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Abstract

PURPOSE:

Patients with biochemical failure (BF) after radical prostatectomy may benefit from dose-intensified salvage radiation therapy (SRT) of the prostate bed. We performed a randomized phase III trial assessing dose intensification.

PATIENTS AND METHODS:

Patients with BF but without evidence of macroscopic disease were randomly assigned to either 64 or 70 Gy. Three-dimensional conformal radiation therapy or intensity-modulated radiation therapy/rotational techniques were used. The primary end point was freedom from BF. Secondary end points were acute toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0) and quality of life (QoL) according to the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires C30 and PR25.

RESULTS:

Three hundred fifty patients were enrolled between February 2011 and April 2014. Three patients withdrew informed consent, and three patients were not eligible, resulting in 344 patients age 48 to 75 years in the safety population. Thirty patients (8.7%) had grade 2 and two patients (0.6%) had grade 3 genitourinary (GU) baseline symptoms. Acute grade 2 and 3 GU toxicity was observed in 22 patients (13.0%) and one patient (0.6%), respectively, with 64 Gy and in 29 patients (16.6%) and three patients (1.7%), respectively, with 70 Gy (P = .2). Baseline grade 2 GI toxicity was observed in one patient (0.6%). Acute grade 2 and 3 GI toxicity was observed in 27 patients (16.0%) and one patient (0.6%), respectively, with 64 Gy, and in 27 patients (15.4%) and four patients (2.3%), respectively, with 70 Gy (P = .8). Changes in early QoL were minor. Patients receiving 70 Gy reported a more pronounced and clinically relevant worsening in urinary symptoms (mean difference in change score between arms, 3.6; P = .02).

CONCLUSION:

Dose-intensified SRT was associated with low rates of acute grade 2 and 3 GU and GI toxicity. The impact of dose-intensified SRT on QoL was minor, except for a significantly greater worsening in urinary symptoms. 

Author information

Ghadjar P1, Hayoz S2, Bernhard J2, Zwahlen DR2, Hölscher T2, Gut P2, Guckenberger M2, Hildebrandt G2, Müller AC2, Plasswilm L2, Papachristofilou A2, Stalder L2, Biaggi-Rudolf C2, Sumila M2, Kranzbühler H2, Najafi Y2, Ost P2, Azinwi NC2, Reuter C2, Bodis S2, Kaouthar K2, Wust P2, Thalmann GN2, Aebersold DM2.​

1 Pirus Ghadjar, Jürg Bernhard, George N. Thalmann, and Daniel M. Aebersold, Inselspital, Bern University Hospital, and University of Bern; Stefanie Hayoz, Lukas Stalder, and Christine Biaggi-Rudolf, Swiss Group for Clinical Cancer Research Coordinating Center; Jürg Bernhard, International Breast Cancer Study Group Coordinating Center, Bern; Daniel R. Zwahlen, Kantonsspital Graubünden, Chur; Philipp Gut, Kantonsspital Luzern, Luzern; Ludwig Plasswilm, Kantonsspital St Gallen, St Gallen; Alexandros Papachristofilou, University Hospital Basel, Basel; Marcin Sumila, Hirslanden Hospital Group, Zürich; Helmut Kranzbühler, Stadtspital Triemli, Zürich; Yousef Najafi, University Hospital Zürich, Zürich; Ngwa C. Azinwi, Istituto Oncologico della Svizzera Italiana, Bellinzona; Christiane Reuter, Kantonsspital Münsterlingen, Münsterlingen; Stephan Bodis, Kantonsspital Aarau, Aarau; Khanfir Kaouthar, Hôpital Valais, Sion, Switzerland; Pirus Ghadjar and Peter Wust, Charité Universitätsmedizin, Berlin; Tobias Hölscher, University Hospital Dresden, Dresden; Matthias Gluckenberger, University Hospital Würzburg, Würzburg; Guido Hildebrandt, University Hospital Rostock, Rostock; Arndt-Christian Müller, University Hospital Tübingen, Tübingen, Germany; and Piet Ost, Ghent University Hospital, Ghent, Belgium. pirus.ghadjar@charite.de.

2 Pirus Ghadjar, Jürg Bernhard, George N. Thalmann, and Daniel M. Aebersold, Inselspital, Bern University Hospital, and University of Bern; Stefanie Hayoz, Lukas Stalder, and Christine Biaggi-Rudolf, Swiss Group for Clinical Cancer Research Coordinating Center; Jürg Bernhard, International Breast Cancer Study Group Coordinating Center, Bern; Daniel R. Zwahlen, Kantonsspital Graubünden, Chur; Philipp Gut, Kantonsspital Luzern, Luzern; Ludwig Plasswilm, Kantonsspital St Gallen, St Gallen; Alexandros Papachristofilou, University Hospital Basel, Basel; Marcin Sumila, Hirslanden Hospital Group, Zürich; Helmut Kranzbühler, Stadtspital Triemli, Zürich; Yousef Najafi, University Hospital Zürich, Zürich; Ngwa C. Azinwi, Istituto Oncologico della Svizzera Italiana, Bellinzona; Christiane Reuter, Kantonsspital Münsterlingen, Münsterlingen; Stephan Bodis, Kantonsspital Aarau, Aarau; Khanfir Kaouthar, Hôpital Valais, Sion, Switzerland; Pirus Ghadjar and Peter Wust, Charité Universitätsmedizin, Berlin; Tobias Hölscher, University Hospital Dresden, Dresden; Matthias Gluckenberger, University Hospital Würzburg, Würzburg; Guido Hildebrandt, University Hospital Rostock, Rostock; Arndt-Christian Müller, University Hospital Tübingen, Tübingen, Germany; and Piet Ost, Ghent University Hospital, Ghent, Belgium.