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Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial

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James, Nicholas D, Sydes, Matthew R, Mason, Malcolm D, Clarke, Noel W, Anderson, John, Dearnaley, David P, Dwyer, John, Jovic, Gordana, Ritchie, Alastair WS, Russell, J Martin, Sanders, Karen, Thalmann, George N, Bertelli, Gianfilippo, Birtle, Alison J, O'Sullivan, Joe M, Protheroe, Andrew, Sheehan, Denise, Srihari, Narayanan, Parmar, Mahesh KB·2012·The Lancet Oncology
DOI 10.1016/s1470-2045(12)70088-8PMC PMC3398767
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Abstract

BACKGROUND: Long-term hormone therapy alone is standard care for metastatic or high-risk, non-metastatic prostate cancer. STAMPEDE--an international, open-label, randomised controlled trial--uses a novel multiarm, multistage design to assess whether the early additional use of one or two drugs (docetaxel, zoledronic acid, celecoxib, zoledronic acid and docetaxel, or zoledronic acid and celecoxib) improves survival in men starting first-line, long-term hormone therapy. Here, we report the preplanned, second intermediate analysis comparing hormone therapy plus celecoxib (arm D) with hormone therapy alone (control arm A). METHODS: Eligible patients were men with newly diagnosed or rapidly relapsing prostate cancer who were starting long-term hormone therapy for the first time. Hormone therapy was given as standard care in all trial arms, with local radiotherapy encouraged for newly diagnosed patients without distant metastasis. Randomisation was done using minimisation with a random element across seven stratification factors. Patients randomly allocated to arm D received celecoxib 400 mg twice daily, given orally, until 1 year or disease progression (including prostate-specific antigen [PSA] failure). The intermediate outcome was failure-free survival (FFS) in three activity stages; the primary outcome was overall survival in a subsequent efficacy stage. Research arms were compared pairwise against the control arm on an intention-to-treat basis. Accrual of further patients was discontinued in any research arm showing safety concerns or insufficient evidence of activity (lack of benefit) compared with the control arm. The minimum targeted activity at the second intermediate activity stage was a hazard ratio (HR) of 0·92. This trial is registered with ClinicalTrials.gov, number NCT00268476, and with Current Controlled Trials, number ISRCTN78818544. FINDINGS: 2043 patients were enrolled in the trial from Oct 17, 2005, to Jan 31, 2011, of whom 584 were randomly allocated to receive hormone therapy alone (control group; arm A) and 291 to receive hormone therapy plus celecoxib (arm D). At the preplanned analysis of the second intermediate activity stage, with 305 FFS events (209 in arm A, 96 in arm D), there was no evidence of an advantage for hormone therapy plus celecoxib over hormone therapy alone: HR 0·94 (95% CI 0·74-1·20). [corrected]. 2-year FFS was 51% (95% CI 46-56) in arm A and 51% (95% CI 43-58) in arm D. There was no evidence of differences in the incidence of adverse events between groups (events of grade 3 or higher were noted at any time in 123 [23%, 95% CI 20-27] patients in arm A and 64 [25%, 19-30] in arm D). The most common grade 3-5 events adverse effects in both groups were endocrine disorders (55 [11%] of patients in arm A vs 19 [7%] in arm D) and musculoskeletal disorders (30 [6%] of patients in arm A vs 15 [6%] in arm D). The independent data monitoring committee recommended stopping accrual to both celecoxib-containing arms on grounds of lack of benefit and discontinuing celecoxib for patients currently on treatment, which was endorsed by the trial steering committee. INTERPRETATION: Celecoxib 400 mg twice daily for up to 1 year is insufficiently active in patients starting hormone therapy for high-risk prostate cancer, and we do not recommend its use in this setting. Accrual continues seamlessly to the other research arms and follow-up of all arms will continue to assess effects on overall survival. FUNDING: Cancer Research UK, Pfizer, Novartis, Sanofi-Aventis, Medical Research Council (London, UK).

