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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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6. 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

7. 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

8. 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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9. ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer

Author

Parmar MKB, Torri V, Bonaventura A, Bonazzi C, Colombo N, Delaloye JF, Marsoni S, Mangioni C, Sandercock J, Sessa C, Williams C, Tinazzi A, Flann M, Geiser K, Scorpiglione N, Stewart JF, Chaves J, Palmeiro E, Curtain A, McCormack T, Gennatas C, Marras F, Oppo TG, Balestrino M, Malzoni C, Malzoni M, Belli M, Geminiani ML, Crestani G, Monaco A, Vavala V, Piatto E, Barattini G, Fornara PG, Chetri MC, Santeufemia G, Artioli F, Carone D, Fanizza G, Trentadue R, Priolo D, Scollo P, Nigro SC, Petrina M, Mastrantonio P, Spanna GD, Zagni R, Belloni C, Colleoni R, Redaelli L, Cavagnini A, Di Costanzo G, Perroni D, Arienti S, Orfanotti G, Cantoni FM, Secli R, Bianchi A, Martinello R, Mollica G, Maizzi D, Picchiarelli ME, Fiorini G, Borsani M, Colombo E, Garsia S, Melgrati L, Paggi G, Brunenghi GM, Casini M, Isa L, Algeri R, Prozio G, Belfiore G, Angelini F, D'Aprile M, Moreschi M, Mauri ML, Natale N, Senzani FM, Pavanato G, Poggi G, Garuti G, Luerti M, Cruciani G, Pagano F, Baccolo M, Poddi ER, Bocciolone L, Sabelli MA, Maggi R, Restelli C, D'Antona A, Locatelli MC, Pessi A, Raina A, Chiari S, Gabriele A, Pittelli MR, Iacobelli P, Dogliotti L, Gorzegno G, Musso P, Vegna G, Coco G, Alletti DG, Picciotto F, Lucchese V, Epis A, di Palumbo VS, Drudi G, Ravaioli A, Zampella D, Morandi MG, Gorga G, Zucchelli C, Cariello S, Galletto L, Sussio M, Massacesi L, Massacesi M, Carli A, Tucci E, Tajani E, Corrado G, Bumma S, Durando A, Massobrio M, Sberveglieri M, Biasio M, Guercio E, Jura R, Danese S, Wierdis T, Farnelli C, Tarantino G, Grassi R, Repetti F, Rocchi B, Grampa M, Ercoli A, Griso C, Signori E, Zanini L, Presti M, Klimek M, Urbanski K, Biswas A, Viegas O, Kochli O, Dreher E, Fey M, Beck G, Ludin J, Bonnefoi H, Krauer F, Bauer J, Delmore G, Furrer C, Lorenz U, Thurlimann B, Bronz L, Sanna P, Wyss D, Goldhirsch A, Gyr T, Leidi L, Pastorelli G, Pagani O, Rey P, Hailer U, Benz J, Kaye SB, Reed NS, Symonds RP, Atkinson RJ, Axford AT, Rustin G, Seckl MJ, Green JA, Scott IV, Guthrie D, Harper PG, Calman F, Dobbs HJ, Weir P, Cassoni A, Lederman JA, Souhami RL, Bozzino J, Adab F, Redman CWE, Scoble JE, Paterson M, Daniel F, Cowley N, Williams CJ, Spooner D, Hong A, McIllmurray M, Hendy-Ibbs P, Hall V, Iveson TJ, Whitehouse JMA, Garry R, Lamont A, Robinson A, Trask CW, Clubb AW, Murrell D, Newman G, Wilkins M, Goldthorp WO, Roberts JK, Radstone DJ, Whipp MJ, Ledermann JA, Pater J, Buyse M, Omura G, Parmar, Mkb, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, Jf, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, Jf, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, Tg, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, Ml, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, Pg, Chetri, Mc, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, Sc, Petrina, M, Mastrantonio, P, Spanna, Gd, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, Fm, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, Me, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, Gm, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, Ml, Natale, N, Senzani, Fm, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, Er, Bocciolone, L, Sabelli, Ma, Maggi, R, Restelli, C, D'Antona, A, Locatelli, Mc, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, Mr, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, Dg, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, Mg, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, Sb, Reed, N, Symonds, Rp, Atkinson, Rj, Axford, At, Rustin, G, Seckl, Mj, Green, Ja, Scott, Iv, Guthrie, D, Harper, Pg, Calman, F, Dobbs, Hj, Weir, P, Cassoni, A, Lederman, Ja, Souhami, Rl, Bozzino, J, Adab, F, Redman, Cwe, Scoble, Je, Paterson, M, Daniel, F, Cowley, N, Williams, Cj, Spooner, D, Hong, A, Mcillmurray, M, Hendy-Ibbs, P, Hall, V, Iveson, Tj, Whitehouse, Jma, Garry, R, Lamont, A, Robinson, A, Trask, Cw, Clubb, Aw, Murrell, D, Newman, G, Wilkins, M, Goldthorp, Wo, Roberts, Jk, Radstone, Dj, Whipp, Mj, Ledermann, Ja, Pater, J, Buyse, M, and Omura, G

