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1. Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Author

Bliss, Judith M., Tovey, Holly, Evans, Abigail, Holcombe, Chris, Horgan, Kieran, Mallon, Elizabeth, Vidya, Raghavan, Skene, Anthony, Dodson, Andrew, Hills, Margaret, Detre, Simone, Zabaglo, Lila, Banerji, Jane, Kilburn, Lucy, Morden, James P., Robertson, John F. R., Smith, Ian, and Dowsett, Mitch

Published
2023
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2. HER2-enriched subtype and novel molecular subgroups drive aromatase inhibitor resistance and an increased risk of relapse in early ER+/HER2+ breast cancer

Author

Evans, Abigail, Ball, Adrian, Johri, Akhil, Nejim, Ali, Jones, Alison, Corder, Allan, Thorne, Amanda, Anand, Ambika, Chakrabarti, Amitabha, Robinson, Anne, Skene, Anthony, Modi, Anupam, Patel, Ashraf, Kothari, Ashutosh, McFall, Brendan, Mortimer, Caroline, Lee, Caroline, Chan, Charlie, Abson, Charlotte, Holcombe, Christopher, Hinton, Christopher, Hollywood, Ciaran, Murphy, Claire, Crowley, Clare, Harding-Mackean, Claudia, Griffith, Clive, Lewanski, Conrad, Rea, Daniel, Hwang, David, Crawford, Derek, Thekkinkattil, Dinesh, Ferguson, Douglas, Adamson, Douglas, Wheatley, Duncan, Ravichandran, Duraisamy, Babu, Ed, Hyett, Elaine, Ashkanani, Fawzia, Hoar, Fiona, Kenny, Frances, Dyke, Gary, Sparrow, Geoffrey, Gilbert, Cunnick, Giles, Algurafi, Hafiz, Sweetland, Helen, Prof, Highes-Davies, Hamed, Hisham, Smith, Ian, Laidlaw, Ian, Khattak, Ilyas, Newby, Jacqueline, Rees-Lee, Jacqueline, Kokan, Jalal, Barrett, Jane, Naik, Jay Dolatrai, Vaidya, Jayant, Forrest, Jennifer, Parmar, Jitendra, Adams, Jocelyn, Fox, John, Roberts, Jonathan, Dawson, Jonathan, Doughty, Julie, Donnelly, Jull, Dunn, Kathleen, Chin, Kian, Horgan, Kieran, Thakur, Kislaya, Barthelmes, Ludger, Wyld, Lynda, Bhattacharyya, Madhumita, Hadaki, Maher, Kishore, Makam, Ornstein, Marcus, Bramley, Maria, Bews-Hair, Maria, Parton, Marina, Sibbering, Mark, Kissin, Mark, Churn, Mark, Hogg, Martin, Quigley, Mary, Hatton, Matthew, Winter, Matthew, Adelekan, Matthew, Shere, Michael, Carr, Michael, Williams, Michael, Absar, Mohammed, Sharif, Muhammad, Kelleher, Muireann, Walji, Nawaz, Williams, Nicholas, Gallegos, Nicholas, Bundred, Nigel, Hatcher, Olivia, Crellin, Perric, Crane, Peter, Donnelly, Peter, Kneeshaw, Peter, Walker, Philip, Sinha, Prakash, Bhaskar, Pudhupalayam, Soulsby, Racheal, Todd, Radha, Vidya, Raghavan, Mehra, Rakesh, Prasad, Ramachandran, Cutress, Ramsay, Sharma, Ravi, Roylance, Rebecca, Goranova, Rebecca, Salman, Reem Ramzi, Bonom, Riccardo, Johnson, Richard, Sutton, Richard, Linforth, Rick, Coleman, Rob, Grieve, Robert, Leonard, Robert, Reichert, Robert, Kennedy, Robert, Agarwal, Roshan, Allerton, Rozenn, Burcombe, Russell, Davis, Ruth, Narayanan, Sankaran, Chandrasekharan, Sankaran, Vesty, Sarah, Seetharam, Seema, Ledwidge, Serena, Iqbal, Shabana, Wahee, Shamaela, Silva, Shobha, Pain, Simon, Holt, Simon, Thomson, Simon, Smith, Simon, Ellenbogen, Simon, Laws, Siobhan, Chan, Stephen, Johnston, Stephen, Holt, Steve, Thrush, Steven, McIntosh, Stuart, Chatterjee, Sumohan, Cleator, Susan, Usman, Tamoor, Johnson, Tayo, Kovacs, Tibor, Irvine, Tracey, Barthkur, Urmila, Pope, Vanessa, Brown, Victoria Alexandra, Muralikrishna, Vummiti, Samra, Walid, Maxwell, William, Winters, Zoe, Bergamino, Milana A., López-Knowles, Elena, Morani, Gabriele, Tovey, Holly, Kilburn, Lucy, Schuster, Eugene F., Alataki, Anastasia, Hills, Margaret, Xiao, Hui, Holcombe, Chris, Robertson, John F., Smith, Ian E., Bliss, Judith M., Dowsett, Mitch, and Cheang, Maggie C.U.

Published
2022
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3. Overall survival after mastectomy versus breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer: meta-analysis.

Author

Rajan, Kiran K, Fairhurst, Katherine, Birkbeck, Beth, Novintan, Shonnelly, Wilson, Rebecca, Savović, Jelena, Holcombe, Chris, and Potter, Shelley

Subjects
LUMPECTOMY, RADIOTHERAPY, BREAST cancer, MASTECTOMY, OVERALL survival, NEOADJUVANT chemotherapy
Abstract

Background Breast-conserving surgery with adjuvant radiotherapy and mastectomy are currently offered as equivalent surgical options for early-stage breast cancer based on RCTs from the 1970s and 1980s. However, the treatment of breast cancer has evolved and recent observational studies suggest a survival advantage for breast-conserving surgery with adjuvant radiotherapy. A systematic review and meta-analysis was undertaken to summarize the contemporary evidence regarding survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for women with early-stage breast cancer. Methods A systematic search of MEDLINE, the Cochrane Central Register of Controlled Trials (CENTRAL), and Embase that identified studies published between 1 January 2000 and 18 December 2023 comparing overall survival after breast-conserving surgery with adjuvant radiotherapy versus mastectomy for patients with unilateral stage 1–3 breast cancer was undertaken. The main exclusion criteria were studies evaluating neoadjuvant chemotherapy, rare breast cancer subtypes, and specific breast cancer populations. The ROBINS-I tool was used to assess risk of bias, with the overall certainty of evidence assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tool. Studies without critical risk of bias were included in a quantitative meta-analysis. Results From 11 750 abstracts, 108 eligible articles were identified, with one article including two studies; 29 studies were excluded from the meta-analysis due to an overall critical risk of bias, 42 studies were excluded due to overlapping study populations, and three studies were excluded due to reporting incompatible results. A total of 35 observational studies reported survival outcomes for 909 077 patients (362 390 patients undergoing mastectomy and 546 687 patients undergoing breast-conserving surgery with adjuvant radiotherapy). The pooled HR was 0.72 (95% c.i. 0.68 to 0.75, P < 0.001), demonstrating improved overall survival for patients undergoing breast-conserving surgery with adjuvant radiotherapy. The overall certainty of the evidence was very low. Conclusion This meta-analysis provides evidence suggesting a survival advantage for women undergoing breast-conserving surgery with adjuvant radiotherapy for early-stage breast cancer compared with mastectomy. Although these results should be interpreted with caution, they should be shared with patients to support informed surgical decision-making. [ABSTRACT FROM AUTHOR]

Published
2024
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7. Abstract P2-03-07: Multi-parametric algorithm integrating on-treatment Ki67 value and standard clinicopathological variables to predict risk of recurrences for women &gt; 70 years old with early ER+HER2- tumours in POETIC trial

Author

Cheang, Maggie Chon U, primary, Dewan, Monisha, additional, Kilburn, Lucy, additional, Morani, Gabriele, additional, Zabaglo, Lila, additional, Sidhu, Kally, additional, Tovey, Holly, additional, Zhu, Xixuan, additional, Holcombe, Chris, additional, Skene, Anthony, additional, Smith, Ian, additional, Robertson, John, additional, Ring, Alistair, additional, Turner, Nicholas, additional, Bliss, Judith, additional, and Dowsett, Mitch, additional

