European urology · 2024
Long-term Outcomes and Patterns of Relapse Following High-dose Elective Salvage Radiotherapy and Hormone Therapy in Oligorecurrent Pelvic Nodes in Prostate Cancer: OLIGOPELVIS (GETUG-P07).
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
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Vaugier Loig, Morvan Cyrille, Pasquier David, Buthaud Xavier, Magné Nicolas, Beckendorf Veronique, Sargos Paul, Crehange Gilles, Pommier Pascal, Loos Genevieve, Hasbini Ali, Latorzeff Igor, Silva Marlon, Paul Julie, Blanc-Lapierre Audrey, Supiot Stéphane
Аннотация
BACKGROUND AND OBJECTIVE: Androgen deprivation therapy (ADT) is a mainstay in metastatic prostate cancer, while additional salvage radiotherapy may offer prolonged remission for patients with regional node relapses. We performed an open-label, phase II trial to assess the long-term outcomes and patterns of relapse of 6-months ADT and elective pelvic radiotherapy in men with oligorecurrent (<6) pelvic nodes in prostate cancer (Oligopelvis GETUG-P07).
METHODS: We analyzed the 5-yr outcomes. Progression was defined as two consecutive prostate-specific antigen levels above the level at inclusion and/or clinical progression as per RECIST 1.1 and/or death from any cause.
KEY FINDINGS AND LIMITATIONS: Sixty-seven patients were recruited. The median follow-up was 6.1 yr (95%CI: 5.9-6.3). Grade 2+ 3-yr, 4-yr and 5-yr genito-urinary and gastro-intestinal toxicities affected 15%, 9%, 4% and 2%, 3%, 4% of non-progressive patients, respectively. 5-yr progression-free, biochemical relapse-free and ADT-free survivals were 39%, 31% and 64%, respectively. In total, 45 patients had progression and 38 had the following clinical progression: local (18%), N1 (29%), M1a (50%), M1b (32%) and M1c (11%).
CONCLUSIONS AND CLINICAL IMPLICATIONS: Finally, combined elective pelvic radiotherapy and ADT appeared to prolong tumor control with limited toxicity. At 5 years, one third of patients had not relapsed biochemically. The major site of relapse was para-aortic lymph nodes.
METHODS: We analyzed the 5-yr outcomes. Progression was defined as two consecutive prostate-specific antigen levels above the level at inclusion and/or clinical progression as per RECIST 1.1 and/or death from any cause.
KEY FINDINGS AND LIMITATIONS: Sixty-seven patients were recruited. The median follow-up was 6.1 yr (95%CI: 5.9-6.3). Grade 2+ 3-yr, 4-yr and 5-yr genito-urinary and gastro-intestinal toxicities affected 15%, 9%, 4% and 2%, 3%, 4% of non-progressive patients, respectively. 5-yr progression-free, biochemical relapse-free and ADT-free survivals were 39%, 31% and 64%, respectively. In total, 45 patients had progression and 38 had the following clinical progression: local (18%), N1 (29%), M1a (50%), M1b (32%) and M1c (11%).
CONCLUSIONS AND CLINICAL IMPLICATIONS: Finally, combined elective pelvic radiotherapy and ADT appeared to prolong tumor control with limited toxicity. At 5 years, one third of patients had not relapsed biochemically. The major site of relapse was para-aortic lymph nodes.