Published
1998

10. ICON2: randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer. ICON Collaborators. International Collaborative Ovarian Neoplasm Study

Author

Parmar, MKB, Torri, V, Bonaventura, A, Bonazzi, C, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, McCormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, McIllmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G., COLOMBO, NICOLETTA, Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, and Omura, G

Subjects
Antineoplastic Combined Chemotherapy Protocol, Ovarian Neoplasm, Alopecia, Leukopenia, Middle Aged, Thrombocytopenia, Carboplatin, Antineoplastic Agent, Doxorubicin, Proportional Hazards Model, Female, Survival Analysi, Cisplatin, Cyclophosphamide, Aged, Human
Abstract

A series of meta-analyses of randomised controlled trials raised the question of whether the three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) was more or less effective than optimal-dose single-agent carboplatin for women with advanced ovarian cancer.

Published
1998

11. Randomized clinical trial of adjuvant radiotherapy and 5-fluorouracil infusion in colorectal cancer (AXIS)

Author

Miller, R, Dewar, EP, Kapadia, CR, Nejim, A, Hutchinson, IF, McAdam, WA, Morris, IR, Deasy, JM, Irwin, ST, Oates, GD, O'Dwyer, STP, Dorricott, NJ, Stock, SE, Wilkinson, MJS, Ostick, DG, Hobbiss, JH, Farrands, PA, Ross, AHM, Sauven, P, Sandilands, DGD, De Castella, HC, McCarthy, D, Lee, P, Allen-Mersh, TG, Haynes, S, Bristol, JB, Donovan, IA, Neoptolemos, JP, Wolverson, RL, Silverman, SH, Lee, M, Backhouse, C, Millar, DM, Kirwan, WO, Edwards, P, Morran, CG, Maddox, C, Palmer, JG, Nicoll, J, Jacob, GH, Archbold, JAA, Bell, JC, Rennie, JA, Turner, AR, Turner, J, Fearon, KCH, Vaar, A, Ratsep, V, Nasmyth, DG, McKee, RF, Cooke, TG, McArdle, C, Stephenson, RF, Baxter, JN, Rew, DA, Thomson, WHF, Gear, MW, Allan, A, Pearson, HJ, Goldberg, PA, Kmiot, WAW, Irving, MH, Bancewicz, J, Mughal, M, Jones, DJ, Kipping, RA, Dudley, NE, Mortensen, NJ, Parker, M, Armistead, PR, Gillison, EW, Loughlin, V, Kelly, MJ, Mosley, J, Cade, D, Guy, A, Moorehead, J, Harvey, CF, Parisi, VP, Delrio, P, Jones, DRB, Bozzino, JM, Griffin, SM, Griffith, CDM, Bulman, A, Stebbings, WSL, Deakin, M, Adab, F, Goulbourne, IA, Berry, AR, Cunningham, FO, Ingoldby, CJH, Talbot, R, Burgess, P, Stamatakis, J, Offori, T, Cullen, PT, Logie, JRC, Thomson, A, Maybury, NK, Fozard, BJ, Cooper, MJ, Vellacott, KD, Shorthouse, AJ, Poston, GJ, Simkin, EP, McIntosh, HR, Karran, DR, Royle, GT, Karanjia, N, Marks, CG, Maxwell, RJ, Varma, JS, Simson, JNL, Burkitt, D, Johnson, CD, Steer, HW, Primrose, JN, McGinn, FP, Taylor, I, Zeiderman, MR, Sagor, GR, Hawley, P, Northover, JMA, Donaldson, DR, Scott, HJ, Gallagher, P, Crossling, FT, McKelvey, STD, Rickett, JW, Kingston, RD, Davidson, T, Boulos, PB, Smith, DC, Smith, IS, Gillespie, G, Kashi, SH, Grieve, RJ, Fraser, IA, Roberts, PN, Lam, FT, Parker, RW, Stockdale, A, Jurewicz, A, Woodward, DAK, Taylor, BA, Thomas, JM, Sarin, S, Reilly, DT, Stebbings, W, Hamer-Hodges, DW, Nixon, SJ, Saunders, JH, Macintyre, IMC, Yosef, H, Smith, AN, Lock, MR, Lake, SP, Smart, PJG, Grimley, R, Hall, R, Jamison, MH, Jenkinson, LR, James, RD, Donaldson, D, Gray, R, Stenning, SP, Garten, L, McQueen, A, Simnett, S, Johnstone, C, Cain, D, Lallemand, E, Peto, R, Finan, P, Slevin, M, Altman, D, and Collaborators, AXIS