Published
2023
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8. Abstract PD15-10: PD15-10 Impact of procedure type on long-term revisional surgery and secondary reconstruction following immediate breast reconstruction: The UK Brighter national population-based cohort study

Author

Johnson, Leigh, primary, White, Paul, additional, Jeevan, Ranjeet, additional, Browne, John, additional, Gulliver-Clarke, Carmel, additional, O’Donoghue, Joe, additional, Mohiuddin, Syed, additional, Hollingworth, William, additional, Fairbrother, Patricia, additional, MacKenzie, Mairead, additional, Holcombe, Chris, additional, and Potter, Shelley, additional

Published
2023
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10. Abstract PD15-09: PD15-09 Impact of procedure type on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter Study

Author

Johnson, Leigh, primary, White, Paul, additional, Jeevan, Ranjeet, additional, Browne, John, additional, Gulliver-Clarke, Carmel, additional, O’Donoghue, Joe, additional, Mohiuddin, Syed, additional, Hollingworth, William, additional, Fairbrother, Patricia, additional, MacKenzie, Mairead, additional, Holcombe, Chris, additional, and Potter, Shelley, additional

Published
2023
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11. Abstract P2-03-08: Deconstructing the molecular characteristics of ER+ HER2+ early breast cancer in the POETIC trial using multiplex immunofluorescence and gene expression profiles

Author

Zhu, Xixuan, primary, Xiao, Hui, additional, López-Knowles, Elena, additional, Sirvén, Milana A. Bergamino, additional, Alataki, Anastasia, additional, Maxwell, Perry, additional, Tovey, Holly, additional, Kilburn, Lucy, additional, Holcombe, Chris, additional, Skene, Anthony, additional, Smith, Ian, additional, Robertson, John, additional, Hoadley, Katherine A, additional, Salgado, Roberto, additional, Bliss, Judith, additional, Turner, Nicholas, additional, Salto-Tellez, Manuel, additional, Schuster, Gene, additional, Dowsett, Mitch, additional, and Cheang, Maggie Chon U, additional

Published
2023
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12. Abstract P2-15-03: Impact of radiotherapy on the long-term patient-reported outcomes of immediate breast reconstruction: The UK Brighter

Author

Johnson, Leigh, primary, White, Paul, additional, Jeevan, Ranjeet, additional, Browne, John, additional, Gulliver-Clarke, Carmel, additional, O’Donoghue, Joe, additional, Mohiuddin, Syed, additional, Hollingworth, William, additional, Fairbrother, Patricia, additional, MacKenzie, Mairead, additional, Holcombe, Chris, additional, and Potter, Shelley, additional

Published
2023
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13. Correction: Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Author

Dave, Rajiv V., Kim, Baek, Courtney, Alona, O’Connell, Rachel, Rattay, Tim, Taxiarchi, Vicky P., Kirkham, Jamie J., Camacho, Elizabeth M., Fairbrother, Patricia, Sharma, Nisha, Cartlidge, Christopher W. J., Horgan, Kieran, McIntosh, Stuart A., Leff, Daniel R., Vidya, Raghavan, Potter, Shelley, Holcombe, Chris, Copson, Ellen, Coles, Charlotte E., Cutress, Ramsey I., Gandhi, Ashu, and Kirwan, Cliona C.

Published
2021
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14. The TeaM (Therapeutic Mammaplasty) study: Protocol for a prospective multi-centre cohort study to evaluate the practice and outcomes of therapeutic mammaplasty

Author

Baker, Elizabeth, Kim, Baek, Rattay, Tim, Williams, Kathryn, Ives, Charlotte, Remoundos, Dennis, Holcombe, Chris, Gardiner, Matthew D., Jain, Abhilash, Sutton, Richard, Achuthan, Rajgopal, Turton, Philip, Fairbrother, Patricia, Brock, Lisa, Aggarwal, Shweta, Basu, Naren, Murphy, John, Trickey, Adam, Macmillan, R. Douglas, and Potter, Shelley

Published
2016
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15. Bridging pre-surgical endocrine therapy for breast cancer during the COVID-19 pandemic: outcomes from the B-MaP-C study

Author

Dave, Rajiv, Elsberger, Beatrix, Taxiarchi, Paraskevi, Gandhi, Ashu, Kirwan, Cliona, Kim, Baek, Camacho, Liz, Coles, Charlotte, Copson, Ellen, Courtney, Alona, Horgan, Kieran, Fairbrother, Patricia, Holcombe, Chris, Kirkham, Jamie, Leff, Daniel, McIntosh, Stuart, O’Connell, Rachel, Pardo, Ricardo, Potter, Shelley, Rattay, Tim, Sharma, Nisha, Vidya, Raghavan, and Cutress, Ramsey

Subjects
Breast cancer, SDG 3 - Good Health and Well-being, COVID-19, Neoadjuvant endocrine therapy, Bridging endocrine therapy
Abstract

Purpose: The B-MaP-C study investigated changes to breast cancer care that were necessitated by the COVID-19 pandemic. Here we present a follow-up analysis of those patients commenced on bridging endocrine therapy (BrET), whilst they were awaiting surgery due to reprioritisation of resources.Methods: This multicentre, multinational cohort study recruited 6045 patients from the UK, Spain and Portugal during the peak pandemic period (Feb-July 2020). Patients on BrET were followed up to investigate the duration of, and response to, BrET. This included changes in tumour size to reflect downstaging potential, and changes in cellular proliferation (Ki67), as a marker of prognosis.Results: 1094 patients were prescribed BrET, over a median period of 53 days (IQR 32-81 days). The majority of patients (95.6%) had strong ER expression (Allred score 7-8/8). Very few patients required expedited surgery, due to lack of response (1.2%) or due to lack of tolerance/compliance (0.8%). There were small reductions in median tumour size after 3 months' treatment duration; median of 4 mm [IQR - 20, 4]. In a small subset of patients (n = 47), a drop in cellular proliferation (Ki67) occurred in 26 patients (55%), from high (Ki67 ≥ 10%) to low (< 10%), with at least one month's duration of BrET.Discussion: This study describes real-world usage of pre-operative endocrine therapy as necessitated by the pandemic. BrET was found to be tolerable and safe. The data support short-term (≤ 3 months) usage of pre-operative endocrine therapy. Longer-term use should be investigated in future trials.

Published
2023

16. Menstrual cycle associated changes in hormone-related gene expression in oestrogen receptor positive breast cancer

Author

Haynes, Ben P., Ginsburg, Ophira, Gao, Qiong, Folkerd, Elizabeth, Afentakis, Maria, Buus, Richard, Quang, Le Hong, Thi Han, Pham, Khoa, Pham Hong, Dinh, Nguyen Van, To, Ta Van, Clemons, Mark, Holcombe, Chris, Osborne, Caroline, Evans, Abigail, Skene, Anthony, Sibbering, Mark, Rogers, Clare, Laws, Siobhan, Noor, Lubna, Smith, Ian E., and Dowsett, Mitch

Published
2019
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17. Helicobacter pylori : its role in the aetiology of non-ulcer dyspepsia in northern Nigeria

Author

Holcombe, Chris

Subjects
616.3
Abstract

In a pilot study dyspepsia was found to account for 20/1,000 admissions at the University of Maiduguri Teaching Hospital, in Northern Nigeria, the majority of these patients had non-ulcer dyspepsia. In a prospective study of patients presenting with carefully defined non-ulcer dyspepsia 53 of 57 patients had gastritis and of these 46/53 (87%) were infected by the bacteria Helicobacter pylori (H.pvlori). As a result of this pilot study and a subsequent review of the literature it was hypothesised that H.pvlori is the cause of non-ulcer dyspepsia in northern Nigeria. The strong association of H.pylori with non-ulcer dyspepsia was confirmed in a prospective study of 138 patients, 126 (91%) of whom had gastritis and of these 120 (95%) were infected by H.pvlori. However this high prevalence of H.pvlori infection must be judged against the prevalence of infection in the general population. In a random serological survey 228/268 (85%) subjects over 5 years had IgG antibodies to H.pylori. This is not significantly different from that found in patients with nonulcer dyspepsia (87%). H.pvlori infection was also present in 80% of 40 asymptomatic volunteers. H.pvlori acting alone does not cause non-ulcer dyspepsia, but may play a role in combination with other factors. If this is the case, clearance of the organism should lead to improvement or resolution of symptoms. Therefore 130 patients were entered into a therapeutic trial of a combination antacid (Gelusil) one tablet four times a day versus an anti-H.pylori regime (DeNol 240 mg four times a day and amoxycillin, 500mg four times a day for the first 14 days). One hundred and nine patients were reassessed at the end of treatment. Symptoms completely resolved in 1 of 23 patients (4.4%) who had taken Gelusil and 28 of 86 (32%) of patients who had taken bismuth & amoxycillin, a statistically significant difference (p<0.01). However, resolution of symptoms was not related to H.pvlori clearance. These studies do not provide any evidence to support a role for H.pvlori in the cause of non-ulcer dyspepsia in northern Nigeria, thus disproving the hypothesis.

