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

Clarke, N W and Ali, A and Ingleby, F C and Hoyle, A and Amos, C L and Attard, G and Brawley, C D and Calvert, J and Chowdhury, S and Cook, A and Cross, W and Dearnaley, D P and Douis, H and Gilbert, D and Gillessen, S and Jones, R J and Langley, R E and MacNair, A and Malik, Z and Mason, M D and Matheson, D and Millman, R and Parker, C C and Ritchie, A W S and Rush, H and Russell, J M and Brown, J and Beesley, S and Birtle, A and Capaldi, L and Gale, J and Gibbs, S and Lydon, A and Nikapota, A and Omlin, A and O'Sullivan, J M and Parikh, O and Protheroe, A and Rudman, S and Srihari, N N and Simms, M and Tanguay, J S and Tolan, S and Wagstaff, J and Wallace, J and Wylie, J and Zarkar, A and Sydes, M R and Parmar, M K B and James, N D (2019) Addition of docetaxel to hormonal therapy in low- and high-burden metastatic hormone sensitive prostate cancer: long-term survival results from the STAMPEDE trial. Annals of oncology : official journal of the European Society for Medical Oncology. ISSN 1569-8041.

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Official URL: https://academic.oup.com/annonc/article/doi/10.109...

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

Item Type: Article
Subjects: QY Clinical pathology
QZ Pathology. Oncology
Divisions: Clinical Support > Radiology
Planned IP Care > Oncology and Clinical Haematology
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Depositing User: Mr Philip O'Reilly
Date Deposited: 07 Oct 2019 13:49
Last Modified: 07 Oct 2019 13:49
URI: http://www.repository.uhblibrary.co.uk/id/eprint/2455

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