SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer

Strahlentherapie und Onkologie, May 2016

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.

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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)


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Monika Rucinska, Anna Kieszkowska-Grudny, Sergiusz Nawrocki. SHARP hypofractionated stereotactic radiotherapy is well tolerated in prostate cancer, Strahlentherapie und Onkologie, 2016, pp. 449-457, Volume 192, Issue 7, DOI: 10.1007/s00066-016-0971-2