Published
1992

18. Correction: Proliferation and AKT Activity Biomarker Analyses after Capivasertib (AZD5363) Treatment of Patients with ER+ Invasive Breast Cancer (STAKT)

Author

Robertson, John F.R., primary, Coleman, Robert E., additional, Cheung, Kwok-Leung, additional, Evans, Abigail, additional, Holcombe, Chris, additional, Skene, Anthony, additional, Rea, Daniel, additional, Ahmed, Samreen, additional, Jahan, Ali, additional, Horgan, Kieran, additional, Rauchhaus, Petra, additional, Littleford, Roberta, additional, Amy Cheung, S.Y., additional, Cullberg, Marie, additional, de Bruin, Elza C., additional, Koulai, Loumpiana, additional, Lindemann, Justin P.O., additional, Pass, Martin, additional, Rugman, Paul, additional, Schiavon, Gaia, additional, Deb, Rahul, additional, Finlay, Pauline, additional, Foxley, Andrew, additional, and Gee, Julia M.W., additional

Published
2022
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19. Additional file 3 of Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Author

Bliss, Judith M., Tovey, Holly, Evans, Abigail, Holcombe, Chris, Horgan, Kieran, Mallon, Elizabeth, Vidya, Raghavan, Skene, Anthony, Dodson, Andrew, Hills, Margaret, Detre, Simone, Zabaglo, Lila, Banerji, Jane, Kilburn, Lucy, Morden, James P., Robertson, John F. R., Smith, Ian, and Dowsett, Mitch

Abstract

Additional file 3: Fig. S3. Log fold change in Ki67 A. for patients allocated control by sample. type, B. for patients allocated AI by sample type and choice of AI. Presented separately for HER2- and HER2- patients.

Published
2023
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20. Additional file 1 of Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Author

Bliss, Judith M., Tovey, Holly, Evans, Abigail, Holcombe, Chris, Horgan, Kieran, Mallon, Elizabeth, Vidya, Raghavan, Skene, Anthony, Dodson, Andrew, Hills, Margaret, Detre, Simone, Zabaglo, Lila, Banerji, Jane, Kilburn, Lucy, Morden, James P., Robertson, John F. R., Smith, Ian, and Dowsett, Mitch

Abstract

Additional file 1: Fig. S1. Distribution of Ki67Baseline a. Distribution of Ki67 % positive cells b. Distribution of ln(Ki67+0.1) c. Distribution of Ki67Baseline by HER2 status

Published
2023
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21. Additional file 2 of Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Author

Bliss, Judith M., Tovey, Holly, Evans, Abigail, Holcombe, Chris, Horgan, Kieran, Mallon, Elizabeth, Vidya, Raghavan, Skene, Anthony, Dodson, Andrew, Hills, Margaret, Detre, Simone, Zabaglo, Lila, Banerji, Jane, Kilburn, Lucy, Morden, James P., Robertson, John F. R., Smith, Ian, and Dowsett, Mitch

Abstract

Additional file 2: Fig. S2. Distribution of A. log(Ki67Baseline +0.1) for all patients, B. log(Ki672week +0.1) in patients allocated control, C. log fold. change Ki67 in patients allocated control, D. log(Ki672week +0.1) in patients allocated AI and E. log fold change Ki67 in patients allocated AI. Presented separately for HER2- and HER2+ patients.

Published
2023
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22. Additional file 4 of Clinico-pathologic relationships with Ki67 and its change with short-term aromatase inhibitor treatment in primary ER + breast cancer: further results from the POETIC trial (CRUK/07/015)

Author

Bliss, Judith M., Tovey, Holly, Evans, Abigail, Holcombe, Chris, Horgan, Kieran, Mallon, Elizabeth, Vidya, Raghavan, Skene, Anthony, Dodson, Andrew, Hills, Margaret, Detre, Simone, Zabaglo, Lila, Banerji, Jane, Kilburn, Lucy, Morden, James P., Robertson, John F. R., Smith, Ian, and Dowsett, Mitch

Abstract

Additional file 4: Table S1. Univariable and multivariable linear regression results for change in Ki67 in patients allocated to control by HER2 status. Table S2. Multivariable linear regression results for change in Ki67 in patients allocated to control by HER2 status showing adjustment for sample type. Table S3. Multivariable linear regression results for change in Ki67 in patients allocated to AI by HER2 status showing adjustment for sample type and AI choice. Table S4. CCCA by AI and sample type in patients allocated AI.

Published
2023
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23. Improving outcomes for women aged 70 years or above with early breast cancer: research programme including a cluster RCT

Author

Wyld, Lynda, primary, Reed, Malcolm WR, additional, Collins, Karen, additional, Ward, Sue, additional, Holmes, Geoff, additional, Morgan, Jenna, additional, Bradburn, Mike, additional, Walters, Stephen, additional, Burton, Maria, additional, Lifford, Kate, additional, Edwards, Adrian, additional, Brain, Kate, additional, Ring, Alistair, additional, Herbert, Esther, additional, Robinson, Thompson G, additional, Martin, Charlene, additional, Chater, Tim, additional, Pemberton, Kirsty, additional, Shrestha, Anne, additional, Nettleship, Anthony, additional, Richards, Paul, additional, Brennan, Alan, additional, Cheung, Kwok Leung, additional, Todd, Annaliza, additional, Harder, Helena, additional, Audisio, Riccardo, additional, Battisti, Nicolo Matteo Luca, additional, Wright, Juliet, additional, Simcock, Richard, additional, Murray, Christopher, additional, Thompson, Alastair M, additional, Gosney, Margot, additional, Hatton, Matthew, additional, Armitage, Fiona, additional, Patnick, Julietta, additional, Green, Tracy, additional, Revill, Deirdre, additional, Gath, Jacqui, additional, Horgan, Kieran, additional, Holcombe, Chris, additional, Winter, Matt, additional, Naik, Jay, additional, and Parmeshwar, Rishi, additional

Published
2022
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24. Observational cohort study in older women with early breast cancer: Use of radiation therapy and impact on health-related quality of life and mortality

Author

Hatton, Matthew Q., Reed, Malcolm W.R., Herbert, Esther, Morgan, Jenna L., Bradburn, Michael, Simcock, Richard, Walters, Stephen J., Collins, Karen A., Ward, Sue E., Holmes, Geoffrey R., Burton, Maria, Lifford, Kate J., Edwards, Adrian, Robinson, Thompson G., Martin, Charlene, Chater, Tim, Pemberton, Kirsty J., Brennan, Alan, Leung Cheung, Kwok, Todd, Annaliza, Audisio, Riccardo A., Wright, Juliet, Green, Tracy, Revell, Deirdre, Gath, Jacqui, Horgan, Kieran, Holcombe, Chris, Winter, Matthew C., Naik, Jay, Parmeshwar, Rishi, Gosney, Margot A., Thompson, Alastair M., Wyld, Lynda, and Ring, Alistair

Subjects
Oncology, Radiology Nuclear Medicine and imaging, Hematology
Published
2021

25. Best-BRA (Is subpectoral or prepectoral implant placement best in immediate breast reconstruction?): a protocol for a pilot randomised controlled trial of subpectoral versus prepectoral immediate implant-based breast reconstruction in women following mastectomy

