SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer
Strahlenther Onkol (2016) 192:449–457
DOI 10.1007/s00066-016-0971-2
ORIGINAL ARTICLE
SHARP hypofractionated stereotactic radiotherapy is well tolerated
in prostate cancer
Toxicity and quality of life assessment
Monika Rucinska1,2 · Anna Kieszkowska-Grudny3 · Sergiusz Nawrocki4
Received: 24 November 2015 / Accepted: 23 March 2016 / Published online: 25 May 2016
© The Author(s) 2016. This article is available at SpringerLink with Open Access
Abstract
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 T1cT2cN0M0, 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
Monika Rucinska
1
Department of Oncology, University of Warmia and Mazury
in Olsztyn, Olsztyn, Poland
2
Department of Radiation Oncology, Independent Public
Health Care Facility of the Ministry of the Interior with
Warmia and Mazury Oncology Centre in Olsztyn, Wojska
Polskiego 37, 10-228 Olsztyn, Poland
3
Polish Association of Cognitive and Behavioural Therapy,
Minds of Hope, Warsaw, Poland
4
Department of Oncology and Radiotherapy, Medical
University of Silesia, Katowice, Poland
(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 welltolerated 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.
Keywords Hypofractionated stereotactic radiotherapy ·
Quality of Life · Rectum · Bladder · Organs of risk
Hypofraktionierte stereotaktische Radiotherapie
SHARP ist eine gut tolerierte Behandlung beim
Prostatakarzinom
Beurteilung der Toxizität und Lebensqualität
Zusammenfassung
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.
K
450
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 PSAWert (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 GradII-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 Followup-Untersuchungen müssen noch folgen.
Strahlenther Onkol (2016) 192:449–457
The goal of radiotherapy is to deliver an adequate dose
of radiation to the target, in this case the prostate, with
an appropriate margin and while minimizing the dose to
normal tissues (in the rectum, bladder, bulb of penis, and
femoral heads). Three-dimensional conformal radiation
therapy (3D-CRT) has replaced the old two-dimensional
technique and has been the standard treatment for prostate
cancer patients for years. Dose escalation with intensitymodulated radiation therapy (IMRT) resulted in improved
cancer control in comparison to 3D-CRT, without increased
toxicity [3]. IMRT has now been established as the standard external beam modality in low-risk prostate cancer
[4–6]. Image-guided radiotherapy (IGRT) is used to reduce
the volume of irradiated normal tissue [7, 8]. Recent data
suggest that hypofractionated radiotherapy (2.5–3.1 Gy per
fraction) results in high local control of prostate cancer with
acceptable toxicity [9–11]. Stereotactic body radiation therapy (SBRT) is an extreme form of hypofractionation that
uses several high-dose fractions (6–7 Gy). The first publications on hypofractionation in the treatment of prostate
cancer patients came out in the early 1990s [12, 13]. For
intermediate-risk patients, androgen deprivation therapy is
recommended, and should start 6 months before external
beam radiotherapy [14].
The prognosis for most prostate cancer patients, particularly those in an early stage and independent of treatment
options, is very good. For prostate cancer survi (...truncated)