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3. Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

Author

Potter, Shelley, primary, Conroy, Elizabeth J, additional, Cutress, Ramsey I, additional, Williamson, Paula R, additional, Whisker, Lisa, additional, Thrush, Steven, additional, Skillman, Joanna, additional, Barnes, Nicola L P, additional, Mylvaganam, Senthurun, additional, Teasdale, Elisabeth, additional, Jain, Abhilash, additional, Gardiner, Matthew D, additional, Blazeby, Jane M, additional, Holcombe, Chris, additional, Achuthan, R, additional, Adwan, I, additional, Aggarwal, S, additional, Ahmed, M, additional, Akelund, M, additional, Akolekar, D, additional, Al-Jibury, O, additional, Amanita, M, additional, Appleton, D, additional, Archampong, D, additional, Asgiersson, K, additional, Athwal, R, additional, Augusti, A, additional, Ayaani, S, additional, Bains, S, additional, Baker, B, additional, Baker, E, additional, Baldota, S, additional, Banerjee, D, additional, Barker, S, additional, Barr, L, additional, Barry, P, additional, Basu, N, additional, Bathla, S, additional, Bishop, N, additional, Boland, G, additional, Branford, O A, additional, Bright-Thomas, R, additional, Brindle, R, additional, Brock, L, additional, Brown, V, additional, Bux, F, additional, Byrne, G, additional, Cain, H, additional, Caldon, L, additional, Callaghan, M, additional, Carbone, A, additional, Carpenter, R, additional, Cawthorn, S, additional, Chagla, L, additional, Challoner, T, additional, Chalmers, C, additional, Chalmers, R, additional, Chambers, S, additional, Chana, M, additional, Chand, N, additional, Chandran, V, additional, Chandrashekar, M, additional, Charfare, H, additional, Chatterjee, J, additional, Chatterjee, S, additional, Chattopadhyay, R, additional, Chaudry, A, additional, Chin, K, additional, Chong, K, additional, Chouhan, A, additional, Choy, C, additional, Christopoulos, P, additional, Clarke, D, additional, Clarke, S, additional, Clayton, E, additional, Clifford, R, additional, Cocker, D, additional, Collin, T, additional, Collis, N, additional, Conroy, F, additional, Constantinou, C, additional, Conway, A, additional, Cook, J, additional, Coombs, N, additional, Cox, K, additional, Critchley, A, additional, Dakka, M, additional, Dani, M, additional, Daoud, R, additional, Darragh, L, additional, Darvesh, S, additional, Dash, I, additional, Datta, S, additional, Davies, E, additional, Dawson, S, additional, De Sousa, E, additional, Debnath, D, additional, Deol, H, additional, Devalia, H, additional, Di Micco, R, additional, Dicks, JR, additional, Dickson, J, additional, Dobner, N, additional, Dobson, G, additional, Dunne, N, additional, Egbeare, D, additional, El Sharief, D, additional, Elfadl, D, additional, Eltigani, E, additional, Enver, D, additional, Erel, E, additional, Evans, A, additional, Exarchos, G, additional, Fage, E, additional, Fatayer, H, additional, Fenn, C, additional, Ferguson, D, additional, Foulkes, R, additional, Franks, J, additional, Fung, V, additional, Galea, M, additional, Gandamihardja, T, additional, Gandhi, A, additional, Garnsey, C, additional, Gateley, C, additional, Gattuso, J, additional, Gawne, S, additional, Geerthan, N, additional, Ghattura, A, additional, Giaramadze, A, additional, Gill, J, additional, Godden, AR, additional, Goh, S, additional, Govindarajulu, S, additional, Goyal, S, additional, Graja, T, additional, Granger, S, additional, Green, M, additional, Grover, K, additional, Gui, G, additional, Gurung, R, additional, Gutteridge, E, additional, Hakim, A, additional, Halka, A, additional, Hamilton-Burke, W, additional, Hamo, I, additional, Harding-Mackean, C, additional, Hargreaves, A, additional, Harries, S, additional, Harris, K, additional, Harris, P, additional, Harrison, S, additional, Harvey, J, additional, Hashem, M, additional, Hassan, U, additional, Henderson, J, additional, Henton, J, additional, Hignett, S, additional, Hodgkins, K, additional, Horgan, K, additional, Horn, S, additional, Hu, J, additional, Hussain, A, additional, Iddon, J, additional, Iqbal, A, additional, Irri, R, additional, Irvine, T, additional, Irwin, G, additional, Iskender, A, additional, Ismail, A, additional, Ives, C, additional, James, K, additional, James, R, additional, Jiwa, N, additional, Jobson, M, additional, Joglekar, S, additional, Johnson, L, additional, Johnson, R, additional, Jones, L, additional, Ju