Author

Roberts, Kirsty, primary, Mills, Nicola, additional, Metcalfe, Chris, additional, Lane, Athene, additional, Clement, Clare, additional, Hollingworth, William, additional, Taylor, Jodi, additional, Holcombe, Chris, additional, Skillman, Joanna, additional, Fairhurst, Katherine, additional, Whisker, Lisa, additional, Cutress, Ramsey, additional, Thrush, Steven, additional, Fairbrother, Patricia, additional, and Potter, Shelley, additional

Published
2021
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26. Protocol for a national cohort study to explore the long-term clinical and patient-reported outcomes and cost-effectiveness of implant-based and autologous breast reconstruction after mastectomy for breast cancer: the brighter study

Author

Johnson, Leigh, primary, Holcombe, Chris, additional, O’Donoghue, Joe M, additional, Jeevan, Ranjeet, additional, Browne, John, additional, Fairbrother, Patricia, additional, MacKenzie, Mairead, additional, Gulliver-Clarke, Carmel, additional, White, Paul, additional, Mohiuddin, Syed, additional, Hollingworth, William, additional, and Potter, Shelley, additional

Published
2021
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27. Bridging the Age Gap in breast cancer: Impact of chemotherapy on quality of life in older women with early breast cancer

Author

Reed, Malcolm W.R., Herbert, Esther, Morgan, Jenna L., Collins, Karen A., Ward, Sue E., Holmes, Geoffrey R., Bradburn, Michael, Walters, Stephen J., Burton, Maria, Lifford, Kate, Edwards, Adrian, Robinson, Thompson G., Martin, Charlene, Chater, Tim, Pemberton, Kirsty J., Shrestha, Anne, Brennan, Alan, Cheung, Kwok L., Todd, Annaliza, Audisio, Riccardo A., Wright, Juliet, Simcock, Richard, Green, Tracey, Revell, Deirdre, Gath, Jacqui, Horgan, Kieran, Holcombe, Chris, Winter, Matthew C., Naik, Jay, Parmeshwar, Rishi, Gosney, Margot A., Hatton, Matthew Q., Thompson, Alastair M., Wyld, Lynda, and Ring, Alistair

Subjects
Breast cancer, Older patients, Adjuvant chemotherapy, Quality of life
Abstract

Introduction: Older patients with early breast cancer (EBC) derive modest survival benefit from chemotherapy but have increased toxicity risk. Data on the impact of chemotherapy for EBC on quality of life in older patients are limited, but this is a key determinant of treatment acceptance. We aimed to investigate its effect on quality of life in older patients enrolled in the Bridging the Age Gap study.Materials and methods: A prospective, multicentre, observational study of EBC patients ≥70 years old was conducted in 2013–2018 at 56 UK hospitals. Demographics, patient, tumour characteristics, treatments and adverse events were recorded. Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires (EORTC-QLQ) C30, BR23 and ELD 15 plus the Euroqol-5D (eq-5d) over 24 months and analysed at each time point using baseline adjusted linear regression analysis and propensity score-matching.Results: Three thousand and four hundred sixteen patients were enrolled in the study; 1520 patients undergoing surgery and who had high-risk EBC were included in this analysis. 376/1520 (24.7%) received chemotherapy. At 6 months, chemotherapy had a significant negative impact in several EORTC-QLQ-C30 domains, including global health score, physical, role, social functioning, cognition, fatigue, nausea/vomiting, dyspnoea, appetite loss, diarrhoea and constipation. Similar trends were documented on other scales (EORTC-QLQ-BR23, EORTC-QLQ-ELD15 and EQ-5D-5L). Its impact was no longer significant at 18–24 months in unmatched and matched cohorts.Conclusions: The negative impact of chemotherapy on quality-of-life is clinically and statistically significant at 6 months but resolves by 18 months, which is crucial to inform decision-making for older patients contemplating chemotherapy.Trial registration number ISRCTN 46099296.

Published
2021

28. Exploring women’s experiences of implant loss after immediate implant-based breast reconstruction:A qualitative study

Author

Mahoney, Bere, Walklet, Elaine, Bradley, Eleanor, Thrush, Steven, Skillman, Joanna, Whisker, Lisa, Barnes, Nicola, Holcombe, Chris, and Potter, Shelley

Subjects
breast cancer, implant based reconstruction, Qualitative study
Abstract

Background: Immediate implant-based breast reconstruction (IBBR) is the most commonly performed reconstructive procedure in the UK but almost one-in-ten women will experience implant loss and reconstructive failure following this technique. Little is known about how implant loss impacts on patients’ quality-of-life. The first phase of the LiBRA study aimed to use qualitative methods to explore women’s experiences of implant loss and develop recommendations to improve care. Methods: Semi-structured interviews were conducted with a purposive sample of women who experienced implant loss following immediate IBBR, for malignancy or risk-reduction across six centres. Interviews explored decision-making for IBBR and experiences of implant loss and support received. Thematic analysis was used to explore the qualitative interview data. Sampling, data collection and analysis were undertaken concurrently and iteratively until data saturation was achieved. Results: Twenty-four patients were interviewed; 19 had surgery for malignancy and 5 for risk-reduction. The median time between implant loss and interview was 42 months (range 22-52). Ten women had undergone secondary reconstruction; two were awaiting surgery and 12 had declined further reconstruction. Three key themes were identified. These were the need for: i) accurate information about the risks and benefits of IBBR; ii) more information about ‘early-warning’ signs of post-operative problems to empower women to seek help; and, iii) better support for patients following implant-loss. Conclusions: Implant loss is a devastating event for many women but better information and support preoperatively and more holistic patient-centred care for patients who develop complications may significantly improve the experience and outcome of care.

Published
2020

29. MOESM11 of Impact of aromatase inhibitor treatment on global gene expression and its association with antiproliferative response in ER+ breast cancer in postmenopausal patients

Author

Gao, Qiong, López-Knowles, Elena, Cheang, Maggie, Morden, James, Ribas, Ricardo, Kally Sidhu, Evans, David, Martins, Vera, Dodson, Andrew, Skene, Anthony, Holcombe, Chris, Mallon, Elizabeth, Evans, Abigail, Bliss, Judith, Robertson, John, Smith, Ian, Lesley-Ann Martin, and Dowsett, Mitch

Subjects
sense organs, skin and connective tissue diseases
Abstract

Additional file 11: Figure S8. Heatmap of Spearman correlations (r-value and p -value) between change in gene signature scores and i) percentage of 2-week change in Ki67 protein expression and ii) residual KI67. r-values bottom, p-values top. (a) HER2- tumours, n=135. (b) HER2+ tumours, n=22.

Published
2020
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32. Additional file 1 of Rivaroxaban compared to no treatment in ER-negative stage I–III early breast cancer patients (the TIP Trial): study protocol for a phase II preoperative window-of-opportunity study design randomised controlled trial

Author

Castle, John, Blower, Emma, Bundred, Nigel J., Harvey, James R., Jecko Thachil, Marshall, Andrea, Cox, Karina, Cicconi, Silvia, Holcombe, Chris, Palmieri, Carlos, and Cliona C. Kirwan

Abstract

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2020
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33. Abstract GS2-02: 12 year results of anastrozole versus tamoxifen for the prevention of breast cancer in postmenopausal women with locally excised ductal carcinoma in-situ

Author

Sestak, Ivana, primary, Cuzick, Jack, additional, Bonanni, Bernardo, additional, Bundred, Nigel, additional, Levy, Christelle, additional, Loib, Sibylle, additional, Neven, Patrick, additional, Stierer, Michael, additional, Holcombe, Chris, additional, Coleman, Robert, additional, Forbes, John, additional, and Howell, Anthony, additional

Published
2021
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34. A Novel Mixed-Methods Platform Study Protocol for Investigating New Surgical Devices, with Embedded Shared Learning: Ibra-net Breast Lesion Localisation Study

Author

Bromley, Hannah L., primary, Dave, Rajiv, additional, Holcombe, Chris, additional, Potter, Shelley, additional, Maxwell, Anthony J., additional, Kirwan, Cliona, additional, Mylvaganam, Senthurun, additional, Elgammal, Suzanne, additional, Morgan, Jenna, additional, Down, Sue, additional, Masudi, Tahir, additional, Sami, Amtul, additional, Barnes, Nicola, additional, and Harvey, James, additional

