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17 results on '"Loi, Shrushma"'

1. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Author

Agarwal, Roshan, Algurafi, Hafiz, Allerton, Rozenn, Archer, Caroline, Armstrong, Anne, Bale, Catherine, Barraclough, Lisa, Barthakur, Urmila, Bedi, Carolyn, Benstead, Kim, Bloomfield, David, Bowen, Rebecca, Bradley, Chris, Brown, Jane, Butt, Mohammad, Churn, Mark, Cleator, Susan, Cliff, Joanne, Crellin, Perric, Daly, Margaret, De Silva-Minor, Shiroma, Dhadda, Amandeep, Din, Omar, Down, Sue, Earl, Helena, Eaton, David, Eichholz, Andrew, Epurescu, Daniel, Goh, Chee, Goodman, Andrew, Grieve, Robert, Hadaki, Maher, Harper-Wynne, Catherine, Harries, Mark, Hayward, Larry, Humphreys, Alison, Innes, Helen, Jafri, Mariam, Jegannathen, Apurna, Kelleher, Muireann, Kristeleit, Hartmut, Lee, Daniela, Lupton, Susan, MacGregor, Carol, Malik, Zafar, Mansi, Janine, Marshall, Jennifer, McAdam, Karen, McGolick, Trevor, Mehra, Rakesh, Miles, David, Mithal, Natasha, Moss, Charlotte, Moss, Aian, Mukesh, Mukesh, Neal, Anthony, Nelmes, Daniel, Neville-Webbe, Helen, Newby, Jacqueline, O'Reilly, Susan, Ostler, Peter, Persic, Mojca, Pettit, Laura, Raj, Sanjay, Raja, Fharat, Rea, Daniel, Reed, Catherine, Rigg, Anne, Roe, Helen, Shah, Nihal, Simmonds, Peter, Sims, Eliot, Smith, Sarah, Storey, Nicola, Taylor, Wendy, Thanvi, Narottam, Tipples, Karen, Vaidya, Jayant, Varughese, Mohini, Vinayan, Anup, Walji, Nawaz, Waters, Simon, Woodings, Pamela, Wright, Kathryn, Yahya, Sundus, Earl, Helena M, Hiller, Louise, Vallier, Anne-Laure, Loi, Shrushma, Hughes-Davies, Luke, Harnett, Adrian N, Ah-See, Mei-Lin, Simcock, Richard, Howe, Donna, Raynes, Kerry, Higgins, Helen B, Wilcox, Maggie, Plummer, Chris, Gounaris, Ioannis, Mahler–Araujo, Betania, Provenzano, Elena, Chhabra, Anita, Abraham, Jean E, Caldas, Carlos, Hall, Peter S, McCabe, Christopher, Hulme, Claire, Wardley, Andrew M, Cameron, David A, and Dunn, Janet A

Published
2019
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2. Determining the optimal route of faecal microbiota transplant in patients with ulcerative colitis: the STOP-Colitis pilot RCT.

Author

Quraishi, Mohammed N, Moakes, Catherine A, Yalchin, Mehmet, Segal, Jonathan, Ives, Natalie J, Magill, Laura, Manzoor, Susan E, Gerasimidis, Konstantinos, Loi, Shrushma, McMullan, Christel, Mathers, Jonathan, Quince, Christopher, Kaur, Manjinder, Loman, Nicholas J, Sharma, Naveen, Hawkey, Peter, McCune, Victoria, Nichols, Ben, Svolos, Vaios, and Kerbiriou, Caroline

Published
2024
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5. O9 STOP-colitis pilot: prospective, open-label, randomised study comparing nasogastric versus colonic FMT delivery in ulcerative colitis

Author

Quraishi, Mohammed Nabil, primary, Yalchin, Mehmet, additional, Blackwell, Clare, additional, Segal, Jonathan, additional, Sharma, Naveen, additional, Hawkey, Peter, additional, McCune, Victoria, additional, Hewitt, Catherine, additional, Ives, Natalie J, additional, Loi, Shrushma, additional, Magill, Laura, additional, Manzoor, Susan, additional, Gerasimidis, Konstantinos, additional, Loman, Nicholas J, additional, McMullan, Christel, additional, Mathers, Jonathan, additional, Quince, Christopher, additional, Crees, Nicola, additional, Hansen, Richard, additional, Hart, Ailsa L, additional, Gaya, Daniel R, additional, and Iqbal, Tariq H, additional

