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2. 204 REFINE-Lung is a multicentre phase III study to determine the optimal frequency of pembrolizumab in advanced non-small cell lung cancer (NSCLC) utilising a novel multi-arm design

Author

Ghorani, Ehsan, primary, Quartagno, Matteo, additional, Blackhall, Fiona, additional, O'Brien, Mary, additional, Ottensmeier, Christian, additional, Pizzo, Elena, additional, Spicer, James, additional, Gilbert, Duncan, additional, Baker, Alex, additional, Badman, Philip, additional, Milner-Watts, Charlotte, additional, D. d'Arienzo, Paolo, additional, Dangoor, Adam, additional, Adhikaree, Jason, additional, Evans, Joanne, additional, Leite, Pollyanna, additional, Keni, Manjusha, additional, Steele, Nicola, additional, Gomes, Fabio, additional, Gomez-Randulfe, Igor, additional, Belitei, Petru, additional, Stewart, Grant, additional, Barrie, Colin, additional, Geldart, Tom, additional, Jain, Pooja, additional, Liu, Justin KH, additional, Zubairi, Ishtaiq, additional, Muthukumar, Dakshinamoorthy, additional, Gray, Lucy, additional, Treece, Sarah, additional, Aleksic, Aleksandar, additional, Tsaknis, Georgios, additional, Rathbone, Emma, additional, Shaw, Paul, additional, Tarver, Kathryn, additional, Parmar, Mahesh K.B., additional, and Seckl, Michael J., additional

Published
2024
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3. 84 National Real World Study of Adjuvant Osimertinib in Resected EGFR Mutated Lung Cancer

Author

Ragd Sami, Elghadi, primary, Sabeshan, Pratheeshan, additional, Datta, Ishita, additional, Jha, Ayush, additional, Abdelkhalek, Hossam, additional, Ahmed, Samreen, additional, Ahmad, Tanya, additional, Anum, Sultan, additional, Aziz, Hala, additional, Baijal, Shobhit, additional, Batool, Rubab, additional, Bean, Emma, additional, Campbell, Lynn, additional, Cave, Judith, additional, Cove-Smith, Laura, additional, Dimitrakakis, Emmanouil, additional, Evans, Joanne, additional, Fares, Aya, additional, Gardiner, Jill, additional, Geldart, Tom, additional, Gennatas, Spyros, additional, Georgiou, Alexandras, additional, Ghafoor, Qamar, additional, Gilligan, David, additional, Hall, Sally, additional, Harrison, Imogen, additional, Hassan, Heba, additional, Jain, Pooja, additional, Janjua, Tanzeel, additional, Johnston, Edwina, additional, Kumar, Gaurav, additional, Kussaibati, Racha, additional, Li, Louise, additional, Lobo, Diana, additional, Masento, Sebastien, additional, McGeoch, Adam, additional, Muller, Daniel, additional, O'Beirne, Helen, additional, Powell, Ceri, additional, Shah, Riyaz, additional, Steele, Nicola, additional, Summers, Yvonne, additional, Tsagkaraki, Ismini, additional, Verissimo, Tiago, additional, Walls, Gerard, additional, Weir, Eleanor, additional, Xing, Eunice, additional, Zaki, Kam, additional, Zlotkowski, Piotr, additional, Newsom-Davis, Tom, additional, Moss, Anna, additional, Belitei, Petru, additional, Dorey, Nicole, additional, Earwaker, Philip, additional, Franks, Kevin, additional, Fraser, Ian, additional, Greystoke, Alastair, additional, Hughes, Daniel, additional, Kantilal, Kavita, additional, Mangan, Yvonne, additional, Medley, Louise, additional, MuthUnited Kingdomumar, Dakshinamoorthy, additional, Peedell, Clive, additional, Solomon, Cleo, additional, Stevenson, Robert, additional, Thompson, Nicola, additional, Turnbull, Helen, additional, Walters, Sara, additional, and Watkins, Steven, additional

Published
2024
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4. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial

Author

Price, Gillian, Shaw, Paul, Cave, Judith, Naik, Jay, Ford, Amy, Geldhart, Tom, Dancey, Gairin, Papadatos, Dionysis, Polychronis, Andy, Jankowska, Petra, Scott, Angela, Gardiner, Jill, Cominos, Mathilda, Campbell, Lynn, MacGregor, Carol, Mullholand, Lois, Chitnis, Meenali, Dougherty, Gary, Fennell, Dean A, Ewings, Sean, Ottensmeier, Christian, Califano, Raffaele, Hanna, Gerard G, Hill, Kayleigh, Danson, Sarah, Steele, Nicola, Nye, Mavis, Johnson, Lucy, Lord, Joanne, Middleton, Calley, Szlosarek, Peter, Chan, Sam, Gaba, Aarti, Darlison, Liz, Wells-Jordan, Peter, Richards, Cathy, Poile, Charlotte, Lester, Jason F, and Griffiths, Gareth

