Expanded access programmes: patient interests versus clinical trial integrity

被引:10
作者
Lorigan, Paul [1 ]
Ascierto, Paolo A. [2 ]
Dummer, Reinhard [3 ]
Eggermont, Alexander M.
Flaherty, Keith T. [4 ]
Garbe, Claus [5 ]
Gogas, Helen [6 ]
Hauschild, Axel [7 ]
Kefford, Richard F. [8 ,9 ,10 ]
Kirkwood, John M. [12 ]
Larkin, James [13 ]
Long, Georgina V. [8 ,9 ]
Maio, Michele [11 ]
McArthur, Grant A. [14 ,15 ]
Ribas, Antoni [16 ]
Robert, Caroline [17 ]
Schadendorf, Dirk
Sondak, Vernon K. [18 ]
Wolchok, Jedd D. [19 ]
Hudson, Andrew M. [1 ]
机构
[1] Univ Manchester, Christie NHS Fdn Trust, Manchester, Lancs, England
[2] Fdn Pascale, Ist Nazl Tumori, Naples, Italy
[3] Univ Zurich, Zurich, Switzerland
[4] Massachusetts Gen Hosp, Boston, MA 02114 USA
[5] Univ Med Ctr Tubingen, Tubingen, Germany
[6] Univ Athens, Dept Med, Athens, Greece
[7] Univ Hosp Schleswig Holstein, Kiel, Germany
[8] Melanoma Inst Australia, Sydney, NSW, Australia
[9] Univ Sydney, Sydney, NSW 2006, Australia
[10] Macquarie Univ, Sydney, NSW 2109, Australia
[11] Univ Hosp Siena, Siena, Italy
[12] Univ Pittsburgh, Melanoma Program, Inst Canc, Pittsburgh, PA USA
[13] Royal Marsden Hosp NHS Fdn Trust, London, England
[14] Peter MacCallum Canc Ctr, East Melbourne, Vic, Australia
[15] Univ Melbourne, Parkville, Vic 3052, Australia
[16] Univ Calif Los Angeles, Los Angeles, CA USA
[17] INSERM U981, Villejuif, France
[18] Univ S Florida, H Lee Moffitt Canc Ctr, Tampa, FL 33682 USA
[19] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
关键词
ADVANCED MELANOMA; TREMELIMUMAB; IPILIMUMAB; NIVOLUMAB; SURVIVAL;
D O I
10.1016/S1470-2045(14)71161-1
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
引用
收藏
页码:15 / 17
页数:3
相关论文
共 10 条
[1]
[Anonymous], JAMA
[2]
Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials [J].
Flaherty, Keith T. ;
Hennig, Michael ;
Lee, Sandra J. ;
Ascierto, Paolo A. ;
Dummer, Reinhard ;
Eggermont, Alexander M. M. ;
Hauschild, Axel ;
Kefford, Richard ;
Kirkwood, John M. ;
Long, Georgina V. ;
Lorigan, Paul ;
Mackensen, Andreas ;
McArthur, Grant ;
O'Day, Steven ;
Patel, Poulam M. ;
Robert, Caroline ;
Schadendorf, Dirk .
LANCET ONCOLOGY, 2014, 15 (03) :297-304
[3]
Medicines and Healthcare products Regulatory Agency, 2014, EARL ACC MED SCHEM
[4]
Is Tremelimumab Beneficial in Advanced Melanoma? Reply [J].
Ribas, Antoni ;
Hauschild, Axel ;
Kefford, Richard .
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (22) :2836-2837
[5]
Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma [J].
Ribas, Antoni ;
Kefford, Richard ;
Marshall, Margaret A. ;
Punt, Cornelis J. A. ;
Haanen, John B. ;
Marmol, Maribel ;
Garbe, Claus ;
Gogas, Helen ;
Schachter, Jacob ;
Linette, Gerald ;
Lorigan, Paul ;
Kendra, Kari L. ;
Maio, Michele ;
Trefzer, Uwe ;
Smylie, Michael ;
McArthur, Grant A. ;
Dreno, Brigitte ;
Nathan, Paul D. ;
Mackiewicz, Jacek ;
Kirkwood, John M. ;
Gomez-Navarro, Jesus ;
Huang, Bo ;
Pavlov, Dmitri ;
Hauschild, Axel .
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (05) :616-622
[6]
Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial [J].
Robert, Caroline ;
Ribas, Antoni ;
Wolchok, Jedd D. ;
Hodi, F. Stephen ;
Hamid, Omid ;
Kefford, Richard ;
Weber, Jeffrey S. ;
Joshua, Anthony M. ;
Hwu, Wen-Jen ;
Gangadhar, Tara C. ;
Patnaik, Amita ;
Dronca, Roxana ;
Zarour, Hassane ;
Joseph, Richard W. ;
Boasberg, Peter ;
Chmielowski, Bartosz ;
Mateus, Christine ;
Postow, Michael A. ;
Gergich, Kevin ;
Elassaiss-Schaap, Jeroen ;
Li, Xiaoyun Nicole ;
Iannone, Robert ;
Ebbinghaus, Scot W. ;
Kang, S. Peter ;
Daud, Adil .
LANCET, 2014, 384 (9948) :1109-1117
[7]
Survival, Durable Tumor Remission, and Long-Term Safety in Patients With Advanced Melanoma Receiving Nivolumab [J].
Topalian, Suzanne L. ;
Sznol, Mario ;
McDermott, David F. ;
Kluger, Harriet M. ;
Carvajal, Richard D. ;
Sharfman, William H. ;
Brahmer, Julie R. ;
Lawrence, Donald P. ;
Atkins, Michael B. ;
Powderly, John D. ;
Leming, Philip D. ;
Lipson, Evan J. ;
Puzanov, Igor ;
Smith, David C. ;
Taube, Janis M. ;
Wigginton, Jon M. ;
Kollia, Georgia D. ;
Gupta, Ashok ;
Pardoll, Drew M. ;
Sosman, Jeffrey A. ;
Hodi, F. Stephen .
JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (10) :1020-+
[8]
US Food and Drug Administration, 2014, FIN RUL EXP ACC INV
[9]
Nivolumab plus Ipilimumab in Advanced Melanoma [J].
Wolchok, Jedd D. ;
Kluger, Harriet ;
Callahan, Margaret K. ;
Postow, Michael A. ;
Rizvi, Naiyer A. ;
Lesokhin, Alexander M. ;
Segal, Neil H. ;
Ariyan, Charlotte E. ;
Gordon, Ruth-Ann ;
Reed, Kathleen ;
Burke, Matthew M. ;
Caldwell, Anne ;
Kronenberg, Stephanie A. ;
Agunwamba, Blessing U. ;
Zhang, Xiaoling ;
Lowy, Israel ;
Inzunza, Hector David ;
Feely, William ;
Horak, Christine E. ;
Hong, Quan ;
Korman, Alan J. ;
Wigginton, Jon M. ;
Gupta, Ashok ;
Sznol, Mario .
NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (02) :122-133
[10]
Guidelines for the Evaluation of Immune Therapy Activity in Solid Tumors: Immune-Related Response Criteria [J].
Wolchok, Jedd D. ;
Hoos, Axel ;
O'Day, Steven ;
Weber, Jeffrey S. ;
Hamid, Omid ;
Lebbe, Celeste ;
Maio, Michele ;
Binder, Michael ;
Bohnsack, Oliver ;
Nichol, Geoffrey ;
Humphrey, Rachel ;
Hodi, F. Stephen .
CLINICAL CANCER RESEARCH, 2009, 15 (23) :7412-7420