Published
2021
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35. Proliferation and AKT Activity Biomarker Analyses after Capivasertib (AZD5363) Treatment of Patients with ER+ Invasive Breast Cancer (STAKT)

Author

Robertson, John F.R., primary, Coleman, Robert E., additional, Cheung, Kwok-Leung, additional, Evans, Abigail, additional, Holcombe, Chris, additional, Skene, Anthony, additional, Rea, Daniel, additional, Ahmed, Samreen, additional, Jahan, Ali, additional, Horgan, Kieran, additional, Rauchhaus, Petra, additional, Littleford, Roberta, additional, Cheung, S.Y. Amy, additional, Cullberg, Marie, additional, de Bruin, Elza C., additional, Koulai, Loumpiana, additional, Lindemann, Justin P.O., additional, Pass, Martin, additional, Rugman, Paul, additional, Schiavon, Gaia, additional, Deb, Rahul, additional, Finlay, Pauline, additional, Foxley, Andrew, additional, and Gee, Julia M.W., additional

Published
2019
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36. The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study

Author

O’Connell, Rachel L., Rattay, Tim, Dave, Rajiv V., Trickey, Adam, Skillman, Joanna, Barnes, Nicola L. P., Gardiner, Matthew, Harnett, Adrian, Potter, Shelley, Holcombe, Chris, iBRA-2 Steering Group, Breast Reconstruction Research Collaborative, and Malata, Charles M.

Abstract

Background:\ud \ud Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy.\ud \ud Methods:\ud \ud Consecutive women undergoing mastectomy ± IBR for breast cancer July–December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored.\ud \ud Results:\ud \ud A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays.\ud \ud Conclusions:\ud \ud IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients.

Published
2019

37. The impact of immediate breast reconstruction on the time to delivery of adjuvant therapy: the iBRA-2 study

Author

O'Connell, Rachel L, Rattay, Tim, Dave, Rajiv V, Trickey, Adam, Skillman, Joanna, Barnes, Nicola LP, Gardiner, Matthew, Harnett, Adrian, Potter, Shelley, Holcombe, Chris, Blazeby, Jane, Conroy, Elizabeth, O'Brien, Ciara, Williamson, Paula, Curnier, Alain, Tadros, Amir, Depasquale, Ivan, Masannat, Yazan A, Smyth, Elizabeth, Fuller, Mairi, Bourne, Roger, Heys, Steven, Hamo, Ishrak, Aloraifi, Fatima, Fopp, Laura, Bali, Radhika, Bache, Sarah, Benyon, Sarah L, Irwin, Michael S, Agrawal, Amit, Malata, Charles M, Murphy, Claire, Misky, Adam, Chicken, Dennis Wayne, Abdullah, Nassreen, Hill, Arnold DK, Cullinane, Carolyn, Irwin, Gareth, McIntosh, Stuart A, Refsum, Sigi, Sloan, Samantha, Mallon, Peter, Sirianni, Chiara, Khattak, Ilyas, Nagachandra, Geerthan, Kiruparan, Pasupathy, Debanth, Debasish, Davey, Simon, Curran, Terry-Ann, Svenning, Matilda, Govindarajulu, Sasirekha, Rayter, Zenon, Ainsworth, Rachel, Cawthorn, Simon, Sahu, Ajay, Wilson, Sherif, Prousskaia, Elena, Accurso, Antonello, Rocco, Nicola, Di Micco, Rosa, Limite, Gennaro, Ceccarino, Raffaele, Liccardo, Raffaele, Coco, Guido, Nizamoglu, Metin, Morgan, Mary, Ramakrishnan, Venkat, Catanuto, Giuseppe, Wilkins, Alex, McManus, Penelope, Kneeshaw, Peter, Grover, Kartikae, Mahapatra, Tapan, Wooler, Brendan, Elahi, Bilal, Ihsan, Naila, Bucknor, Alexandra, Reissis, Dimitris, Hunter, Judith, Wood, Simon, Jallali, Navid, Henry, Francis P, Verjee, Liaquat S, Lee, Jason, Khan, Shazia M, Azmy, Iman, Massey, Julia, Hollywood, Ciaran, Oluwajana, Michael, Bathla, Sonia, Seward, Joanna, Harding-MacKean, Claudia, Lane, Risha, Murali, Kothandaraman, Biswas, Bashishta, Trapszo, Pawel, Seetharam, Seema, Kennedy, Katy, Alder, Louise, Graja, Tomasz, Amin, Khalid, Kokan, Jalal, Roshanlall, Chandeena, Gill, Emma, Kulkarni, Dhananjay, Dixon, JM, Young, Oliver, Saleem, Talha, Biddle, M, Kearns, Marie, Weiler-Mithoff, Eva, Chew, Ben, Malyon, Andy, Scott, John, McGill, David, Mackay, Iain, Bains, Salena, Barrows, Sara, Pilgrim, Simon, Shokuhi, Sheila, Lambert, Kelly, Kenny, Frances, Valassiadou, Kalliope, Kaushik, Monika, Krupa, Jaroslaw, Dragoumis, Dimitris, Ain, Quratul, Lampropoulos, Pavlos, Moss, Sarah, Khalil, Haitham, Haq, Anwar, Balasubramanian, Balapathiran, Charalampou-Dis, Petros, Hamed, Hisham, Kothari, Ashutosh, Kovacs, Tibor, Douek, Michael, Mehmood, Iftikhar, Ray, Biswajit, Adelekan, Matthew, Humphreys, Laura, Tayeh, Salim, Choy, Christina, Parvanta, Laila, Michieletto, Silvia, Saibene, Tania, O'Brien, James, Down, Sue, Downey, Sarah, Pereira, Jerome, Sami, AS, Gvaramadze, Anzors, Jibril, Jibril A, Thekkinkattil, Dinesh, Udayasankar, S, Khawaja, Saira, Shariaha, Yousef, Holt, Simon, James, Ruth, Rizki, Hirah, Kirkpatrick, Katharine, Ravichandran, Duraisamy, Shrestha, Deepak, Barua, Ellora, Akolekar, Deepika, Hamad, Ahmed, Kleidi, Eleftheria, Hignett, Susan, Pope, Vanessa, Naseem, Salma, Isherwood, Jennifer, Soulsby, Rachel, Taylor, Amanda, Chin, Kian, Nguyen, Dai, Guest, Francesca, Thorne, Amanda, Kirchhoff, Chris, Murphy, Declan C, Lo, Michelle, Harcourt, Ruth, Pain, Simon J, Hussien, Maged I, Zechmeister, Katalin, Sassoon, EM, Figus, Andrea, Haywood, Richard M, Ali, Rozina, Alexander, Susanna, Geropantas, Konstantinos, Epurescu, Daniel, Lewis, Rebecca, Fafemi, Oladapo, Gahir, Jasdeep, Gandamihardja, Tasha, Kelsall, Jennett, Muhibullah, Nazli, Otieno, Charlene, Mazari, Fayyaz, Dauria, Marta, Whisker, Lisa, Macmillan, Douglas, Gutteridge, Eleanor, Rasheed, Tuabin, Khout, Hazem, Asgeirsson, Kristjan, McCulley, Stephen, Mariniello, Maria Donatella, Roncella, Manuela, Ghilli, Matteo, Colizzi, Livio, Rossetti, Elena, Marzia, Lo Russo, Fustaino, Loredana, Li, Alessandro Quattrini, Harvey, Kate L, Windle, Rebecca, Remoundos, Dionysios Dennis, Roy, Pankaj, MacLean, Gael, Adwani, Asha, Popa, Elena, Goh, Steven, Shetty, Geeta, Clark, Sarah, Bernaudo, Lorenzo, Agrawal, Avi, Mansfield, Lucy, Tebbal, Sally, Patel, Ashraf, Grassi, Veronica, Pujji, Ojas, Hamnett, Kathryn, Basu, Naren, Granger, Emily, Durbar, Michael, Pikoulas, Panagiotis, Garnsey, Clare, Walker, Philip, Vollermere, Angela J, Michalakis, Ioannis, Jones, Robin, Youssef, Mina, Ives, Charlotte, Masood, Mohammad, Dunn, Julie, Olsen, Sisse, Ferguson, Douglas, Tillett, Rachel, Allan, Anna, Woollard, Alex, Canny, Rebecca, Woollard, Alexander, Mosahebi, Afshin, Hamilton, Stephen, Ghali, Shadi, Marsh, Daniel, Chana, Jagdeep, Sojitra, Nilesh, Younis, Ibby, Rainsbury, Dick, Chand, Natalie, Kalles, Vasileios, Stebbing, Anne, Harris, Kevin, Laws, Siobhan, Tansley, Anne, Mitchell, Geraldine, de Sousa, Emma, Henderson, Julia, Chandrashekar, Mysore, Pereira, Bernadette, Constantinou, Chloe, Elfadl, Dalia, Irakleidis, Foivos, Hernan, Izaro, Byrne, Miriam, To, Natalie, O'Connell, Rachel, Rusby, Jennifer, Barry, Peter, Krupa, Katerine, Allum, William, MacNeill, Fiona, Roche, Nicola, Gui, Gerald, Ramsey, Kelvin, Harris, Paul, James, Stuart, Power, Kieran, Sutton, Richard, McIntosh, Jamie, Laurence, Nicola, MacLennan, Louise, Milligan, Robert, Cain, Henry, Critchley, Adam, O'Donoghue, Joe, Kalra, Loraine, Collis, Nick, Weston-Petrides, Gina, Fiddes, Roanne, Brown, Victoria, Aertssen, Anna, Slade-Sharman, Diana, Khan, Mansoor, McGuiness, Caroline, Amorosi, Vittoria, Fabio, Santanelli di Pompeo, Exarchos, Georgios, Jiwa, Natasha, Hu, Jennifer, Ledwidge, Serena, Johnson, Laura, Peel, Anthony, Dhooma, Naseem, Farrell, Eric, Devane, Liam, Tevlin, Ruth, McDermott, Enda, Prichard, Ruth, Evoy, Denis, Rothwell, Jane, Geraghty, James, Morrison, Colin, Lawlor, Catriona, Langlands, Fiona, Taylor, Lauren, Turton, Philip, Achuthan, Raj, Horgan, Kieran, Mckenzie, Shireen, Hogan, Brian, Lansdown, Mark, Navin, Channegowda, Sherwin, Liz, Mortimer, Caroline, Garg, Neeraj, Adam, Rahma, Arif, Tahera, Kryjak, Zbigniew, Ali, Deedar, Sowdi, Ravi, Fage, Elena, Mylvaganam, Senthurun, Matey, Pilar, Vidya, Raghavan, Sircar, Tapan, Asaad, Oubida, Bhaskar, Pud, Dordea, Matei, Chrysafi, Ada, McCartan, Damian, Dave, Rajiv, Foster, Rachel, Wilson, Rebecca, Okwemba, Sylvia, Majeed, Yousef, Mathen, Vinod, Murphy, John, Barnes, Nicola, Gandhi, Ashu, Harvey, James, Kirwan, Cliona C, Johnson, Richard, Patel, Krupali, Ribas, Maria Dalmau, Vigneswaran, Natali, Challoner, Tom, Park, Alan, Rizkalla, Maged, Tomlins, Abigail, McEvoy, Kat, Jafferbhoy, Sadaf, Soumian, Soni, Narayanan, Sankaran, Kirby, Robert, Bajrusevic, Sladana, Maalo, Joseph, Charalambous, Michalis, Lai, Lee Min, Chong, Kelvin, Thomson, Simon, Monib, Sherif, Chagla, Leena, Audisio, Riccardo, Taghizadeh, Rieka, Iqbal, Azhar, James, Karen, Callaghan, Maria, Poonawala, Shabbir, Lund, Jonathan, Vinayagam, Raman, Thrush, Steven, Thomas, Rachel Bright, Mullan, Michelle, Taylor, Jevan, Yoshimura, Ryo, Mathew, Tom, Jones, Ben Mancey, Munot, Kailas, Nasr, Rana, Piper, Jenny, El-Sharief, Deena, Mustafa, Mohammed, Dumitru, Dorin, Christopoulos, Petros, O'Leary, Peter, Athanasiou, Irene, Johns, Neil, Mehta, Disha, Bibi, Saira, Syed, Farah, Koris, Jacob, Healy, Samuel, Shanks, Lindsay, Oliver, James, Bucata, Claudiu, Clarke, Natalie, Bignell, Kym, Akerlund, Malin, Brock, Lisa, Hallam, Kelly, Howes, Rachel, Armstrong, Alexander, Sethu, Claire, Zeidan, Bashar, Sjokvist, Olivia, Tasoulis, Marios, Sundaramoorthy, Souganthy, Harris, Chad, Wintrip, Dorothy, Lymperopoulos, N, Jain, Yogesh, Balata, Safa Ahmed, Grp, iBRA-2 Steering, and Collab, Breast Reconstruction Res

