European journal of cancer (Oxford, England : 1990) · 2026
Survival modelling of relapse-free survival and competing-risk analysis in patients with high-risk localized prostate cancer treated in GETUG-12.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Vicier Cécile, Erdogan Farah, Allouache Nedjla, Delva Remy, Gravis Gwenaëlle, Rolland Frédéric, Priou Frank, Ferrero Jean-Marc, Houede Nadine, Mourey Loïc, Theodore Christine, Krakowski Ivan, Berdah Jean-François, Baciuchka Marjorie, Laguerre Brigitte, Fléchon FlechonAude, Gross-Goupil Marine, Cojean-Zelek Isabelle, Oudard Stéphane, Labourey Jean-Luc, Chinet-Charrot Paule, Legouffe Eric, Lagrange Jean-Léon, Linassier Claude, Deplanque Gaël, Beuzeboc Philippe, Davin Jean-Louis, Brihoum Meryem, Culine Stéphane, Fizazi Karim, Le Teuff Gwénaël
Аннотация
BACKGROUND: Androgen-deprivation therapy (ADT) plus radiotherapy is a standard of care for men with high-risk localized prostate cancer (PC). Adding docetaxel in this setting demonstrated better relapse-free survival (RFS) but not survival. Few data are available on relapse patterns. Our aim was to investigate whether different patterns of relapses exist in men with high-risk localized PC.
PATIENTS AND METHODS: Prospective data from the GETUG12 phase 3 randomized controlled trial comparing ADT alone vs ADT + docetaxel and estramustine (DE) was examined. RFS (main endpoint) was analysed using parametric survival models and second event-free survival (SEFS) defined from biochemical progression (BP) was analysed using a competing-risk approach.
RESULTS: Overall, 413 patients were randomized from 2002 to 2006, 206 treated with ADT and 207 with ADT+DE, in addition to local treatment. First analysis showed that the piecewise-exponential model with two time-intervals ([0-3[; ≥3 years) was the model that best characterized RFS with no time-dependent effect of risk factors and treatment. Second analyses limited to patients with a BP showed that the risk of a second event was significantly lower in patients with a longer time-interval from randomization to BP (hazard ratio (HR≥ 3 versus < 3 years): 0.49 [95% CI 0.30-0.79]). In competing-risk analysis, a significant and protective effect of this time-interval was observed for metastases (sub-HR≥ 3 versus < 3 years: 0.41 [0.23-0.73] accounting for salvage treatment.
CONCLUSION: Time-interval from randomization to BP is a major prognostic factor for developing local or distant recurrences for patients with high-risk localized PC.
PATIENTS AND METHODS: Prospective data from the GETUG12 phase 3 randomized controlled trial comparing ADT alone vs ADT + docetaxel and estramustine (DE) was examined. RFS (main endpoint) was analysed using parametric survival models and second event-free survival (SEFS) defined from biochemical progression (BP) was analysed using a competing-risk approach.
RESULTS: Overall, 413 patients were randomized from 2002 to 2006, 206 treated with ADT and 207 with ADT+DE, in addition to local treatment. First analysis showed that the piecewise-exponential model with two time-intervals ([0-3[; ≥3 years) was the model that best characterized RFS with no time-dependent effect of risk factors and treatment. Second analyses limited to patients with a BP showed that the risk of a second event was significantly lower in patients with a longer time-interval from randomization to BP (hazard ratio (HR≥ 3 versus < 3 years): 0.49 [95% CI 0.30-0.79]). In competing-risk analysis, a significant and protective effect of this time-interval was observed for metastases (sub-HR≥ 3 versus < 3 years: 0.41 [0.23-0.73] accounting for salvage treatment.
CONCLUSION: Time-interval from randomization to BP is a major prognostic factor for developing local or distant recurrences for patients with high-risk localized PC.