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Figure 1 Trial profile HT=hormone therapy. FFS=failure-free survival. *Two patients were excluded from the activity analysis in arm A because of errors in event dates that were unresolved at the time of this intermediate analysis. Both patients reported FFS events before randomisation. †Patients are conservatively excluded from the safety analysis if they have not returned follow-up data or reported a serious adverse event; this is expected since accrual was ongoing at the time of analysis and some patients would not have reached their first on-trial assessment point.
Figure 1 Trial profile HT=hormone therapy. FFS=failure-free survival. *Two patients were excluded from the activity analysis in arm A because of errors in event dates that were unresolved at the time of this intermediate analysis. Both patients reported FFS events before randomisation. †Patients are conservatively excluded from the safety analysis if they have not returned follow-up data or reported a serious adverse event; this is expected since accrual was ongoing at the time of analysis and some patients would not have reached their first on-trial assessment point.CC BY · PubMed Central
Figure 2 Time on celecoxib for patients in arm D (hormone therapy plus celecoxib) Only patients who reported starting celecoxib treatment are included. Patients still on celecoxib are censored at the date of last treatment. Patients were provided with sufficient tablets for 12 months of treatment. The drop at 12 months reflects patients completing their trial treatment; events before then represent patients stopping trial treatment sooner, for any reason.
Figure 2 Time on celecoxib for patients in arm D (hormone therapy plus celecoxib) Only patients who reported starting celecoxib treatment are included. Patients still on celecoxib are censored at the date of last treatment. Patients were provided with sufficient tablets for 12 months of treatment. The drop at 12 months reflects patients completing their trial treatment; events before then represent patients stopping trial treatment sooner, for any reason.CC BY · PubMed Central
Figure 3 Kaplan-Meier curve of failure-free survival in arm A (hormone therapy alone) versus arm D (hormone therapy plus celecoxib) HT=hormone therapy. C=celecoxib.
Figure 3 Kaplan-Meier curve of failure-free survival in arm A (hormone therapy alone) versus arm D (hormone therapy plus celecoxib) HT=hormone therapy. C=celecoxib.CC BY · PubMed Central

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Metadata

Authors
James, N. D., Sydes, M. R., Mason, M. D., Clarke, N. W., Anderson, J., Dearnaley, D. P., Dwyer, J., Jovic, G., Ritchie, A. W., Russell, J. M., Sanders, K., Thalmann, G. N., Bertelli, G., Birtle, A. J., O'Sullivan, J. M., Protheroe, A., Sheehan, D., Srihari, N., & Parmar, M. K.
Affiliations
  • University of Birmingham (GB)
  • MRC Clinical Trials Unit at UCL (GB)
  • Cardiff University (GB)
  • University of Manchester (GB)
  • Royal Hallamshire Hospital (GB)
  • Institute of Cancer Research (GB)
  • Cancer Research UK (GB)
  • Beatson West of Scotland Cancer Centre (GB)
  • University Hospital of Bern (CH)
  • Singleton Hospital (GB)
  • Churchill Hospital (GB)
  • Shrewsbury and Telford Hospital NHS Trust (GB)
Corresponding author
Sydes, Matthew R
ORCID
Venue
The Lancet Oncology
Publisher
Elsevier BV
Published
2012-05
Volume
13
Issue
5
Pages
549-558
ISSN
1470-2045 (ISSN-L)
DOI
10.1016/s1470-2045(12)70088-8
PMC
PMC3398767
OpenAlex
W2142016013
Cited by
123
References
39
Citations by year
2025: 2 · 2024: 7 · 2023: 3 · 2022: 4 · 2021: 7 · 2020: 21 · 2019: 8 · 2018: 11 · 2017: 10 · 2016: 16 · 2015: 5 · 2014: 13 · 2013: 12 · 2012: 4
FWCI
8.76
Type
journal article
Language
en
Update notices
erratum (2013-01-01)
Open access
Licence
Locations
  • The Lancet Oncology (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • Bern Open Repository and Information System (University of Bern) (submittedVersion)
  • ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • ORCA Online Research @Cardiff (Cardiff University) (submittedVersion)
  • University of Birmingham Research Portal (University of Birmingham) (submittedVersion)
  • Research Portal (Queen's University Belfast) (submittedVersion)
Funders
Cancer Research UK (CRUK/06/019)
Topics
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Prostate Cancer Treatment and Research
  • Health Sciences › Medicine › Urology › Prostate Cancer Diagnosis and Treatment
  • Health Sciences › Medicine › Oncology › Bone health and treatments
Keywords
hormone therapy, hormone-sensitive prostate cancer, STAMPEDE trial, failure-free survival, overall survival, docetaxel, zoledronic acid, prostate-specific antigen failure, newly diagnosed prostate cancer, local radiotherapy
MeSH terms
Celecoxib, Aged, Androgen Antagonists, Antineoplastic Agents, Humans, Gonadotropin-Releasing Hormone, Male, Middle Aged, Orchiectomy, Prostatic Neoplasms, Pyrazoles, Sulfonamides

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