Published
2021
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6. Six versus 12 months’ adjuvant trastuzumab in patients with HER2-positive early breast cancer: the PERSEPHONE non-inferiority RCT

Author

Earl, Helena, primary, Hiller, Louise, additional, Vallier, Anne-Laure, additional, Loi, Shrushma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Rea, Daniel, additional, Howe, Donna, additional, Raynes, Kerry, additional, Higgins, Helen B, additional, Wilcox, Maggie, additional, Plummer, Chris, additional, Mahler-Araujo, Betania, additional, Provenzano, Elena, additional, Chhabra, Anita, additional, Gasson, Sophie, additional, Balmer, Claire, additional, Abraham, Jean E, additional, Caldas, Carlos, additional, Hall, Peter, additional, Shinkins, Bethany, additional, McCabe, Christopher, additional, Hulme, Claire, additional, Miles, David, additional, Wardley, Andrew M, additional, Cameron, David A, additional, and Dunn, Janet A, additional

Published
2020
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7. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Author

Earl, Helena M, Hiller, Louise, Vallier, Anne-Laure, Loi, Shrushma, McAdam, Karen, Hughes-Davies, Luke, Harnett, Adrian N, Ah-See, Mei-Lin, Simcock, Richard, Rea, Daniel, Raj, Sanjay, Woodings, Pamela, Harries, Mark, Howe, Donna, Raynes, Kerry, Higgins, Helen B, Wilcox, Maggie, Plummer, Chris, Mansi, Janine, Gounaris, Ioannis, Mahler-Araujo, Betania, Provenzano, Elena, Chhabra, Anita, Abraham, Jean E, Caldas, Carlos, Hall, Peter S, McCabe, Christopher, Hulme, Claire, Miles, David, Wardley, Andrew M, Cameron, David A, Dunn, Janet A, PERSEPHONE Steering Committee And Trial Investigators, Earl, Helena [0000-0003-1549-8094], Abraham, Jean [0000-0003-0688-4807], Caldas, Carlos [0000-0003-3547-1489], and Apollo - University of Cambridge Repository

Subjects
Adult, Aged, 80 and over, Receptor, ErbB-2, Injections, Subcutaneous, Breast Neoplasms, Middle Aged, Trastuzumab, Disease-Free Survival, Drug Administration Schedule, United Kingdom, Young Adult, Antineoplastic Agents, Immunological, Treatment Outcome, Chemotherapy, Adjuvant, Humans, Female, Prospective Studies, Infusions, Intravenous, Aged
Abstract

BACKGROUND: Adjuvant trastuzumab significantly improves outcomes for patients with HER2-positive early breast cancer. The standard treatment duration is 12 months but shorter treatment could provide similar efficacy while reducing toxicities and cost. We aimed to investigate whether 6-month adjuvant trastuzumab treatment is non-inferior to the standard 12-month treatment regarding disease-free survival. METHODS: This study is an open-label, randomised phase 3 non-inferiority trial. Patients were recruited from 152 centres in the UK. We randomly assigned patients with HER2-positive early breast cancer, aged 18 years or older, and with a clear indication for chemotherapy, by a computerised minimisation process (1:1), to receive either 6-month or 12-month trastuzumab delivered every 3 weeks intravenously (loading dose of 8 mg/kg followed by maintenance doses of 6 mg/kg) or subcutaneously (600 mg), given in combination with chemotherapy (concurrently or sequentially). The primary endpoint was disease-free survival, analysed by intention to treat, with a non-inferiority margin of 3% for 4-year disease-free survival. Safety was analysed in all patients who received trastuzumab. This trial is registered with EudraCT (number 2006-007018-39), ISRCTN (number 52968807), and ClinicalTrials.gov (number NCT00712140). FINDINGS: Between Oct 4, 2007, and July 31, 2015, 2045 patients were assigned to 12-month trastuzumab treatment and 2044 to 6-month treatment (one patient was excluded because they were double randomised). Median follow-up was 5·4 years (IQR 3·6-6·7) for both treatment groups, during which a disease-free survival event occurred in 265 (13%) of 2043 patients in the 6-month group and 247 (12%) of 2045 patients in the 12-month group. 4-year disease-free survival was 89·4% (95% CI 87·9-90·7) in the 6-month group and 89·8% (88·3-91·1) in the 12-month group (hazard ratio 1·07 [90% CI 0·93-1·24], non-inferiority p=0·011), showing non-inferiority of the 6-month treatment. 6-month trastuzumab treatment resulted in fewer patients reporting severe adverse events (373 [19%] of 1939 patients vs 459 [24%] of 1894 patients, p=0·0002) or stopping early because of cardiotoxicity (61 [3%] of 1939 patients vs 146 [8%] of 1894 patients, p