Subjects
Adult, Cancer Research, medicine.medical_specialty, Time Factors, medicine.medical_treatment, Mammaplasty, trainee collaboratives, Breast Neoplasms, Article, Cohort Studies, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Breast cancer, breast cancer, Adjuvant therapy, cohort study, Medicine, Humans, Prospective Studies, Prospective cohort study, Mastectomy, Aged, Cancer, Aged, 80 and over, Manchester Cancer Research Centre, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, adjuvant therapy, immediate breast reconstruction, Middle Aged, medicine.disease, Surgery, Radiation therapy, Oncology, Centre for Surgical Research, Chemotherapy, Adjuvant, Outcomes research, 030220 oncology & carcinogenesis, Surgical oncology, Female, Breast reconstruction, business, Complication, Cohort study
Abstract

Background: Immediate breast reconstruction (IBR) is routinely offered to improve quality-of-life for women requiring mastectomy, but there are concerns that more complex surgery may delay adjuvant oncological treatments and compromise long-term outcomes. High-quality evidence is lacking. The iBRA-2 study aimed to investigate the impact of IBR on time to adjuvant therapy.Methods: Consecutive women undergoing mastectomy ± IBR for breast cancer July–December, 2016 were included. Patient demographics, operative, oncological and complication data were collected. Time from last definitive cancer surgery to first adjuvant treatment for patients undergoing mastectomy ± IBR were compared and risk factors associated with delays explored.Results: A total of 2540 patients were recruited from 76 centres; 1008 (39.7%) underwent IBR (implant-only [n = 675, 26.6%]; pedicled flaps [n = 105,4.1%] and free-flaps [n = 228, 8.9%]). Complications requiring re-admission or re-operation were significantly more common in patients undergoing IBR than those receiving mastectomy. Adjuvant chemotherapy or radiotherapy was required by 1235 (48.6%) patients. No clinically significant differences were seen in time to adjuvant therapy between patient groups but major complications irrespective of surgery received were significantly associated with treatment delays.Conclusions: IBR does not result in clinically significant delays to adjuvant therapy, but post-operative complications are associated with treatment delays. Strategies to minimise complications, including careful patient selection, are required to improve outcomes for patients.

Published
2019

38. Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK 'Alert Level 4' phase of the B-MaP-C study.

Author

Dave, Rajiv V., Kim, Baek, Courtney, Alona, O'Connell, Rachel, Rattay, Tim, Taxiarchi, Vicky P., Kirkham, Jamie J., Camacho, Elizabeth M., Fairbrother, Patricia, Sharma, Nisha, Cartlidge, Christopher W. J., Horgan, Kieran, McIntosh, Stuart A., Leff, Daniel R., Vidya, Raghavan, Potter, Shelley, Holcombe, Chris, Copson, Ellen, Coles, Charlotte E., and Cutress, Ramsey I.

