Can molecular biomarker-based patient selection in Phase I trials accelerate anticancer drug development?

被引:53
作者
Carden, Craig P. [1 ,2 ]
Sarker, Debashis [1 ]
Postel-Vinay, Sophie [1 ]
Yap, Timothy A. [1 ,3 ]
Attard, Gerthardt [1 ,2 ]
Banerji, Udai [1 ,2 ]
Garrett, Michelle D. [3 ]
Thomas, George V. [2 ]
Workman, Paul [3 ]
Kaye, Stan B. [1 ,2 ]
de Bono, Johann S. [1 ,2 ]
机构
[1] Royal Marsden Hosp, Drug Dev Unit, Sutton SM2 5PT, Surrey, England
[2] Inst Canc Res, Med Sect, Sutton SM2 5NG, Surrey, England
[3] Inst Canc Res, Haddow Labs, Canc Res UK Ctr Canc Therapeut, Sutton SM2 5NG, Surrey, England
关键词
CIRCULATING TUMOR-CELLS; GENE-EXPRESSION SIGNATURE; BREAST-CANCER; LUNG-CANCER; CLINICAL-TRIALS; ABIRATERONE ACETATE; MONOCLONAL-ANTIBODY; THERAPEUTIC TARGET; TYROSINE KINASE; ONCOLOGY TRIALS;
D O I
10.1016/j.drudis.2009.11.006
中图分类号
R9 [药学];
学科分类号
100702 [药剂学];
摘要
Anticancer drug development remains slow, costly and inefficient. One way of addressing this might be the use of predictive biomarkers to select patients for Phase I/II trials. Such biomarkers, which predict response to molecular-targeted agents, have the potential to enrich these trials with patients more likely to benefit. Doing so could maximize the efficiency of anticancer drug development by facilitating earlier clinical qualification of predictive biomarkers and generating valuable information on cancer biology. In this review, we suggest a new model of early clinical trial design, which incorporates patient selection through predictive molecular biomarkers for selected targeted agents.
引用
收藏
页码:88 / 97
页数:10
相关论文
共 105 条
[1]
Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer [J].
Amado, Rafael G. ;
Wolf, Michael ;
Peeters, Marc ;
Van Cutsem, Eric ;
Siena, Salvatore ;
Freeman, Daniel J. ;
Juan, Todd ;
Sikorski, Robert ;
Suggs, Sid ;
Radinsky, Robert ;
Patterson, Scott D. ;
Chang, David D. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (10) :1626-1634
[2]
Clinical outcome and prognostic factors for patients treated within the context of a phase I study: the Royal Marsden Hospital experience [J].
Arkenau, H-T ;
Olmos, D. ;
Ang, J. E. ;
de Bono, J. ;
Judson, I. ;
Kaye, S. .
BRITISH JOURNAL OF CANCER, 2008, 98 (06) :1029-1033
[3]
Duplication of the fusion of TMPRSS2 to ERG sequences identifies fatal human prostate cancer [J].
Attard, G. ;
Clark, J. ;
Ambroisine, L. ;
Fisher, G. ;
Kovacs, G. ;
Flohr, P. ;
Berney, D. ;
Foster, C. S. ;
Fletcher, A. ;
Gerald, W. L. ;
Moller, H. ;
Reuter, V. ;
De Bono, J. S. ;
Scardino, P. ;
Cuzick, J. ;
Cooper, C. S. .
ONCOGENE, 2008, 27 (03) :253-263
[4]
Phase I clinical trial of a selective inhibitor of CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer commonly remains hormone driven [J].
Attard, Gerhardt ;
Reid, Alison H. M. ;
Yap, Timothy A. ;
Raynaud, Florence ;
Dowsett, Mitch ;
Settatree, Sarah ;
Barrett, Mary ;
Parker, Christopher ;
Martins, Vanessa ;
Folkerd, Elizabeth ;
Clark, Jeremy ;
Cooper, Colin S. ;
Kaye, Stan B. ;
Dearnaley, David ;
Lee, Gloria ;
de Bono, Johann S. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (28) :4563-4571
[5]
Selective Inhibition of CYP17 With Abiraterone Acetate Is Highly Active in the Treatment of Castration-Resistant Prostate Cancer [J].
Attard, Gerhardt ;
Reid, Alison H. M. ;
A'Hern, Roger ;
Parker, Christopher ;
Oommen, Nikhil Babu ;
Folkerd, Elizabeth ;
Messiou, Christina ;
Molife, L. Rhoda ;
Maier, Gal ;
Thompson, Emilda ;
Olmos, David ;
Sinha, Rajesh ;
Lee, Gloria ;
Dowsett, Mitch ;
Kaye, Stan B. ;
Dearnaley, David ;
Kheoh, Thian ;
Molina, Arturo ;
de Bono, Johann S. .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (23) :3742-3748
[6]
Characterization of ERG, AR and PTEN Gene Status in Circulating Tumor Cells from Patients with Castration-Resistant Prostate Cancer [J].
Attard, Gerhardt ;
Swermenhuis, Joost F. ;
Olmos, David ;
Reid, Alison H. M. ;
Vickers, Elaine ;
A'Hern, Roger ;
Levink, Rianne ;
Coumans, Frank ;
Moreira, Joana ;
Riisnaes, Ruth ;
Oommen, Nikhil Babu ;
Hawche, George ;
Jameson, Charles ;
Thompson, Emilda ;
Sipkema, Ronald ;
Carden, Craig P. ;
Parker, Christopher ;
Dearnaley, David ;
Kaye, Stan B. ;
Cooper, Colin S. ;
Molina, Arturo ;
Cox, Michael E. ;
Terstappen, Leon W. M. M. ;
de Bono, Johann S. .
CANCER RESEARCH, 2009, 69 (07) :2912-2918
[7]
KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: The OPUS experience [J].
Bokemeyer, C. ;
Bondarenko, I. ;
Hartmann, J. T. ;
De Braud, F. G. ;
Volovat, C. ;
Nippgen, J. ;
Stroh, C. ;
Celik, I. ;
Koralewski, P. .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (15)
[8]
Fluorouracil, Leucovorin, and Oxaliplatin With and Without Cetuximab in the First-Line Treatment of Metastatic Colorectal Cancer [J].
Bokemeyer, Carsten ;
Bondarenko, Igor ;
Makhson, Anatoly ;
Hartmann, Joerg T. ;
Aparicio, Jorge ;
de Braud, Filippo ;
Donea, Serban ;
Ludwig, Heinz ;
Schuch, Gunter ;
Stroh, Christopher ;
Loos, Anja H. ;
Zubel, Angela ;
Koralewski, Piotr .
JOURNAL OF CLINICAL ONCOLOGY, 2009, 27 (05) :663-671
[9]
Proteomic analysis of breast cancer molecular subtypes and biomarkers of response to targeted kinase inhibitors using reverse-phase protein microarrays [J].
Boyd, Zachary S. ;
Wu, Qun Jenny ;
O'Brien, Carol ;
Spoerke, Jill ;
Savage, Heidi ;
Fielder, Paul J. ;
Arnler, Lukas ;
Yan, Yibing ;
Lackner, Mark R. .
MOLECULAR CANCER THERAPEUTICS, 2008, 7 (12) :3695-3706
[10]
*CANC RES UK, 2009, PROGN PRED BIOM BM R