Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial

Gravis, Gwénaëlle; Fizazi, Karim; Joly, Florence; Oudard, Stéphane; Priou, Franck; Esterni, Benjamin; Latorzeff, I.; Delva, R.; Krakowski, I.; Laguerre, Brigitte; Rolland, Frédéric; Théodore, Christine; Deplanque, Gaël; Ferrero, Jean Marc; Pouessel, Damien; Mourey, Loïc; Beuzeboc, Philippe; Zanetta, Sylvie; Habibian, Muriel; Berdah, Jean François; Dauba, Jérôme; Baciuchka, Marjorie; Platini, Christian; Linassier, Claude; Labourey, Jean-Luc; Machiels, Jean Pascal; Kouri, Claude El; Ravaud, Alain; Suc, Etienne; Eymard, Jean Christophe; Hasbini, Ali; Bousquet, Guilhem; Soulié, M.

doi:10.1016/s1470-2045(12)70560-0

Cited by 612 publications

(472 citation statements)

References 24 publications

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“…[12][13][14] We have previously reported that treatment with docetaxel at the inception of ADT increased median survival from 71 months to 81 months as well as overall survival (hazard ratio for death, 0.76). 15,16 These results, along with those of a systematic review that included other trials [17][18][19] and of a meta-analysis, 16 led to docetaxel becoming a part of the standard of care for suitable patients with prostate cancer who had not received previous hormone therapy.…”

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confidence: 99%

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

et al. 2017

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BACKGROUND\ud Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design.\ud METHODS\ud We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer).\ud RESULTS\ud A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events).\ud CONCLUSIONS\ud Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476, and Current Controlled Trials number, ISRCTN78818544.

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confidence: 99%

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

et al. 2017

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“…Finally, approximately half the patients had good prognosis at baseline (49% in ADT plus docetaxel arm and 50% in ADT alone arm) as defined by the Glass criteria 33 (appendicular vs axial disease; ECOG performance status of 0 vs 1-3; PSA concentration <65 ng/mL vs 65 ng/mL or more; and Gleason score <8 vs ≥8) or by volume of disease. 31 The E3805 Trial, also known as CHAARTED, was the second phase III trial that reported to compare combined ADT plus docetaxel versus docetaxel alone in patients with metastatic CSPC. 18 It was originally designed to include only patients with high-volume disease (defined as the presence of visceral metastases or ≥4 bone lesions with ≥1 beyond the vertebral body and pelvis), with a planned sample size of 568 patients.…”

Section: Docetaxel In Metastatic Cspcmentioning

confidence: 99%

Chemotherapy for metastatic castration‐sensitive prostate cancer

Parimi

2016

Int J of Urology

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Incorporation of docetaxel into metastatic castration-sensitive prostate cancer treatment has added a new treatment option to a disease state that had previously not seen change for decades. Early attempts of a chemo-hormonal approach for castration-sensitive prostate cancer were not successful. With the demonstration of survival benefits using docetaxel in patients with metastatic castration-resistant prostate cancer, this encouraged continued research with docetaxel given earlier in the disease course. Three randomized phase III trials have defined the benefits of docetaxel in the metastatic castration-sensitive prostate cancer setting; however, there remain questions and controversies on the appropriate and optimal patient selection.

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“…This trial included 272 patients with metastatic disease at diagnosis and 108 who had received prior radical treatment. [46] Most recently, the STAMPEDE trial reported a significant OS benefit for the addition of docetaxel to initial ADT (median survival 77 months versus 67 months for ADT alone; hazard radio 0.76 (95% CI 0.63, 0.91;p=0.003)) in men with metastatic or locally advanced disease. [43] In summary, despite some conflicting results, it seems clear that the addition of docetaxel at the point of initial ADT results in improved OS for men presenting with metastatic disease at diagnosis.…”

Section: Non-castrate Metastatic (M1) Recurrence Following Local Therapymentioning

confidence: 99%

“…[46][47][48] Neither agent has provided survival benefit. The STAMPEDE trial failed to show a survival benefit from adding ZA to ADT alone (HR 0.93, 95% CI 0.79,1.11; p=0.437) or to ADT plus docetaxel in men with locally advanced or metastatic prostate cancer.…”

Section: Bone Therapies For Recurrent Crpc (M1 and M0)mentioning

confidence: 99%

Emerging treatments for recurrent prostate cancer

Hanna

Jones

2015

Future Oncology

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Despite radical treatment, many men with prostate cancer will develop recurrence of their disease. In an exciting era of new therapies for prostate cancer in general, we focus on how these will specifically benefit those men with recurrent disease. We consider salvage treatments aimed at those with local recurrence confined to the prostate gland, therapies for those presenting with metastatic recurrence and the approach to men presenting with a rising prostate-specific antigen but no demonstrable disease (M0). In general, men with recurrent disease are often under-represented in randomized clinical trials. Consequently, evidence to guide treatment for these men is often lacking and this needs to be addressed in order to improve and better define our approach to this problem in the future.

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Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial

Cited by 612 publications

References 24 publications

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

Chemotherapy for metastatic castration‐sensitive prostate cancer

Emerging treatments for recurrent prostate cancer

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