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Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1061-1067. doi: 10.1016/j.ijrobp.2018.12.020. Epub 2018 Dec 14.

Early Toxicity of a Phase 2 Trial of Combined Salvage Radiation Therapy and Hormone Therapy in Oligometastatic Pelvic Node Relapses of Prostate Cancer (OLIGOPELVIS GETUG P07).

Author information

1
Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, St-Herblain, France.
2
Department of Biostatistics, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, Nantes, St-Herblain, France.
3
Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Angers, France.
4
Academic Radiation Oncology Department, Centre Oscar Lambret, Lille, France; Centre de Recherche en Informatique, Signal et Automatique de Lille, CRIStAL UMR CNRS 9189, Université de Lille, Lille, France.
5
Department of Radiation Oncology, Centre Catherine de Sienne, Nantes, France.
6
Department of Radiation Oncology, Institut de Cancérologie de la Loire, St Priest en Jarez, France.
7
Department of Radiation Oncology, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France.
8
Department of Radiation Oncology, Institut Bergonié, Bordeaux, France.
9
Department of Radiation Oncology, Georges-Francois Leclerc Cancer Center, Dijon, France.
10
Department of Radiation Oncology, Centre Léon Bérard, Lyon, France.
11
Department of Radiation Oncology, Centre Jean Perrin, Clermont-Ferrand, France.
12
Department of Radiation Oncology, Clinique Pasteur, Brest, France.
13
Department of Radiation Oncology, Oncorad Clinique Pasteur, Toulouse, France.
14
Department of Radiation Oncology, Centre Francois Baclesse, Caen, France.
15
Department of Radiation Oncology, Centre Jean Bernard, Le Mans, France.
16
Department of Radiation Oncology, Hopital Henri Mondor, Créteil, France.
17
Department of Biostatistics, Institut de Cancérologie de l'Ouest, Boulevard J. Monod, Nantes, St-Herblain, France; Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), UMR 1232 Inserm - 6299 CNRS, Institut de Recherche en Santé de l'Université de Nantes, Nantes, France.
18
Department of Radiation Oncology, Institut de Cancérologie de l'Ouest, Nantes, St-Herblain, France; Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), UMR 1232 Inserm - 6299 CNRS, Institut de Recherche en Santé de l'Université de Nantes, Nantes, France. Electronic address: stephane.supiot@ico-unicancer.fr.

Abstract

PURPOSE:

Limited pelvic nodal relapse of prostatic cancer is a paramount challenge for locoregional salvage treatments. Salvage whole pelvis radiation therapy as considered in the BLINDED trial is an attractive option, but there are concerns about its toxicity. This article describes early toxicity with the technique.

METHODS AND MATERIALS:

BLINDED was a prospective multicenter phase 2 trial investigating high-dose salvage pelvic irradiation with an additional dose to the fluorocholine-based positron emission tomography-positive pelvic lymph nodes, combined with 6-month androgen blockade. The prescribed dose was 54 Gy in 1.8 Gy fractions with up to 66 Gy in 2.2 Gy fractions to the pathologic pelvic lymph nodes. Early toxicity was defined as toxicity until 1 year after radiation therapy. Patients quality of life was assessed using the European Organisation for Research and Treatment of Cancer questionnaires (QLQ-C30 and QLQ-PR25).

RESULTS:

Seventy-four patients were recruited in 15 French radiation oncology departments between August 2014 and July 2016. Seven were excluded before treatment because of violation of the inclusion criteria. The intention-to-treat analysis therefore included 67 patients. Half had received prior prostatic irradiation. Median age was 67.7 ± 6.5 years. Grade 2 acute urinary toxicity was observed in 9 of 67 patients (13.4%), and grade 2 1-year toxicity occurred in 4 of 67 patients (6%). Three patients (4.4%) had grade 3 urinary toxicity. Grade 2 acute digestive toxicity was observed in 10 of 67 patients (14.9%), and grade 2 1-year toxicity occurred in 4 of 67 patients (6%). Patients with prior prostate bed irradiation did not exhibit increased urinary or digestive toxicity. The European Organisation for Research and Treatment of Cancer questionnaire scores at 1 year did not worsen significantly.

CONCLUSIONS:

The acute and 1-year toxicity of the BLINDED protocol was satisfactory, even in patients with a history of prostatic irradiation.

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