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54. Angiokines associated with outcomes after sunitinib or everolimus treatment in patients with non-clear cell renal cell carcinoma

Author

Armstrong, Andrew J., Nixon, Andrew B., Carmack, Andrea, Eisen, Tim, Stadler, Walter M., Jones, Robert J., Garcia, Jorge A., Vaishampayan, Ulka N., Picus, Joel, Hawkins, Robert E., Hainsworth, John D., Kollmannsberger, Christian K., Logan, Theodore F., Puzanov, Igor, Pickering, Lisa M., Ryan, Christopher W., Protheroe, Andrew, George, Daniel J., and Halabi, Susan

Subjects
urologic and male genital diseases
Abstract

Purpose: Biomarkers are needed in patients with non-clear cell renal cell carcinomas (NC-RCC) to inform treatment selection but also to identify novel therapeutic targets. We thus sought to profile circulating angiokines in the context of a randomized treatment trial of everolimus versus sunitinib. \ud \ud Experimental Design: ASPEN (NCT01108445) was an international, randomized, open-label phase 2 trial of patients with metastatic papillary, chromophobe, or unclassified NC-RCC with no prior systemic therapy. Patients were randomized to everolimus or sunitinib and treated until disease progression or unacceptable toxicity. The primary endpoint was radiographic progression-free survival (PFS) defined by RECIST 1.1 criteria. Plasma angiokines were collected at baseline, cycle 3, and progression and associated with PFS and overall survival. \ud \ud Results: We enrolled 108 patients, 51 received sunitinib and 57 everolimus; of these, 89 patients had evaluable plasma for 23 angiokines. At the final data cutoff, 87 PFS and 62 mortality events had occurred. Angiokines that were independently adversely prognostic for OS were osteopontin (OPN), HGF, and VCAM-1, and these were also associated with poor risk disease. SDF-1 was associated with improved survival. OPN was also significantly associated with worse PFS. No statistically significant angiokine-treatment outcome interactions were observed for sunitinib or everolimus. OPN, HGF, TIMP-1, VCAM-1, PDGF-AA and IL-6 levels increased with progression on everolimus, while OPN, PlGF, TIMP-1, VEGF, and soluble VEGFR-2 and VCAM-1 increased with progression on sunitinib. \ud \ud Conclusions: In patients with metastatic non-clear cell RCC, we identified several poor prognosis angiokines and immunomodulatory chemokines during treatment with sunitinib or everolimus, particularly OPN.

Published
2021

57. mTOR and VEGF Tissue Biomarkers and Sunitinib/Everolimus Outcomes in Non-Clear Cell Renal Cancer

Author

Halabi, Susan, primary, Yang, Qian, additional, Carmack, Andrea, additional, Zhang, Shiqi, additional, Foo, Wen-Chi, additional, Eisen, Tim, additional, Stadler, Walter, additional, Jones, Robert J., additional, Garcia, Jorge, additional, Vaishampayan, Ulka, additional, Picus, Joel, additional, Hawkins, Robert, additional, Hainsworth, John, additional, Kollmannsberger, Christian, additional, Logan, Theodore, additional, Puzanov, Igor, additional, Pickering, Lisa, additional, Ryan, Christopher, additional, Protheroe, Andrew, additional, George, Daniel, additional, and Armstrong, Andrew, additional

Published
2021
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58. RAMPART: A phase III multi-arm multi-stage trial of adjuvant checkpoint inhibitors in patients with resected primary renal cell carcinoma (RCC) at high or intermediate risk of relapse

Author

Oza, Bhavna, primary, Frangou, Eleni, additional, Smith, Ben, additional, Bryant, Hanna, additional, Kaplan, Rick, additional, Choodari-Oskooei, Babak, additional, Powles, Tom, additional, Stewart, Grant D., additional, Albiges, Laurence, additional, Bex, Axel, additional, Choueiri, Toni K., additional, Davis, Ian D., additional, Eisen, Tim, additional, Fielding, Alison, additional, Harrison, David, additional, McWhirter, Anita, additional, Mulhere, Salena, additional, Nathan, Paul, additional, Rini, Brian, additional, Ritchie, Alastair, additional, Scovell, Sarah, additional, Shakeshaft, Clare, additional, Stockler, Martin R., additional, Thorogood, Nat, additional, Parmar, Mahesh K.B., additional, Larkin, James, additional, and Meade, Angela, additional

Published
2021
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59. RAMPART: A model for a regulatory-ready academic-led phase III trial in the adjuvant renal cell carcinoma setting

