5 results on '"Robinson, Angus J."'
Search Results
2. 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
- Author
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James, Nicholas D, Sydes, Matthew R, Clarke, Noel W, Mason, Malcolm D, Dearnaley, David P, Spears, Melissa R, Ritchie, Alastair W S, Parker, Christopher C, Russell, J Martin, Attard, Gerhardt, de Bono, Johann, Cross, William, Jones, Rob J, Thalmann, George, Amos, Claire, Matheson, David, Millman, Robin, Alzouebi, Mymoona, Beesley, Sharon, Birtle, Alison J, Brock, Susannah, Cathomas, Richard, Chakraborti, Prabir, Chowdhury, Simon, Cook, Audrey, Elliott, Tony, Gale, Joanna, Gibbs, Stephanie, Graham, John D, Hetherington, John, Hughes, Robert, Laing, Robert, McKinna, Fiona, McLaren, Duncan B, O'Sullivan, Joe M, Parikh, Omi, Peedell, Clive, Protheroe, Andrew, Robinson, Angus J, Srihari, Narayanan, Srinivasan, Rajaguru, Staffurth, John, Sundar, Santhanam, Tolan, Shaun, Tsang, David, Wagstaff, John, and Parmar, Mahesh K B
- Published
- 2016
- Full Text
- View/download PDF
3. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5‐year follow‐up results from the STAMPEDE randomised trial (NCT00268476)
- Author
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James, Nicholas D., Clarke, Noel W., Cook, Adrian, Ali, Adnan, Hoyle, Alex P., Attard, Gert, Brawley, Chris D., Chowdhury, Simon, Cross, William R., Dearnaley, David P., Bono, Johann S., Montana, Carlos Diaz, Gilbert, Duncan, Gillessen, Silke, Gilson, Clare, Jones, Rob J., Langley, Ruth E., Malik, Zafar I., Matheson, David J., Millman, Robin, Parker, Chris C., Pugh, Cheryl, Rush, Hannah, Russell, J. Martin, Berthold, Dominic R., Buckner, Michelle L., Mason, Malcolm D., Ritchie, Alastair W.S., Birtle, Alison J., Brock, Susannah J., Das, Prantik, Ford, Dan, Gale, Joanna, Grant, Warren, Gray, Emma K., Hoskin, Peter, Khan, Mohammad M., Manetta, Caroline, McPhail, Neil J., O'Sullivan, Joe M., Parikh, Omi, Perna, Carla, Pezaro, Carmel J., Protheroe, Andrew S., Robinson, Angus J., Rudman, Sarah M., Sheehan, Denise J., Srihari, Narayanan N., Syndikus, Isabel, Tanguay, Jacob, Thomas, Carys W., Vengalil, Salil, Wagstaff, John, Wylie, James P., Parmar, Mahesh K.B., and Sydes, Matthew R.
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Male ,Cancer Research ,Prednisolone ,Abiraterone Acetate ,Prostatic Neoplasms ,Androgen Antagonists ,B700 ,Hormones ,Prostatic Neoplasms, Castration-Resistant ,Treatment Outcome ,Oncology ,SDG 3 - Good Health and Well-being ,Antineoplastic Combined Chemotherapy Protocols ,Humans ,Prednisone ,Aged ,Follow-Up Studies ,Retrospective Studies - Abstract
Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multi-arm, multi-stage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 yrs after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomized patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards & flexible parametric models, adjusted for baseline stratification factors. 1003 patients were contemporaneously randomized (Nov-2011--Jan-2014): median age 67 yr; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% un-assessable; median PSA 97 ng/mL. At 6.1 yr median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0·60 (95%CI:0·50—0·71; P = 0.31x10−9) favoured SOC + AAP, with 5-yr survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0·55; 95%CI:0·41—0·76) and high-risk (HR = 0·54; 95%CI:0·43—0·69) patients. Median and current maximum time on SOC + AAP was 2.4 yr and 8.1 yr. Toxicity at 4 yr post-randomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group.\ud \ud This article is protected by copyright. All rights reserved.