Hwang, M, additional, Kalles, V, additional, Kanesalingam, K, additional, Karat, I, additional, Kaushik, M, additional, Kennedy, K, additional, Khalifa, E, additional, Khan, H, additional, Khanbhai, M, additional, Khawaja, S, additional, Khout, H, additional, Kiernan, T, additional, Kim, B, additional, Kirkpatrick, K, additional, Kiruparan, P, additional, Kirwan, C, additional, Kishore, M, additional, Kneeshaw, P, additional, Knight, A, additional, Kohlhardt, S, additional, Krupa, J, additional, Krupa, K, additional, Kuruvilla, R, additional, Laban, C, additional, Lai, LM, additional, Laidlaw, I, additional, Lambert, K, additional, Langlands, F, additional, Lansdown, M, additional, Laurence, N, additional, Laws, S, additional, Ledwidge, S, additional, Lefemine, V, additional, Lennon, H, additional, Linforth, R, additional, Little, K, additional, Luangsomboon, A, additional, Lund, J, additional, Maalo, J, additional, MacLennan, L, additional, Macmillan, RD, additional, MacNeil, F, additional, Mahapatra, TK, additional, Mallidis, E, additional, Mallon, P, additional, Manoloudakis, N, additional, Maraqa, L, additional, Marla, S, additional, Masood, S, additional, Massey, J, additional, Masudi, T, additional, Matey, P, additional, Mazari, F, additional, McCulley, S, additional, McEvoy, K, additional, Mcintosh, J, additional, McIntosh, S, additional, McKenzie, S, additional, McManus, P, additional, McNicholas, J, additional, Michalakis, I, additional, Mills, N, additional, Mitchell, G, additional, Monib, S, additional, Mullan, M, additional, Murphy, C, additional, Murphy, G, additional, Murphy, J, additional, Murthy, B, additional, Musa, S, additional, Nagra, G, additional, Nangalia, R, additional, Narayanan, S, additional, Nasr, R, additional, Navin, C, additional, Newton, R, additional, Nicholson, S, additional, Nuru, N, additional, O'Connell, R, additional, O'Donoghue, J, additional, Ogedegbe, A, additional, Olayinka, OS, additional, Olsen, S, additional, Osborn, G, additional, Osborne, C, additional, Osman, H, additional, Otieno, C, additional, Pakzad, F, additional, Park, A, additional, Parker, S, additional, Partlett, P, additional, Parvaiz, A, additional, Parvanta, L, additional, Patel, G, additional, Peel, A, additional, Peiris, L, additional, Pennick, M, additional, Peppe, A, additional, Perry, D, additional, Pilgrim, S, additional, Piper, J, additional, Poonawalla, S, additional, Popa, E, additional, Pope, V, additional, Pugh, P, additional, Rainsbury, D, additional, Ramsey, K, additional, Rasheed, T, additional, Rathinaezhil, R, additional, Rattay, T, additional, Ravichandran, D, additional, Reed, M, additional, Refsum, S, additional, Remoundos, D, additional, Rigby, K, additional, Robertson, S, additional, Robinson, A, additional, Robinson, J, additional, Roche, N, additional, Roy, PJ, additional, Runkel, M, additional, Rusby, J, additional, Saha, S, additional, Saidan, Z, additional, Salab, M, additional, Saleh, M, additional, Salem, F, additional, Sami, A, additional, Samlalsingh, S, additional, Sarfraz, N, additional, Shah, R, additional, Shaheed, S, additional, Sharaiha, Y, additional, Shetty, G, additional, Shotton, R, additional, Sircar, T, additional, Skene, E, additional, Sloan, S, additional, Smith, B, additional, Smith, J, additional, Soldanova, L, additional, Soliman, F, additional, Soumian, S, additional, Stevens, J, additional, Steventon, C, additional, Stewart-Parker, E, additional, Stringfellow, T, additional, Sutaria, R, additional, Sutton, R, additional, Sweetland, H, additional, Swiech, B, additional, Tadiparthi, S, additional, Tafazal, H, additional, Taheri, N, additional, Tait, C, additional, Tan, M, additional, Tang, S, additional, Tansley, A, additional, Tate, S, additional, Tayeh, S, additional, Taylor, A, additional, Taylor, J, additional, Thawdar, P, additional, Thomas, C, additional, Thomas, S, additional, Thomson, S, additional, Thorne, A, additional, Tillett, R, additional, Tolkien, Z, additional, Tomlins, A, additional, Topps, A, additional, Tsang, F, additional, Turner, EJ, additional, Turton, P, additional, Udayasankar, S, additional, Ugolini, F, additional, Vaughan Williams, E, additional, Vidya, R, additional, Vijaynagar, B, additional, Vinayagam, R, additional, Volleamere, A, additional, Voynov, V, additional, Waheed, S, additional, Walker, T, additional, Walsh, U, additional, Warner, R, additional, Waters, R, additional, Wilkins, A, additional, Williams, K, additional, Wilson, G, additional, Wiltsher, M, additional, Wooler, B, additional, Wright, C, additional, Wright, M, additional, Wyld, L, additional, Youssef, M, additional, Zabkiewicz, C, additional, Zammit, C, additional, Zeidan, B, additional, and Zheng, D, additional