Author

Meade, Angela, primary, Oza, Bhavna, additional, Frangou, Eleni, additional, Smith, Ben, additional, Bryant, Hanna, additional, Kaplan, Rick, additional, Choodari-Oskooei, Babak, additional, Powles, Tom, additional, Stewart, Grant D., additional, Albiges, Laurence, additional, Bex, Axel, additional, Choueiri, Toni K., additional, Davis, Ian D., additional, Eisen, Tim, additional, Fielding, Alison, additional, Harrison, David J., additional, McWhirter, Anita, additional, Mulhere, Salena, additional, Nathan, Paul, additional, Rini, Brian, additional, Ritchie, Alastair, additional, Scovell, Sarah, additional, Shakeshaft, Clare, additional, Stockler, Martin R., additional, Thorogood, Nat, additional, Larkin, James, additional, and Parmar, Mahesh K.B., additional

Published
2021
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60. Additional file 3 of The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer ��� a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Subjects
Data_FILES
Abstract

Additional file 3.

Published
2021
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61. Additional file 2 of The WIRE study a phase II, multi-arm, multi-centre, non-randomised window-of-opportunity clinical trial platform using a Bayesian adaptive design for proof-of-mechanism of novel treatment strategies in operable renal cell cancer ��� a study protocol

Author

Ursprung, Stephan, Mossop, Helen, Gallagher, Ferdia A., Sala, Evis, Skells, Richard, Sipple, Jamal A. N., Mitchell, Thomas J., Chhabra, Anita, Fife, Kate, Matakidou, Athena, Young, Gemma, Walker, Amanda, Thomas, Martin G., Ortuzar, Mireia Crispin, Sullivan, Mark, Protheroe, Andrew, Oades, Grenville, Venugopal, Balaji, Warren, Anne Y., Stone, John, Eisen, Tim, Wason, James, Welsh, Sarah J., and Stewart, Grant D.

Subjects
Data_FILES
Abstract

Additional file 2.

Published
2021
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67. Correction: Angiokines Associated with Outcomes after Sunitinib or Everolimus Treatment in Patients with Non–Clear Cell Renal Cell Carcinoma

Author

Armstrong, Andrew J., primary, Nixon, Andrew B., additional, Carmack, Andrea, additional, Yang, Qian, additional, Eisen, Tim, additional, Stadler, Walter M., additional, Jones, Robert J., additional, Garcia, Jorge A., additional, Vaishampayan, Ulka N., additional, Picus, Joel, additional, Hawkins, Robert E., additional, Hainsworth, John D., additional, Kollmannsberger, Christian K., additional, Logan, Theodore F., additional, Puzanov, Igor, additional, Pickering, Lisa M., additional, Ryan, Christopher W., additional, Protheroe, Andrew, additional, George, Daniel J., additional, and Halabi, Susan, additional

Published
2021
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68. ctDNA detection by personalised assays in early-stage NSCLC

Author

Heider, Katrin, primary, Wan, Jonathan C. M., additional, Gale, Davina, additional, Ruiz-Valdepenas, Andrea, additional, Mouliere, Florent, additional, Morris, James, additional, Qureshi, Nagmi R., additional, Qian, Wendi, additional, Knock, Helena, additional, Wulff, Jerome, additional, Howarth, Karen, additional, Green, Emma, additional, Castedo, Jenny, additional, Rundell, Viona, additional, Cooper, Wendy N., additional, Eisen, Tim, additional, Smith, Christopher G., additional, Massie, Charles, additional, Gilligan, David, additional, Harden, Susan V., additional, Rassl, Doris M., additional, Rintoul, Robert C., additional, and Rosenfeld, Nitzan, additional

Published
2021
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69. Additional file 1 of Treatment patterns and health outcomes in metastatic renal cell carcinoma patients treated with targeted systemic therapies in the UK

Author

Hawkins, Robert, Fife, Kate, Hurst, Michael, Wang, Meng, Niroshini Naicker, Nolasco, Sarah, Eisen, Tim, Matakidou, Athena, and Gordon, Jason

Abstract

Additional file 1: Supplementary Table 1. Time-to-events by LOT. Supplementary Table 2. Adverse events by LOT. Supplementary Figure 1. Treatment pathways for patients receiving systemic therapies. Supplementary Figure 2. Overall survival from 2LOT stratified by key baseline characteristics. Supplementary Figure 3. Overall survival by LOT in patients receiving interleukin-2/interferon-alpha at any LOT

Published
2020
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70. Sorafenib in advanced clear-cell renal-cell carcinoma

Author

Escudier, Bernard; Eisen, Tim; Stadler, Walter M.; Szczylik, Cezary; Oudard, Stephane; Siebels, Michael

Subjects
Carcinoma, Renal cell -- Drug therapy
Abstract

A phase 3, randomized, double-blind, placebo-controlled trial of sorafenib, a multikinase inhibitor of tumor-cell proliferation and angiogenesis in patients with advanced clear-cell renal-cell carcinoma was conducted. Results revealed that oral sorafenib therapy prolonged progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom first-line therapy had failed.