Abstract

Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions.Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated 'standard' or 'COVID-altered', in the preoperative, operative and post-operative setting.Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had 'COVID-altered' management. 'Bridging' endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2-9%) using 'NHS Predict'. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey.Conclusions: The majority of 'COVID-altered' management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown. [ABSTRACT FROM AUTHOR]

Published
2021
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41. A Prospective Study of the Association of Metacognitive Beliefs and Processes with Persistent Emotional Distress After Diagnosis of Cancer

Author

Cook, Sharon, Salmon, Peter, Dunn, Graham, Holcombe, Chris, Cornford, Philip, and Fisher, Peter

Subjects
Causal predictors, Clinical Psychology, Breast cancer, Prostate cancer, Metacognitive beliefs, Experimental and Cognitive Psychology, Original Article, Emotional distress, C800
Abstract

Two hundred and six patients, diagnosed with primary breast or prostate cancer completed self-report questionnaires on two occasions: before treatment (T1) and 12 months later (T2). The questionnaires included: the Hospital Anxiety and Depression Scale; Impact of Events Scale; the Metacognitions Questionnaire-30 (MCQ-30) and the Illness Perceptions Questionnaire-revised. A series of regression analyses indicated that metacognitive beliefs at T1 predicted between 14 and 19 % of the variance in symptoms of anxiety, depression and trauma at T2 after controlling for age and gender. For all three outcomes, the MCQ-30 subscale ‘negative beliefs about worry’ made the largest individual contribution with ‘cognitive confidence’ also contributing in each case. For anxiety, a third metacognitive variable, ‘positive beliefs about worry’ also predicted variance in T2 symptoms. In addition, hierarchical analyses indicated that metacognitive beliefs explained a small but significant amount of variance in T2 anxiety (2 %) and T2 depression (4 %) over and above that explained by demographic variables, T1 symptoms and T1 illness perceptions. The findings suggest that modifying metacognitive beliefs and processes has the potential to alleviate distress associated with cancer.

Published
2014

42. Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study.

Author

Davies, Gareth, Mills, Nicola, Holcombe, Chris, Potter, Shelley, on behalf of the iBRA Steering Group, Barnes, N. L. P., Blazeby, J. M., Branford, O. A., Cutress, R. I., Gardiner, M. D., Holcombe, C., Jain, A., McEvoy, K., Mills, N., Mylvaganam, S., Potter, S., Skillman, J. M., Teasdale, E. M., Thrush, S., and Tolkien, Z.

Subjects
MAMMAPLASTY, MEDICAL personnel, QUALITATIVE research, BREAST surgery, SEMI-structured interviews
Abstract

Background: Implant-based breast reconstruction (IBBR) is the most commonly performed breast reconstruction technique worldwide but the technique is evolving rapidly. High-quality evidence is needed to support practice. Randomised controlled trials (RCTs) provide the best evidence but can be challenging to conduct. iBRA is a four-phased study which aimed to inform the feasibility, design and conduct of an RCT in IBBR. In phase 3, the randomisation acceptability study, an electronic survey and qualitative interviews were conducted to explore professionals' perceptions of future trials in IBBR. Findings from the interviews are presented here.Methods: Semi-structured qualitative interviews were undertaken with a purposive sample of 31 health professionals (HPs) who completed the survey to explore their attitudes to the feasibility of potential RCTs in more detail. All interviews were transcribed verbatim and data were analysed thematically using constant comparative techniques. Sampling, data collection and analysis were undertaken iteratively and concurrently until data saturation was achieved.Results: Almost all HPs acknowledged the need for better evidence to support the practice of IBBR and most identified RCTs as generating the highest-quality evidence. Despite highlighting potential challenges, most participants supported the need for an RCT in IBBR. A minority, however, were strongly opposed to a future trial. The opposition and challenges identified centred around three key themes; (i) limited understanding of pragmatic study design and the value of randomisation in minimising bias; (ii) clinician and patient equipoise and (iii) aspects of surgical culture and training that were not supportive of RCTs.Conclusion: There is a need for well-designed, large-scale RCTs to support the current practice of IBBR but barriers to their acceptability are evident. The perceived barriers to RCTs in breast reconstruction identified in this study are not insurmountable and have previously been overcome in other similar surgical trials. This may represent an opportunity, not only to establish the evidence base for IBBR, but also to improve engagement in RCTs in breast surgery in general to ultimately improve outcomes for patients.Trial Registration: International Standard Randomised Controlled Trial Number ISRCTN37664281. [ABSTRACT FROM AUTHOR]

Published
2020
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43. Impact of aromatase inhibitor treatment on global gene expression and its association with antiproliferative response in ER+ breast cancer in postmenopausal patients.

Author

Gao, Qiong, López-Knowles, Elena, Cheang, Maggie Chon U., Morden, James, Ribas, Ricardo, Sidhu, Kally, Evans, David, Martins, Vera, Dodson, Andrew, Skene, Anthony, Holcombe, Chris, Mallon, Elizabeth, Evans, Abigail, Bliss, Judith M., Robertson, John, Smith, Ian, Martin, Lesley-Ann, Dowsett, Mitch, and POETIC Trial Management Group and Trialists

Subjects
AROMATASE inhibitors, GENE expression, BREAST cancer, CELL cycle regulation, GENE regulatory networks, PATIENT Activation Measure, LETROZOLE
Abstract

Background: Endocrine therapy reduces breast cancer mortality by 40%, but resistance remains a major clinical problem. In this study, we sought to investigate the impact of aromatase inhibitor (AI) therapy on gene expression and identify gene modules representing key biological pathways that relate to early AI therapy resistance.Methods: Global gene expression was measured on pairs of core-cut biopsies taken at baseline and at surgery from 254 patients with ER-positive primary breast cancer randomised to receive 2-week presurgical AI (n = 198) or no presurgical treatment (control n = 56) from the POETIC trial. Data from the AI group was adjusted to eliminate artefactual process-related changes identified in the control group. The response was assessed by changes in the proliferation marker, Ki67.Results: High baseline ESR1 expression associated with better AI response in HER2+ tumours but not HER2- tumours. In HER2- tumours, baseline expression of 48 genes associated with poor antiproliferative response (p < 0.005) including PERP and YWHAQ, the two most significant, and the transcription co-regulators (SAP130, HDAC4, and NCOA7) which were among the top 16 most significant. Baseline gene signature scores measuring cell proliferation, growth factor signalling (ERBB2-GS, RET/GDNF-GS, and IGF-1-GS), and immune activity (STAT1-GS) were significantly higher in poor AI responders. Two weeks of AI caused downregulation of genes involved in cell proliferation and ER signalling, as expected. Signature scores of E2F activation and TP53 dysfunction after 2-week AI were associated with poor AI response in both HER2- and HER2+ patients.Conclusions: There is a high degree of heterogeneity in adaptive mechanisms after as little as 2-week AI therapy; however, all appear to converge on cell cycle regulation. Our data support the evaluation of whether an E2F signatures after short-term exposure to AI may identify those patients most likely to benefit from the early addition of CDK4/6 inhibitors.Trial Registration: ISRCTN, ISRCTN63882543, registered on 18 December 2007. [ABSTRACT FROM AUTHOR]

Published
2019
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44. A Requiem For Vagotomy

Author

Kerrigan, David, Johnson, Alan, Mullan, Fred J., Spencer, E. F. A., Johnston, George W., and Holcombe, Chris

Published
1991

47. Additional file 3: Figure S1. of Heterogeneity in global gene expression profiles between biopsy specimens taken peri-surgically from primary ER-positive breast carcinomas

Author

Lรณpez-Knowles, Elena, Gao, Qiong, Cheang, Maggie, Morden, James, Parker, Joel, Lesley-Ann Martin, Pinhel, Isabel, McNeill, Fiona, Hills, Margaret, Detre, Simone, Afentakis, Maria, Zabaglo, Lila, Dodson, Andrew, Skene, Anthony, Holcombe, Chris, Robertson, John, Smith, Ian, Bliss, Judith, and Dowsett, Mitch