Published
2019
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8. STOP-Colitis pilot trial protocol: a prospective, open-label, randomised pilot study to assess two possible routes of faecal microbiota transplant delivery in patients with ulcerative colitis

Author

Quraishi, Mohammed Nabil, primary, Yalchin, Mehmet, additional, Blackwell, Clare, additional, Segal, Jonathan, additional, Sharma, Naveen, additional, Hawkey, Peter, additional, McCune, Victoria, additional, Hart, Ailsa L, additional, Gaya, Daniel, additional, Ives, Natalie J, additional, Magill, Laura, additional, Loi, Shrushma, additional, Hewitt, Catherine, additional, Gerasimidis, Konstantinos, additional, Loman, Nicholas James, additional, Hansen, Richard, additional, McMullan, Christel, additional, Mathers, Jonathan, additional, Quince, Christopher, additional, Crees, Nicola, additional, and Iqbal, Tariq, additional

Published
2019
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9. 6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial

Author

Earl, Helena M, primary, Hiller, Louise, additional, Vallier, Anne-Laure, additional, Loi, Shrushma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Harnett, Adrian N, additional, Ah-See, Mei-Lin, additional, Simcock, Richard, additional, Rea, Daniel, additional, Raj, Sanjay, additional, Woodings, Pamela, additional, Harries, Mark, additional, Howe, Donna, additional, Raynes, Kerry, additional, Higgins, Helen B, additional, Wilcox, Maggie, additional, Plummer, Chris, additional, Mansi, Janine, additional, Gounaris, Ioannis, additional, Mahler–Araujo, Betania, additional, Provenzano, Elena, additional, Chhabra, Anita, additional, Abraham, Jean E, additional, Caldas, Carlos, additional, Hall, Peter S, additional, McCabe, Christopher, additional, Hulme, Claire, additional, Miles, David, additional, Wardley, Andrew M, additional, Cameron, David A, additional, Dunn, Janet A, additional, Agarwal, Roshan, additional, Algurafi, Hafiz, additional, Allerton, Rozenn, additional, Archer, Caroline, additional, Armstrong, Anne, additional, Bale, Catherine, additional, Barraclough, Lisa, additional, Barthakur, Urmila, additional, Bedi, Carolyn, additional, Benstead, Kim, additional, Bloomfield, David, additional, Bowen, Rebecca, additional, Bradley, Chris, additional, Brown, Jane, additional, Butt, Mohammad, additional, Churn, Mark, additional, Cleator, Susan, additional, Cliff, Joanne, additional, Crellin, Perric, additional, Daly, Margaret, additional, De Silva-Minor, Shiroma, additional, Dhadda, Amandeep, additional, Din, Omar, additional, Down, Sue, additional, Earl, Helena, additional, Eaton, David, additional, Eichholz, Andrew, additional, Epurescu, Daniel, additional, Goh, Chee, additional, Goodman, Andrew, additional, Grieve, Robert, additional, Hadaki, Maher, additional, Harper-Wynne, Catherine, additional, Hayward, Larry, additional, Humphreys, Alison, additional, Innes, Helen, additional, Jafri, Mariam, additional, Jegannathen, Apurna, additional, Kelleher, Muireann, additional, Kristeleit, Hartmut, additional, Lee, Daniela, additional, Lupton, Susan, additional, MacGregor, Carol, additional, Malik, Zafar, additional, Marshall, Jennifer, additional, McGolick, Trevor, additional, Mehra, Rakesh, additional, Mithal, Natasha, additional, Moss, Charlotte, additional, Moss, Aian, additional, Mukesh, Mukesh, additional, Neal, Anthony, additional, Nelmes, Daniel, additional, Neville-Webbe, Helen, additional, Newby, Jacqueline, additional, O'Reilly, Susan, additional, Ostler, Peter, additional, Persic, Mojca, additional, Pettit, Laura, additional, Raja, Fharat, additional, Reed, Catherine, additional, Rigg, Anne, additional, Roe, Helen, additional, Shah, Nihal, additional, Simmonds, Peter, additional, Sims, Eliot, additional, Smith, Sarah, additional, Storey, Nicola, additional, Taylor, Wendy, additional, Thanvi, Narottam, additional, Tipples, Karen, additional, Vaidya, Jayant, additional, Varughese, Mohini, additional, Vinayan, Anup, additional, Walji, Nawaz, additional, Waters, Simon, additional, Wright, Kathryn, additional, and Yahya, Sundus, additional