Published
2019
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4. Current practice and short-term outcomes of therapeutic mammaplasty in the international TeaM multicentre prospective cohort study

Author

O'Connell, R L, primary, Baker, E, additional, Trickey, A, additional, Rattay, T, additional, Whisker, L, additional, Macmillan, R D, additional, Potter, S, additional, Achuthan, R, additional, Aggarwal, S, additional, Basu, N, additional, Brock, L, additional, Fairbrother, P, additional, Gardiner, M D, additional, Holcombe, C, additional, Ives, C, additional, Jain, A, additional, Kim, B, additional, Murphy, J, additional, Remoundos, D, additional, Sutton, R, additional, Turton, P, additional, Williams, K, additional, MacLeod, C, additional, Smyth, E, additional, Depasquale, I, additional, Fuller, M, additional, Saeed, N, additional, Masannat, Y, additional, Tan Mohd Amin, A, additional, Agrawal, A, additional, Irwin, G, additional, Sloan, S, additional, Refsum, S, additional, McIntosh, S, additional, Ibrahim, A, additional, Sahu, A, additional, Govindarajulu, S, additional, Cawthorn, S, additional, Accurso, A, additional, Rathinaezhil, R, additional, Wilkins, A, additional, Khalifa, E, additional, Grover, K, additional, McManus, P, additional, Kneeshaw, P, additional, Mahapatra, T, additional, Azmy, I, additional, Massey, J, additional, Trapszo, P, additional, lane, R, additional, Seetharam, S, additional, Rocco, N, additional, Roshanlall, C, additional, Kokan, J, additional, Amin, K, additional, Leeper, A, additional, Kulkarni, D, additional, Dixon, J M, additional, Young, O, additional, Saleem, T, additional, McIlhenny, J, additional, Malyon, A, additional, Mansell, J, additional, Ogsto, K, additional, Romics, L, additional, Dragoumis, D, additional, Krupa, J, additional, Valassiadou, K, additional, Lambert, K, additional, Kaushik, M, additional, Shokuhi, S, additional, Pilgrim, S, additional, Wei, X, additional, Lee, J, additional, Al Allak, A, additional, Fowler, C, additional, Massey, E, additional, Court, F, additional, Hunt, R, additional, Vestey, S, additional, Khalil, H, additional, Elgammal, M, additional, Parvanta, L, additional, Sami, A S, additional, Gvaramadze, A, additional, Thekkinkattil, D, additional, Kirkpatrick, K, additional, James, R, additional, Noshirwani, A, additional, Arif, T, additional, Kryjak, Z, additional, Taylor, A, additional, Syed, F H, additional, Safdar, G, additional, Chin, K, additional, Soulsby, R, additional, Thorne, A, additional, Guest, F, additional, El Abbar, M, additional, Munnoch, D A, additional, Macaskill, E J, additional, Hogg, F, additional, McGee, P, additional, Pitsinis, V, additional, Smith, J, additional, Makkiyah, S, additional, Mustafa, S, additional, Otieno, C, additional, Photiou, D, additional, Macmillan, D, additional, Gutteridge, E, additional, Mazari, F, additional, Oni, G, additional, Khout, H, additional, Kelsall, J, additional, Hallam, K, additional, Asgeirron, K, additional, D'Auria, M, additional, Al