Subjects
Adult, Male, medicine.medical_specialty, Antimetabolites, Antineoplastic, Colorectal cancer, medicine.medical_treatment, Gastroenterology, law.invention, Folinic acid, Randomized controlled trial, law, Internal medicine, Preoperative Care, medicine, Humans, Infusions, Intravenous, Survival analysis, Aged, Aged, 80 and over, Postoperative Care, business.industry, Heparin, Portal Vein, Rectal Neoplasms, Hazard ratio, Cancer, Anticoagulants, Middle Aged, medicine.disease, Survival Analysis, Surgery, Radiation therapy, Treatment Outcome, Fluorouracil, Colonic Neoplasms, Patient Compliance, Drug Therapy, Combination, Female, Radiotherapy, Adjuvant, business, medicine.drug, Follow-Up Studies
Abstract

Background Postoperative portal vein infusion (PVI) of 5-fluorouracil (5-FU) is a well tolerated and widely applicable treatment for colorectal cancer that might have an enormous public health impact, even if it produced survival benefits of just a few per cent. Very large trials are required to detect such differences, and the Adjuvant X-ray and 5-FU Infusion Study (AXIS) is the largest such trial yet reported. Methods Consenting patients with presumed colorectal cancer were randomized to surgery with or without 7 days of PVI (1 g 5-FU plus 5000 units heparin in 1 litre 5 per cent dextrose infused over each 24-h period). In addition, patients with rectal cancer could be randomized to radiotherapy or no radiotherapy to be given either before or after surgery. Results Between November 1989 and December 1997, 3583 patients were randomized with respect to PVI. The survival hazard ratios (95 per cent confidence interval (c.i.)) in all patients randomized and in the curatively resected subgroup (71·2 per cent of patients) were 1·00 (0·92 to 1·11) and 0·94 (0·83 to 1·06) respectively. Tests for heterogeneity suggested a greater treatment benefit for patients with colonic cancer than for patients with rectal cancer with respect to disease-free survival (hazard ratio 0·79 versus 1·03; P = 0·07), and there was a non-significant trend with respect to overall survival (hazard ratio 0·87 versus 1·03; P = 0·17). No survival benefit was seen in the 761 patients randomized with respect to radiotherapy; although not statistically significant, the impact on local recurrence rates was similar to that reported in the literature. Conclusion No overall benefit of PVI was established in AXIS when colonic and rectal cancers were considered together, but the evidence suggesting a differential treatment effect according to site of cancer in AXIS was strongly supported by a meta-analysis incorporating the previous trials. Combining the data gave hazard ratios of 0·82 and 1·00 for colonic and rectal tumours respectively (test for interaction, P = 0·024), equating to an absolute survival benefit for patients with colonic cancer of 5·8 (95 per cent c.i. 2·8 to 8·5) per cent, a level close to that seen for prolonged systemic therapy.