Published
2021
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5. Large cell neuroendocrine lung carcinoma: consensus statement from The British Thoracic Oncology Group and the Association of Pulmonary Pathologists

Author

Lindsay, Colin R., Shaw, Emily C., Moore, David A., Rassl, Doris, Jamal-Hanjani, Mariam, Steele, Nicola, Naheed, Salma, Dick, Craig, Taylor, Fiona, Adderley, Helen, Black, Fiona, Summers, Yvonne, Evans, Matt, Rice, Alexandra, Fabre, Aurelie, Wallace, William A., Nicholson, Siobhan, Haragan, Alex, Taniere, Phillipe, Nicholson, Andrew G., Laing, Gavin, Cave, Judith, Forster, Martin D., Blackhall, Fiona, Gosney, John, Popat, Sanjay, and Kerr, Keith M.

Published
2021
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6. Pegargiminase Plus First-Line Chemotherapy in Patients With Nonepithelioid Pleural Mesothelioma

Author

Szlosarek, P, Creelan, B, Sarkodie, T, Nolan, L, Taylor, P, Olevsky, O, Grosso, F, Cortinovis, D, Chitnis, M, Roy, A, Gilligan, D, Kindler, H, Papadatos-Pastos, D, Ceresoli, G, Mansfield, A, Tsao, A, O’Byrne, K, Nowak, A, Steele, J, Sheaff, M, Shiu, C, Kuo, C, Johnston, A, Bomalaski, J, Zauderer, M, Fennell, D, Rybkin, I, Rolfo, C, Mackean, M, Steele, N, Franks, K, Shaw, P, Lind, M, Upadhyay, S, John, T, Karapetis, C, Srivastav, R, Mencoboni, M, Chella, A, Zilembo, N, de Marinis, F, Stella, M, Chong, I, Wang, C, Null, N, Szlosarek, Peter W., Creelan, Benjamin C., Sarkodie, Thomas, Nolan, Luke, Taylor, Paul, Olevsky, Olga, Grosso, Federica, Cortinovis, Diego, Chitnis, Meenali, Roy, Amy, Gilligan, David, Kindler, Hedy, Papadatos-Pastos, Dionysis, Ceresoli, Giovanni L., Mansfield, Aaron S., Tsao, Anne, O’Byrne, Kenneth J., Nowak, Anna K., Steele, Jeremy, Sheaff, Michael, Shiu, Chiung-Fang, Kuo, Chih-Ling, Johnston, Amanda, Bomalaski, John, Zauderer, Marjorie G., Fennell, Dean A., Rybkin, Igor I., Rolfo, Christian D., MacKean, Melanie, Steele, Nicola, Franks, Kevin, Shaw, Paul, Lind, Michael J., Upadhyay, Sunil, John, Thomas, Karapetis, Christos, Srivastav, Ratnesh, Mencoboni, Manlio, Chella, Antonio, Zilembo, Nicoletta, de Marinis, Filippo, Stella, Maria Giulia, Chong, Inn-Wen, Wang, Chin-Chou, null, null, Szlosarek, P, Creelan, B, Sarkodie, T, Nolan, L, Taylor, P, Olevsky, O, Grosso, F, Cortinovis, D, Chitnis, M, Roy, A, Gilligan, D, Kindler, H, Papadatos-Pastos, D, Ceresoli, G, Mansfield, A, Tsao, A, O’Byrne, K, Nowak, A, Steele, J, Sheaff, M, Shiu, C, Kuo, C, Johnston, A, Bomalaski, J, Zauderer, M, Fennell, D, Rybkin, I, Rolfo, C, Mackean, M, Steele, N, Franks, K, Shaw, P, Lind, M, Upadhyay, S, John, T, Karapetis, C, Srivastav, R, Mencoboni, M, Chella, A, Zilembo, N, de Marinis, F, Stella, M, Chong, I, Wang, C, Null, N, Szlosarek, Peter W., Creelan, Benjamin C., Sarkodie, Thomas, Nolan, Luke, Taylor, Paul, Olevsky, Olga, Grosso, Federica, Cortinovis, Diego, Chitnis, Meenali, Roy, Amy, Gilligan, David, Kindler, Hedy, Papadatos-Pastos, Dionysis, Ceresoli, Giovanni L., Mansfield, Aaron S., Tsao, Anne, O’Byrne, Kenneth J., Nowak, Anna K., Steele, Jeremy, Sheaff, Michael, Shiu, Chiung-Fang, Kuo, Chih-Ling, Johnston, Amanda, Bomalaski, John, Zauderer, Marjorie G., Fennell, Dean A., Rybkin, Igor I., Rolfo, Christian D., MacKean, Melanie, Steele, Nicola, Franks, Kevin, Shaw, Paul, Lind, Michael J., Upadhyay, Sunil, John, Thomas, Karapetis, Christos, Srivastav, Ratnesh, Mencoboni, Manlio, Chella, Antonio, Zilembo, Nicoletta, de Marinis, Filippo, Stella, Maria Giulia, Chong, Inn-Wen, Wang, Chin-Chou, and null, null

