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1. Risk of Bowel Obstruction in Patients Undergoing Neoadjuvant Chemotherapy for High-risk Colon Cancer: A Nested Case-control Matched Analysis of an International, Multi-centre, Randomised Controlled Trial (FOxTROT)

Author

Glasbey, James, Glasbey, James, Beggs, Andrew, Glimelius, Bengt, Gray, Richard, Handley, Kelly, Laurberg, Søren, Magill, Laura, Murakami, Keigo, Palmer, Andy, Quirke, Philip, Seligman, Jenny, Seymour, Matt, Sinha, Yash, West, Nick, Morton, Dion, Glasbey, James, Handley, Kelly, Palmer, Andy, Morton, Dion, Crosby, T., Olliff, J., Peto (Chair), R., Brown, Gina, Ferry, David, Glimelius, Bengt, Gray, Richard, Handley, Kelly, Ismail, Tariq, Laurberg, Søren, Magill, Laura, Morton, Dion, Oliver, Alf, Quirke, Phil, Seymour, Matt, Scott, Nigel, Seligman, Jenny, Swift, Ian, Warren, Bryan, West, Nick, Northover, J., Parmar (Chair), M., Slevin, M., Magill, Laura, Gray, Richard, Handley, Kelly, Wilcockson, Adrian, Gray, Zoe, Lancaster, Dominic, Brown, James, Palmer, Andrew, Adie, Ladan, Kennedy, Georgia, Eld, M., Holt, G., Yilmaz, M., Spendler, K. Garm, Hansen, F., Laurberg, S., Rosenkilde, M., Ahlstrom, H., Glimelius, B., Abgamu, D., Day, N., Walsh, C., Bannister, J., Furniss, D., Morgan, S., Walkington, L., Yates, S., Branagan, G., Mustajab, A., O’Neil, H., Rees, C., Geh, I., Hendrickse, C., Langman, G., Pallan, A., Conn, A., Lowe, A., Ostrowski, J., Steward, M., Callaway, M., Falk, S., Thomas, M., Wong, N., Cast, J., Hartley, J., Roy, R., Tiam, R., Blunt, D., Cleator, S., Dawson, P., Goldin, R., Gujral, D., Lowdell, C., Ziprin, P., Clenton, S., Dewdney, A., Euinton, H., Furniss, D., Gupta, R., Tarapowewalla, D., Wilshaw, V., Braun, M., Chakrabarty, B., Hill, J., Laasch, H., Saunders, M., Cruickshank, N., Davies, M., Muzaffar, S., Orme, A., Punia, P., Rea, D., Campbell, F., Hughes, M., Palmer, D., Rooney, P., Abbott, G., Hamid, B., Vimalachandran, D., Berry, J., Hinson, F., Maarouf, Z., Nicoll, J., Adams, C., Denson, J., Jackson, S., Sherriff, D., Kweka, E., McAdam, G., Peters, M., Roy, R., Khaira, M., Kurien, G., Robinson, J., Wadsley, J., White, D., Young, R., Dega, R., Lamparelli, M., Orbell, J., Osborne, R., Taylor, P., Thomas, T., Gopalakrishnan, K., Jadhav, V., Scott-Brown, M., Baijal, S., Chapman, M., Glaholm, J., Nelson, C., Singh, R., Harrison, J., Last, K., Scott, D., Scullion, D., Lind, P., Milosavljevic, Z., Dent, J., Ilsley, D., Littleford, S., Roberts, C., Crabtree, M., Orrell, J., Sherwin, E., Smith, S., Soomal, R., Braun, M., De, A., Khan, A., Khan, U., Lavin, V., McBain, C., Radharkrishna, G., Sil, R., Weerasinghe, S., Hill, J., Lee, S., Wright, P., Church, R., Holland, C., Kunene, V., Thompson, A., Glynne-Jones, R., Goh, V., Livingstone, J., Richman, P., Barlow, C., Burn, P., Geraghty, J., Walther, J., Grumett, S., Mangalika, S., Qaiyum, M., Williams, G., Borgstein, R., Bridgewater, J., Melville, D., Rees, J., Coxon, F., Hainsworth, P., Needham, S., Scott, J., Asmussen, J., Hansen, T., Jensen, K., Pfeiffer, P., Alkhaldi, A., Brittenden, J., Jackson, A., Kamposioras, K., Kumaran, G., Macklin, C., Alexander, J., Harle, A., Hickish, T., Talbot, R., Tarver, D., Bridgewater, J., Partridge, W., Sundaresan, V., Vivekanandan, S., Agrawal, N., Higginson, A., Muthuramalingam, S., O’Leary, D., Devarajan, G., Gulati, M., Kerwat, R., Maisey, N., Mikhaeel, G., Ismail, T., Middleton, G., Page, A., Steven, N., Taniere, P., Gutmann, J., Huang, J., Raouf, S., Dunn, W., Escola, C. Lopez, Potter, V., Scholefield, J., Walker, G., Zaitoun, A., Eason, D., McPhail, N., Mmeka, W., Stenhouse, G., Watson, A., Fozard, B., Hickish, T., Snape, S., Ellis, R., Faux, W., Jenkins, R., Maskell, G., Kulkarni, R., Lund, J., Menon, S., Singh, R., Chandler, I., Daniels, I., Harries, S., Osborne, M., Bell, J., Krell, D., Mayer, A., Ogunbiyi, O., Watkins, J., Bronder, C., Eaton, D., Taylor, A., Brown, G., Cunningham, D., Tekkis, P., Wotherspoon, A., Dobson, M., Mitchell, P., Pitt, M., Scott, N., Susnerwala, S., Adab, F., Britton, I., Ghiridaran, S., Howitt, C., Kirby, R., Biddlestone, L., Dalton, S., De Winton, E., Phillips, A., Ferry, D., Grumett, S., Kawesha, A., Maleki, K., Momtahan, N., Burnett, H., Hayes, S., Soop, M., Branagan, G., Cook, I., Cook, S., Iveson, T., Shablak, A., Coup, A., Hamid, A., Moore, P., O’Toole, L., Pai, D., Bateman, A., Bateman, A., Blaquiere, R., Nichols, P., Chappell, M., Dworkin, M., Jain, S., Tsang, D., Hopkins, K., Loveday, E., Lyons, A., Rooney, N., Ali, N., Chatterjee, M., Chiphang, A., Dundas, S., Myint, A. Sun, Zeiderman, M., Beharry, N., Chong, H., Lofts, F., Melville, D., Finan, P., Seymour, M., Tolan, D., West, N., Anyamene, N., Burling, D., Kennedy, R., Moorghen, M., Agrawal, S., Hasan, J., Mehta, S., Saeed, M., Burgess, P., John, L., Lowndes, S., Planner, A., Campbell, F., Hughes, M., Rooney, P., Smith, D., Hochhauser, D., Obichere, A., Rodriguez-Justo, M., Shiu, K., Taylor, S., Correa, P., James, S., Shatwell, W., Williams, N., Brady, J., Lanaspre, E., Mikhaeel, G., Ahmad, M., Gill, T., Wilson, D., Adams, R., Beehen, R., Morgan, M., Lindh, B., Adams, R., Morgan, M., Ford, A., Gopal, K., Pranesh, N., Shareef, D., Tighe, M., Busby, K., Correa, P., Sanders, S., Sinha, R., Ahmad, R., Desai, S., Ramesh, S., Hilman, S., Lott, M., O’Brien, J., Radstone, D., West, D., Amin, S., Hampton, J., Hornbuckle, J., Kitsanta, P., Ali, M., Desai, A., Hadaki, M., Hall, M., Arul, D., Hochhauser, D., Leonard, P., Mukhtar, H., Murray, D., Baxter, A., Churn, M., Farrugia, D., Lake, S., Smith, G., Bansal, A., Chandran, P., Corr, C., Gollins, S., Davenport, A., Saunders, M., Sukumar, S., Bathurst, N., Beaumont, E., Cooper, E., Francis, N., Sephton, M., Sparrow, G., Clarke, A., Haselden, J., Last, K., Woodcock, N., Atkinson, M., Gollins, S., Gupta, M., Maw, A., Abdullah, N., Bale, C., and Lord, M.