- Published
- 2022
4. 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
- Author
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Cook, Audrey, Beesley, Sharon, O'Sullivan, Joe M, Birtle, Alison J, Thalmann, George, Graham, John D, Spears, Melissa R, Brock, Susannah, Srinivasan, Rajaguru, Protheroe, Andrew, Sydes, Matthew R, Laing, Robert, Cross, William, Matheson, David, Tsang, David, Parmar, Mahesh K B, Sundar, Santhanam, McKinna, Fiona, Parikh, Omi, Chowdhury, Simon, Robinson, Angus J, De Bono, Johann, Elliott, Tony, Mason, Malcolm D, Parker, Christopher C, Alzouebi, Mymoona, Gibbs, Stephanie, Dearnaley, David P, Millman, Robin, Russell, J Martin, Tolan, Shaun, Chakraborti, Prabir, Cathomas, Richard, Srihari, Narayanan, Clarke, Noel W, Peedell, Clive, James, Nicholas D, Staffurth, John, Gale, Joanna, Hetherington, John, Amos, Claire, Attard, Gerhardt, Hughes, Robert, Jones, Rob J, Ritchie, Alastair W S, McLaren, Duncan B, Wagstaff, John, STAMPEDE investigators, Adab, F., Adeyoju, A., Ahmed, I., Alcock, C., Al-hasso, A., Alonzi, R., Alzouebi, M., Andrade, G., Andrews, S., Ansari, J., Anyamene, N., Azzabi, A., Bahl, A., Ballesteros-Quintail, D., Banerjee, G., Barber, J., Baria, K., Beaney, R., Beesley, S., Beresford, M., Bertelli, G., Bhalla, N., Bhana, R., Birtle, A., Bloomfield, D., Bowen, J., Brady, J., Brierly, R., Brock, S., Brown Richard, B., Brown, S., Button, M., Camilleri, P., Capaldi, L., Castell, F., Chadwick, E., Chakraborti, P., Chan, A., Chan, O., Charnley, N., Chetiyawardana, S., Choudhurey, A., Choudhury, A., Chowdhury, S., Churn, M., Clarke, A., Clarke, N., David, J.C., Cook, A., Cowan, R., Crabb, S., Crawford, M., Crellin, P., Cross, W., Das, T., Davies, J., Dearnaley, D., Dickson, J., Durrani, S., Edwards, A., Eichholz, A., Elliott, T., Eswar, C., Falconer, A., Ferguson, C., Ford, D., Ford, V., Frew, J., Frim, O., Gale, J., Gibbs, S., Glen, H., Graham, J.D., Grant, W., Gray, E., Guerrero-Urbano, T., Gupta, N., Hamid, A., Hamilton, J., Hardman, J., Harland, S., Harper, P., Heath, C., Henry, A., Herbert, C., Hetherington, J., Hill, E., Hilman, S., Hingorani, M., Hofmann, U., Hoskin, P., Huddart, R., Hughes, R., Hughes, S., Ibrahim, A., Jain, S., James, N., Jenkins, P., Jones, R., Kagzi, M., Karp, S., Kehagioglou, P., Kelly, K., Koh, P.K., Keni, M., Khaksar, S., Khan, O., Khoo, V., Kirkbride, P., Kumar, A., Kumar, M., Kumar, S., Laing, R., Lamb, C., Lau, M., Lees, K., Leone, P., Lester, J., Littler, J., Livsey, J., Logue, J., Loughrey, C., Lydon, A., Macgregor, C., Maddineni, S., Mahmood, R., Malik, Z., Mangar, S., Mason, M., Mazhar, D., McGovern, U., McKinna, F., McLaren, D., McMenemin, R., McPhail, N., Melcher, L., Mills, J., Mitchell, D., Mithal, N., Money-Kyrle, J., Montazeri, A., Morris, S., Mort, D., Mukhopadhyay, T., Muthukumar, D., Neave, F., Newby, J., Newman, H., Nicoll, J., Nikapota, A., O'Donnell, H., Ostler, P., O'Sullivan, J., Palaniappan, N., Panades, M., Pantelides, M., Panwar, U., Parikh, O., Parker, C.C., Pattu, P., Paul, A., Payne, H., Pedley, I., Peedell, C., Mau, D.P., Pickering, L., Pigott, K., Plataniotis, G., Popert, R., Porfiri, E., Prashant, R., Prescott, S., Protheroe, A., Pudney, D., Pwint, T., Ramachandra, P., Raman, R., Rimmer, Y., Robinson, A.J., Robson, P., Rogers, P., Russell, M., Sabharwal, A., Sadozye, A., Sangar, V., Sarwar, N., Saunders, D., Sayers, I., Scrase, C., Sentamans, C., Shaffer, R., Shakespeare, D., Sheehan, D., Poh, L.S., Sidek, N., Simms, M., Sivapalasuntharam, A., Sizer, B., Smith-Howell, M., Sparrow, G., Sreenivasan, T., Srihari, N., Srinivasan, R., Staffurth, J., Stewart, D., Stewart, S., Stockdale, A., Subramaniam, R., Sundar, S., Syndikus, I., Tanguay, J., Taylor, H., Thomas, C., Thompson, A., Tipples, K., Tolan, S., Tran, A., Tsang, D., Van der Voet, H., Varela Maria, V., Varughese, M., Venkitaraman, R., Venugopal, B., Wagstaff, J., Walker, G., Wallace, J., Wells, P., Westbury, C., Wheater, M., Whelan, P., Wilkins, M., Wilson, P., Wise, M., Wood, K., Woodward, C., Worlding, J., Wylie, J., Zarkar, A., Berthold, D., Cathomas, R., Durr, D., Engeler, D., Herrera, F., Jichlinski, P., Popescu, R., Prensser, S., Rentsch, C., Roth, B., Seifest, B., Siciliano, D., Strebel, R., and Thalmann, G.