Published
2007

74. Angiokines Associated with Targeted Therapy Outcomes in Patients with Non–Clear Cell Renal Cell Carcinoma

Author

Armstrong, Andrew J., primary, Nixon, Andrew B., additional, Carmack, Andrea, additional, Yang, Qian, additional, Eisen, Tim, additional, Stadler, Walter M., additional, Jones, Robert J., additional, Garcia, Jorge A., additional, Vaishampayan, Ulka N., additional, Picus, Joel, additional, Hawkins, Robert E., additional, Hainsworth, John D., additional, Kollmannsberger, Christian K., additional, Logan, Theodore F., additional, Puzanov, Igor, additional, Pickering, Lisa M., additional, Ryan, Christopher W., additional, Protheroe, Andrew, additional, George, Daniel J., additional, and Halabi, Susan, additional

Published
2021
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77. Authorsʼ response

Author

Field, John K, Baldwin, David, Brain, Kate, Devaraj, Anand, Eisen, Tim, Duffy, Stephen W, Hansell, David M, Kerr, Keith, Page, Richard, Parmar, Mahash, Weller, David, Whynes, David, and Williamson, Paula

Published
2013
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83. Authorsʼ response

Author

Field, John, Baldwin, David, Brain, Kate, Devaraj, Anand, Eisen, Tim, Duffy, Stephen W, Hansell, David M, Kerr, Keith, Page, Richard, Parmar, Mahash, Weller, David, Whynes, David, and Williamson, Paula

Published
2012
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88. Individualised Predictions of the Survival Benefit Due to Adjuvant Therapy in a Randomised Trial of Sorafenib after Nephrectomy for Localised Renal Cell Carcinoma

Author

Lawrence, Nicola J., primary, Martin, Andrew, additional, Davis, Ian D., additional, Troon, Simon, additional, Sengupta, Shomik, additional, Hovey, Elizabeth, additional, Coskinas, Xanthi, additional, Kaplan, Richard, additional, Smith, Benjamin, additional, Ritchie, Alastair W. S., additional, Meade, Angela, additional, Goh, Jeffrey, additional, Gurney, Howard, additional, Harrison, Michelle, additional, Fife, Kate, additional, Eisen, Tim, additional, Blinman, Prunella, additional, and Stockler, Martin R., additional

Published
2020
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89. Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial

Author

Eisen, Tim, primary, Frangou, Eleni, additional, Oza, Bhavna, additional, Ritchie, Alastair W.S., additional, Smith, Benjamin, additional, Kaplan, Rick, additional, Davis, Ian D., additional, Stockler, Martin R., additional, Albiges, Laurence, additional, Escudier, Bernard, additional, Larkin, James, additional, Bex, Axel, additional, Joniau, Steven, additional, Hancock, Barry, additional, Hermann, Gregers G., additional, Bellmunt, Joaquim, additional, Hodgkinson, Elizabeth, additional, Stewart, Grant D., additional, Barber, Jim, additional, Brown, Janet, additional, McMenemin, Rhona, additional, Nathan, Paul, additional, Pickering, Lisa M., additional, Parmar, Mahesh K.B., additional, and Meade, Angela, additional

Published
2020
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90. Abstract 736: ctDNA detection in early stage non-small cell lung cancer

Author

Heider, Katrin, primary, Wan, Jonathan C., additional, Gale, Davina, additional, Ruiz-Valdepenas, Andrea, additional, Mouliere, Florent, additional, Morris, James, additional, Qureshi, Nagmi R., additional, Qian, Wendi, additional, Wulff, Jerome, additional, Demiris, Nikolaos, additional, Howarth, Karen, additional, Green, Emma, additional, Rundell, Viona, additional, Eisen, Tim, additional, Cooper, Wendy, additional, Smith, Christopher G., additional, Massie, Charles, additional, Harden, Susan, additional, Rassl, Doris M., additional, Rintoul, Robert C., additional, and Rosenfeld, Nitzan, additional

Published
2020
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100. MOESM6 of The VENUSS prognostic model to predict disease recurrence following surgery for non-metastatic papillary renal cell carcinoma: development and evaluation using the ASSURE prospective clinical trial cohort

Author

Klatte, Tobias, Gallagher, Kevin, Afferi, Luca, Volpe, Alessandro, Kroeger, Nils, Ribback, Silvia, McNeill, Alan, Riddick, Antony, Armitage, James, Tevita ‘Aho, Eisen, Tim, Fife, Kate, Bex, Axel, Pantuck, Allan, and Stewart, Grant

Abstract

Additional file 6: Figure S6. cumulative incidence of disease recurrence of patients with PRCC recruited into ASSURE according to UISS, Leibovich Score 2018 and VENUSS group.

Published
2019
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