Published
2023
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2. Risk of Bowel Obstruction in Patients Undergoing Neoadjuvant Chemotherapy for High-risk Colon Cancer

Author

Glasbey, James, Beggs, Andrew, Glimelius, Bengt, Gray, Richard, Handley, Kelly, Laurberg, Søren, Magill, Laura, Murakami, Keigo, Palmer, Andy, Quirke, Philip, Seligman, Jenny, Seymour, Matt, Sinha, Yash, West, Nick, Morton, Dion, Glasbey, James, Handley, Kelly, Palmer, Andy, Morton, Dion, Crosby, T., Olliff, J., Peto (Chair), R., Brown, Gina, Ferry, David, Glimelius, Bengt, Gray, Richard, Handley, Kelly, Ismail, Tariq, Laurberg, Søren, Magill, Laura, Morton, Dion, Oliver, Alf, Quirke, Phil, Seymour, Matt, Scott, Nigel, Seligman, Jenny, Swift, Ian, Warren, Bryan, West, Nick, Northover, J., Parmar (Chair), M., Slevin, M., Magill, Laura, Gray, Richard, Handley, Kelly, Wilcockson, Adrian, Gray, Zoe, Lancaster, Dominic, Brown, James, Palmer, Andrew, Adie, Ladan, Kennedy, Georgia, Eld, M., Holt, G., Yilmaz, M., Spendler, K. Garm, Hansen, F., Laurberg, S., Rosenkilde, M., Ahlstrom, H., Glimelius, B., Abgamu, D., Day, N., Walsh, C., Bannister, J., Furniss, D., Morgan, S., Walkington, L., Yates, S., Branagan, G., Mustajab, A., O’Neil, H., Rees, C., Geh, I., Hendrickse, C., Langman, G., Pallan, A., Conn, A., Lowe, A., Ostrowski, J., Steward, M., Callaway, M., Falk, S., Thomas, M., Wong, N., Cast, J., Hartley, J., Roy, R., Tiam, R., Blunt, D., Cleator, S., Dawson, P., Goldin, R., Gujral, D., Lowdell, C., Ziprin, P., Clenton, S., Dewdney, A., Euinton, H., Furniss, D., Gupta, R., Tarapowewalla, D., Wilshaw, V., Braun, M., Chakrabarty, B., Hill, J., Laasch, H., Saunders, M., Cruickshank, N., Davies, M., Muzaffar, S., Orme, A., Punia, P., Rea, D., Campbell, F., Hughes, M., Palmer, D., Rooney, P., Abbott, G., Hamid, B., Vimalachandran, D., Berry, J., Hinson, F., Maarouf, Z., Nicoll, J., Adams, C., Denson, J., Jackson, S., Sherriff, D., Kweka, E., McAdam, G., Peters, M., Roy, R., Khaira, M., Kurien, G., Robinson, J., Wadsley, J., White, D., Young, R., Dega, R., Lamparelli, M., Orbell, J., Osborne, R., Taylor, P., Thomas, T., Gopalakrishnan, K., Jadhav, V., Scott-Brown, M., Baijal, S., Chapman, M., Glaholm, J., Nelson, C., Singh, R., Harrison, J., Last, K., Scott, D., Scullion, D., Lind, P., Milosavljevic, Z., Dent, J., Ilsley, D., Littleford, S., Roberts, C., Crabtree, M., Orrell, J., Sherwin, E., Smith, S., Soomal, R., Braun, M., De, A., Khan, A., Khan, U., Lavin, V., McBain, C., Radharkrishna, G., Sil, R., Weerasinghe, S., Hill, J., Lee, S., Wright, P., Church, R., Holland, C., Kunene, V., Thompson, A., Glynne-Jones, R., Goh, V., Livingstone, J., Richman, P., Barlow, C., Burn, P., Geraghty, J., Walther, J., Grumett, S., Mangalika, S., Qaiyum, M., Williams, G., Borgstein, R., Bridgewater, J., Melville, D., Rees, J., Coxon, F., Hainsworth, P., Needham, S., Scott, J., Asmussen, J., Hansen, T., Jensen, K., Pfeiffer, P., Alkhaldi, A., Brittenden, J., Jackson, A., Kamposioras, K., Kumaran, G., Macklin, C., Alexander, J., Harle, A., Hickish, T., Talbot, R., Tarver, D., Bridgewater, J., Partridge, W., Sundaresan, V., Vivekanandan, S., Agrawal, N., Higginson, A., Muthuramalingam, S., O’Leary, D., Devarajan, G., Gulati, M., Kerwat, R., Maisey, N., Mikhaeel, G., Ismail, T., Middleton, G., Page, A., Steven, N., Taniere, P., Gutmann, J., Huang, J., Raouf, S., Dunn, W., Escola, C. Lopez, Potter, V., Scholefield, J., Walker, G., Zaitoun, A., Eason, D., McPhail, N., Mmeka, W., Stenhouse, G., Watson, A., Fozard, B., Hickish, T., Snape, S., Ellis, R., Faux, W., Jenkins, R., Maskell, G., Kulkarni, R., Lund, J., Menon, S., Singh, R., Chandler, I., Daniels, I., Harries, S., Osborne, M., Bell, J., Krell, D., Mayer, A., Ogunbiyi, O., Watkins, J., Bronder, C., Eaton, D., Taylor, A., Brown, G., Cunningham, D., Tekkis, P., Wotherspoon, A., Dobson, M., Mitchell, P., Pitt, M., Scott, N., Susnerwala, S., Adab, F., Britton, I., Ghiridaran, S., Howitt, C., Kirby, R., Biddlestone, L., Dalton, S., De Winton, E., Phillips, A., Ferry, D., Grumett, S., Kawesha, A., Maleki, K., Momtahan, N., Burnett, H., Hayes, S., Soop, M., Branagan, G., Cook, I., Cook, S., Iveson, T., Shablak, A., Coup, A., Hamid, A., Moore, P., O’Toole, L., Pai, D., Bateman, A., Bateman, A., Blaquiere, R., Nichols, P., Chappell, M., Dworkin, M., Jain, S., Tsang, D., Hopkins, K., Loveday, E., Lyons, A., Rooney, N., Ali, N., Chatterjee, M., Chiphang, A., Dundas, S., Myint, A. Sun, Zeiderman, M., Beharry, N., Chong, H., Lofts, F., Melville, D., Finan, P., Seymour, M., Tolan, D., West, N., Anyamene, N., Burling, D., Kennedy, R., Moorghen, M., Agrawal, S., Hasan, J., Mehta, S., Saeed, M., Burgess, P., John, L., Lowndes, S., Planner, A., Campbell, F., Hughes, M., Rooney, P., Smith, D., Hochhauser, D., Obichere, A., Rodriguez-Justo, M., Shiu, K., Taylor, S., Correa, P., James, S., Shatwell, W., Williams, N., Brady, J., Lanaspre, E., Mikhaeel, G., Ahmad, M., Gill, T., Wilson, D., Adams, R., Beehen, R., Morgan, M., Lindh, B., Adams, R., Morgan, M., Ford, A., Gopal, K., Pranesh, N., Shareef, D., Tighe, M., Busby, K., Correa, P., Sanders, S., Sinha, R., Ahmad, R., Desai, S., Ramesh, S., Hilman, S., Lott, M., O’Brien, J., Radstone, D., West, D., Amin, S., Hampton, J., Hornbuckle, J., Kitsanta, P., Ali, M., Desai, A., Hadaki, M., Hall, M., Arul, D., Hochhauser, D., Leonard, P., Mukhtar, H., Murray, D., Baxter, A., Churn, M., Farrugia, D., Lake, S., Smith, G., Bansal, A., Chandran, P., Corr, C., Gollins, S., Davenport, A., Saunders, M., Sukumar, S., Bathurst, N., Beaumont, E., Cooper, E., Francis, N., Sephton, M., Sparrow, G., Clarke, A., Haselden, J., Last, K., Woodcock, N., Atkinson, M., Gollins, S., Gupta, M., Maw, A., Abdullah, N., Bale, C., and Lord, M.