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RC0254 ,Medicine(all) ,SDG 3 - Good Health and Well-being ,610 Medicine & health ,Adult ,Aged ,Aged, 80 and over ,Androgen Antagonists/administration & dosage ,Androgen Antagonists/adverse effects ,Antineoplastic Agents, Hormonal/administration & dosage ,Antineoplastic Agents, Hormonal/adverse effects ,Antineoplastic Combined Chemotherapy Protocols/adverse effects ,Antineoplastic Combined Chemotherapy Protocols/therapeutic use ,Diphosphonates/administration & dosage ,Diphosphonates/adverse effects ,Disease Progression ,Docetaxel ,Drug Administration Schedule ,Humans ,Imidazoles/administration & dosage ,Imidazoles/adverse effects ,Kaplan-Meier Estimate ,Male ,Middle Aged ,Neoplasm Metastasis ,Prostatic Neoplasms/drug therapy ,Taxoids/administration & dosage ,Taxoids/adverse effects ,Treatment Outcome ,Zoledronic Acid - Abstract
BACKGROUND: Long-term hormone therapy has been the standard of care for advanced prostate cancer since the 1940s. STAMPEDE is a randomised controlled trial using a multiarm, multistage platform design. It recruits men with high-risk, locally advanced, metastatic or recurrent prostate cancer who are starting first-line long-term hormone therapy. We report primary survival results for three research comparisons testing the addition of zoledronic acid, docetaxel, or their combination to standard of care versus standard of care alone.METHODS: Standard of care was hormone therapy for at least 2 years; radiotherapy was encouraged for men with N0M0 disease to November, 2011, then mandated; radiotherapy was optional for men with node-positive non-metastatic (N+M0) disease. Stratified randomisation (via minimisation) allocated men 2:1:1:1 to standard of care only (SOC-only; control), standard of care plus zoledronic acid (SOC + ZA), standard of care plus docetaxel (SOC + Doc), or standard of care with both zoledronic acid and docetaxel (SOC + ZA + Doc). Zoledronic acid (4 mg) was given for six 3-weekly cycles, then 4-weekly until 2 years, and docetaxel (75 mg/m(2)) for six 3-weekly cycles with prednisolone 10 mg daily. There was no blinding to treatment allocation. The primary outcome measure was overall survival. Pairwise comparisons of research versus control had 90% power at 2·5% one-sided α for hazard ratio (HR) 0·75, requiring roughly 400 control arm deaths. Statistical analyses were undertaken with standard log-rank-type methods for time-to-event data, with hazard ratios (HRs) and 95% CIs derived from adjusted Cox models. This trial is registered at ClinicalTrials.gov (NCT00268476) and ControlledTrials.com (ISRCTN78818544).FINDINGS: 2962 men were randomly assigned to four groups between Oct 5, 2005, and March 31, 2013. Median age was 65 years (IQR 60-71). 1817 (61%) men had M+ disease, 448 (15%) had N+/X M0, and 697 (24%) had N0M0. 165 (6%) men were previously treated with local therapy, and median prostate-specific antigen was 65 ng/mL (IQR 23-184). Median follow-up was 43 months (IQR 30-60). There were 415 deaths in the control group (347 [84%] prostate cancer). Median overall survival was 71 months (IQR 32 to not reached) for SOC-only, not reached (32 to not reached) for SOC + ZA (HR 0·94, 95% CI 0·79-1·11; p=0·450), 81 months (41 to not reached) for SOC + Doc (0·78, 0·66-0·93; p=0·006), and 76 months (39 to not reached) for SOC + ZA + Doc (0·82, 0·69-0·97; p=0·022). There was no evidence of heterogeneity in treatment effect (for any of the treatments) across prespecified subsets. Grade 3-5 adverse events were reported for 399 (32%) patients receiving SOC, 197 (32%) receiving SOC + ZA, 288 (52%) receiving SOC + Doc, and 269 (52%) receiving SOC + ZA + Doc.INTERPRETATION: Zoledronic acid showed no evidence of survival improvement and should not be part of standard of care for this population. Docetaxel chemotherapy, given at the time of long-term hormone therapy initiation, showed evidence of improved survival accompanied by an increase in adverse events. Docetaxel treatment should become part of standard of care for adequately fit men commencing long-term hormone therapy.FUNDING: Cancer Research UK, Medical Research Council, Novartis, Sanofi-Aventis, Pfizer, Janssen, Astellas, NIHR Clinical Research Network, Swiss Group for Clinical Cancer Research.
