Cancer genomics: the challenge of drug accessibility

被引:16
作者
Lewin, Jeremy [1 ]
Siu, Lillian L. [1 ]
机构
[1] Univ Toronto, Univ Hlth Network, Princess Margaret Canc Ctr, Bras Drug Dev Program,Div Med Oncol & Hematol, Toronto, ON, Canada
关键词
cancer; drug access; drug development; genomics; personalized medicine; OFF-LABEL USE; TARGETED THERAPY; BREAST-CANCER; ONCOLOGY; TRIAL; REIMBURSEMENT; ENROLLMENT; ERLOTINIB; MEDICINE;
D O I
10.1097/CCO.0000000000000185
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose of review Although significant strides have been made in genome sequencing technology, target-drug matching remains challenging. This article highlights the difficulties associated with patients accessing targeted drugs based on genomic information, and some proposed solutions. Recent findings Although cancers are increasingly stratified according to molecular subgroups, challenges remain in improving patient outcome based on drug-target matching. Before a drug-target match is even proposed, significant expertise is required of the clinician to interpret genomic information. Once a potential match is made, barriers remain for patients to access treatment via clinical trials, as approved agents on-label or off-label, or through expanded access programs. Solutions to improve drug accessibility are actively being investigated. Several prospective trials using molecular characterization as an entry to access target-drug matching are underway. For those unable to access target-drug matching on trial, proposals for a facilitated access program and registry have been suggested. Summary Although improvements have been made in the drug development and approval timelines, drug accessibility based on molecular characterization remains problematic. However, with the emergence of novel trial designs, and efforts to enhance drug access outside of clinical trial settings, opportunities for drug-target matching are improving.
引用
收藏
页码:250 / 257
页数:8
相关论文
共 45 条
[1]  
Abernethy AP, 2009, ANN INTERN MED, V150, P336, DOI 10.7326/0003-4819-150-5-200903030-00107
[3]   Prioritizing targets for precision cancer medicine [J].
Andre, F. ;
Mardis, E. ;
Salm, M. ;
Soria, J. -C. ;
Siu, L. L. ;
Swanton, C. .
ANNALS OF ONCOLOGY, 2014, 25 (12) :2295-2303
[4]   Comparative genomic hybridisation array and DNA sequencing to direct treatment of metastatic breast cancer: a multicentre, prospective trial (SAFIR01/UNICANCER) [J].
Andre, Fabrice ;
Bachelot, Thomas ;
Commo, Frederic ;
Campone, Mario ;
Arnedos, Monica ;
Dieras, Veronique ;
Lacroix-Triki, Magali ;
Lacroix, Ludovic ;
Cohen, Pascale ;
Gentien, David ;
Adelaide, Jose ;
Dalenc, Florence ;
Goncalves, Anthony ;
Levy, Christelle ;
Ferrero, Jean-Marc ;
Bonneterre, Jacques ;
Lefeuvre, Claudia ;
Jimenez, Marta ;
Filleron, Thomas ;
Bonnefoi, Herve .
LANCET ONCOLOGY, 2014, 15 (03) :267-274
[5]   I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy [J].
Barker, A. D. ;
Sigman, C. C. ;
Kelloff, G. J. ;
Hylton, N. M. ;
Berry, D. A. ;
Esserman, L. J. .
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2009, 86 (01) :97-100
[6]  
Bedard P, 2013, J CLIN ONCOL, V31, P11002, DOI [10.1200/jco.2013.31.15_suppl.11002, DOI 10.1200/JCO.2013.31.15_SUPPL.11002]
[7]   Tumour heterogeneity in the clinic [J].
Bedard, Philippe L. ;
Hansen, Aaron R. ;
Ratain, Mark J. ;
Siu, Lillian L. .
NATURE, 2013, 501 (7467) :355-364
[8]   The ethics of off-label use of drugs: oncology pharmacy in Italy [J].
Bernardi, A. ;
Pegoraro, R. .
JOURNAL OF CLINICAL PHARMACY AND THERAPEUTICS, 2008, 33 (02) :95-99
[9]   The off-label use of drugs in oncology: a position paper by the European Society for Medical Oncology (ESMO) [J].
Casali, P. G. .
ANNALS OF ONCOLOGY, 2007, 18 (12) :1923-1925
[10]   Improved Survival with Vemurafenib in Melanoma with BRAF V600E Mutation [J].
Chapman, Paul B. ;
Hauschild, Axel ;
Robert, Caroline ;
Haanen, John B. ;
Ascierto, Paolo ;
Larkin, James ;
Dummer, Reinhard ;
Garbe, Claus ;
Testori, Alessandro ;
Maio, Michele ;
Hogg, David ;
Lorigan, Paul ;
Lebbe, Celeste ;
Jouary, Thomas ;
Schadendorf, Dirk ;
Ribas, Antoni ;
O'Day, Steven J. ;
Sosman, Jeffrey A. ;
Kirkwood, John M. ;
Eggermont, Alexander M. M. ;
Dreno, Brigitte ;
Nolop, Keith ;
Li, Jiang ;
Nelson, Betty ;
Hou, Jeannie ;
Lee, Richard J. ;
Flaherty, Keith T. ;
McArthur, Grant A. .
NEW ENGLAND JOURNAL OF MEDICINE, 2011, 364 (26) :2507-2516