Published
2024
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4. Best time to assess complete clinical response after chemoradiotherapy in squamous cell carcinoma of the anus (ACT II): a post-hoc analysis of randomised controlled phase 3 trial

Author

Glynne-Jones, R, Sebag-Montefiore, D, Meadows, HM, Cunningham, D, Begum, R, Adab, F, Benstead, K, Harte, RJ, Stewart, J, Beare, S, Hackshaw, A, and Kadalayil, L

Subjects
Oncology
Abstract

BACKGROUND:Guidelines for anal cancer recommend assessment of response at 6-12 weeks after starting treatment. Using data from the ACT II trial, we determined the optimum timepoint to assess clinical tumour response after chemoradiotherapy.METHODS:The previously reported ACT II trial was a phase 3 randomised trial of patients of any age with newly diagnosed, histologically confirmed, squamous cell carcinoma of the anus without metastatic disease from 59 centres in the UK. We randomly assigned patients (by minimisation) to receive either intravenous mitomycin (one dose of 12 mg/m2 on day 1) or intravenous cisplatin (one dose of 60 mg/m2 on days 1 and 29), with intravenous fluorouracil (one dose of 1000 mg/m2 per day on days 1-4 and 29-32) and radiotherapy (50·4 Gy in 28 daily fractions); and also did a second randomisation after initial therapy to maintenance chemotherapy (fluorouracil and cisplatin) or no maintenance chemotherapy. The primary outcome was complete clinical response (the absence of primary and nodal tumour by clinical examination), in addition to overall survival and progression-free survival from time of randomisation. In this post-hoc analysis, we analysed complete clinical response at three timepoints: 11 weeks from the start of chemoradiotherapy (assessment 1), 18 weeks from the start of chemoradiotherapy (assessment 2), and 26 weeks from the start of chemoradiotherapy (assessment 3) as well as the overall and progression-free survival estimates of patients with complete clinical response or without complete clinical response at each assessment. We analysed both the overall trial population and a subgroup of patients who had attended each of the three assessments by modified intention-to-treat. This study is registered at controlled-trials.com, ISRCTN 26715889.FINDINGS:We enrolled 940 patients from June 4, 2001, until Dec 16, 2008. Complete clinical response was achieved in 492 (52%) of 940 patients at assessment 1 (11 weeks), 665 (71%) of patients at assessment 2 (18 weeks), and 730 (78%) of patients at assessment 3 (26 weeks). 691 patients attended all three assessments and in this subgroup, complete clinical response was reported in 441 (64%) patients at assessment 1, 556 (80%) at assessment 2, and 590 (85%) at assessments 3. 151 (72%) of the 209 patients who had not had a complete clinical response at assessment 1 had a complete clinical response by assessment 3. In the overall trial population of 940 patients, 5 year overall survival in patients who had a clinical response at assessments 1, 2, 3 was 83% (95% CI 79-86), 84% (81-87), and 87% (84-89), respectively and was 72% (66-78), 59% (49-67), and 46% (37-55) for patients who did not have a complete clinical response at assessments 1, 2, 3, respectively. In the subgroup of 691 patients, 5 year overall survival in patients who had a clinical response at assessment 1, 2, 3 was 85% (81-88), 86% (82-88), and 87% (84-90), respectively, and was 75% (68-80), 61% (50-70), and 48% (36-58) for patients who did not have a complete clinical response at assessment 1, 2, 3, respectively. Similarly, progression-free survival in both the overall trial population and the subgroup was longer in patients who had a complete clinical response, compared with patients who did not have a complete clinical response, at all three assessments.INTERPRETATION:Many patients who do not have a complete clinical response when assessed at 11 weeks after commencing chemoradiotherapy do in fact respond by 26 weeks, and the earlier assessment could lead to some patients having unnecessary surgery. Our data suggests that the optimum time for assessment of complete clinical response after chemoradiotherapy for patients with squamous cell carcinoma of the anus is 26 weeks from starting chemoradiotherapy. We suggest that guidelines should be revised to indicate that later assessment is acceptable.