Abstract

IMPORTANCE Arginine deprivation using ADI-PEG20 (pegargiminase) combined with chemotherapy is untested in a randomized study among patients with cancer. ATOMIC-Meso (ADI-PEG20 Targeting of Malignancies Induces Cytotoxicity-Mesothelioma) is a pivotal trial comparing standard first-line chemotherapy plus pegargiminase or placebo in patients with nonepithelioid pleural mesothelioma. OBJECTIVE To determine the effect of pegargiminase-based chemotherapy on survival in nonepithelioid pleural mesothelioma, an arginine-auxotrophic tumor. DESIGN, SETTING, AND PARTICIPANTS Thiswas a phase 2-3, double-blind randomized clinical trial conducted at 43 centers in 5 countries that included patients with chemotherapy-naive nonepithelioid pleural mesothelioma from August 1, 2017, to August 15, 2021, with at least 12 months' follow-up. Final follow-up was on August 15, 2022. Data analysis was performed from March 2018 to June 2023. INTERVENTION Patients were randomly assigned (1:1) to receive weekly intramuscular pegargiminase (36.8mg/m2) or placebo. All patients received intravenous pemetrexed (500mg/m2) and platinum (75-mg/m2 cisplatin or carboplatin area under the curve 5) chemotherapy every 3 weeks up to 6 cycles. Pegargiminase or placebo was continued until progression, toxicity, or 24 months. MAIN OUTCOMES AND MEASURES The primary end pointwas overall survival, and secondary end points were progression-free survival and safety. Response rate by blinded independent central review was assessed in the phase 2 portion only. RESULTS Among 249 randomized patients (mean [SD] age, 69.5 [7.9] years; 43 female individuals [17.3%] and 206 male individuals [82.7%]), all were included in the analysis. The median overall survival was 9.3 months (95%CI, 7.9-11.8 months) with pegargiminase-chemotherapy as compared with 7.7 months (95%CI, 6.1-9.5 months) with placebo-chemotherapy (hazard ratio [HR] for death, 0.71; 95%CI, 0.55-0.93; P = .02). The median progression-free survival was 6.2 months (

Published
2024

9. Niraparib efficacy in patients with unresectable mesothelioma: a randomised phase II trial of niraparib versus active symptom control in patients with previously treated mesothelioma: NERO (TRIALS IN PROGRESS)

Author

Fennell, Dean, primary, Griffiths, Daniel, additional, Eminton, Zina, additional, Morgan-Fox, Abigail, additional, Hill, Kayleigh, additional, Nearchou, Theodora, additional, Johnson, Lucy, additional, Harding, Stephanie, additional, Poile, Charlotte, additional, Bzura, Aleksandra, additional, Spicer, Jake, additional, Nye, Mavis, additional, Cave, Judith, additional, Danson, Sarah, additional, Toy, Elizabeth, additional, Jain, Pooja, additional, Steele, Nicola, additional, Shaw, Paul, additional, Taylor, Paul, additional, Szlosarek, Peter, additional, Papadatos-Pastos, Dionysis, additional, Lind, Michael, additional, Dulloo, Sean, additional, Saman, Harman, additional, Bajaj, Amrita, additional, Luo, Jin-Li, additional, Darlison, Liz, additional, and Griffiths, Gareth, additional

Published
2023
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10. Pembrolizumab for advanced non-small cell lung cancer (NSCLC): Impact of autoimmune comorbidity and outcomes following treatment completion.

Author

Ansel, Sonam, Rulach, Robert, Trotter, Nicola, and Steele, Nicola

Subjects
AUTOIMMUNE disease treatment, THERAPEUTIC use of antineoplastic agents, LUNG cancer, IMMUNE checkpoint inhibitors, CONFIDENCE intervals, PROGRAMMED death-ligand 1, UNCERTAINTY, METASTASIS, RETROSPECTIVE studies, ADRENAL insufficiency, TREATMENT effectiveness, COMPARATIVE studies, KAPLAN-Meier estimator, DESCRIPTIVE statistics, SURVIVAL analysis (Biometry), PATIENT compliance, IMMUNOTHERAPY, COMORBIDITY
Abstract

