Early toxicity of a phase II trial of combined salvage radiotherapy and hormone therapy in oligometastatic pelvic node relapses of prostate cancer (OLIGOPELVIS GETUG P07).

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

BLINDED was a prospective multi-center phase II trial investigating high-dose salvage pelvic irradiation with an additional dose to the fluorocholine-based positron-emission-tomography (FCH-PET)-positive pelvic lymph nodes (PLN), combined with six-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 pathological PLN. Early toxicity was defined until one year after radiotherapy. Patients quality of life was assessed using the EORTC questionnaires (QLQ-C30 and QLQ-PR25).

Seventy-four patients were recruited in fifteen 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 sixty-seven patients. Half of them had received prior prostatic irradiation. Median age was 67.7 ± 6.5 years. Grade 2 acute urinary toxicity was observed in 9/67 patients (13.4%) and grade 2 one-year toxicity in 4/67 patients (6%). Three patients (4.4%) had grade 3 urinary toxicity. Grade 2 acute digestive toxicity was observed in 10/67 patients (14.9%) and grade 2 one-year toxicity in 4/67 patients (6%). Patients with prior prostate bed irradiation did not exhibit increased urinary or digestive toxicity. EORTC questionnaire scores at one year did not worsen significantly.

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

International journal of radiation oncology, biology, physics. 2018 Dec 14 [Epub ahead of print]

Loig Vaugier, Clément Palpacuer, Emmanuel Rio, Aurore Goineau, David Pasquier, Xavier Buthaud, Guy De Laroche, Véronique Beckendorf, Paul Sargos, Gilles Créhange, Pascal Pommier, Geneviève Loos, Ali Hasbini, Igor Latorzeff, Marlon Silva, Fabrice Denis, Jean-Léon Lagrange, Loic Campion, Stéphane Supiot

Department of Radiation Oncology, Institut de Cancérologie de l`Ouest, Boulevard J. Monod, F-44800 Nantes, St-Herblain France., Department of Biostatistics, Institut de Cancérologie de l`Ouest, Boulevard J. Monod, F-44800 Nantes, St-Herblain France., Department of Radiation Oncology, Institut de Cancérologie de l`Ouest, Angers, France., 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, France., Department of Radiation Oncology, Centre Catherine de Sienne, Nantes, France., Department of Radiation Oncology, Institut de Cancérologie de la Loire, St Priest en Jarez, France., Department of Radiation Oncology, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France., Department of Radiation Oncology, Institut Bergonié, Bordeaux, France., Department of Radiation Oncology, Georges-Francois Leclerc Cancer Center, Dijon, France., Department of Radiation Oncology, Centre Léon Bérard, Lyon, France., Department of Radiation Oncology, Centre Jean Perrin, Clermont-Ferrand, France., Department of Radiation Oncology, Clinique Pasteur, Brest, France., Department of Radiation Oncology, Oncorad Clinique Pasteur, Toulouse, France., Department of Radiation Oncology, Centre Francois Baclesse, Caen, France., Department of Radiation Oncology, Centre Jean Bernard, Le Mans, France., Department of Radiation Oncology, Hopital Henri Mondor, Créteil, France., Department of Biostatistics, Institut de Cancérologie de l`Ouest, Boulevard J. Monod, F-44800 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, 8 quai Moncousu, BP 70721, 44007 Nantes Cedex 1, France., Department of Radiation Oncology, Institut de Cancérologie de l`Ouest, Boulevard J. Monod, F-44800 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, 8 quai Moncousu, BP 70721, 44007 Nantes Cedex 1, France. Electronic address: .