Published
2003

13. G4 First results of a phase III multicenter randomized controlled trial of intensity modulated (IMRT) versus conventional radiotherapy (RT) in head and neck cancer (PARSPORT: ISRCTN48243537; CRUK/03/005)

Author

Nutting, C., primary, A'Hern, R., additional, Rogers, M.S., additional, Sydenham, M.A., additional, Adab, F., additional, Harrington, K., additional, Jefferies, S., additional, Scrase, C., additional, Yap, B.K., additional, and Hall, E., additional

Published
2009
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14. 7102 Updated results of the BC2001 phase III randomized trial of standard vs reduced high dose volume radiotherapy for muscle invasive bladder cancer (ISCRTN:68324339): tumour control, toxicity and quality of life

Author

Huddart, R., primary, James, N.D., additional, Adab, F., additional, Syndikus, I., additional, Jenkins, P., additional, Rawlings, C., additional, Rogers, S., additional, Lewis, R., additional, Hendron, C., additional, Hussain, S., additional, and Hall, E., additional

Published
2009
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15. First results of a phase III multicenter randomized controlled trial of intensity modulated (IMRT) versus conventional radiotherapy (RT) in head and neck cancer (PARSPORT: ISRCTN48243537; CRUK/03/005)

Author

Nutting, C., primary, A'Hern, R., additional, Rogers, M. S., additional, Sydenham, M. A., additional, Adab, F., additional, Harrington, K., additional, Jefferies, S., additional, Scrase, C., additional, Yap, B. K., additional, and Hall, E., additional

Published
2009
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17. ICON2: Randomised trial of single-agent carboplatin against three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) in women with ovarian cancer

Author

Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G, Parmar, MKB, McCormack, T, McIllmurray, M, Omura, G., COLOMBO, NICOLETTA, Parmar, M, Torri, V, Bonaventura, A, Bonazzi, C, Colombo, N, Delaloye, J, Marsoni, S, Mangioni, C, Sandercock, J, Sessa, C, Williams, C, Tinazzi, A, Flann, M, Geiser, K, Scorpiglione, N, Stewart, J, Chaves, J, Palmeiro, E, Curtain, A, Mccormack, T, Gennatas, C, Marras, F, Oppo, T, Balestrino, M, Malzoni, C, Malzoni, M, Belli, M, Geminiani, M, Crestani, G, Monaco, A, Vavala, V, Piatto, E, Barattini, G, Fornara, P, Chetri, M, Santeufemia, G, Artioli, F, Carone, D, Fanizza, G, Trentadue, R, Priolo, D, Scollo, P, Nigro, S, Petrina, M, Mastrantonio, P, Spanna, G, Zagni, R, Belloni, C, Colleoni, R, Redaelli, L, Cavagnini, A, Di Costanzo, G, Perroni, D, Arienti, S, Orfanotti, G, Cantoni, F, Secli, R, Bianchi, A, Martinello, R, Mollica, G, Maizzi, D, Picchiarelli, M, Fiorini, G, Borsani, M, Colombo, E, Garsia, S, Melgrati, L, Paggi, G, Brunenghi, G, Casini, M, Isa, L, Algeri, R, Prozio, G, Belfiore, G, Angelini, F, D'Aprile, M, Moreschi, M, Mauri, M, Natale, N, Senzani, F, Pavanato, G, Poggi, G, Garuti, G, Luerti, M, Cruciani, G, Pagano, F, Baccolo, M, Poddi, E, Bocciolone, L, Sabelli, M, Maggi, R, Restelli, C, D'Antona, A, Locatelli, M, Pessi, A, Raina, A, Chiari, S, Gabriele, A, Pittelli, M, Iacobelli, P, Dogliotti, L, Gorzegno, G, Musso, P, Vegna, G, Coco, G, Alletti, D, Picciotto, F, Lucchese, V, Epis, A, di Palumbo, V, Drudi, G, Ravaioli, A, Zampella, D, Morandi, M, Gorga, G, Zucchelli, C, Cariello, S, Galletto, L, Sussio, M, Massacesi, L, Massacesi, M, Carli, A, Tucci, E, Tajani, E, Corrado, G, Bumma, S, Durando, A, Massobrio, M, Sberveglieri, M, Biasio, M, Guercio, E, Jura, R, Danese, S, Wierdis, T, Farnelli, C, Tarantino, G, Grassi, R, Repetti, F, Rocchi, B, Grampa, M, Ercoli, A, Griso, C, Signori, E, Zanini, L, Presti, M, Klimek, M, Urbanski, K, Biswas, A, Viegas, O, Kochli, O, Dreher, E, Fey, M, Beck, G, Ludin, J, Bonnefoi, H, Krauer, F, Bauer, J, Delmore, G, Furrer, C, Lorenz, U, Thurlimann, B, Bronz, L, Sanna, P, Wyss, D, Goldhirsch, A, Gyr, T, Leidi, L, Pastorelli, G, Pagani, O, Rey, P, Hailer, U, Benz, J, Kaye, S, Reed, N, Symonds, R, Atkinson, R, Axford, A, Rustin, G, Seckl, M, Green, J, Scott, I, Guthrie, D, Harper, P, Calman, F, Dobbs, H, Weir, P, Cassoni, A, Lederman, J, Souhami, R, Bozzino, J, Adab, F, Redman, C, Scoble, J, Paterson, M, Daniel, F, Cowley, N, Spooner, D, Hong, A, Mcillmurray, M, Hendy Ibbs, P, Hall, V, Iveson, T, Whitehouse, J, Garry, R, Lamont, A, Robinson, A, Trask, C, Clubb, A, Murrell, D, Newman, G, Wilkins, M, Goldthorp, W, Roberts, J, Radstone, D, Whipp, M, Ledermann, J, Pater, J, Buyse, M, Omura, G, Parmar, MKB, McCormack, T, McIllmurray, M, Omura, G., and COLOMBO, NICOLETTA