Introduction: Pembrolizumab, an immune-checkpoint inhibitor, is approved for first-line treatment of metastatic NSCLC in patients with tumours expressing programmed death-ligand 1 (PD-L1) with tumour proportion score (TPS) of ≥50%. We aimed to clarify some uncertainties regarding use of immunotherapy in patients with previous autoimmune (AI) disorders and assess real-world outcomes following treatment completion. Methods: We performed a retrospective case record review of 82 patients with tumours expressing PD-L1 at TPS ≥ 50% and receiving first-line Pembrolizumab. Survival was estimated using the Kaplan Meier method. Results: After 36.93 months (IQR: 34.37–40.20) median follow-up, median OS was 13.6 months (95% CI 8.9–19.3). There were 10 patients (12%) with AI co-morbidities and there was a trend toward improved median OS for this group versus those without AI comorbidity, 42 months (14.87-NR) versus 10.7 months (7.3–17.8), p = 0.073. Sixteen patients (20%) with nonprogressive disease at 2 years had significantly better median OS compared to those who did not complete 2 years of treatment, NR (42- NR) and 8.7 (5.8–14.1), p < 0.001. Immune related adverse events (irAE) of any grade occurred in 90% of the AI cohort compared with 70.8% of patients without AI comorbidity. Low grade adrenal insufficiency was the only irAE which occurred at a significantly higher rate in the AI group, p = 0.02. Conclusion: Patients with previous AI diseases tolerate treatment well, and there is a non-significant trend for improved outcomes in this group. Patients who complete the course of pembrolizumab have significantly better survival outcomes than those who do not. [ABSTRACT FROM AUTHOR]

Published
2023
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11. CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial

Author

Fennell, Dean A., Kirkpatrick, Emma, Cozens, Kelly, Nye, Mavis, Lester, Jason, Hanna, Gerard, Steele, Nicola, Szlosarek, Peter, Danson, Sarah, Lord, Joanne, Ottensmeier, Christian, Barnes, Daniel, Hill, Stephanie, Kalevras, Mihalis, Maishman, Tom, and Griffiths, Gareth

Published
2018
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12. Abstract 2975: RAS precision medicine transatlantic partnership: Exploration of RAS and NF1 co-mutations in NSCLC

Author

Adderley, Helen M., primary, Aldea, Mihaela, additional, Aredo, Jaqueline, additional, Carter, Mathew, additional, Church, Matthew, additional, Nicola, Pantelis, additional, Weaver, Jamie, additional, Ghaus, Aisha, additional, Vasseur, Damien, additional, Krebs, Matthew, additional, Steele, Nicola, additional, Blackhall, Fiona, additional, Wakelee, Heather, additional, Besse, Benjamin, additional, and Lindsay, Colin, additional

Published
2022
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15. Olaparib as Maintenance Treatment in Patients with Chemosensitive Small Cell Lung Cancer (STOMP): A Randomised, Double-Blind, Placebo-Controlled Phase II Trial

Author

Woll, Penella J., primary, Gaunt, Piers, additional, Danson, Sarah, additional, Steele, Nicola, additional, Ahmed, Samreen, additional, Mulatero, Clive, additional, Shah, Riyaz, additional, Bhosle, Jaishree, additional, Hodgkinson, Elizabeth, additional, Watkins, Ben, additional, and Billingham, Lucinda J., additional

Published
2022
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17. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial

Author

Fennell, Dean A, primary, Ewings, Sean, additional, Ottensmeier, Christian, additional, Califano, Raffaele, additional, Hanna, Gerard G, additional, Hill, Kayleigh, additional, Danson, Sarah, additional, Steele, Nicola, additional, Nye, Mavis, additional, Johnson, Lucy, additional, Lord, Joanne, additional, Middleton, Calley, additional, Szlosarek, Peter, additional, Chan, Sam, additional, Gaba, Aarti, additional, Darlison, Liz, additional, Wells-Jordan, Peter, additional, Richards, Cathy, additional, Poile, Charlotte, additional, Lester, Jason F, additional, Griffiths, Gareth, additional, Price, Gillian, additional, Shaw, Paul, additional, Cave, Judith, additional, Naik, Jay, additional, Ford, Amy, additional, Geldhart, Tom, additional, Dancey, Gairin, additional, Papadatos, Dionysis, additional, Polychronis, Andy, additional, Jankowska, Petra, additional, Scott, Angela, additional, Gardiner, Jill, additional, Cominos, Mathilda, additional, Campbell, Lynn, additional, MacGregor, Carol, additional, Mullholand, Lois, additional, Chitnis, Meenali, additional, and Dougherty, Gary, additional

Published
2021
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18. 193 - Niraparib efficacy in patients with unresectable mesothelioma: a randomised phase II trial of niraparib versus active symptom control in patients with previously treated mesothelioma: NERO (TRIALS IN PROGRESS)