Published
2017
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5. Virtual imaging for patient information on radiotherapy planning and delivery

Author

Sule-Suso, J, Finney, S, Bisson, J, Hammersley, S, Jassal, S, Knight, C, Ellis, C, Sargeant, S, Lam, K, Belcher, J, Collins, D, Bhana, R, Adab, F, O'Donovan, C, and Moloney, A

Subjects
RC705, R735, R1, RA, RC
Abstract

Purpose or Objective: To assess whether both patients and\ud their relatives would welcome further information on a oneto-one basis on RT planning and delivery using the virtual\ud reality (VR) system VERT.

Published
2016

6. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy

Author

James, N, de Bono, J, Spears, M, Clarke, NW, Mason, M, Dearnaley, D, Ritchie, A, Amos, C, Gilson, C, Jones, R, Matheson, DJ, Millman, R, Attard, G, Chowdhury, S, Cross, W, Gillessen, S, Parker, C, Russell, M, Berthold, D, Brawley, C, Adab, F, Aung, S, Birtle, AJ, Bowen, J, Brock, S, Chakraborti, P, Ferguson, C, Gale, J, Gray, E, Hingorani, M, Hoskin, P, Lester, J, Malik, Z, McKinna, F, McPhail, N, Money-Kyrle, J, O'Sullivan, J, Parikh, O, Protheroe, A, Robinson, A, Srihari, N, Thomas, C, Wagstaff, J, Wylie, J, Zarkar, A, Parmar, M, Sydes, M, James, N, de Bono, J, Spears, M, Clarke, NW, Mason, M, Dearnaley, D, Ritchie, A, Amos, C, Gilson, C, Jones, R, Matheson, DJ, Millman, R, Attard, G, Chowdhury, S, Cross, W, Gillessen, S, Parker, C, Russell, M, Berthold, D, Brawley, C, Adab, F, Aung, S, Birtle, AJ, Bowen, J, Brock, S, Chakraborti, P, Ferguson, C, Gale, J, Gray, E, Hingorani, M, Hoskin, P, Lester, J, Malik, Z, McKinna, F, McPhail, N, Money-Kyrle, J, O'Sullivan, J, Parikh, O, Protheroe, A, Robinson, A, Srihari, N, Thomas, C, Wagstaff, J, Wylie, J, Zarkar, A, Parmar, M, and Sydes, M

Abstract

BACKGROUND Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design. METHODS We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer). RESULTS A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastat

Published
2017

7. EP-1461: Virtual imaging for patient information on radiotherapy planning and delivery

Author

Sulé-Suso, J., primary, Finney, S., additional, Bisson, J., additional, Hammersley, S., additional, Jassal, S., additional, Knight, C., additional, Ellis, C., additional, Sargeant, S., additional, Lam, K., additional, Belcher, J., additional, Collins, D., additional, Bhana, R., additional, Adab, F., additional, O'Donovan, C., additional, and Moloney, A., additional

Published
2016
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8. 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

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.

Subjects
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
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9. Enhanced crystalline cellulose degradation by a novel metagenome-derived cellulase enzyme.

Author

Kholousi Adab F, Mehdi Yaghoobi M, and Gharechahi J

Subjects
Animals, Metagenome, Camelus, Cellulose, Microbiota, Cellulase genetics
Abstract

Metagenomics has revolutionized access to genomic information of microorganisms inhabiting the gut of herbivorous animals, circumventing the need for their isolation and cultivation. Exploring these microorganisms for novel hydrolytic enzymes becomes unattainable without utilizing metagenome sequencing. In this study, we harnessed a suite of bioinformatic analyses to discover a novel cellulase-degrading enzyme from the camel rumen metagenome. Among the protein-coding sequences containing cellulase-encoding domains, we identified and subsequently cloned and purified a promising candidate cellulase enzyme, Celcm05-2, to a state of homogeneity. The enzyme belonged to GH5 subfamily 4 and exhibited robust enzymatic activity under acidic pH conditions. It maintained hydrolytic activity under various environmental conditions, including the presence of metal ions, non-ionic surfactant Triton X-100, organic solvents, and varying temperatures. With an optimal temperature of 40 °C, Celcm05-2 showcased remarkable efficiency when deployed on crystalline cellulose (> 3.6 IU/mL), specifically Avicel, thereby positioning it as an attractive candidate for a myriad of biotechnological applications spanning biofuel production, paper and pulp processing, and textile manufacturing. Efficient biodegradation of waste paper pulp residues and the evidence of biopolishing suggested that Celcm05-2 can be used in the bioprocessing of cellulosic craft fabrics in the textile industry. Our findings suggest that the camel rumen microbiome can be mined for novel cellulase enzymes that can find potential applications across diverse biotechnological processes., (© 2024. The Author(s).)