Abstract

A series of meta-analyses of randomised controlled trials raised the question of whether the three-drug combination of CAP (cyclophosphamide, doxorubicin, and cisplatin) was more or less effective than optimal-dose single-agent carboplatin for women with advanced ovarian cancer.

Published
1998

18. Modified de Gramont with oxaliplatin in the first-line treatment of advanced colorectal cancer

Author

Braun, M S, primary, Adab, F, additional, Bradley, C, additional, McAdam, K, additional, Thomas, G, additional, Wadd, N J, additional, Rea, D, additional, Philips, R, additional, Twelves, C, additional, Bozzino, J, additional, MacMillan, C, additional, Saunders, M P, additional, Counsell, R, additional, Anderson, H, additional, McDonald, A, additional, Stewart, J, additional, Robinson, A, additional, Davies, S, additional, Richards, F J, additional, and Seymour, M T, additional

Published
2003
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20. Leg Length and Age of Puberty Among Men and Women from a Developing Population: The Guangzhou Biobank Cohort Study.

Author

SCHOOLING, C. M., C. Q. JIANG, T. H. LAM, W. S. ZHANG, K. K. CHENG, G. M. LEUNG, and ADAB, F.

Subjects
PUBERTY -- Physiological aspects, LEG physiology, LEG length inequality, REGRESSION analysis, STATURE
Abstract

The article describes a study which examined the associations of recalled age of puberty with subischeal leg length and relative leg length using multivariable linear regression in 10,046 older Chinese from the Guangzhou Biobank Cohort Study (Phase 3). The researchers hypothesized that there might be sex-specific associations with age of puberty in relation to leg length, relative leg length, as sitting height to leg ratio. The study concludes that these factors may be biomarkers of different exposures in men and women.

Published
2010
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23. 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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24. 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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25. 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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26. Parotid-sparing intensity modulated versus conventional radiotherapy in head and neck cancer (PARSPORT): a phase 3 multicentre randomised controlled trial.

Author

Nutting CM, Morden JP, Harrington KJ, Urbano TG, Bhide SA, Clark C, Miles EA, Miah AB, Newbold K, Tanay M, Adab F, Jefferies SJ, Scrase C, Yap BK, A'Hern RP, Sydenham MA, Emson M, and Hall E

Subjects
Female, Humans, Longitudinal Studies, Male, Middle Aged, Neoplasm Staging, Head and Neck Neoplasms radiotherapy, Parotid Gland, Radiotherapy, Intensity-Modulated methods, Xerostomia complications
Abstract

