisse: Die Analyse umfasste 68 Prostatakarzinompatienten (medianes Alter 73, Spanne 55–83 Jahre) im klinischen Staging T1c–T2cN0M0, mit einem medianen Gleason-Score von 6 (Spanne 3–8) und einem medianen PSA-Wert (prostataspezifisches Antigen) von 10 ng/ml (Spanne 4–20 ng/ml). Eine neoadjuvante Androgendeprivationstherapie erhielten 52 Patienten (76,5 %); die Hormontherapie beendet 31 Patienten (45,5 %) nach 6 Monaten und 21 Patienten (31 %) nach 2–3 Jahren. Das durchschnittliche und mediane Follow-up dauerte 24 Monate (Spanne 18–45). Der mediane PSA-Nadir betrug 0,03 ng/ml für alle Patienten und 0,6 ng/ml für Patienten ohne Hormontherapie. PSA-Versagen und akute Grad-IV-Toxizitäten traten nicht auf. Ein Patient (1,5 %) hatte eine Grad-III- und 24 Patienten (35,3 %) eine Grad-II-Harnblasentoxizität, kein Patient eine Grad-III- und 7 Patienten (10,3 %) eine akute Grad-II-Rektumtoxizität. Späte gastrointestinale oder urogenitale Toxizitäten III. oder IV. Grades wurden nicht berichtet. Bei 8 Patienten (11,8 %) traten späte Miktionsbeschwerden II. Grades und bei 3 Patienten (4,4 %) gastrointestinale Symptome auf. Globaler Gesundheitsstatus/QoL war gut und besserte sich in der untersuchten Zeit.

Schlussfolgerung: SBRT ist beim Prostatakarzinom eine gut tolerierte Behandlung hinsichtlich Toxizität und QoL, ohne negativen Einfluss auf das Alltagsleben und dem wichtigen Vorteil einer kurzen Behandlungszeit. Langfristige Follow-up-Untersuchungen müssen noch folgen.

Keywords: Bladder; Hypofractionated stereotactic radiotherapy; Organs of risk; Quality of Life; Rectum.

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Figures

Fig. 1
Fig. 1
Acute and late gastrointestinal (a) and genitourinary (b) toxicities according to Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) score
Fig. 2
Fig. 2
Mean results of quality of life functional scales (a) and assessment of symptoms (b) in three measuring points of observation (in median 9, 21 and 30 months after end of radiotherapy). a Scale I (left site) presents subscales of QoL: physical functioning, emotional functioning, cognitive functioning, role functioning and social functioning; scale II (right site) presents summary results for all functional scales. Lower results indicate better functioning. b Scale I (left site) presents subscales of each symptoms: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties; scale II (right site) presents summary results for all symptoms. Lower results indicate fewer symptoms
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