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A Randomized Trial Comparing Hypofractionated and Conventionally Fractionated Three-Dimensional External-Beam Radiotherapy for Localized Prostate Adenocarcinoma

A Report on Acute Toxicity

Eine randomisierte Studie zum Vergleich der hypofraktionierten und konventionellen Strahlentherapie beim lokalisierten Adenokarzinom der Prostata. Erster Bericht der Akuttoxizität

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Purpose:

To compare acute gastrointestinal (GI) and genitourinary (GU) toxicity between patient groups with localized prostate adenocarcinoma, treated with conventionally fractionated (CFRT) and hypofractionated (HFRT) three-dimensional conformal external-beam radiotherapy (3D-CRT).

Patients and Methods:

91 patients were enrolled into a randomized study with a minimum follow-up of 3 months. 44 men in the CFRT arm were irradiated with 74 Gy in 37 fractions at 2 Gy per fraction for 7.5 weeks. 47 men in the HFRT arm were treated with 57 Gy in 17 fractions for 3.5 weeks, given as 13 fractions of 3 Gy plus four fractions of 4.5 Gy. The clinical target volume (CTV) included the prostate and the base of seminal vesicles. The CTV-to-PTV (planning target volume) margin was 8–10 mm. Study patients had portal imaging and/or simulation performed on the first fractions and repeated at least weekly.

Results:

No acute grade 3 or 4 toxicities were observed. The grade 2 GU acute toxicity proportion was significantly lower in the HFRT arm: 19.1% versus 47.7% (χ2-test, p = 0.003). The grade 2 GU acute toxicity-free survival was significantly better in the HFRT arm (log-rank test, p = 0.008). The median duration of overall GI acute toxicity was shorter with HFRT: 3 compared to 6 weeks with CFRT (median test, p = 0.017).

Conclusion:

In this first evaluation, the HFRT schedule is feasible and induces acceptable or even lower acute toxicity compared with the toxicities in the CFRT schedule. Extended follow-up is needed to justify this fractionation schedule’s safety in the long term.

Ziel:

Es soll die Frage beantwortet werden, ob bei der Behandlung des lokalisierten Adenokarzinoms der Prostata ein hypofraktioniertes Schema (HFRT) die gleichen Tumorkontroll- und Nebenwirkungsraten zeigt wie ein konventionelles Schema (CFRT). Hier wird uber die ersten Ergebnisse zu den Nebenwirkungen berichtet.

Patienten und Methodik:

91 Patienten wurden im Rahmen einer Studie randomisiert behandelt, die minimale Nachbeobachtungszeit lag bei 3 Monaten. Im CFRT-Arm (44 Patienten) betrug die Dosis 74 Gy (37 × 2 Gy/d), im HFRT-Arm (47 Patienten) 57 Gy (17 × 3 Gy/d, 4 × 4,5 Gy/d). Das klinische Zielvolumen (CTV) umfasste die Prostata und die Basis der Samenblaschen, der Sicherheitsrand um das CTV betrug 8–10 mm. Verifikationsaufnahmen (EPI ["electronic portal imaging"]) wurden zu Beginn der Behandlung und danach wochentlich angefertigt.

Ergebnisse:

Nebenwirkungen der Grade 3 und 4 wurden nicht beobachtet. Die Rate an urologischen Grad-2-Nebenwirkungen war fur die HFRT mit 19,1% im Vergleich zu 47,7% bei der CFRT signifikant geringer (χ2-Test, p = 0,003). Auserdem traten die Grad-2-Nebenwirkungen im HFRT-Arm deutlich spater auf als im CFRT-Arm (Log-Rank-Test, p = 0,008). Gastrointestinale Grad-2-Nebenwirkungen hielten bei der HFRT im Median 3 Wochen, bei der CFRT 6 Wochen an (Mediantest, p = 0,017).

Schlussfolgerung:

In der ersten Auswertung zeigen sich Vorteile fur das HRFT-Schema in Bezug auf die Frequenz und die Dauer der Grad-2-Toxizitaten. Es ist aber eine langere Nachbeobachtungszeit notwendig, um dieses Schema als sicher akzeptieren zu konnen.

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Authors and Affiliations

  1. Department of Radiotherapy, Institute of Oncology, Vilnius University, Vilnius, Lithuania

    Darius Norkus, Albert Miller, Juozas Kurtinaitis & Konstantinas Povilas Valuckas

  2. Department of Radiology, Clemenshospital, Münster, Germany

    Uwe Haverkamp

  3. Department of Radiotherapy, Riga Eastern Hospital, Latvian Oncology Center, Riga, Latvia

    Sergey Popov

  4. Institute of Radiology and Radiotherapy (RNS), St. Josefs Hospital, Wiesbaden, Germany

    Franz-Josef Prott

  5. Department of Radiotherapy, Institute of Oncology, Vilnius University, Santariskiu 1, 08660, Vilnius, Lithuania

    Darius Norkus

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  1. Darius Norkus
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  2. Albert Miller
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  7. Konstantinas Povilas Valuckas
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Correspondence to Darius Norkus.

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Norkus, D., Miller, A., Kurtinaitis, J. et al. A Randomized Trial Comparing Hypofractionated and Conventionally Fractionated Three-Dimensional External-Beam Radiotherapy for Localized Prostate Adenocarcinoma. Strahlenther Onkol 185, 715–721 (2009). https://doi.org/10.1007/s00066-009-1982-z

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  • DOI: https://doi.org/10.1007/s00066-009-1982-z

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