Background: Xerostomia is the most common late side-effect of radiotherapy to the head and neck. Compared with conventional radiotherapy, intensity-modulated radiotherapy (IMRT) can reduce irradiation of the parotid glands. We assessed the hypothesis that parotid-sparing IMRT reduces the incidence of severe xerostomia., Methods: We undertook a randomised controlled trial between Jan 21, 2003, and Dec 7, 2007, that compared conventional radiotherapy (control) with parotid-sparing IMRT. We randomly assigned patients with histologically confirmed pharyngeal squamous-cell carcinoma (T1-4, N0-3, M0) at six UK radiotherapy centres between the two radiotherapy techniques (1:1 ratio). A dose of 60 or 65 Gy was prescribed in 30 daily fractions given Monday to Friday. Treatment was not masked. Randomisation was by computer-generated permuted blocks and was stratified by centre and tumour site. Our primary endpoint was the proportion of patients with grade 2 or worse xerostomia at 12 months, as assessed by the Late Effects of Normal Tissue (LENT SOMA) scale. Analyses were done on an intention-to-treat basis, with all patients who had assessments included. Long-term follow-up of patients is ongoing. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN48243537., Findings: 47 patients were assigned to each treatment arm. Median follow-up was 44·0 months (IQR 30·0-59·7). Six patients from each group died before 12 months and seven patients from the conventional radiotherapy and two from the IMRT group were not assessed at 12 months. At 12 months xerostomia side-effects were reported in 73 of 82 alive patients; grade 2 or worse xerostomia at 12 months was significantly lower in the IMRT group than in the conventional radiotherapy group (25 [74%; 95% CI 56-87] of 34 patients given conventional radiotherapy vs 15 [38%; 23-55] of 39 given IMRT, p=0·0027). The only recorded acute adverse event of grade 2 or worse that differed significantly between the treatment groups was fatigue, which was more prevalent in the IMRT group (18 [41%; 99% CI 23-61] of 44 patients given conventional radiotherapy vs 35 [74%; 55-89] of 47 given IMRT, p=0·0015). At 24 months, grade 2 or worse xerostomia was significantly less common with IMRT than with conventional radiotherapy (20 [83%; 95% CI 63-95] of 24 patients given conventional radiotherapy vs nine [29%; 14-48] of 31 given IMRT; p<0·0001). At 12 and 24 months, significant benefits were seen in recovery of saliva secretion with IMRT compared with conventional radiotherapy, as were clinically significant improvements in dry-mouth-specific and global quality of life scores. At 24 months, no significant differences were seen between randomised groups in non-xerostomia late toxicities, locoregional control, or overall survival., Interpretation: Sparing the parotid glands with IMRT significantly reduces the incidence of xerostomia and leads to recovery of saliva secretion and improvements in associated quality of life, and thus strongly supports a role for IMRT in squamous-cell carcinoma of the head and neck., Funding: Cancer Research UK (CRUK/03/005)., (Copyright © 2011 Elsevier Ltd. All rights reserved.)

Published
2011
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27. Influence of resection margins on survival for patients with pancreatic cancer treated by adjuvant chemoradiation and/or chemotherapy in the ESPAC-1 randomized controlled trial.

Author

Neoptolemos JP, Stocken DD, Dunn JA, Almond J, Beger HG, Pederzoli P, Bassi C, Dervenis C, Fernandez-Cruz L, Lacaine F, Buckels J, Deakin M, Adab FA, Sutton R, Imrie C, Ihse I, Tihanyi T, Olah A, Pedrazzoli S, Spooner D, Kerr DJ, Friess H, and Büchler MW

Subjects
Adenocarcinoma surgery, Adenocarcinoma therapy, Aged, Chemotherapy, Adjuvant, Female, Humans, Male, Middle Aged, Pancreas pathology, Pancreatic Neoplasms surgery, Pancreatic Neoplasms therapy, Prognosis, Proportional Hazards Models, Quality of Life, Radiotherapy, Adjuvant, Survival Rate, Adenocarcinoma mortality, Antineoplastic Agents therapeutic use, Pancreatectomy, Pancreatic Neoplasms mortality
Abstract