zubaidi, S, additional, McCulley, S, additional, Rasheed, T, additional, Bailey, J, additional, Muhibullah, N, additional, Tenovici, A, additional, Remoundos, D D, additional, Chaidos, N, additional, Predescu, O, additional, Roy, P, additional, Windle, R, additional, Popa, E, additional, Shetty, G, additional, Rezulski, J, additional, Goh, S, additional, Abdullah, T, additional, Khawaja, S, additional, Udayasankar, S, additional, Tebbal, S, additional, Grassi, V, additional, Talbot, A, additional, Singh, J, additional, Smith, A, additional, Volleamere, A, additional, Garnsey, C, additional, Pikoulas, P, additional, Ferguson, D, additional, Tillett, R, additional, Dean, S, additional, Olsen, S, additional, Rainsbury, R M, additional, Peiris, L, additional, Sjokvist, O, additional, Laws, S, additional, Tansley, A, additional, De Sousa, E, additional, Mitchell, G, additional, Henderson, J, additional, Chandrashekar, M, additional, Micha, A, additional, Godden, A, additional, Pereira, B, additional, Constantinou, C, additional, Rusby, J, additional, Krupa, K, additional, To, N, additional, Barry, P, additional, Critchley, A, additional, Cain, H, additional, O'Donoghue, J, additional, Henton, J, additional, Kalra, L, additional, MacLennan, L, additional, Bennett, R, additional, Nicholson, S, additional, Paolini, G, additional, Francesco Renzi, L, additional, Di Pompeo, S, additional, Ria, V, additional, Hu, J, additional, Johnson, L, additional, Lewis, R S, additional, Hadad, S, additional, Sundaramoorthy, S, additional, Sharma, A, additional, Toomey, D, additional, Banerjee, D, additional, Shuk Kay Tang, S, additional, Taylor, L, additional, McKenzie, S, additional, Ahmad, T, additional, Absar, M, additional, Nasir, N, additional, Jerzy Rychlik, I, additional, Darragh, L, additional, Johnston, R, additional, Kirk, S, additional, Rees Lee, J, additional, Green, M, additional, Chong, K, additional, Lai, L M, additional, Choong, J, additional, Ullah, Z, additional, Chagla, L, additional, Koshy, O, additional, Bathla, S, additional, Kiernan, T, additional, Ashok Bhojwani, A, additional, Lund, J, additional, James, K, additional, Callaghan, M, additional, Vinayagam, R, additional, Poonawala, S, additional, Taylor, J, additional, Mullan, M, additional, Bright Thomas, R, additional, Gandhi, A, additional, Byrne, G, additional, Ibrahim, I, additional, Harvey, J, additional, Highton, L, additional, Chrysafi, A, additional, Jones, R Hawley, additional, Barnes, N, additional, Morris, O, additional, Chatterjee, S, additional, Mathen, V, additional, Majeed, Y, additional, Kirwan, C, additional, Jones, B Mancey, additional, El Sharief, D, additional, Munot, K, additional, Nasr, R, additional, and Frame, R, additional