Author

Fennell, Dean, Griffiths, Daniel, Eminton, Zina, Morgan-Fox, Abigail, Hill, Kayleigh, Nearchou, Theodora, Johnson, Lucy, Harding, Stephanie, Poile, Charlotte, Bzura, Aleksandra, Spicer, Jake, Nye, Mavis, Cave, Judith, Danson, Sarah, Toy, Elizabeth, Jain, Pooja, Steele, Nicola, Shaw, Paul, Taylor, Paul, Szlosarek, Peter, Papadatos-Pastos, Dionysis, Lind, Michael, Dulloo, Sean, Saman, Harman, Bajaj, Amrita, Luo, Jin-Li, Darlison, Liz, and Griffiths, Gareth

Published
2023
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21. Additional file 2: of CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial

Author

Fennell, Dean, Kirkpatrick, Emma, Cozens, Kelly, Nye, Mavis, Lester, Jason, Hanna, Gerard, Steele, Nicola, Szlosarek, Peter, Danson, Sarah, Joanne Lord, Ottensmeier, Christian, Barnes, Daniel, Hill, Stephanie, Mihalis Kalevras, Maishman, Tom, and Griffiths, Gareth

Abstract

Informed Consent Form. (PDF 133 kb)

Published
2018
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22. Additional file 1: of CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial

Author

Fennell, Dean, Kirkpatrick, Emma, Cozens, Kelly, Nye, Mavis, Lester, Jason, Hanna, Gerard, Steele, Nicola, Szlosarek, Peter, Danson, Sarah, Joanne Lord, Ottensmeier, Christian, Barnes, Daniel, Hill, Stephanie, Mihalis Kalevras, Maishman, Tom, and Griffiths, Gareth

Abstract

SPIRIT Checklist. (DOC 121 kb)

Published
2018
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25. Association between progression-free survival (PFS) rate (PFSR) and overall survival (OS) in LUME-Meso, a study of nintedanib (N) vs. placebo (P) in combination with first-line pemetrexed/cisplatin (PEM/CIS) in patients (pts) with malignant pleural mesothelioma (MPM).

Author

Pavlakis, Nick, primary, Grosso, Federica, additional, Steele, Nicola L., additional, Nowak, Anna K., additional, Novello, Silvia, additional, Popat, Sanjay, additional, Greillier, Laurent, additional, Reck, Martin, additional, John, Tom, additional, Taylor, Paul, additional, Leighl, Natasha B., additional, Ceresoli, Giovanni Luca, additional, Sørensen, Jens Benn, additional, Planchard, David, additional, Hughes, Brett Gordon Maxwell, additional, Mazieres, Julien, additional, Socinski, Mark A., additional, von Wangenheim, Ute, additional, Barrueco, Jose, additional, and Scagliotti, Giorgio V., additional

Published
2018
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26. CONFIRM: A phase III randomized trial to evaluate the efficacy of nivolumab versus placebo in relapsed mesothelioma.

Author

Fennell, Dean Anthony, primary, Kirkpatrick, Emma Victoria, additional, Cozens, Kelly, additional, Danson, Sarah, additional, Hanna, Gerard G., additional, Lester, Jason Francis, additional, Lord, Joanne, additional, Nye, Mavis, additional, Ottensmeier, Christian H.H, additional, Szlosarek, Peter Wojciech, additional, Steele, Nicola L., additional, Barnes, Daniel T, additional, Vadher, Karan D, additional, Maishman, Tom, additional, Hill, Stephanie J, additional, and Griffiths, Gareth, additional

Published
2018
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27. Tumor burden (TB) and treatment exposure (TE) in patients (pts) with malignant pleural mesothelioma (MPM) receiving nintedanib (N)/placebo (P) in combination with first-line pemetrexed/cisplatin (PEM/CIS) in phase II of the LUME-Meso study.

Author

Popat, Sanjay, primary, Grosso, Federica, additional, Steele, Nicola, additional, Nowak, Anna K., additional, Novello, Silvia, additional, Greillier, Laurent, additional, Reck, Martin, additional, John, Tom, additional, Taylor, Paul, additional, Leighl, Natasha B., additional, Ceresoli, Giovanni Luca, additional, Sørensen, Jens Benn, additional, Pavlakis, Nick, additional, Planchard, David, additional, Hughes, Brett Gordon Maxwell, additional, Mazieres, Julien, additional, Socinski, Mark A., additional, Buchner, Hannes, additional, Barrueco, Jose, additional, and Scagliotti, Giorgio V., additional

Published
2018
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28. Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial

Author

Grosso, Federica, primary, Steele, Nicola, additional, Novello, Silvia, additional, Nowak, Anna K., additional, Popat, Sanjay, additional, Greillier, Laurent, additional, John, Thomas, additional, Leighl, Natasha B., additional, Reck, Martin, additional, Taylor, Paul, additional, Planchard, David, additional, Sørensen, Jens Benn, additional, Socinski, Mark A., additional, von Wangenheim, Ute, additional, Loembé, Arsène Bienvenu, additional, Barrueco, José, additional, Morsli, Nassim, additional, and Scagliotti, Giorgio, additional

Published
2017
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29. Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma:Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial

Author

Grosso, Federica, Steele, Nicola, Novello, Silvia, Nowak, Anna K, Popat, Sanjay, Greillier, Laurent, John, Thomas, Leighl, Natasha B, Reck, Martin, Taylor, Paul, Planchard, David, Sørensen, Jens Benn, Socinski, Mark A, von Wangenheim, Ute, Loembé, Arsène Bienvenu, Barrueco, José, Morsli, Nassim, Scagliotti, Giorgio, Grosso, Federica, Steele, Nicola, Novello, Silvia, Nowak, Anna K, Popat, Sanjay, Greillier, Laurent, John, Thomas, Leighl, Natasha B, Reck, Martin, Taylor, Paul, Planchard, David, Sørensen, Jens Benn, Socinski, Mark A, von Wangenheim, Ute, Loembé, Arsène Bienvenu, Barrueco, José, Morsli, Nassim, and Scagliotti, Giorgio

Abstract

Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to assess efficacy and safety of nintedanib plus chemotherapy as first-line treatment of malignant pleural mesothelioma (MPM). Phase II results are reported here. Patients and Methods Chemotherapy-naïve patients with unresectable, nonsarcomatoid MPM (Eastern Cooperative Oncology Group performance status 0 to 1), stratified by histology (epithelioid or biphasic), were randomly assigned in a 1:1 ratio to up to six cycles of pemetrexed and cisplatin plus nintedanib (200 mg twice daily) or placebo followed by nintedanib plus placebo monotherapy until progression. The primary end point was progression-free survival (PFS). Results Eighty-seven patients were randomly assigned. The median number of pemetrexed and cisplatin cycles was six; the median treatment duration for nintedanib was 7.8 months and 5.3 months for placebo. Primary PFS favored nintedanib (hazard ratio [HR], 0.56; 95% CI, 0.34 to 0.91; P = .017), which was confirmed in updated PFS analyses (HR, 0.54; 95% CI, 0.33 to 0.87; P = .010). A trend toward improved overall survival also favored nintedanib (HR, 0.77; 95% CI, 0.46 to 1.29; P = .319). Benefit was evident in epithelioid histology, with a median overall survival gain of 5.4 months (HR, 0.70; 95% CI, 0.40 to 1.21; P = .197; median [nintedanib v placebo], 20.6 months v 15.2 months) and median PFS gain of 4.0 months (HR, 0.49; 95% CI, 0.30 to 0.82; P = .006; median [nintedanib v placebo], 9.7 v 5.7 months). Neutropenia was the most frequent grade ≥ 3 adverse event (AE; nintedanib 43.2% v placebo 12.2%); rates of febrile neutropenia were low (4.5% in nintedanib group v 0% in placebo group). AEs leading to discontinuation were reported in 6.8% of those receiving nintedanib versus 17.1% of those in the placebo group. Conclusion Addition of nintedanib to pemetrexed plus cisplatin resulted in PFS improvement. AEs were manageable. The clinical benefit was evident in patients with epith

Published
2017

31. SELECT-3: a phase I study of selumetinib in combination with platinum-doublet chemotherapy for advanced NSCLC in the first-line setting

Author

Greystoke, Alastair, primary, Steele, Nicola, additional, Arkenau, Hendrik-Tobias, additional, Blackhall, Fiona, additional, Md Haris, Noor, additional, Lindsay, Colin R, additional, Califano, Raffaele, additional, Voskoboynik, Mark, additional, Summers, Yvonne, additional, So, Karen, additional, Ghiorghiu, Dana, additional, Dymond, Angela W, additional, Hossack, Stuart, additional, Plummer, Ruth, additional, and Dean, Emma, additional

Published
2017
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32. TAX-TORC: A phase I trial of vistusertib (AZD2014) in combination with weekly paclitaxel with integrated pharmacodynamic (PD) and molecular characterization (MC) studies.

