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Phase II study of accelerated Linac-based SBRT in five consecutive fractions for localized prostate cancer

Phase-II-Studie zur Linac-basierten akzelerierten SBRT in fünf konsekutiven Fraktionen bei lokal begrenztem Prostatakarzinom

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Abstract

Aim

The goal was to evaluate feasibility, side effects and biochemical no evidence of disease (bNED) after stereotactic body radiation therapy (SBRT) delivered on 5 consecutive days for localized prostate cancer (PC).

Methods

The study was approved by the ethical committee and started in March 2014. Inclusion criteria were age ≤85 years, WHO performance status ≤2, histologically proven adenocarcinoma, low–intermediate risk, no previous surgery (except transurethral resection of the prostate), and a pre-SBRT International Prostatic Symptoms Score of 0–7. The radiotherapy regimen consisted of 35 Gy for low-risk and 37.5 Gy for intermediate-risk PC in 5 consecutive fractions.

Results

At the time of the analysis, 52 patients were recruited to the study (median age 73 years, range 55–83 years; median follow-up 34 months, range 12–49 months; 34 patients low-risk and 18 intermediate risk). The median initial prostate-specific antigen (PSA) was 5.9 ng/ml (range 1.8–15.7). Acute genitourinary (GU) toxicity was G0 (grade 0) 36/52 (69%), G1 11/52 (21%), G2 5/52 (10%), while acute rectal (GI) toxicity was G0 43/52 (83%), G1 8/52 (15%), G2 1/52 (2%). No acute toxicity ≥G3 was recorded. At the time of analysis late GU and GI toxicities were as follows: GU-G0 43/52 (83%), GU-G1 7/52 (13%), GU-G2 2/52 (4%); GI-G0 48/52 (92%), GI-G1 2/52 (4%), GI-G2 2/52 (4%). No late toxicities ≥G3 were recorded. bNED was 98%. One patient with intermediate PC had distant progression.

Conclusions

Accelerated SBRT for low-intermediate PC is feasible and well tolerated with comparable oncological outcome as described for other series with the same RT technique but treatment delivery on every other day. Longer follow-up is needed to the assess late toxicity profile and long-term clinical outcome.

Zusammenfassung

Fragestellung

Ziel war die Evaluation von Durchführbarkeit, Nebenwirkungen und biochemischer Kontrolle (bNED) der extrakraniellen Körperstereotaxie (SBRT) bei lokalisiertem Prostatakarzinom (PC) an 5 aufeinanderfolgenden Tagen.

Methoden

Nach positivem Ethikvotum begann die Patientenrekrutierung im März 2014. Einschlusskriterien waren: Alter ≤85 Jahre, WHO-Performance-Status ≤2, histologisch nachgewiesenes Adenokarzinom, niedrige bis intermediäre Risikokonstellation, keine vorherige Operation (außer transurethrale Prostataresektion) und ein prä-SBRT International Prostatic Symptoms Score von 0–7. Das Fraktionierungsschema war 35 Gy bei niedrigem und 37,5 Gy bei intermediärem Risiko an 5 aufeinanderfolgenden Tagen.

Ergebnisse

Zum Zeitpunkt der Analyse wurden 52 Patienten im Rahmen der Phase-II-Studie behandelt (mittleres Alter 73 Jahre, Spanne 55–83 Jahre; medianes Follow-up 34 Monate, Spanne 12–49 Monate; 34 Patienten mit niedrigem Risiko, 18 Patienten mit intermediärem Risiko). Das mediane initiale prostataspezifische Antigen (PSA) betrug 5,9 ng/ml (Spanne 1,8–15,7 ng/ml). Akute urogenitale Nebenwirkungen (GU) waren: G0 36/52 (69%), G1 11/52 (21%), G2 5/52 (10%). Die akute rektale (GI) Toxizität war: G0 43/52 (83%), G1 8/52 (15%), G2 1/52 (2%). Es gab keine akute Grad-3-Toxizität. Zum Zeitpunkt der Analyse waren die späten GU- und GI-Toxizitäten: GU-G0 43/52 (83%), GU-G1 7/52 (13%), GU-G2 2/52 (4%); GI-G0 48/52 (92%), GI-G1 2/52 (4%), GI-G2 2/52 (4%). Es lagen keine Spätnebenwirkungen ≥G3 vor. bNED war 98%. Ein Patient mit intermediärem Risiko hatte einen distanten Progress.

Schlussfolgerung

Eine akzelerierte SBRT bei PC mit niedrigem bis intermediärem Risiko ist durchführbar und gut verträglich, mit vergleichbaren onkologische Ergebnisse wie in anderen Studien unter Anwendung der gleichen RT-Technik, aber Bestrahlungen an alternierenden Tagen. Eine längere Nachbeobachtung ist notwendig, um Spätnebenwirkungsprofil und klinische Langzeitergebnisse zu beurteilen.

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Authors and Affiliations

  1. Radiation Oncology, Sacro Cuore Don Calabria Hospital, Negrar-Verona, Italy

    Filippo Alongi, Rosario Mazzola MD, Alba Fiorentino, Vanessa Figlia, Fabiana Gregucci & Ruggero Ruggieri

  2. University of Brescia, Brescia, Italy

    Filippo Alongi

  3. Radiation Oncology, University Hospital, LMU Munich, Munich, Germany

    Stefanie Corradini

  4. Radiation Oncology School, University of Palermo, Palermo, Italy

    Dario Aiello

  5. Urology, Sacro Cuore Don Calabria Cancer Care Center, Negrar-Verona, Italy

    Riccardo Ballario & Stefano Cavalleri

Authors
  1. Filippo Alongi
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  2. Rosario Mazzola MD
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Corresponding author

Correspondence to Rosario Mazzola MD.

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Conflict of interest

F. Alongi, R. Mazzola, A. Fiorentino, S. Corradini, D. Aiello, V. Figlia, F. Gregucci, R. Ballario, S. Cavalleri and R. Ruggieri declare that they have no competing interests.

Ethical standards

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.

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Alongi, F., Mazzola, R., Fiorentino, A. et al. Phase II study of accelerated Linac-based SBRT in five consecutive fractions for localized prostate cancer. Strahlenther Onkol 195, 113–120 (2019). https://doi.org/10.1007/s00066-018-1338-7

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