Objective: To assess the influence of resection margins on survival for patients with resected pancreatic cancer treated within the context of the adjuvant European Study Group for Pancreatic Cancer-1 (ESPAC-1) study., Summary Background Data: Pancreatic cancer is associated with a poor long-term survival rate of only 10% to 15% after resection. Patients with positive microscopic resection margins (R1) have a worse survival, but it is not known how they fare in adjuvant studies., Methods: ESPAC-1, the largest randomized adjuvant study of resectable pancreatic cancer ever performed, set out to look at the roles of chemoradiation and chemotherapy. Randomization was stratified prospectively by resection margin status., Results: Of 541 patients with a median follow-up of 10 months, 101 (19%) had R1 resections. Resection margin status was confirmed as an influential prognostic factor, with a median survival of 10.9 months for R1 versus 16.9 months months for patients with R0 margins. Resection margin status remained an independent factor in a Cox proportional hazards model only in the absence of tumor grade and nodal status. There was a survival benefit for chemotherapy but not chemoradiation, irrespective of R0/R1 status. The median survival was 19.7 months with chemotherapy versus 14.0 months without. For patients with R0 margins, chemotherapy produced longer survival compared with to no chemotherapy. This difference was less apparent for the smaller subgroup of R1 patients, but there was no significant heterogeneity between the R0 and R1 groups., Conclusions: Resection margin-positive pancreatic tumors represent a biologically more aggressive cancer; these patients benefit from resection and adjuvant chemotherapy but not chemoradiation. The magnitude of benefit for chemotherapy treatment is reduced for patients with R1 margins versus those with R0 margins. Patients with R1 tumors should be included in future trials of adjuvant treatments and randomization and analysis should be stratified by this significant prognostic factor.

Published
2001
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28. A histopathological assessment of the response of rectal adenocarcinoma to combination chemo-radiotherapy: relationship to apoptotic activity, p53 and bcl-2 expression.

Author

Scott N, Hale A, Deakin M, Hand P, Adab FA, Hall C, Williams GT, and Elder JB

Subjects
Adenocarcinoma drug therapy, Adenocarcinoma physiopathology, Adenocarcinoma radiotherapy, Chemotherapy, Adjuvant, Humans, Mitotic Index drug effects, Mitotic Index radiation effects, Radiotherapy, Adjuvant, Rectal Neoplasms drug therapy, Rectal Neoplasms physiopathology, Rectal Neoplasms radiotherapy, Adenocarcinoma pathology, Adenocarcinoma therapy, Apoptosis drug effects, Apoptosis radiation effects, Gene Expression Regulation, Neoplastic drug effects, Gene Expression Regulation, Neoplastic radiation effects, Proto-Oncogene Proteins c-bcl-2 metabolism, Rectal Neoplasms pathology, Rectal Neoplasms therapy, Tumor Suppressor Protein p53 metabolism
Abstract

Aims: To investigate the use of pre-operative chemo-irradiation in downstaging advanced rectal cancer prior to surgical resection., Methods: We examined the pathological effects of chemo-irradiation on 24 rectal tumours and correlated the efficacy of treatment with the level of apoptosis, mitosis, P53 and bcl-2 protein expression on pre-treatment biopsies., Results: All tumours were resectable following chemo-irradiation. Six cancers showed complete regression with no viable tumour in the resection specimen. A significant correlation was found between spontaneous tumour apoptosis and tumour regression., Conclusions: Our results suggest that in rectal cancer the apoptotic rate in untreated tumour tissue may predict sensitivity to radiation and cytotoxic agents. No relationship was found between regression and mitotic rate, p53 or bcl-2 expression.

Published
1998
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29. Carboplatin and retroperitoneal fibrosis.

Author

Adab FA and Mould JJ

Subjects
Carboplatin therapeutic use, Female, Humans, Middle Aged, Ovarian Neoplasms drug therapy, Radiography, Retroperitoneal Fibrosis diagnostic imaging, Carboplatin adverse effects, Retroperitoneal Fibrosis chemically induced
Abstract

A patient treated for ovarian epithelial cancer by total abdominal hysterectomy (TAH), bilateral salpingo-oophorectomy (BSO), total omentectomy and five courses of single agent carboplatin chemotherapy, developed retroperitoneal fibrosis. This was diagnosed at exploratory laparotomy 6 months after completing treatment. No predisposing drug history existed in this patient. We believe that there have been no previous reports of an association between retro peritoneal fibrosis and carboplatin treatment.

Published
1992
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