Published
2018
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8. Longitudinal analyses of the effects of neutralizing antibodies on interferon beta-1b in relapsing-remitting multiple sclerosis

Author

Petkau, AJ, White, RA, Ebers, GC, Reder, AT, Sibley, WA, Lublin, FD, Paty, DW, Duquette, P, Girard, M, Despault, L, DuBois, R, Knobler, RL, Kelley, L, Francis, GS, Lapierre, Y, Antel, J, Freedman, M, Hum, S, Greenstein, JI, Mishra, B, Muldoon, J, Whitaker, JN, Evans, BK, Layton, B, Laguna, J, Krikawa, J, Oger, JJ, Kastrukoff, LF, Moore, GRW, Hashimoto, SA, Morrison, W, Nelson, J, Goodin, DS, Massa, SM, Gutteridge, E, Arnason, BGW, Noronha, A, Martia, R, Rice, GPA, Lesaux, J, Johnson, KP, Panitch, HS, Bever, CT, Conway, K, Wallenberg, JC, Bedell, L, van den Noort, S, Weinshenker, B, Weiss, W, Reingold, S, Pachner, A, and Taylor, W

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, Exacerbation, Neopterin, Gastroenterology, Antibodies, Central nervous system disease, Disability Evaluation, 03 medical and health sciences, Multiple Sclerosis, Relapsing-Remitting, 0302 clinical medicine, Adjuvants, Immunologic, Internal medicine, Secondary Prevention, medicine, Humans, Longitudinal Studies, 030212 general & internal medicine, Neutralizing antibody, Expanded Disability Status Scale, biology, business.industry, Multiple sclerosis, Interferon beta-1b, Interferon-beta, Middle Aged, medicine.disease, Confidence interval, Titer, Treatment Outcome, Neurology, Immunology, biology.protein, Female, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

We have analysed dataon exacerbation rates, Expanded Disability Status Scale (EDSS) scores, and lesion burdens using the results of two neutralizing antibody (NAB) assays (CPE and MxA) from the pivotal relapsing i/remitting multiple sclerosis (MS) trial of interferon beta-1b (IFNB) with a longitudinal approach, where the influence of NABs in individual patients is assessed by comparing responses during NABpositive and NAB-negative periods. There are apparent influences on exacerbation rate related to dose of IFNB, titer level, and duration of positivity. With the MxA assay, exacerbation rates after switching to NAB-positive status are estimated to be 28% higher [95% confidence interval (CI): ( o/15%, 92%)] and o/2% higher [95% CI: ( o/21%, 21%)] on the low- and high-dose IFNB arms, respectively. When compared with all NAB-negative periods, exacerbation rates during NAB-positive periods are estimated to be 29% higher [95% CI: (0%, 67%)] and 18% higher [95% CI: (0%, 40%)] on the low- and high-dose IFNB arms, respectively. When NAB-positive patients again become NAB-negative, no evidence of increased exacerbation rates could then be demonstrated. More detailed exploratory analyses indicate that the effects are most evident in the approximately 20% of patients developing high titers. In these patients, the influence of NABs may be self-limited, as titers often diminish or NABs become undetectable with time. Multiple Sclerosis (2004) 10, 126i/138

Published
2004

11. Neutralizing antibodies during treatment of multiple sclerosis with interferon beta-1b: Experience during the first three years

Author

Duquette, P, Girard, M, Dubois, R, Kobler, RL, Lublin, F, Kelley, L, Francis, GS, Freedman, M, Greenstein, JI, Mishra, B, DeLillio, N, Whitaker, J, Layton, B, Sibley, WA, Laguna, J, Krikawa, J, Paty, DW, Oger, JJ, Kastrukoff, LF, Morrison, W, Nelson, J, Goodin, D, Massa, SM, Gutteridge, E, Arnason, BGW, Noronha, A, Reder, AT, Martia, R, Ebers, GC, Rice, GPA, Lesaux, J, Johnson, KP, Panitch, HS, Bever, CT, Conway, K, Li, DKB, Tanton, EL, Zhao, GJ, Flak, B, Riddebough, A, Cover, K, Rhodes, B, Cook, A, Smith, K, Costley, L, Renneberg, S, Shaw, T, Genton, M, vandenNoort, S, Weinshenker, B, Weiss, W, Reingold, S, Taylor, W, Wallenberg, JC, Bedell, L, and Lublin, FD