Published
2024
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10. Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy.

Author

James ND, de Bono JS, Spears MR, Clarke NW, Mason MD, Dearnaley DP, Ritchie AWS, Amos CL, Gilson C, Jones RJ, Matheson D, Millman R, Attard G, Chowdhury S, Cross WR, Gillessen S, Parker CC, Russell JM, Berthold DR, Brawley C, Adab F, Aung S, Birtle AJ, Bowen J, Brock S, Chakraborti P, Ferguson C, Gale J, Gray E, Hingorani M, Hoskin PJ, Lester JF, Malik ZI, McKinna F, McPhail N, Money-Kyrle J, O'Sullivan J, Parikh O, Protheroe A, Robinson A, Srihari NN, Thomas C, Wagstaff J, Wylie J, Zarkar A, Parmar MKB, and Sydes MR

Subjects
Abiraterone Acetate adverse effects, Adult, Aged, Aged, 80 and over, Androgen Antagonists adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Humans, Male, Middle Aged, Neoplasm Metastasis drug therapy, Neoplasm Recurrence, Local drug therapy, Prednisolone adverse effects, Prostate-Specific Antigen blood, Prostatic Neoplasms mortality, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms surgery, Steroid 17-alpha-Hydroxylase antagonists & inhibitors, Survival Analysis, Abiraterone Acetate administration & dosage, Androgen Antagonists administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Prednisolone administration & dosage, Prostatic Neoplasms drug therapy
Abstract

Background: Abiraterone acetate plus prednisolone improves survival in men with relapsed prostate cancer. We assessed the effect of this combination in men starting long-term androgen-deprivation therapy (ADT), using a multigroup, multistage trial design., Methods: We randomly assigned patients in a 1:1 ratio to receive ADT alone or ADT plus abiraterone acetate (1000 mg daily) and prednisolone (5 mg daily) (combination therapy). Local radiotherapy was mandated for patients with node-negative, nonmetastatic disease and encouraged for those with positive nodes. For patients with nonmetastatic disease with no radiotherapy planned and for patients with metastatic disease, treatment continued until radiologic, clinical, or prostate-specific antigen (PSA) progression; otherwise, treatment was to continue for 2 years or until any type of progression, whichever came first. The primary outcome measure was overall survival. The intermediate primary outcome was failure-free survival (treatment failure was defined as radiologic, clinical, or PSA progression or death from prostate cancer)., Results: A total of 1917 patients underwent randomization from November 2011 through January 2014. The median age was 67 years, and the median PSA level was 53 ng per milliliter. A total of 52% of the patients had metastatic disease, 20% had node-positive or node-indeterminate nonmetastatic disease, and 28% had node-negative, nonmetastatic disease; 95% had newly diagnosed disease. The median follow-up was 40 months. There were 184 deaths in the combination group as compared with 262 in the ADT-alone group (hazard ratio, 0.63; 95% confidence interval [CI], 0.52 to 0.76; P<0.001); the hazard ratio was 0.75 in patients with nonmetastatic disease and 0.61 in those with metastatic disease. There were 248 treatment-failure events in the combination group as compared with 535 in the ADT-alone group (hazard ratio, 0.29; 95% CI, 0.25 to 0.34; P<0.001); the hazard ratio was 0.21 in patients with nonmetastatic disease and 0.31 in those with metastatic disease. Grade 3 to 5 adverse events occurred in 47% of the patients in the combination group (with nine grade 5 events) and in 33% of the patients in the ADT-alone group (with three grade 5 events)., Conclusions: Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure-free survival than ADT alone. (Funded by Cancer Research U.K. and others; STAMPEDE ClinicalTrials.gov number, NCT00268476 , and Current Controlled Trials number, ISRCTN78818544 .).

Published
2017
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