Abstract

Paired correlations in study I. Correlation of detectable probes by Pearson correlation in 23 pairs of samples. Figure S2. Examples of paired correlations in study I. Correlation of detectable probes by Pearson correlation: the three samples with the highest correlations, median correlation and the lowest correlations. Figure S3. Correlation of 18 genes in study I. Pearson correlation of 18 genes commonly studied in breast cancer in 23 pairs of samples. Figure S4. Scatterplots of numeric differences between correlation coefficients to average gene expression profiles of intrinsic subtypes for each tumor in study I (S4A and B) and study II (S4C and D). Difference between luminal A and luminal B centroids (A and C), and luminal B and HER2-enriched centroids (C and D). Open circle: concordant subtype assignments between the two time points. Triangle: discordant subtype assignments between the two time points. Figure S5. Paired correlations in study II. Correlation of detectable probes by Pearson correlation in 56 pairs of samples. Figure S6. Correlations of 18 genes in study II. Pearson correlation of 18 genes commonly studied in breast cancer in 56 pairs of samples. (PDF 1479 kb)

Published
2016
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48. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): A double-blind, randomised controlled trial

Author

Forbes, John F, Sestak, Ivana, Howell, Anthony, Bonanni, Bernardo, Bundred, Nigel, Levy, Christelle, von Minckwitz, Gunter, Eiermann, Wolfgang, Neven, Patrick, Stierer, Michael, Holcombe, Chris, Coleman, Robert E, Jones, Louise, Ellis, Ian, Cuzick, Jack, Sainsbury, Richard, Garber, Judy, Warwick, Jane, Buchanan, Mary, Buser, Katharina, Cawthorn, Simon, Coleman, Robert, Dowsett, Mitch, Eastell, Richard, Ejlertsen, Bent, Forbes, John, Kahan, Zsuzsanna, Baclesse, François, Mansel, Robert, Palva, Tiina, Rydén, Lisa, Stuart, Mary, Vaz, Fatima, Marsiglia, Hugo, Benyoucef, Ahmed, Berton-Rigaud, Dominique, Loustalot, Catherine, Serin, Daniel, Kerbrat, Pierre, Eymard, Jean-Christophe, Giard-Lefevre, Sylvia, Bonichon-Lamichhane, Nathalie, Monnier, Alain, Tubiana-Mathieu, Nicole, Piot, Gilles, de Lara, Christine Tunon, Bernard, Olivier, Simon-Swirski, Hélène, Gladieff, Laurence, Regaud, I Claudius, Fouchet-Goudier, Marie-Joseph, Dohollou, Nadine, Aquitaine, Nord, Elgard-Maitre, Anne-Marie, Bergerat, Jean-Pierre, Petit, Thierry, Marti, Adina, Toussaint, Caroline, Del Piano, Francesco, Ibrahim, Mahmoud, Fric, Danièle, Hönig, Arnd, Müller, Volkmar, Marmé, Frederik, Rautenberg, Beate, Schmidt, Marcus, Hanusch, Claus, Paepke, Stefan, Kaltenecker, Gabriele, Lemster, Sabine, Tio, Joke, Reimer, Toralf, Schnappauf, Benjamin, Baumann, Klaus, Schrader, Iris, Mundhenke, Christoph, Liedtke, Cornelia, Meinerz, Wolfgang, Thomssen, Christoph, Christl, Klaus, Hitschold, Thomas, Goerke, Kay, Kast, Karin, Runnebaum, Ingo, Lindner, Christoph, Scheidel, Peter, Herwig, Uwe, Bangemann, Nikola, Sommer, Harald, Göhring, Kornelia, Tulusan, Augustinus, Stauß, Eva, Köhler, Günter, Zahm, Dirk, Augustin, Doris, Hocke, Andrea, Neunhöffer, Tanja, Schmatloch, Sabine, Heinrich, Georg, Groß, Sabine, Breitbach, G P, Scharl, Anton, Klare, Peter, Stefek, Andrea, Hoffmann, Gerald, Martignoni, Franca, Weiss, Erich, Emons, Günter, Tesch, Hans-Christian, Beckmann, Matthias, Schmutzler, Rita, Schütte, Martin, Aktas, Bahriye, Hille-Betz, Ursula, Deryal, Mustafa, Dan Costa, Serban, Blümel, Beate, Göhring, Uwe-Jochen, Kleine-Tebbe, Anke, Schumacher, Claudia, Jasmin, Pourfard, Christoph, Uleer, Kullmer, Uwe, Krabisch, Petra, Gätje, Regine, Schwenzer, Thomas, Hindenburg, Hans-Joachim, Rempen, Andreas, Höffkes, Heinz-Gert, Stickeler, Elmar, Reffert, Christian, Seitz, Stephan, Splitt, Gerd, Böhne, Petra, Gnauert, Karsten, Strittmatter, Hans-Joachim, Baake, Gerold, Rezai, Mahdi, Noesselt, Thomas, Köhne, C-H, Hanf, Volker, Strumberg, Dirk, Dall, Peter, Schleicher, Peter, Schleicher, Bernd, Beldermann, Frank, Berghorn, Michael, Baerens, Dirk-Thoralf, Kolberg, Hans-Christian, Bauer, Lelia, Brucker, Cosima, Steck, Thomas, Boyle, Frances, Chaudhuri, Anupam, Wagga, Wagga, Moylan, Eugene, Donovan, Jenny, Della-Fiorentina, Stephen, Abdi, Ehtesham, Marx, Gavin, Beadle, Geoffrey, Donovan, Michael, Bennett, Ian, Gill, Peter Grantley, Baker, Caroline, Masters, Richard, Blum, Robert, Collins, John, Law, Michael, Hart, Stewart, Kannourakis, George, Snyder, Raymond, Joseph, David, McCrystal, Michael, Campbell, Ian, Jakesz, Raimund, Selim, Ursula, Singer, Christian, Heck, Dietmar, Greil, Richard, Ramoni, Angela, Bjelic-Radisic, Vesna, Reichenauer, Arno, Horvath, Wilfried, Thaler, Josef, Fridrik, Michael, Keckstein, Joerg, Jan, Lamote, L'Hermitte, Marc, Roelstrate, Heidi, Dirix, Luc, Bambust, Inneke, Seret, Monique, Liebens, Fabienne, Maerevoet, Maria, D'Hondt, Lionel, Berliere, Martine, Nogaret, Jean-Marie, Simon, Phillipe, O'Hanlon, Deirdre, Redmond, Henry Paul, Hill, Arnold, Evoy, Denis, Kerin, Michael, Gupta, Rajnish, Martin, Michael J, Fritis, Marcela, Schwartz, Ricardo, Yañez, Maria Loreto, Peralta, Octavio, Graiff, Claudio, Artioli, Fabrizio, Generali, Daniele, Orzalesi, Lorenzo, Visini, Marilena, Michiara, Maria, Pavesi, Lorenzo, Ravaioli, Alberto, Porpiglia, Mauro, Puglisi, Fabio, Pinotti, Graziella, Brincat, Stephen, Buser, Katharina S, Rabaglio, Manuela, Rauch, Daniel, 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Paula, Stouraitis, Marina, Sundberg, Jan, Babiker, Abdel, Collins, Rory, Klijn, Jan, Ralston, Stuart, Tattersall, Martin, Weller, Ian, De Sousa, Andreia, Edwards, Rob, Ferguson, Sheila, Hickman, Jane, Johnson, Damian, Haidar, Nadia, Hammond, Victoria, Heighway, Emma, Ndoutoumou, Amalia, Sahota, Navdip, White, Laura, Aigret, Benoit, Batra, Priyanka, Knox, Jill, Oke, Adedayo, Ostler, Richard, and Sasieni, Peter

Subjects
Medicine (all), Medizin, skin and connective tissue diseases
Abstract

Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS.In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358.Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6-8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64-1·23]). The non-inferiority of anastrozole was established (upper 95% CI

Published
2016

49. Additional file 1: of Heterogeneity in global gene expression profiles between biopsy specimens taken peri-surgically from primary ER-positive breast carcinomas

Author

LĂłpez-Knowles, Elena, Gao, Qiong, Cheang, Maggie, Morden, James, Parker, Joel, Lesley-Ann Martin, Pinhel, Isabel, McNeill, Fiona, Hills, Margaret, Detre, Simone, Afentakis, Maria, Zabaglo, Lila, Dodson, Andrew, Skene, Anthony, Holcombe, Chris, Robertson, John, Smith, Ian, Bliss, Judith, and Dowsett, Mitch

Abstract

Supplementary information. Additional description of the materials and methods. (DOCX 24 kb)

Published
2016
Full Text
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