- Published
- 2016
- Full Text
- View/download PDF
5. Abiraterone acetate plus prednisolone for metastatic patients starting hormone therapy: 5-year follow-up results from the STAMPEDE randomised trial (NCT00268476).
- Author
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James ND, Clarke NW, Cook A, Ali A, Hoyle AP, Attard G, Brawley CD, Chowdhury S, Cross WR, Dearnaley DP, de Bono JS, Diaz-Montana C, Gilbert D, Gillessen S, Gilson C, Jones RJ, Langley RE, Malik ZI, Matheson DJ, Millman R, Parker CC, Pugh C, Rush H, Russell JM, Berthold DR, Buckner ML, Mason MD, Ritchie AWS, Birtle AJ, Brock SJ, Das P, Ford D, Gale J, Grant W, Gray EK, Hoskin P, Khan MM, Manetta C, McPhail NJ, O'Sullivan JM, Parikh O, Perna C, Pezaro CJ, Protheroe AS, Robinson AJ, Rudman SM, Sheehan DJ, Srihari NN, Syndikus I, Tanguay JS, Thomas CW, Vengalil S, Wagstaff J, Wylie JP, Parmar MKB, and Sydes MR
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- Abiraterone Acetate therapeutic use, Aged, Androgen Antagonists therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Follow-Up Studies, Hormones, Humans, Male, Prednisolone therapeutic use, Prednisone therapeutic use, Retrospective Studies, Treatment Outcome, Prostatic Neoplasms pathology, Prostatic Neoplasms, Castration-Resistant drug therapy
- Abstract
Abiraterone acetate plus prednisolone (AAP) previously demonstrated improved survival in STAMPEDE, a multiarm, multistage platform trial in men starting long-term hormone therapy for prostate cancer. This long-term analysis in metastatic patients was planned for 3 years after the first results. Standard-of-care (SOC) was androgen deprivation therapy. The comparison randomised patients 1:1 to SOC-alone with or without daily abiraterone acetate 1000 mg + prednisolone 5 mg (SOC + AAP), continued until disease progression. The primary outcome measure was overall survival. Metastatic disease risk group was classified retrospectively using baseline CT and bone scans by central radiological review and pathology reports. Analyses used Cox proportional hazards and flexible parametric models, accounting for baseline stratification factors. One thousand and three patients were contemporaneously randomised (November 2011 to January 2014): median age 67 years; 94% newly-diagnosed; metastatic disease risk group: 48% high, 44% low, 8% unassessable; median PSA 97 ng/mL. At 6.1 years median follow-up, 329 SOC-alone deaths (118 low-risk, 178 high-risk) and 244 SOC + AAP deaths (75 low-risk, 145 high-risk) were reported. Adjusted HR = 0.60 (95% CI: 0.50-0.71; P = 0.31 × 10
-9 ) favoured SOC + AAP, with 5-years survival improved from 41% SOC-alone to 60% SOC + AAP. This was similar in low-risk (HR = 0.55; 95% CI: 0.41-0.76) and high-risk (HR = 0.54; 95% CI: 0.43-0.69) patients. Median and current maximum time on SOC + AAP was 2.4 and 8.1 years. Toxicity at 4 years postrandomisation was similar, with 16% patients in each group reporting grade 3 or higher toxicity. A sustained and substantial improvement in overall survival of all metastatic prostate cancer patients was achieved with SOC + abiraterone acetate + prednisolone, irrespective of metastatic disease risk group., (© 2022 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)- Published
- 2022
- Full Text
- View/download PDF
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