Key findings - Hormonal treatment combined with chemotherapy
Additional information
16.4.2025
| ADT = androgen deprivation therapy; ECOG = Eastern Cooperative Oncology Group; FU = follow-up; HR = hazard ratio; ISUP = International Society for Urological Pathology; mo = month; n = number of patients; OS = overall survival; P = prednisone; PSA-DT = prostate-specific antigen-doubling time. | ||||||
| STAMPEDE «James ND, Sydes MR, Clarke NW ym. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, mu»1, «Clarke NW, Ali A, Ingleby FC ym. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Ann»2 | GETUG «Gravis G, Fizazi K, Joly F ym. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol 201»3 | CHAARTED «Sweeney CJ, Chen YH, Carducci M ym. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med 2015;373:737-46 »4, «Kyriakopoulos CE, Chen YH, Carducci MA ym. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin O»5 | ||||
|---|---|---|---|---|---|---|
| ADT | ADT + Docetaxel + P | ADT | ADT + Docetaxel | ADT | ADT + Docetaxel | |
| N | 1,184 | 592 | 193 | 192 | 393 | 397 |
| Newly diagnosed M+ | 58% | 59% | 75% | 67% | 73% | 73% |
| Key inclusion Criteria | Patients scheduled for long-term ADT newly diagnosed M1 or N+ situations locally advanced (at least two of cT3 cT4, ISUP grade ≥ 4, PSA ≥ 40 ng/mL) relapsing locally treated disease with a PSA > 4 ng/mL and a PSA-DT < 6 mo. or PSA > 20 ng/mL, or nodal or metastatic relapse | Metastatic disease Karnofsky score ≥ 70% | Metastatic disease ECOG PS 0, 1 or 2 | |||
| Primary objective | OS | OS | OS | |||
| Median follow up (mo) | 43; 78.2 (update M1) | 50 | 54 (update) | |||
| HR (95% CI) | 0.78 (0.66–0.93) | 1.01 (0.75–1.36) | 0.72 (0.59–0.89) | |||
| M1 only | ||||||
| N | 1,086 | - | - | |||
| HR (95% CI) | 0.81 (0.69–0.95) | - | - | |||
References
- James ND, Sydes MR, Clarke NW ym. Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial. Lancet 2016;387:1163-77 «PMID: 26719232»PubMed
- Clarke NW, Ali A, Ingleby FC ym. Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Ann Oncol 2019;30:1992-2003 «PMID: 31560068»PubMed
- Gravis G, Fizazi K, Joly F ym. Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Lancet Oncol 2013;14:149-58 «PMID: 23306100»PubMed
- Sweeney CJ, Chen YH, Carducci M ym. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer. N Engl J Med 2015;373:737-46 «PMID: 26244877»PubMed
- Kyriakopoulos CE, Chen YH, Carducci MA ym. Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer: Long-Term Survival Analysis of the Randomized Phase III E3805 CHAARTED Trial. J Clin Oncol 2018;36:1080-1087 «PMID: 29384722»PubMed