Brain Malignancy Steering Committee clinical trials planning workshop: Report from the Targeted Therapies Working Group

被引:23
作者
Alexander, Brian M. [1 ]
Galanis, Evanthia [2 ]
Yung, W. K. Alfred [3 ]
Ballman, Karla V. [2 ]
Boyett, James M. [4 ]
Cloughesy, Timothy F. [5 ]
Degroot, John F. [3 ]
Huse, Jason T. [6 ]
Mann, Bhupinder [7 ]
Mason, Warren [8 ]
Mellinghoff, Ingo K. [6 ]
Mikkelsen, Tom [9 ]
Mischel, Paul S. [10 ]
O'Neill, Brian P. [2 ]
Prados, Michael D. [11 ]
Sarkaria, Jann N. [2 ]
Tawab-Amiri, Abdul [7 ]
Trippa, Lorenzo [1 ]
Ye, Xiaobu [12 ]
Ligon, Keith L. [1 ]
Berry, Donald A. [3 ]
Wen, Patrick Y. [1 ]
机构
[1] Dana Farber Brigham & Womens Canc Ctr, Boston, MA USA
[2] Mayo Clin, Rochester, MN USA
[3] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA
[4] St Jude Childrens Res Hosp, Memphis, TN 38105 USA
[5] Univ Calif Los Angeles, Los Angeles, CA USA
[6] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
[7] Natl Canc Inst, Bethesda, MD USA
[8] Princess Margaret Canc Ctr, Toronto, ON, Canada
[9] Henry Ford Hosp, Detroit, MI 48202 USA
[10] Univ Calif San Diego, San Diego, CA 92103 USA
[11] Univ Calif San Francisco, San Francisco, CA 94143 USA
[12] Johns Hopkins Univ, Baltimore, MD USA
关键词
adaptive randomization; biomarkers; clinical trials; glioblastoma; NEWLY-DIAGNOSED GLIOBLASTOMA; PROGRESSION-FREE SURVIVAL; INTEGRATED GENOMIC ANALYSIS; RANDOMIZED PHASE-III; I-SPY; ISOCITRATE DEHYDROGENASE; ADAPTIVE RANDOMIZATION; ADJUVANT TEMOZOLOMIDE; MUTATIONAL ANALYSIS; TUMOR SAMPLES;
D O I
10.1093/neuonc/nou154
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
Glioblastoma is the most common primary brain malignancy and is associated with poor prognosis despite aggressive local and systemic therapy, which is related to a paucity of viable treatment options in both the newly diagnosed and recurrent settings. Even so, the rapidly increasing number of targeted therapies being evaluated in oncology clinical trials offers hope for the future. Given the broad range of possibilities for future trials, the Brain Malignancy Steering Committee convened a clinical trials planning meeting that was held at the Udvar-Hazy Center in Chantilly, Virginia, on September 19 and 20, 2013. This manuscript reports the deliberations leading up to the event from the Targeted Therapies Working Group and the results of the meeting.
引用
收藏
页码:180 / 188
页数:9
相关论文
共 47 条
[1]
Progression-free survival: too much risk, not enough reward? [J].
Alexander, Brian M. ;
Trippa, Lorenzo .
NEURO-ONCOLOGY, 2014, 16 (05) :615-616
[2]
Biomarker-based adaptive trials for patients With glioblastoma-lessons from I-SPY 2 [J].
Alexander, Brian M. ;
Wen, Patrick Y. ;
Trippa, Lorenzo ;
Reardon, David A. ;
Yung, Wai-Kwan Alfred ;
Parmigiani, Giovanni ;
Berry, Donald A. .
NEURO-ONCOLOGY, 2013, 15 (08) :972-978
[3]
Alexander BM, 2011, EXPERT REV NEUROTHER, V11, P1399, DOI [10.1586/ERN.11.134, 10.1586/ern.11.134]
[4]
[Anonymous], 2008, NATURE, V455, P1061
[5]
The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme [J].
Ballman, Karla V. ;
Buckner, Jan C. ;
Brown, Paul D. ;
Giannini, Caterina ;
Flynn, Patrick J. ;
LaPlant, Betsy R. ;
Jaeckle, Kurt A. .
NEURO-ONCOLOGY, 2007, 9 (01) :29-38
[6]
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
[7]
Adaptive clinical trials in oncology [J].
Berry, Donald A. .
NATURE REVIEWS CLINICAL ONCOLOGY, 2012, 9 (04) :199-207
[8]
Adaptive Clinical Trials: The Promise and the Caution [J].
Berry, Donald A. .
JOURNAL OF CLINICAL ONCOLOGY, 2011, 29 (06) :606-609
[9]
MGMT promoter methylation status can predict the incidence and outcome of pseudoprogression after concomitant radiochemotherapy in newly diagnosed glioblastoma patients [J].
Brandes, Alba A. ;
Franceschi, Enrico ;
Tosoni, Alicia ;
Blatt, Valeria ;
Pession, Annalisa ;
Tallini, Giovanni ;
Bertorelle, Roberta ;
Bartolini, Stefania ;
Calbucci, Fabio ;
Andreoli, Alvaro ;
Frezza, Giampiero ;
Leonardi, Marco ;
Spagnolli, Federica ;
Ermani, Mario .
JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (13) :2192-2197
[10]
The Somatic Genomic Landscape of Glioblastoma [J].
Brennan, Cameron W. ;
Verhaak, Roel G. W. ;
McKenna, Aaron ;
Campos, Benito ;
Noushmehr, Houtan ;
Salama, Sofie R. ;
Zheng, Siyuan ;
Chakravarty, Debyani ;
Sanborn, J. Zachary ;
Berman, Samuel H. ;
Beroukhim, Rameen ;
Bernard, Brady ;
Wu, Chang-Jiun ;
Genovese, Giannicola ;
Shmulevich, Ilya ;
Barnholtz-Sloan, Jill ;
Zou, Lihua ;
Vegesna, Rahulsimham ;
Shukla, Sachet A. ;
Ciriello, Giovanni ;
Yung, W. K. ;
Zhang, Wei ;
Sougnez, Carrie ;
Mikkelsen, Tom ;
Aldape, Kenneth ;
Bigner, Darell D. ;
Van Meir, Erwin G. ;
Prados, Michael ;
Sloan, Andrew ;
Black, Keith L. ;
Eschbacher, Jennifer ;
Finocchiaro, Gaetano ;
Friedman, William ;
Andrews, David W. ;
Guha, Abhijit ;
Iacocca, Mary ;
O'Neill, Brian P. ;
Foltz, Greg ;
Myers, Jerome ;
Weisenberger, Daniel J. ;
Penny, Robert ;
Kucherlapati, Raju ;
Perou, Charles M. ;
Hayes, D. Neil ;
Gibbs, Richard ;
Marra, Marco ;
Mills, Gordon B. ;
Lander, Eric ;
Spellman, Paul ;
Wilson, Richard .
CELL, 2013, 155 (02) :462-477