Subjects
medicine.medical_specialty, Neurology, Expanded Disability Status Scale, Exacerbation, business.industry, Multiple sclerosis, Interferon beta-1b, medicine.disease, Placebo, Regimen, Internal medicine, Multicenter trial, medicine, Neurology (clinical), business
Abstract

Evidence of diminution of therapeutic efficacy in 35% of interferon beta-1b (IFNB)-treated multiple sclerosis (MS) patients who developed neutralizing antibodies (NABs) led to extensive study of the effects of NABs on therapeutic benefits, side effects, and magnetic resonance imaging (MRI) data. First, we validated the IFNB NAB assay used in the multicenter trial by having representative stored serum samples reanalyzed by an independent laboratory. When NABs developed (as defined), usually in the first year, the exacerbation rates after 18 months resembled placebo rates, the numbers of enlarging MRI lesions significantly increased compared with those in NAB-negative patients, and there was increased new lesion formation in the MRI (p = 0.067). However, worsening of the mean Expanded Disability Status Scale score in the 8-MIU treatment arm was higher in patients who remained NAB-negative in the third year (p = 0.083). NAB-positive patients were not overrepresented among the noncompleters, or in five patients having at least one episode of skin-site necrosis. After 18 months, flu-like symptoms were about twice as common in NAB-negative as in NAB-positive patients, although the frequency did not exceed 21% in any semester. Decisions to discontinue IFNB therapy should be made individually based on clinical response and a positive titer of NABs in the serum with the use of a reliable assay. ELISA and Western blot techniques measure binding antibodies, not NABs specifically, and are unsuitable for use. Possible, but as yet unproven, means of dealing with NAB positivity should be studied in properly designed trials. IFNB-1b remains an effective therapy for a majority (65%) of MS patients having relapses. The annual exacerbation rates in NAB-negative patients receiving the 8-MIU dosage regimen are about 50% of those seen in untreated patients, a greater reduction than the one-third reduction earlier reported for the entire high-dose arm, and a meaningful treatment benefit. NEUROLOGY 1996;47: 889-894

Published
1996

12. INTERFERON BETA-1B IN THE TREATMENT OF MULTIPLE-SCLEROSIS - FINAL OUTCOME OF THE RANDOMIZED CONTROLLED TRIAL

Author

DUQUETTE, P, DESPAULT, L, KNOBLER, R, LUBLIN, F, KELLEY, L, FRANCIS, G, FREEDMAN, M, LAPIERRE, Y, GREENSTEIN, J, MISHRA, B, DELILLIO, N, WHITAKER, J, LAYTON, B, SIBLEY, W, LAGUNA, J, KRIKAWA, J, PATY, D, OGER, J, KASTRUKOFF, L, MORRISON, W, NELSON, J, GOODIN, D, MASSA, S, GUTTERIDGE, E, ARNASON, B, NORONHA, A, REDER, A, MARTIA, R, EBERS, G, RICE, G, LESAUX, J, JOHNSON, K, PANITCH, H, BEVER, C, CONWAY, K, LI, D, TANTON, E, ZHAO, G, FLAK, B, RIDDEHOUGH, A, COVER, K, RHODES, B, COOK, A, SMITH, K, COSTLEY, L, RENNEBERG, S, SHAW, T, GENTON, M, VANDENNOORT, S, WEINSHENKER, B, WEISS, W, REINGOLD, S, TAYLOR, W, WALLENBERG, J, and BEDELL, L