Author

Sundar, Raghav, primary, Basu, Bristi, additional, Wilson, Richard H., additional, Spicer, James F., additional, Jones, Robert Hugh, additional, Krebs, Matthew, additional, Brada, Michael, additional, Talbot, Denis Charles, additional, Steele, Nicola, additional, Hall, Emma, additional, Tovey, Holly, additional, Carreira, Suzanne, additional, de Oliveira, Flavia M, additional, Swales, Karen E, additional, Balarajah, Geetha, additional, Dawes, Joanna C, additional, Parmar, Mona, additional, De Bono, Johann S., additional, and Banerji, Udai, additional

Published
2017
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33. Mature overall survival (OS) results from the LUME-Meso study of nintedanib (N) + pemetrexed/cisplatin (PEM/CIS) vs placebo (P) + PEM/CIS in chemo-naïve patients (pts) with malignant pleural mesothelioma (MPM).

Author

Nowak, Anna K., primary, Grosso, Federica, additional, Steele, Nicola, additional, Novello, Silvia, additional, Popat, Sanjay, additional, Greillier, Laurent, additional, John, Tom, additional, Leighl, Natasha B., additional, Reck, Martin, additional, Pavlakis, Nick, additional, Soerensen, Jens Benn, additional, Planchard, David, additional, Ceresoli, Giovanni Luca, additional, Hughes, Brett Gordon Maxwell, additional, Mazieres, Julien, additional, Socinski, Mark A., additional, Velema, Derek, additional, von Wangenheim, Ute, additional, Morsli, Nassim, additional, and Scagliotti, Giorgio V., additional

Published
2017
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34. OA22.02 Nintedanib plus Pemetrexed/Cisplatin in Patients with MPM: Phase II Findings from the Placebo-Controlled LUME-Meso Trial

Author

Grosso, Federica, primary, Steele, Nicola, additional, Novello, Silvia, additional, Nowak, Anna, additional, Popat, Sanjay, additional, Greillier, Laurent, additional, John, Thomas, additional, Leighl, Natasha, additional, Reck, Martin, additional, Taylor, Paul, additional, Pavlakis, Nick, additional, Sørensen, Jens Benn, additional, Planchard, David, additional, Ceresoli, Giovanni, additional, Hughes, Brett, additional, Mazieres, Julien, additional, Socinski, Mark, additional, Mueller, Martha, additional, Von Wangenheim, Ute, additional, Loembe, Arsene Bienvenu, additional, Morsli, Nassim, additional, Barrueco, Jose, additional, and Scagliotti, Giorgio, additional

Published
2017
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35. P3.02c-003 TAX-TORC: The Novel Combination of Weekly Paclitaxel and the Dual mTORC1/2 Inhibitor AZD2014 for the Treatment of Squamous NSCLC

Author

Krebs, Matthew, primary, Spicer, James, additional, Steele, Nicola, additional, Talbot, Denis, additional, Brada, Michael, additional, Wilson, Richard, additional, Jones, Robert, additional, Basu, Bristi, additional, Dawes, Joanna, additional, Parmar, Mona, additional, Purchase, Beth, additional, Turner, Alison, additional, Hall, Emma, additional, Tovey, Holly, additional, Banerji, Udai, additional, and Yap, Timothy, additional

Published
2017
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36. P1.07-015 STOMP: A UK National Cancer Research Network Randomised, Double Blind, Multicentre Phase II Trial of Olaparib as Maintenance Therapy in SCLC

Author

Woll, Penella, primary, Gaunt, Piers, additional, Steele, Nicola, additional, Ahmed, Samreen, additional, Mulatero, Clive, additional, Shah, Riyaz, additional, Danson, Sarah, additional, Hodgkinson, Elizabeth, additional, James, Karen, additional, Watkins, Ben, additional, Fletcher, Peter, additional, and Billingham, Lucinda, additional

Published
2017
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38. Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: An expert consensus

Author

Cappuzzo, Federico, Moro-Sibilot, Denis, Gautschi, Oliver, Boleti, Ekaterini, Felip, Enriqueta, Groen, Harry J. M., Germonpre, Paul, Meldgaard, Peter, Arriola, Edurne, Steele, Nicola, Fox, Jesme, Schnell, Patrick, Engelsberg, Arne, Wolf, Juergen, Cappuzzo, Federico, Moro-Sibilot, Denis, Gautschi, Oliver, Boleti, Ekaterini, Felip, Enriqueta, Groen, Harry J. M., Germonpre, Paul, Meldgaard, Peter, Arriola, Edurne, Steele, Nicola, Fox, Jesme, Schnell, Patrick, Engelsberg, Arne, and Wolf, Juergen