Published
2019
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11. Trastuzumab-associated cardiac events in the Persephone trial

Author

Earl, Helena M, primary, Vallier, Anne-Laure, additional, Dunn, Janet, additional, Loi, Shrushma, additional, Ogburn, Emma, additional, McAdam, Karen, additional, Hughes-Davies, Luke, additional, Harnett, Adrian, additional, Abraham, Jean, additional, Wardley, Andrew, additional, Cameron, David A, additional, Miles, David, additional, Gounaris, Ioannis, additional, Plummer, Chris, additional, and Hiller, Louise, additional

Published
2016
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16. Adjuvant trastuzumab duration trials in HER2 positive breast cancer - what results would be practice-changing? Persephone investigator questionnaire prior to primary endpoint results

Author

Hiller, Louise, Dunn, Janet A, Loi, Shrushma, Vallier, Anne-Laure, Howe, Donna L, Cameron, David A, Miles, David, Wardley, Andrew M, and Earl, Helena

Subjects
Receptor, erbB-2, Treatment Outcome, Antineoplastic Agents, Immunological, Chemotherapy, Adjuvant, Surveys and Questionnaires, Humans, Breast Neoplasms, Perception, Female, Trastuzumab, Cardiotoxicity, 3. Good health

17. Adjuvant trastuzumab duration trials in HER2 positive breast cancer - what results would be practice-changing? Persephone investigator questionnaire prior to primary endpoint results

Author

Hiller, Louise, Dunn, Janet A, Loi, Shrushma, Vallier, Anne-Laure, Howe, Donna L, Cameron, David A, Miles, David, Wardley, Andrew M, and Earl, Helena M

Subjects
HER2 positive, Receptor, ErbB-2, Trastuzumab cardiotoxicity, Breast Neoplasms, Trastuzumab, Cardiotoxicity, 3. Good health, Investigator questionnaire, Antineoplastic Agents, Immunological, Treatment Outcome, Chemotherapy, Adjuvant, Surveys and Questionnaires, Breast Cancer, Adjuvant trastuzumab duration, Humans, Female, Perception, skin and connective tissue diseases, neoplasms
Abstract

BACKGROUND: Twelve months treatment is the current standard of care for adjuvant trastuzumab in patients with HER2 positive early breast cancer however the optimal duration is not known. Persephone is a non-inferiority randomised controlled trial comparing 6- to 12-months of trastuzumab. In this trial there will be a trade-off between a possible small decrease in disease-free survival (DFS) with 6-months and reduced cardiotoxicity and cost. METHODS: A structured questionnaire asked clinicians who had recruited patients into the Persephone trial about their prior beliefs with regards to the clinical effectiveness of trastuzumab and cardiotoxicity profile, in the comparison of 6- and 12-month durations. RESULTS: Fifty-one clinicians from 40 of the 152 Persephone sites completed the questionnaire. 30/50 responders (60%) believed that 6-months trastuzumab would give the same 4-year DFS rate as 12-months trastuzumab, with 21/50 (42%) holding this belief across all breast cancer subsets. In addition, 46/49 responders (94%) reported expecting to change their clinical practice to 6-months, with their prior beliefs (most commonly 85% 4-year DFS rate with 6-months) being greater than their lowest acceptable rate (most commonly 83% 4-year DFS rate with 6-months). Low levels of cardiotoxicity were expected with both 6 and 12-months trastuzumab, with the majority expecting lower levels with 6-months. With increasing hypothesised differences of cardiotoxicity rates between the two durations, significantly lower levels of 4-year DFS with 6-months trastuzumab were deemed acceptable (p < 0.0001). CONCLUSION: Most responders believe that 6-months trastuzumab is adequate, both overall and within each subset of breast cancer, and plan to change their clinical practice if the Persephone results support their prior belief. An individual patient meta-analysis of the duration trials would give greater precision to estimates of the differences in efficacy and toxicity, and adequate statistical power to establish a 2% level of non-inferiority for 6-months adjuvant trastuzumab.

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