Published
1995

32. Imaging overview of metaplastic carcinomas of the breast: a large study of 71 cases.

Author

Langlands F, Cornford E, Rakha E, Dall B, Gutteridge E, Dodwell D, Shaaban AM, and Sharma N

Abstract

Objective:: To review the clinical presentation, baseline imaging features, surgical management and final surgical pathology of metaplastic carcinoma of the breast., Methods:: A total of 71 cases were identified over a 10-year period from two major UK breast cancer institutions. Imaging at diagnosis including mammography, ultrasound, MRI and CT scans and histological diagnosis were reviewed. Follow-up data including local and systemic recurrence were retrieved., Results:: Of the 71 cases, 60 (84.5%) cases presented with a palpable lump. 60 (84.5%) cases showed a mass on mammography, of whom 47 (78.3%) cases were ill defined and 17.0% cases showed calcifications associated with a mass lesion. All 71 cases were seen as a mass on ultrasound. The imaging score was R3 or R4 in 26 cases and R5 in 47 cases. 16 patients underwent MRI with most (93.8%) showing a solid mass with central necrosis. No metastatic disease was seen in the 13 patients who underwent staging CT. Despite having a larger size, 50% of the cases successfully underwent breast conservative surgery. Positive axillary lymph nodes were seen in 11 (15.5%) cases., Conclusion:: In this series, metaplastic cancers were palpable in 85% cases, tended to be large at the time of presentation and imaging showed characteristics of malignancy. Only 11 (15.5%) cases had nodal involvement., Advances in Knowledge:: Metaplastic carcinomas are often palpable and of large size at the time of presentation. Metaplastic carcinomas raise the concern for malignancy on mammography and ultrasound, warranting further biopsy. Metaplastic carcinomas tend to be grade 3 and triple receptor negative.

Published
2016
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33. Biological effects of fulvestrant on estrogen receptor positive human breast cancer: short, medium and long-term effects based on sequential biopsies.

Author

Agrawal A, Robertson JF, Cheung KL, Gutteridge E, Ellis IO, Nicholson RI, and Gee JM

Subjects
Antineoplastic Agents, Hormonal therapeutic use, Biomarkers, Tumor genetics, Biomarkers, Tumor metabolism, Biopsy, Breast Neoplasms drug therapy, Breast Neoplasms mortality, Breast Neoplasms pathology, Cell Line, Tumor, Estradiol pharmacology, Estradiol therapeutic use, Estrogen Receptor Antagonists therapeutic use, Female, Fulvestrant, Gene Expression, Humans, Kaplan-Meier Estimate, Neoplasm Staging, Phosphorylation, Prognosis, Proto-Oncogene Proteins c-bcl-2 genetics, Proto-Oncogene Proteins c-bcl-2 metabolism, Receptors, Estrogen genetics, Receptors, Progesterone genetics, Receptors, Progesterone metabolism, Antineoplastic Agents, Hormonal pharmacology, Breast Neoplasms metabolism, Estradiol analogs & derivatives, Estrogen Receptor Antagonists pharmacology, Receptors, Estrogen metabolism
Abstract

We report the first study of the biological effect of fulvestrant on ER positive clinical breast cancer using sequential biopsies through to progression. Thirty-two locally/systemically advanced breast cancers treated with first-line fulvestrant (250 mg/month) were biopsied at therapy initiation, 6 weeks, 6 months and progression and immunohistochemically-analyzed for Ki67, ER, EGFR and HER2 expression/signaling activity. This series showed good fulvestrant responses (duration of response [DoR] = 25.8 months; clinical benefit = 81%). Ki67 fell (p < 0.001) in 79% of tumours by 6 months and lower Ki67 at all preprogression time-points predicted for longer DoR. ER and PR significantly decreased in all tumours by 6 months (p < 0.001), with some declines in ER (serine 118) phosphorylation and Bcl-2 (p = 0.007). There were modest HER2 increases (p = 0.034, 29% tumours) and loss of any detectable EGFR phosphorylation (p = 0.024, 50% tumours) and MAP kinase (ERK1/2) phosphorylation (p = 0.019, 65% tumours) by 6 months. While ER remained low, there was some recovery of Ki67, Bcl-2 and (weakly) EGFR/MAPK activity in 45-67% patients at progression. Fulvestrant's anti-proliferative impact is related to DoR, but while commonly downregulating ER and indicators of its signaling and depleting EGFR/MAPK signaling in some patients, additional elements must determine response duration. Residual ER at fulvestrant relapse explains reported sensitivity to further endocrine therapies. Occasional modest treatment-induced HER2 and weakly detectable EGFR/HER2/MAPK signaling at relapse suggests targeting of such activity might have value alongside fulvestrant in some patients. However, unknown pathways must drive relapse in most. Ki67 has biomarker potential to predict fulvestrant outcome and as a quantitative measure of response., (© 2015 The Authors. Published by Wiley Periodicals, Inc. on behalf of UICC.)