Abstract

Within 4 years of the discovery of anaplastic lymphoma kinase (ALK) rearrangements in non-small cell lung cancer (NSCLC), the ALK inhibitor crizotinib gained US and European approval for the treatment of advanced ALK-positive NSCLC. This was due to the striking response data observed with crizotinib in phase I and II trials in patients with ALIC-positive NSCLC, as well as the favorable tolerability and safety profile observed. Recently published phase III data established crizotinib as a new standard of care for this NSCLC molecular subset. A consequence of such rapid approval, however, is the limited clinical experience and relative paucity of information concerning optimal therapy management. In this review, we discuss the development of crizotinib and the clinical relevance of its safety profile, examining crizotinib-associated adverse events in detail and making specific management recommendations. Crizotinib-associated adverse events were mostly mild to moderate in severity in clinical studies, and appropriate monitoring and supportive therapies are considered effective in avoiding the need for dose interruption or reduction in most cases. Therapy management of patients following disease progression on crizotinib is also discussed. Based on available clinical data, it is evident that patients may have prolonged benefit from crizotinib after Response Evaluation Criteria in Solid Tumors-defined disease progression, and crizotinib should be continued for as long as the patient derives benefit. (C) 2014 The Authors. Published by Elsevier Ireland Ltd.

Published
2015

40. Efficacy, cellular and molecular determinants of PD-1 checkpoint inhibition in relapsed mesothelioma.

Author

Fennell, Dean Anthony, Ewings, Sean, Hill, Kayleigh, Poile, Charlotte, Baitei, Essa, Zhou, Zisen, Harber, James, Kamata, Tamihiro, Yang, Hongji, Dzialo, Joanna, Faulkner, Daniel, Ottensmeier, Christian H.H, Danson, Sarah, Steele, Nicola, Mallard, Kim, Wells-Jordan, Peter, Richards, Catherine Jane, Zhang, Min, Lester, Jason, and Griffiths, Gareth Owen

Published
2023
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41. Management of crizotinib therapy for ALK-rearranged non-small cell lung carcinoma: An expert consensus

Author

Cappuzzo, Federico, primary, Moro-Sibilot, Denis, additional, Gautschi, Oliver, additional, Boleti, Ekaterini, additional, Felip, Enriqueta, additional, Groen, Harry J.M., additional, Germonpré, Paul, additional, Meldgaard, Peter, additional, Arriola, Edurne, additional, Steele, Nicola, additional, Fox, Jesme, additional, Schnell, Patrick, additional, Engelsberg, Arne, additional, and Wolf, Jürgen, additional

Published
2015
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44. A Phase 1 Pharmacokinetic and Pharmacodynamic Study of the Histone Deacetylase Inhibitor Belinostat in Patients with Advanced Solid Tumors

Author

Steele, Nicola L., primary, Plumb, Jane A., additional, Vidal, Laura, additional, Tjørnelund, Jette, additional, Knoblauch, Poul, additional, Rasmussen, Annie, additional, Ooi, Chean Eng, additional, Buhl-Jensen, Peter, additional, Brown, Robert, additional, Evans, T.R. Jeffry, additional, and DeBono, Johann S., additional

Published
2008
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45. Are patients in clinical trials representative of the general population? Dose intensity and toxicities associated with FE100C-D chemotherapy in a non-trial population of node positive breast cancer patients compared with PACS-01 trial group

Author

Fraser, Judith, Steele, Nicola, Al Zaman, Aysha, and Yule, Alison

Subjects
*CLINICAL trials, *DRUG therapy, *BREAST cancer patients, *ADJUVANT treatment of cancer, *FEBRILE neutropenia, *DRUG dosage, *ANALYSIS of variance, *BREAST tumors, *CANCER chemotherapy, *COMPARATIVE studies
Abstract

Purpose: In our institution, adjuvant taxanes are currently offered to fit, node positive breast cancer patients who are either Her2 positive (any ER/PR) or triple negative (ER/PR/Her2 negative). The FE100C-D (FE100C×3→docetaxel 100mg/m2 ×3) regime, based on the PACS 01 trial [Roche H, Fumoleau P, Spielmann M, et al. Sequential Adjuvant Epirubicin-Based and Docetaxel Chemotherapy for node positive Breast Cancer Patients: The FNCLCC PACS 01 Trial. J Clin Oncol 2006;24:5664-5671] is used. We retrospectively audited our experience with FE100C-D at The Beatson West of Scotland Cancer Centre and one representative district general hospital (DGH), Falkirk and District Royal Infirmary (FDRI). Patients and methods: Over a two year period, 101 patients commenced adjuvant FE100C-D chemotherapy. Data was matched with the FE100C-D arm of the PACS 01 trial. Results: Median age was 54 years. Twenty-six patients (26%) had ⩾1 episode of febrile neutropaenia (FN), including one fatal episode. Twenty-nine percent of patients required treatment interruption ⩾1 week. Thirty percent of patients had dose reductions. Thirty percent of patients received <90% dose intensity of docetaxel. Conclusion: The FN rate was substantially higher and docetaxel dose intensity substantially lower in our unselected sample of patients than in the reference study. This ‘real-life’ data illustrates the problems of applying clinical trial data to the more generalised patient population. [Copyright &y& Elsevier]

Published
2011
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