Androgen deprivation therapy (ADT) plus docetaxel (D) versus ADT alone for hormone-naïve metastatic prostate cancer (PCa): Long-term analysis of the GETUG-AFU 15 phase III trial.

Abstract

140 Background: ADT is standard treatment for metastatic PCa. Recently, the E3805 trial reported a survival benefit for (ADT+D) in high volume disease (HVD) patients, whereas the GETUG-15 trial did not demonstrate a survival improvement among a less selected group of patients (pts) with hormone-naïve metastatic PCa. We report an updated analysis of overall survival (OS) of the GETUG 15 trial and aligned the definition of HVD and low volume disease (LVD) subgroups. Methods: Long-termOS was analyzed in the intention-to-treat population (n=385 pts). Additionally, we retrospectively assessed the tumor volume as defined per E3805criteria in all patients enrolled in GETUG 15. Results: See Table. With a median follow-up of 82.9 months (95%CI [80.5-84.3]) (vs 50 months (95%CI [80.5-84.3] in the original analysis), 212 patients (55%) have died. The median OS is 46.5 [39.1-60.6] and 60.9 months [46.1-71.4] in the ADT and in the ADT + D arms, respectively (HR: 0.9 [95%CI: 0.7-1.2]). In HVD patients (n=183, 47.5%), median OS rates were 35.1 months [29.9-44.2] in the ADT alone arm and 39 months [28-52.6] in the ADT+D arm (HR: 0.8 [0.6-1.2]). Conclusions: With longer follow-up, the addition of docetaxel to ADT did not significantly improve OS in patients with hormone-naïve metastatic prostate cancer. In the retrospective analysis using aligned definition of volume of metastasis as E3805, the HVD outcomes were similar to E3805 for ADT alone and there was a non-significant 4 months increase in OS with ADT+D, in this underpowered subset. Clinical trial information: 00104715. [Table: see text]

Addition of Docetaxel to Androgen Deprivation Therapy for Patients with Hormone-sensitive Metastatic Prostate Cancer: A Systematic Review and Meta-analysis

“…For OS, the subgroup analysis of patients according to disease volume (high vs low volume) was available for two trials [23,27]. In both trials, high-volume disease was defined as the presence of at least four bone lesions and at least one lesion in any bone beyond the spine/pelvis or the presence of visceral metastasis.…”

Hormonal therapy and chemotherapy in patients with hormone-sensitive prostate cancer

“…Медиана ОВ составила 46,5 мес в группе АДТ и 60,9 мес в группе АДТ + доцетаксел (ОР 0,9; 95 % ДИ 0,7-1,2). Результаты исследования GETUG 15 были схожими с теми, что и в проведенном позднее иссле-довании CHAARTED, однако исследование GETUG 15 показало незначительное улучшение ОВ в группе АДТ + доцетаксел, которое составило около 4 мес [39].…”

Docetaxel in prostate cancer: a familiar face as the new standard in a hormone-sensitive setting

“…Results from three phase III clinical studies that evaluated the role of docetaxel in mHSPC, have been recently reported: CHAARTED study (E3805) [Sweeney et al 2015], GETUG-AFU 15 [Gravis et al 2013;Gravis et al 2015] and the STAMPEDE study [James et al 2016a;James et al 2016b].…”

“…The potential use of docetaxel in the context of hormone-sensitive disease has also been explored in the GETUG-AFU 15 study [Gravis et al 2013;Gravis et al 2015]. GETUG-AFU 15 was a randomized, open-label, phase III study in patients with newly diagnosed mHSCP.…”