Published
2016
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34. The effects of gefitinib in tamoxifen-resistant and hormone-insensitive breast cancer: a phase II study.

Author

Gutteridge E, Agrawal A, Nicholson R, Cheung KL, Robertson J, and Gee J

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Hormonal therapeutic use, Biomarkers, Tumor analysis, Breast Neoplasms mortality, Disease-Free Survival, Drug Resistance, Neoplasm genetics, ErbB Receptors antagonists & inhibitors, Female, Gefitinib, Humans, Middle Aged, Neoplasm Recurrence, Local drug therapy, Receptors, Estrogen biosynthesis, Receptors, Estrogen genetics, Receptors, Progesterone biosynthesis, Receptors, Progesterone genetics, Tamoxifen therapeutic use, Antineoplastic Agents therapeutic use, Breast Neoplasms drug therapy, Drug Resistance, Neoplasm drug effects, Quinazolines therapeutic use
Abstract

Estrogen receptor (ER)-positive acquired tamoxifen-resistant (TAM-R) MCF-7 breast cancer cell lines exhibit epidermal growth factor receptor (EGFR) expression/signaling and are growth-inhibited by gefitinib (IRESSA). We examined the effect of gefitinib on ER-positive TAM-R and ER-negative hormone-insensitive breast cancer in a Phase II study. Fifty-four patients with breast cancer [ER-positive/acquired TAM-R (n = 28); ER-negative (n = 26)] received oral gefitinib 500 mg/day. Tumor biopsies were taken pre- (n = 28) and 8 weeks post-treatment (n = 14 matched samples). Gefitinib was well tolerated and the clinical benefit rate (objective response or stable disease >24 weeks) was 33.3% overall (n = 18/54), and 53.6 and 11.5% in ER-positive/TAM-R and ER-negative patients, respectively. Pretreatment ER and progesterone receptor-positivity were associated with response (p < 0.001 and 0.016, respectively) and longer progression-free survival (PFS; p= 0.001 and 0.013, respectively). All patients expressed EGFR, but high pretreatment levels predicted poorer outcome (p = 0.005) and shorter PFS (p = 0.012) with gefitinib. In patients with clinical benefit, reduced Ki67 staining during treatment (p = 0.024) was commonly observed, and those with >10% decline in EGFR phosphorylation demonstrated parallel decreases in ERK1/2 MAPK phosphorylation. Acquired tamoxifen resistance appears in part mediated through EGFR signaling and can be blocked with gefitinib.

Published
2010
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35. Are current drug development programmes realising the full potential of new agents? Tyrosine kinase inhibitors.

Author

Gutteridge E and Robertson JF

Subjects
Animals, Breast Neoplasms metabolism, Drug Industry methods, ErbB Receptors antagonists & inhibitors, ErbB Receptors metabolism, Erlotinib Hydrochloride, Female, Gefitinib, Humans, Lapatinib, Quinazolines therapeutic use, Receptor, ErbB-2 antagonists & inhibitors, Receptor, ErbB-2 metabolism, Technology, Pharmaceutical methods, Breast Neoplasms drug therapy, Drug Discovery, Protein Kinase Inhibitors therapeutic use
Published
2009
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