Details

Autor(en) / Beteiligte

• Clarke, N.W.
• Ali, A.
• Ingleby, F.C.
• Hoyle, A.
• Amos, C.L.
• Attard, G.
• Brawley, C.D.
• Calvert, J.
• Chowdhury, S.
• Cook, A.
• Cross, W.
• Dearnaley, D.P.
• Douis, H.
• Gilbert, D.
• Gillessen, S.
• Jones, R.J.
• Langley, R.E.
• MacNair, A.
• Malik, Z.
• Mason, M.D.
• Matheson, D.
• Millman, R.
• Parker, C.C.
• Ritchie, A.W.S.
• Rush, H.
• Russell, J.M.
• Brown, J.
• Beesley, S.
• Birtle, A.
• Capaldi, L.
• Gale, J.
• Gibbs, S.
• Lydon, A.
• Nikapota, A.
• Omlin, A.
• O'Sullivan, J.M.
• Parikh, O.
• Protheroe, A.
• Rudman, S.
• Srihari, N.N.
• Simms, M.
• Tanguay, J.S.
• Tolan, S.
• Wagstaff, J.
• Wallace, J.
• Wylie, J.
• Zarkar, A.
• Sydes, M.R.
• Parmar, M.K.B.
• James, N.D.

Titel

Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial

Ist Teil von

• Annals of oncology, 2019-12, Vol.30 (12), p.1992-2003

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2019

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• STAMPEDE has previously reported that the use of upfront docetaxel improved overall survival (OS) for metastatic hormone naïve prostate cancer patients starting long-term androgen deprivation therapy. We report on long-term outcomes stratified by metastatic burden for M1 patients. We randomly allocated patients in 2 : 1 ratio to standard-of-care (SOC; control group) or SOC + docetaxel. Metastatic disease burden was categorised using retrospectively-collected baseline staging scans where available. Analysis used Cox regression models, adjusted for stratification factors, with emphasis on restricted mean survival time where hazards were non-proportional. Between 05 October 2005 and 31 March 2013, 1086 M1 patients were randomised to receive SOC (n = 724) or SOC + docetaxel (n = 362). Metastatic burden was assessable for 830/1086 (76%) patients; 362 (44%) had low and 468 (56%) high metastatic burden. Median follow-up was 78.2 months. There were 494 deaths on SOC (41% more than the previous report). There was good evidence of benefit of docetaxel over SOC on OS (HR = 0.81, 95% CI 0.69–0.95, P = 0.009) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P = 0.827). Analysis of other outcomes found evidence of benefit for docetaxel over SOC in failure-free survival (HR = 0.66, 95% CI 0.57–0.76, P < 0.001) and progression-free survival (HR = 0.69, 95% CI 0.59–0.81, P < 0.001) with no evidence of heterogeneity of docetaxel effect between metastatic burden sub-groups (interaction P > 0.5 in each case). There was no evidence that docetaxel resulted in late toxicity compared with SOC: after 1 year, G3-5 toxicity was reported for 28% SOC and 27% docetaxel (in patients still on follow-up at 1 year without prior progression). The clinically significant benefit in survival for upfront docetaxel persists at longer follow-up, with no evidence that benefit differed by metastatic burden. We advocate that upfront docetaxel is considered for metastatic hormone naïve prostate cancer patients regardless of metastatic burden.